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3. W ith the introduction of the quadrivalent and bivalent HPV vaccines, screening guidelines for the vaccinated population may be modified in the future. At the present time the recommendation is to adhere to the current guidelines (Markowitz et al., 2014). In addition, at the end of 2014, the FDA approved the use of the 9-valent vaccine that protects against not only the four types included in the quadrivalent HPV vaccine (6, 11, 16, 18), available since 2006, but five other types known to cause HPV-associated cancers (31, 33, 45, 52, and 58). The combination of these genotypes in this vaccine is designed to protect against 90% of HPV-associated cancers as well as most external genital warts (FDA, 2014). C. Pap smear classifications The Bethesda System Pap test classification remains the preferred method for reporting cytology results in the United States (T able 20-1). This system has been used since 1988 for reporting cytologic evaluation for the cervix, vagina, and anus and has had only minor revisions since 2004, the latest being in June 2015 (Nayar & Wilbur, 2015; Solomon & Nayar, 2004). The screening for at least 20 years after diagnosis, even if that extends beyond age 65. d. W omen who have undergone a total hysterecto-my for benign conditions and have not had prior CIN 2 (moderate dysplasia) or CIN 3 (severe dysplasia or carcinoma in situ) may discontinue Pap smear screening. According to the American Cancer Society guidelines, the following conditions may increase a patient's risk for CIN and may necessitate more frequent Pap test screening. A specific interval of time is not stated for these special circumstances and should be a decision made between clinician and patient. i. W omen who have human immunodeficien-cy virus (HIV) ii. Women with other immunosuppressive conditions (e. g., organ transplantation) iii. W omen who were exposed to diethylstil-bestrol (DES) in utero iv. W omen previously treated for CIN 2, CIN 3, or cancer Table 20-1 2014 Revised Bethesda System T erminology for the Pap Test Specimen criteria c omments Type Note the type of Pap test (conventional, liquid-based or other) Adequacy (satisfactory for evaluation)Note presence or absence of endocervical transformation zone component and any other indicators, e. g., blood partially obscuring specimen, inflammation, etc. ) Inadequacy (unsatisfactory for evaluation)Specify reasons for rejection/not processing Specify reasons for a processed specimen yet is unsatisfactory for an epithelial abnormality evaluation General categorization (optional) Negative for intraepithelial lesion or malignancy Other: see Interpretation/Results (e. g., Endometrial cells are noted in a woman older than 45 years) Epithelial cell abnormality: see Interpretation/Results (stipulate “squamous” or “glandular,” if relevant) Interpretation (negative for intraepithelial lesion or malignancy and non-neoplastic findings)Negative for Intraepithelial Lesion or Malignancy: no cellular evidence of neoplasia. (Result(s) is/are noted in the General Categorization and/or in the Interpretation/ Result section of the report. ) Non-neoplastic findings (optional to report) Nonneoplastic cellular variants Atrophy Keratotic changes Pregnancy-associated Squamous metaplasia Tubal metaplasia Associated reactive cellular changes Inflammation Intrauterine devices Glandular cells changes following a hysterectomy172 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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the cells are either equivocal or nondiagnostic for either benign conditions or squamous intraepithe-lial neoplasia. 2. A typical squamous cells of undetermined significance cannot rule out high grade (ASC-H): refers to the presence of cells that are not clearly high grade but it cannot be ruled out. report encompasses the components of the specimen type, a statement of adequacy, a general categorization, the use of automated review or ancillary testing, and the interpretation of results. The following nomenclature is used for categorizing cytologic dysplasia or abnormality: 1. A typical squamous cells of undetermined signifi-cance (ASC-US): refers to those samples where (Continued) Table 20-1 2014 Revised Bethesda System T erminology for the Pap Test Specimen criteria c omments Non-neoplastic findings: Organisms Trichomonas vaginalis Fungal organisms consistent with Candida sp. Shift in vaginal flora suggestive of bacterial vaginosis Bacteria consistent with Actinomyces sp. Cellular changes consistent with herpes simplex virus Other:Endometrial cells are noted in a woman older than 45 years (Note if “negative for squamous intraepithelial lesion”). Interpretation (cell abnormalities) Epithelial cell abnormalities (Result(s) is/are noted in the General Categorization and/or in the Interpretation/ Result section of the report. ) Squamous cell Atypical squamous cells of undetermined significance (ASC-US) Cannot exclude HSIL (ASC-H) L Low-grade squamous intraepithelial lesion (LSIL) encompassing: human papillomavirus/mild dysplasia/CIN 1 High-grade squamous intraepithelial lesion (HSIL) encompassing moderate and severe dysplasia, CIN 2, and CIN 3/CIS with features suspicious for invasion (if invasion is suspected). Squamous cell carcinoma Glandular cell Atypical-Endocervical cells, endometrial cells and/or glandular cells (NOS or specify in comments) Atypical-Endocervical and/or glandular cells, favor neoplastic Endocervical adenocarcinoma in situ Adenocarcinoma-Endocervical-Endometrial-Extrauterine-Not otherwise specified (NOS) Other malignant neoplasm Adapted from Nayar R, Wilbur DC (Eds. ) The Bethesda system for reporting cervical cytology. Definitions, criteria, and explanatory notes (3rd edition). New York, NY. Springer; 2015. 173 Introduction and general background

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3. L ow-grade squamous intraepithelial lesion (LSIL): refers to any combination of HPV (cells characteristic of HPV), mild dysplasia, or CIN 1. 4. H igh-grade squamous intraepithelial lesion (HSIL): refers to the presence of moderate to severe dysplasia, carcinoma in situ, or intraepithelial neoplasia grades 2 or 3 (CIN 2 or 3). 5. S quamous cell cancer or suspicious for squamous cell cancer 6. A typical glandular cells of undetermined significance (AGC): refers to endocervical or endometrial cell abnormalities or glandular cells not otherwise specified for site. The range of abnormality can be reactivity (e. g., from an intrauterine device string), adenocarcinoma in situ, or adenocarcinoma (Saslow et al., 2012). The presence of AGC necessitates referral for colposcopy not just a repeat Pap test. D. Management of abnormal cytology 1. T riaging of each category of abnormal cytology is outlined in the algorithms developed at the 2012 consensus conference sponsored by the American Society for Colposcopy and Cervical Pathology (ASCCP). The evidence-based guidelines, including the most recent version, were developed by partici-pants representing all disciplines involved in caring for patients with abnormal cytology (Figures  20-1 through 20-12) (Massad et al., 2013). 2. E valuation techniques: Throughout the algorithms (Figures 20-1 through 20-12), choices can be made as to repeating the Pap smear in a specified interval of time, performing HPV DNA testing, or proceeding to colposcopic evaluation. The high incidence of low-grade squamous intraepithelial lesion with a small proportion of those cases progressing to high-grade squamous intraepithelial lesion has led to a conservative approach to managing adolescent and young women with abnormal cytology (Moscicki & Cox, 2010). a. R epeat Pap smear evaluation confirms the persis-tence or regression of abnormal cells over time. b. H PV DNA testing provides an opportunity to categorize HPV into low-risk and high-risk types. Type-specific HPV testing is also avail-able once the presence of high-risk HPV has been confirmed. Data show that the persistence of high-risk HPV is a risk factor for progression to high-grade intraepithelial neoplasia. c. C olposcopic evaluation with directed biopsy allows the clinician to visually assess the lower genital tract under high-power magnification and evaluate lesions according to color, borders, HPV unknown (any age)HPV negative (age ≥30)Unsatisfactory Cytology Repeat cytology after 2-4 months Abnormal Negative Routine screening (HPV-/unknown) or Cotesting @ 1 year (HPV+)Manage per ASCCP guideline Unsatisfactory Colposcopy HPV positive (age ≥30) Figure 20-1 Unsatisfactory Cytology Content removed due to copyright restrictions174 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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vessels, and surface. Colposcopically directed biopsies are obtained to determine the patho-logic diagnosis of the lesions and guide the treatment and management strategies (Apgar, Brotzman, & Rubin, 2008; Mayeaux & Cox, 2012). The vulva and vagina should be included in the comprehensive evaluation of an abnormal Pap test because the cells from those areas can play a role in the abnormal reading. However, vulvar cytology is not considered effective for evaluating the keratinized epithelium in that site. Biopsy will facilitate obtaining an accurate diagnosis for vulvar lesions. d. E ndocervical sampling with a curette or a cyto-brush is sometimes included in the colposcopic evaluation to further evaluate the endocervical canal. This occurs when glandular abnormality is present or the colposcopic evaluation is unsat-isfactory (the junction of the cervical squamous and columnar epithelium is not visualized on the surface of the cervix). e. E ndometrial sampling should also be included when atypical glandular cells are present and the woman is older than 35 years or at risk for endome-trial cancer. In the 2014 Bethesda Update, benign-appearing endometrial cells should be reported in women ≥ 45 years, noting that endometrial evalu-ation be done only in postmenopausal women. Atypical endometrial cells should always be evalu-ated with endometrial biopsy regardless of age. The following figures illustrate the triage and follow-up of abnormal cytology readings. They are meant to be a guide and not a comprehensive review. For greater detail regarding the evidence-based rationale Ages 21-29+Age ≥30 years HPV negative HPV testing (preferred) Routine screening * Negative for intraepithelial lesion or malignancy+ HPV testing is unacceptable for screening women ages 21-29 years Manage per ASCCP guideline Repeat cytology in 3 years (acceptable) Cytology + HPV test in 1 year Genotyping HPV positive or HPV unknown Cytology NILM* but EC/TZ Absent/Insufficient Figure 20-2 Cytology NILM but EC/TZ Absent/Insuf ficient Content removed due to copyright restrictions175 Introduction and general background

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condylomata, abnormal cytology or positive HPV testing, menstrual history, history of STIs, history of DES exposure, HPV vaccination. 2. F amily history: gynecological cancers 3. P ersonal and social history: age at onset of sexual activity; number of sexual partners; birth control method and condom use; sexual preference; and tobacco, alcohol, and drug use. 4. R eview of systems a. Ge neral health. b. P sychosocial: ability to understand disease and relation to sexual activity, depression, anxiety, and guilt or shame. c. R eproductive: presence of pruritus; vulvar, vagi-nal, or anal pain; dyspareunia; abnormal bleed-ing; abnormal anogenital growths; and vaginal discharge or odor. B. Objective 1. E xternal: gross inspection of vulvar and perianal skin, noting presence of condylomata, ulcers, pigmented lesions, leukoplakia, microtears, inflammation, for the choices, consult the consensus guidelines for cervical cancer screening from the ASCCP (Massad et al., 2013). II. d atabase (may include but is not limited to) A. Subjective 1. P ast health history a. M edical illnesses: immune disorders including HIV, systemic lupus erythematosus, organ trans-plant, or blood dyscrasias. b. M edication history: medications that affect immune response (e. g., prednisone), hormone therapy, or anticoagulant or aspirin therapy. c. A llergy history: iodine d. S urgical history: hysterectomy and excisional or ablative treatment. e. Obs tetric and gynecological history: parity, cur-rent or recent pregnancy, desire for future preg-nancy, history of intraepithelial neoplasia, Repeat cotesting @ 1 year acceptable Cytology negative and HPV negative Repeat cotesting @ 3 years≥ASC or HPV positive Colposcopy Manage per ASCCP guideline Management of Women ≥ Age 30, who are Cytology Negative, but HPV Positive Repeat cotesting @ 1 years HPV 16 or 18 positive HPV 16 and 18 negative HPV DNA typing acceptable Manage per ASCCP guideline Figure 20-3 Management of W omen ≥ Age 30, Who Are Cytology Negative, but HPV Positive Content removed due to copyright restrictions176 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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III. a ssessment A. Determine the diagnosis Genital warts, AIN, VIN, VAIN, CIN, AIS, invasive cancer, or other lesions B. Determine the severity and location 1. L ow-grade: mild dysplasia (intraepithelial neoplasia grade 1) 2. H igh-grade: moderate (intraepithelial neoplasia grade 2) and severe or carcinoma in situ (intraepi-thelial neoplasia grade 3). The conclusions from the Lower Anogenital Squamous T erminology (LAST) consensus conference for cervical histopathology atrophy, raised lesions; colposcopic inspection noting acetowhite epithelium with or without vessel patterns, such as punctation, mosaic, or atypical vessels; and Lugol's nonstaining lesions (avoid if allergic to iodine). 2. S peculum examination: gross inspection of cervix and vagina noting discharge, inflammation, atrophy, leukoplakia, ulcers, and raised lesions; colposcopic examination noting location of squamocolumnar junction, acetowhite epithelium with or without vessel patterns, and Lugol's nonstaining lesions (Mayeaux & Cox, 2012). 3. S upporting data from relevant diagnostic tests, including wet smear and potassium hydroxide (KOH), cytology and histology, and HPV testing, urine or swab. Repeat cytology @ 1 year acceptable Negative ≥ ASC Colposcopy Endocervical sampling preferred in women with no lesions, and those with inadequate colposcopy; it is acceptable for others Manage per ASCCP guideline Management of Women with Atypical Squamous Cells of Undetermined Significance (ASC-US) on Cytology* HPV positive (managed the same as women with LSIL)HPV negative HPV testing preferred Repeat cotesting @ 3 years Routine screening+ * Management options may vary if the woman is pregnant or ages 21-24. + Cytology at 3 years intervals Figure 20-4 Management of W omen with Atypical Squamous Cells of Undetermined Significance (ASC-US) on Cytology Content removed due to copyright restrictions177 Assessment

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IV. g oals of clinical management The choice of treatment is influenced by a number of factors, including the patient's preference; age; parity; the location, extent, and degree of abnormality; cost of treatment; the limi-tations of the healthcare facility to provide certain treatments; the patient's desire for future fertility; the patient's ability to understand and follow the treatment protocol; and probabil-ity of patient follow-up. The dose and duration of treatment should be determined by referring to product guidelines. A. Screening for the purpose of diagnosing or preventing cervical, vaginal, and vulvar cancer Anal and perianal intraepithelial neoplasia are also a growing concern but are not covered in this chapter. Choose a cost-effective available approach for diagnosing precancerous and cancerous lesions. More information regarding the evolving science for screening of the anal canal with digital exam, cytology evaluation, or high-resolution anoscopy (HRA) can be found in a recent review by Moscicki et al., 2015. and its implications for management of high-grade squamous intraepithelial lesions of the cervix have been adopted. Revised terminology for high-grade now combines CIN 2 and CIN 3 and does not try to differentiate between the two (Waxman et al., 2012). The current ASCCP 2013 guidelines do not yet reflect combining CIN 2 and 3 into one high-grade category, thus allowing young women with CIN 2 to be managed expectantly (see Figure 20-9). Management of young women with biopsy con-firmed CIN 2, 3. 3. U nifocal versus multifocal, exocervical, endocervical, vaginal, or vulvar. C. Significance Assess the significance of the diagnosis to the patient and partner(s) D. Motivation and ability Determine the patient's willingness and ability to follow the treatment plan. Repeat cytology @ 12 months preferred Reflex HPV testing acceptable for ASC-US only Management of Women Ages 21-24 years with either Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL) Women ages 21-24 years with ASC-US or LSIL Negative, ASC-US or LSIL Repeat cytology @ 12 months Negative × 2 Routine screening Routine screening≥ ASC Colposcopy ASC-H, AGC, HSILHPV positive HPV negative Figure 20-5 Management of W omen Ages 21-24 Years with Either Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-Grade Squamous Intraepithelial Lesion Content removed due to copyright restrictions178 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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cervical cultures for gonorrhea and Chlamydia, wet smear and KOH, and urine human chorionic gonadotropin. C. Management 1. M ay include treatment of vaginitis, STIs, vaginal atrophy, and dermatosis if symptomatic. 2. T reatment of genital warts: trichloroacetic acid 0. 5%, imiquimod (Aldara®) 5% cream, 5-fluorouracil (Efudex®) 3-5%, and sinecatechin (Veregen®); cryotherapy with liquid nitrogen or cryoprobe; surgical excision; laser therapy; or interferon alfa-2b (Intron®) or observation. 3. T reatment of VIN 2, 3: wide local excision, laser therapy, skinning vulvectomy, imiquimod (Aldara®) 5%, 5-fluorouracil 2-5%, cryotherapy, or observation (Riberio, Figueiredo, Paula, & Borrego, 2012). VIN 1 is no longer categorized as intraepithelial neoplasia that requires treatment. Refer to the International Society for the Study of Vulvovaginal Disease (http://issvd. org/) for more detail (Reyes & Cooper, 2014). B. Treatment Select a treatment plan that reduces symptoms and pre-vents progression. See under management (treatment of CIN) for more detail. C. Patient adherence Select an approach that maximizes patient adherence. V. p lan A. Screening Screening for cervical, vaginal, and vulvar cancer is influenced by the age of the patient, the presence of immunosuppressive diseases or medications, history of DES exposure, and history of CIN 2+ or positive HPV tests (Reed & Fenton, 2013; Rubin, 2007). B. Diagnostic tests May include the following: cervical cytology, HPV DNA testing, anal cytology, biopsy, endocervical curettage, Colposcopy Management of Women with Low-grade Squamous Intraepithelial Lesions (LSIL)* ‡ LSIL with negative HPV test among women ≥ 30 with cotesting LSIL with positive HPV test among women ≥ 30 with cotesting LSIL with no HPV test Repeat cotesting @ 1 year Repeat cotesting @ 3 years * Management options may vary if the woman is pregnant or ages 21-24 years ‡ Manage women ages 25-29 as having LSIL with no HPV test Cytology negative and HPV negative≥ ASC or HPV positive Manage per ASCCP guideline No CIN2, 3 Manage per ASCCP guideline CIN2, 3Preferred Acceptable Non-pregnant and no lesion identified Inadequate colposcopic examination Adequate colposcopy and lesion identified Endocervical sampling “preferred”Endocervical sampling “preferred”Endocervical sampling “acceptable” Figure 20-6 Management of W omen with Low-Grade Squamous Intraepithelial Lesions Content removed due to copyright restrictions179 Plan

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ˆ In women with no cytological, histological, or colposcopically suspected CIN2, 3 or cancer Management of Pregnant Women with Low-grade Squamous Intraepithelial Lesion (LSIL) Pregnant women with LSIL Colposcopy preferred No CIN2, 3ˆ Postpartum follow-up CIN2, 3Defer colposcopy (until at least 6 weeks postpartum) acceptable Manage per ASCCP guideline ˆ Management options may vary if the woman is ages 21-24. Manage per ASCCP guideline Manage per ASCCP guideline Management of Women with Atypical Squamous Cells: Cannot Exclude High-grade SIL (ASC-H)* Colposcopy regardless of HPV status No CIN2,3 CIN2,3 Figure 20-8 Management of W omen with Atypical Squamous Cells: Cannot Exclude High-Grade SIL (ASC-H)Figure 20-7 Management of Pregnant W omen with Low-Grade Squamous Intraepithelial Lesion Content removed due to copyright restrictions Content removed due to copyright restrictions180 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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Colposcopy (Immediate loop electrosurgical excision is unacceptable)Management of Women Ages 21-24 yrs with Atypical Squamous Cells, Cannot Rule Out High Grade SIL (ASC-H) and High-grade Squamous Intraepithelial Lesion (HSl L) Two consecutive cytology negative results and No high-grade colposcopic abnormality Routine screening Biopsy No CIN2, 3 Other results HSIL persists for 24 months with no CIN2, 3 identified Diagnostic excisional procedure+CIN2, 3 High-grade colposcopic lesion or HSIL persists for 1 year Observation with colposcopy & cytology* @ 6 month intervals for up to 2 years Manage per ASCCP guideline * If colposcopy is adequate and endocervical sampling is negative. Otherwise a diagnostic excisional procedure is indicated. + Not if patient is pregnant Manage per ASCCP guideline for young women with CIN2, 3CIN2, 3 (if no CIN2, 3, continue observation) Immediate loop electrosurgical excision+Colposcopy (with endocervical assessment)Management of Women with High-Grade Squamous Intraepithelial lesions (HSIL)* CIN2, 3 No CIN2, 3 Manage per ASCCP guideline Or * Management options may vary if the woman is pregnant, postmenopausal, or ages 21-24 + Not if patient is pregnant or ages 21-24Figure 20-9 Management of W omen Ages 21-24 Years with Atypical Squamous Cells, Cannot Rule Out High-Grade SIL (ASC-H) and High-Grade Squamous Intraepithelial Lesion (HSIL) Figure 20-10 Management of W omen with High-Grade Squamous Intraepithelial Lesions Reprinted from the Journal of Lower Genital Tract Disease, Volume 17, Number 5, with the permission of ASCCP © American Society for Colposcopy and Cervical Pathology 2013. No copies of the algorithms may be made without the prior consent of ASCCP. Content removed due to copyright restrictions Content removed due to copyright restrictions181 Plan

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All subcategories (except atypical endometrial cells) Endometrial and endocervical sampling Colposcopy (with endocervical sampling) and endometrial sampling (If ≥ 35 yrs or at risk for endometrial neoplasia*)Initial Workup of Women with Atypical Glandular Cells (AGC) Atypical endometrial cells No endometrial pathology Colposcopy*Includes unexplained vaginal bleeding or conditions suggesting chronic anovulation. Subsequent Management of Women with Atypical Glandular Cells (AGC) Initial cytology is AGC-NOSInitial cytology is AGC (favor neoplasia) or AIS No CIN2+, AIS or cancer Cotest 3 years later Colposcopy Cotest at 12 & 24 months CIN2+, but no glandular neoplasia Manage per ASCCP guideline No invasive disease Diagnostic excisional procedure+ Both negative Any abnormality +Should provide an intact specimen with interpretable margins. Concomitant endocervical sampling is preferred Figure 20-11 Initial W orkup of Women with Atypical Glandular Cells (AGC) Figure 20-12 Subsequent Management of W omen with Atypical Glandular Cells Reprinted from the Journal of Lower Genital Tract Disease, Volume 17, Number 5, with the permission of ASCCP © American Society for Colposcopy and Cervical Pathology 2013. No copies of the algorithms may be made without the prior consent of ASCCP. Content removed due to copyright restrictions Content removed due to copyright restrictions182 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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4. T reatment of VAIN: 5-fluorouracil 2-5%, laser therapy, surgical or electrosurgical excision, or observation. 5. T reatment of CIN: follow ASCCP Management Guidelines (Figures 20-13 through 20-18). These algorithms allow for appropriate management once colposcopic evaluation has been completed. T reatments include cryotherapy, laser vaporization or excision, loop electrosurgical excision procedure (LEEP), and cold knife cone biopsy. The choice of procedure and whether to use excision or ablation depend on many factors including experience of the provider, availability of equipment, size of the transformation zone and lesions, satisfactory colposcopic examination, insurance coverage, and desires of the patient, especially future fertility (Arbyn et al., 2008; Massad et al., 2013). D. Client education 1. C oncerns and feelings a. Di scuss the emotional impact of HPV-associated disease on the patient's self-esteem, body image, and feelings of trust and safety with her sexual partner. i. M ost women will be exposed to HPV at some time during their lifetime. ii. P artners are usually unaware of their exposure to the virus and their ability to transmit it to their partner. Evaluation of male partner is not usually recommended due to lack of available testing. Males have a very low risk of HPV-related cancer. Female partners should be advised to consult their clinician if recent Pap or HPV testing has not been done. b. Di scuss concerns about cancer and fertility (Rubin & T ripsas, 2010). i. C ancer is preventable with early detection. It typically takes 10-20 years for HPV infec-tion to develop into cancer. Intraepithelial neoplasia is treatable. However, HPV infec-tion may persist after treatment. Follow-up is important. c. A fter surgical excision treatment there is an increased risk of preterm labor. Y oung patients who desire more pregnancies should discuss ablation treatments such as cryotherapy or laser vaporization as an alternative to excision. 2. I nformation a. Di scuss smoking cessation, healthy diet and lifestyle, safer sex, and HPV in pregnancy. i. S moking is a known cofactor in the devel-opment of genital and oral cancers. ii. Die ts high in fruits and vegetables may be beneficial in boosting the immune response. iii. C ondom use reduces but does not eliminate transmission of HPV. Reducing the num-ber of sexual partners can reduce the risk of HPV acquisition and transmission. iv. H PV transmission to the fetus is low. Patient may safely deliver vaginally. b. Di scuss the relationship between HPV and can-cer, and the need for ongoing follow-up (refer to ASCCP guidelines). c. Di scuss diagnostic tests including colposcopy, biopsy, and endocervical curettage. d. Di scuss treatments and side effects. i. A ll treatment methods are associated with some bleeding and discharge. Cryotherapy is also followed by heavy watery discharge for 2-4 weeks. Pelvic rest and avoidance of strenuous activity are recommended for that time after all treatments. e. Di scuss HPV vaccination benefits and limitations. 3. R esources and tools a. h ttp://www. asccp. org b. h ttp://www. cdc. gov/std/hpv/ c. w ww. cervicalcancerfacts. com d. h ttp://www. cancer. org e. h ttp://www. analcancerinfo. ucsf. edu183 Plan

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Management of Women with No Lesion or Biopsy-Confirmed Cervical Intraepithelial Neoplasia — Grade 1 (CIN1) Preceded by “Lesser Abnormalities”* ∞ Follow-up without treatment Cotesting at 12 months HPV(-) and cytology negative Cytology Negative +/-HPV(-)Age appropriate* retesting 3 years later Routine screening*Manage per ASCCP guideline* “Lesser abnormalities” include ASC-US or LSIL Cytlogy, HPV 16+ or 18+, and persistent HPV ∞ Management options may vary if the woman is pregnant or ages 21-24 + Cytology if age <30 years, cotesting if age ≥30 years † Either ablative or excisional methods. Excision preferred if colposcopy inadequate, positive ECC, or previously treated. If persists for at least 2 years Follow-up or treatment†No CIN≥ ASC or HPV(+) CIN2, 3 CIN1Colposcopy Management of Women with No Lesion or Biopsy-Confirmed Cervical Interaepithelial Neoplasia — Grade 1 (CIN1) Preceded by ASH-H or HSIL Cytology Cotesting at 12 and 24 months* Or Or Diagnostic excision procedure^Review of cytological, histological, and colposcopic findings Manage per ASCCP guideline for revised diagnosis HPV(-) and cytology negative at both visits HSIL at either visits HPV(+) or any cytology abnormality except HSIL Colposcopy Age-specific retesting in 3 years++ Only if colposcopy was adequate and endocervical sampling is negative ^ Except in special populations (may include pregnant woman and those ages 21-24) + Cytology if age <30, cotesting if age ≥30 years Figure 20-14 Management of W omen with No Lesion or Biopsy-Confirmed Cervical Intraepithelial Neoplasia-Grade 1 Preceded by Lesser Abnormalities Figure 20-13 Management of W omen with No Lesion or Biopsy Confirmed Cervical Intraepithelial Neoplasia-Grade 1 (CIN1) Preceded by ASC-H or HSIL Cytology Content removed due to copyright restrictions Content removed due to copyright restrictions184 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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Management of Women Ages 21-24 with No Lesion or Biopsy-Confirmed Cervical Intraepithelial Neoplasia — Grade 1 (CIN1) < ASC-H or HSIL ≥ ASC-H or HSILAfter ASC-US or LSIL After ASC-H or HSIL Colposcopy Manage per ASCCP guideline for women ages 21-24 with ASC-H or HSIL using postcolposcopy path for No CIN2, 3Repeat cytology @ 12 mos Repeat cytology @ 12 months Routing screening Negative ≥ ASC Management of Women with Biopsy-Confirmed Cervical Intraepithelial Neoplasia — Grade 2 and 3 (CIN2, 3)* Adequate colposcopy Inadequate colposcopy or recurrent CIN2, 3 or endocervical sampling is CIN2, 3 Either excision† or ablation of T-zone* Routine screening Diagnostic excisional procedure† Cotesting at 12 and 24 months Repeat cotesting in 3 years Colposcopy with endocervical sampling Any test abnormal 2× negative result*Management options will vary in special circumstances or if the woman is pregnantor ages 21-24 †If CIN2, 3 is identified at the margins of an excisionalprocedure or post-procedure ECC, cytology and ECC at4-6 mo is preferred, but repeatexcision is acceptable andhysterectomy is acceptableif re-excision is not feasible. Figure 20-15 Management of W omen Ages 21-24 with No Lesion or Biopsy-Confirmed Cervical Intraepithelial Neoplasia-Grade 1 Figure 20-16 Management of W omen with No Lesion or Biopsy-Confirmed Cervical Intraepithelial Neoplasia-Grades 2 and 3 (CIN2, 3)Content removed due to copyright restrictions Content removed due to copyright restrictions185 Plan

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Management of Young Women with Biopsy-confirmed Cervical Intraepithelial Neoplasia — Grade 2, 3 (CIN2, 3) in Special Circumstances Young women with CIN2, 3 Either treatment or observation is acceptable, provided colposcopy is adequate. When CIN2 is specified, observation is preferred. When CIN3 is specified, or colposcopy is inadequate, treatment is preferred. Observation — colposcopy & cytology @ 6 month intervals for 12 months 2× cytology negative and normal colposcopy Cotest in 1 year Both tests negative Either test abnormal Colposcopy worsens or high-grade cytology or colposcopy persists for 1 Year Cotest in 3 years Repeat colposcopy/biopsy recommended Treatment recommended CIN3 or CIN2, 3 persists for 24 months Treatment using excision or ablation of T-zone Management of Women Diagnosed with Adenocarcinoma in-situ (AIS) during a Diagnostic Excisional Procedure Hysterectomy — preferred Conservation management acceptable if future fertility desired Margins negative Long-term follow-up Re-evaluation @ 6 month — acceptable Re-excision recommended Margins involved or ECC positive * Using a combination of cotesting and colposocopy with endocervical sampling Figure 20-17 Management of Y oung Women with Biopsy-Confirmed Cervical Intraepithelial Neoplasia-Grades 2 and 3 in Special Circumstances Figure 20-18 Management of W omen Diagnosed with Adenocarcinoma In Situ (AIS) During a Diagnostic Excisional Procedure Content removed due to copyright restrictions Content removed due to copyright restrictions186 CHAPTER 20 | Screening for Intraepithelial Neoplasia and Cancer of the Lower Genital Tract

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Moscicki, A. B., & Cox, J. T. (2010). Practice improvement in cervical screening and management (PICSM): Symposium on management of cervical abnormalities in adolescents and young women. Journal of Lower Genital Tract Disease 14, 73Y80. Moscicki, A. B., Darragh, T., Berry-Lawhorn, M. J., Roberts, J., Kjhan, M., Boardman, L., et al. (2015). Screening for anal cancer in women. Journal of Lower Genital Tract Disease, 19(3, Suppl. 2), 27-42. Nayar, R., & Wilbur, D. (2015). The Pap test and Bethesda 2014: “The reports of my demise have been greatly exaggerated” (after a quotation from Mark Twain). Journal of Lower Genital Tract Disease, 19(3), 175-184. Reed, C., & Fenton, S. (2013). Exposure to diethylstilbestrol during sensitive life stages: A legacy of heritable health effects. Birth Defects Research Part C: Embryo T oday, 99(2), 10. 1002/bdrc. 21035. Reyes, M., & Cooper, K. (2014). An update on vulvar intraepithelial neopla-sia: terminology and a practical approach to diagnosis. Journal of Clinical Pathology, 67(4), 290-294. doi: 10. 1136/jclinpath-2013-202117. Epub 2014 Jan 7. Ribeiro, F., Figueiredo, A., Paula, T., Borrego, F. (2012). Vulvar intraepithe-lial: evaluation of treatment modalities. Journal of Lower Genital Tract Disease, 16(3), 313-317. Rubin, M. (2007). Antenatal exposure to DES: Lessons learned... concerns for the future. Obstetrical and Gynecological Survey, 62(8), 1-7. Rubin, M., & T ripsas, C. (2010). Uncertainty, coping strategies and adap-tation in women with human papillomavirus (HPV) on Papanicolaou smears. Journal of Lower Genital Tract Disease, 14(3), 81-89. Saslow, D., Solomon, D., Lawson, H., Killackey, M., Kulasingam, S., Cain, J., et al. (2012). American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology Screening Guidelines for the Prevention and Early Detection of Cervical Cancer. Journal of Lower Genital Tract Disease, 16(3), 1-29. Solomon, D., & Nayar, R. (2004. ) The Bethesda system for reporting cervical cytology: Definitions, criteria, and explanatory notes. New Y ork: Springer. U. S. Preventive Services T ask Force. (2012). Cervical cancer: Screening. Retrieved from http://www. uspreventiveservicestaskforce. org/Page /Document/Update Summary Final/cervical-cancer-screening. Waxman, A. G., Chelmow, D., Darragh, T. M., Lawson, H., & Moscicki, A. (2012). Revised terminology for cervical histopathology and its implications for management of high-grade squamous intraepithelial lesions of the cervix. Obstetrics and Gynecology, 120(6), 1465-1471. Winer, R., Lee, S., Hughes, J., Adam, D., Kiviat, N., & Koutsky, L. (2003). Genital human papillomavirus infection: Incidence and risk factors in a cohort of female university students. American Journal of Epidemiology, 157(3), 218-226. Refe Rence S American College of Obstetricians and Gynecologists. (2012). ACOG practice bulletin No 131: Screening for cervical cancer. Obstetrics and Gynecology, 120(5), 1222-1238. Apgar, B., Brotzman, G., & Rubin, M. (2008). Principles and technique of the colposcopic exam. In B. Apgar, G. Brotzman, & M. Spitzer (Eds. ). Colposcopy principles and practice: An integrated textbook and atlas (2nd ed., pp. 101-125). Philadelphia, PA: W. B. Saunders. Arbyn, M., Kyrgiou, M., Simoens, C., Raifu, A. O., Koliopoulos, G., Martin-Hirsch, P., et al. (2008). Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: Meta-analysis. British Medical Journal, 337, a1284. Food and Drug Administration. (2014, December 10). FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV. FDA News Release. Retrieved from http://www. fda. gov /News Events/Newsroom/Press Announcements/ucm426485. htm. Huh, W. K., Ault, K. A., Chelmow, D., Davey, D., Goulart, R., Garcia, F., et al. (2015). Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Gynecologic Oncology, 136, 178-182. Kjær, S., Frederiksen, E., Munk, C., & Iftner, T. (2010). Long-term abso-lute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection. JNCI: Journal of the National Cancer Institute, 102(1), 1478-1488. Kosiol, J., Lindsay, L., Pimenta, J., Poole, C., Jenkins, D., & Smith, J. (2008). Persistence of human papillomavirus infection and cervical neoplasia: A systematic review and meta analysis. American Journal of Epidemiology, 168(2), 123-137. Li, N., Franceschi, S., Howell-Jones, R., Snijders, P. J., & Clifford, G. M. (2011). Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: Variation by geographical region, histological type and year of publication. International Journal of Cancer, 128(4), 927-935. doi: 10. 1002/ijc. 25396. Markowitz, L., Dunne, E., Saraiya, M., Chesson, H., Curtis, C., Gee, J., et al. (2014). Human papillomavirus vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations and Reports, 63(RR05), 1-30. Massad, S., Einstein, M., Huh, W., Katki, M., Kinney, W., Schiffman, M., et al. (2013). 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. American Society for Colposcopy and Cervical Pathology. Journal of Lower Genital Tract Disease, 17(5), S1Y-S27. Mayeaux, E. J., & Cox, J. T. (Eds. ). (2012). Modern colposcopy textbook and atlas (3rd ed. ). Philadelphia, PA: Wolters Kluwer/Lippincott William & Wilkins. 187 References

Clinical Guidelines for Advanced Practice Nursing-1 1.pdf

include operative sterilization using the Filshie clip or hysteroscopic sterilization (Gariepy, Creinin, Smith, & Xu, 2014). b. L aparoscopy can be performed under general, regional, or local anesthesia with sedation. Fallopian tubes can be ligated, dessicated with electrosurgery, or clamped. c. M inilaparotomy involves a small abdominal incision and requires general anesthesia. Salpingectomy (removal of the fallopian tubes) or any of the previously mentioned procedures can be performed using minilaparotomy. 2. Be nefits a. Both s urgeries provide immediate and perma-nent contraception. b. H ighly effective but failure rates have been shown to be dependent on the age of the woman and the method used (Creinin & Zite, 2014). c. E xtremely safe with rare operative complica-tions. d. C overed benefit of Medi-Cal, Medicaid pro-grams, and the Affordable Care Act. e. L arge case control studies have demonstrated a 39% reduction in the risk of ovarian cancer in women who have had surgical sterilization (Rice, Hankinson, & Tworoger, 2014). 3. R isks and disadvantages a. The re are no absolute contraindications to these procedures, but people with certain health conditions, such as obesity, pelvic adhesions, diabetes, or severe cardiac or lung disease, may not be ideal surgical candidates. b. Ge neral anesthesia may be required. c. A 30-day waiting period post counseling and post consenting is required by federal Medicaid guidelines. d. The re is an increased risk of ectopic pregnancy if the method fails. I. Intr oduction and general background Approximately 37% of reproductive age couples who desire contraception use sterilization, making this the most com-monly used form of contraception in the United States (Bartz & Greenberg, 2008). Female sterilization describes a number of surgical pro-cedures intended to physically prevent sperm from uniting with and fertilizing an egg. Although sterilization surgeries can include the removal of the uterus (hysterectomy), the term “female sterilization” in this chapter describes the more typically performed, less invasive procedures for disrupting fallopian tubal patency. Tubal ligation, either by excision of a portion of the tube, electrosurgical dessication, or tubal occlusion through the use of surgical clips or rings is gen-erally performed via laparoscopy. Tubal occlusion using fallopian inserts (Essure®) can be done hysteroscopically through the cervix, thus avoiding surgical incision. All of these procedures effectively end a woman's fertility. About 700,000 women choose some form of sterilization proce-dures annually. Vasectomy is the male form of sterilization. Approximately half a million men a year choose this perma-nent form of contraception. A vasectomy is a minor surgical procedure that is performed under local anesthesia. One or two small punctures or incisions are made in the scrotum and the vas deferens is ligated, cauterized, or occluded, thus pre-venting sperm from admixing with semen. A. Tubal ligation 1. D efinition and overview a. S terilization is a permanent form of contracep-tion that is highly effective. Recent evaluation of data collected by the U. S. Collaborative Review of Sterilization (CREST), which followed more than 10,000 women with surgical sterilization for up to 14 years, reported a 5-year failure rate of 13/10,000 procedures. These data do not Janis Luft Fema Le and m a L e Ster ILI zat I on© Eliks/Shutterstock; © donatas1205/Shutterstock 188 21Chapt Er

Clinical Guidelines for Advanced Practice Nursing-1 1.pdf

b. The pr ovider must be trained in the use and placement of these devices. Rates of successful bilateral coil placement can range from 76% to 96%. c. C ertain uterine malformations (e. g., bicornuate uterus) may preclude proper placement of the devices. d. W omen must be at least 6 weeks postpartum. e. A 30-day waiting period post counseling and post consenting is required by federal Medicaid guidelines. f. Thi s method affords no protection against STIs. g. P ossibility of regret exists. C. Vasectomy 1. D efinition and overview Vasectomy is male sterilization accomplished by severing the vas deferens, thus preventing sperm from entering the ejaculate. Vasectomies can be done either by making a small incision in the scrotum using a scalpel to access and sever the vas or by using the no-scalpel technique. No incision is made. Rather, the vas is grasped with specialized ring forceps externally and a small puncture is made using dissect-ing forceps to externalize the vas for cutting. The ben-efits of this procedure include less bleeding, a smaller hole in the skin, and fewer complications. Both tech-niques are equally effective (Sharlip et al., 2012). 2. Be nefits a. P rovides permanent contraception with low failure rates, ranging from 0% to 0. 5% when used perfectly b. R equires local anesthesia and can be done in the outpatient setting. c. C ost effective. Covered by Medi-Cal and some Medicaid programs but not the Affordable Care Act. d. N ot partner dependent. 3. R isks and disadvantages a. I t can take up to 3-6 months to achieve complete aspermia. Effective contraception must be used until ejaculate tests negative for the presence of sperm. Most vasectomy “failures” occur within the first 3 months after the procedure. b. The re is postprocedure pain and swelling. c. A 30-day waiting period post counseling and post consenting is required by federal Medicaid guidelines. d. Thi s method affords no protection against STI. e. P ossible regret exists. Although vasectomy rever-sal is often possible, success rates for pregnancy vary from 40% to 90% and can be dependent on the length of time since the original procedure, e. Thi s method affords no protection against sexually transmitted infections (STIs). f. P ossibility of regret exists. B. Transcervical tubal occlusion 1. D efinition and overview Currently, Essure® is the only system of transcervical sterilization available in the United States approved by the Food and Drug Administration. The procedure is done via hysteroscopy and involves placing micro-inserts into the horns of the uterus, causing scarring and occlusion of the fallopian tubes. This is done using local anesthesia only, requires no incision, and thus can be done in an outpatient setting. This method requires an appropriately trained clinician. Accurate insertion of the devices can fail in as many as one in seven placements. Verification of tubal occlusion requires hysterosalpingography (HSG) 3 months after placement of the occluding devices. Essure® microinsert is a tiny coil that consists of a stainless steel inner coil, a nickel titanium outer coil, and polyethelene fibers. After placement, there is a delay in efficacy until tubal fibrosis occurs (typically 3 months) during which alternate contraception must be used. 2. Be nefits a. H ysteroscopy precludes the need for a surgical incision. There is less risk of infection and fast-er recovery time. It may be a better choice for women who are not ideal candidates for even minimally invasive pelvic surgery. b. The re is no need for general or regional anesthe-sia. Generally, only paracervical block or mild oral or intravenous sedation is used, and thus it can be done in an outpatient setting. c. I nitial studies found the method to be highly effective, but failure rates may be underestimated and are probably lower than with surgical steril-ization. Effectiveness can be dependent on the experience of the provider and the compliance of the patient during the 3-month interval until tubal occlusion can be verified (Gariepy et al., 2014). d. I t is covered by Medi-Cal, most Medicaid programs, and the Affordable Care Act. 3. R isks and disadvantages a. The re is a delay in the efficacy of these methods of 3 months or more to allow for sufficient tubal fibrosis to take place. A hysterosalpingogram is required to ensure that the tubes are occluded. Other methods of contraception (but not an intrauterine device) must be used in the 3-month interim between the procedure and until tubal fibrosis can be demonstrated. 189 Introduction and general background

Clinical Guidelines for Advanced Practice Nursing-1 1.pdf

and will not want to bear children in the future, even if life circumstances change. Information must also be provided about the many effective contraceptive choices available. b. Di scuss risks, benefits, discomforts, and recov-ery times associated with various procedures. c. R eview follow-up testing as appropriate. Discuss plan for and provide interim contraception as needed. 2. C onsenting a. I n California, clinicians are required to provide a copy of the sterilization booklet published by the Department of Health Services. In other states, check the state department of health for similar requirements. b. Obt ain informed consent. Federal Medicaid guidelines require written consent signed at least 30 days and no more than 180 days before the planned procedure for patients receiving public funding. A copy must be placed in the medical record and a copy provided to the patient. c. A ssure the patient of his or her right to revoke consent at any time. V. Self-management r esources A. The American Congress of Obstetricians and Gynecologists: Sterilization for men and women: http://www. acog. org/-/media/For-Patients /faq011. pdf?dmc=1&ts=20150920T1518453944 B. Planned Parenthood, Sterilization for women (tubal ligation): http://www. plannedparenthood . org/learn/birth-control/sterilization-women C. Planned Parenthood, Vasectomy: http://www . plannedparenthood. org/learn/birth-control /vasectomy re Ference S American College of Obstetricians and Gynecologists. (2007). Sterilization of women, including those with mental disabilities (ACOG Committee Opinion Number 371). Washington, DC: Author. Bartz, D., & Greenberg J. A. (2008). Sterilization in the United States. Reviews in Obstetrics and Gynecology, 1(1), 23-32. Creinin, M. D., & Zite, N. (2014). Female tubal sterilization: The time has come to routinely consider removal. Obstetrics and Gynecology, 124(3), 596-599. Daniels, K., Daugherty, J., & Jones, J. (2014). Current contraceptive status among women aged 15-44: United States, 2011-2013 (NCHS Data Brief, no. 173). Hyattsville, MD: National Center for Health Statistics, Centers for Disease Control and Prevention. type of procedure, and the skill of the provider performing the reversal (Sharlip et al., 2012). II. d atabase (may include but is not limited to) A. Subjective 1. G ynecological, urologic, medical, and psychosocial history a. P atient desires permanent sterilization. b. P atient has considered and declined other con-traceptive options. c. The re are no medical contraindications to the procedure that would incur high surgical risk. B. Objective 1. C omplete gynecological and urologic examination; negative pregnancy test for women. 2. A bsence of psychiatric or mental disability. a. F or guidance on the issues of mental competency and ability to give informed con-sent for sterilization see http://www. acog. org /Resources-And-Publications/Committee-Opinions/Committee-on-Ethics/Sterilization -of-Women-Including-Those-With-Mental-Disabilities III. a ssessment A. Patient is a candidate for sterilization 1. Ac cording to federal guidelines, candidate must be at least 21 years of age. 2. M entally competent. 3. W omen not currently pregnant. 4. N o medical contraindications to procedure. B. Understands and accepts the permanent nature of the procedure and is prepared to end childbearing IV. Plan A. Client education 1. I nformation and counseling a. Befor e undergoing sterilization, patients must be sure that they no longer want to bear children 190 CHAPTER 21 | Female and Male Sterilization

Clinical Guidelines for Advanced Practice Nursing-1 1.pdf

Sharlip, I. D., Honig, S., Labrecque, M., Marmar, J. L., Ross L. S., Sandlow, J. L., et al. (2012). Vasectomy: American Urologic Association Guideline. Retrieved from www. auanet. org/education/guidelines /vasectomy. cfm. Shih, G., Zhang, Y., Bukowski, K., & Chen, A. (2014). Bringing men to the table: Sterilization can be for him or for her. Clinical Obstetrics and Gynecology, 57(4), 731-740. Gariepy, A. M., Creinin, M. D., Smith, K. J., & Xu, X. (2014). Probability of pregnancy after sterilization: A comparison of hysteroscopic versus lapa-roscopic sterilization. Contraception, 90, 174-181. Pollack, A. E., Thomas, L. J., & Barone, M. A. (2008). Female and male ster-ilization. In R. A. Hatcher, J. T russell, A. E. Nelson, W. Cates, F. Stewart, & D. Kowal (Eds. ). (2009). Contraceptive technology (19th rev. ed., pp. 362-401). New Y ork, NY: Ardent Media. Rice, M. S., Hankinson, S. E., & Tworoger, S. S. (2014). Tubal ligation, hysterectomy, unilateral oophorectomy, and risk of ovarian cancer in the Nurses' Health Studies. Fertility and Sterility, 102(1), 192-198. 191 References

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contraception, placing them at higher risk for sexually trans-mitted infections (STIs). Comfort with and ease of use of the method must also be considered. Age is an important factor, especially with adolescents, who continue to have high unin-tended pregnancy rates. The Centers for Disease Control and Prevention have pub-lished recommendations for Providing Quality Family Planning Services (Gavin et al., 2014), with a focus on improved coun-seling through a client-centered approach that asks about reproductive life plan; respecting age, sexual preference, race, ethnicity, disability, and language limitations. A five-step coun-seling approach with a focus on interactive communication that establishes and maintains rapport is recommended. A special section addresses the needs of adolescents with regard to long-acting reversible contraception (LARC) and recom-mends the discussion of hormonal implants and intrauterine contraception as a safe and highly effective method for adolescent clients. For all patients, LARC provides the best contraceptive efficacy by avoiding less than optimal patient compliance. A. Combined hormonal contraception Combined hormonal contraception (CHC) includes methods that contain both estrogen and a progestin. These include the COC pill, transdermal patch, and vaginal ring. Combined injectable contraceptives are not currently available in the United States. CHC has many advantages beyond prevention of pregnancy. Dysmenorrhea and menorrhagia are often significantly reduced, and menstrual cycle regularity is improved. Symptoms and severity of endometriosis may be reduced, potentially preserving fertility. Premenstrual syndrome and migraine headaches are often improved but may also be increased. Many women benefit from a reduction in incidence of ovarian cyst-related problems when using estrogen-containing methods. Symptoms related to poly-cystic ovary syndrome, such as acne and hirsutism, often improve. Lighter menstrual cycles contribute to lower incidence of iron deficiency anemia. CHC is associated I. Intr oduction and general background Hormonal contraception is used extensively and success-fully throughout the world for family planning. When used properly, it is highly effective and safe. The most common form of hormonal contraception is the combined oral con-traceptive (COC) pill. Other forms include the progestin-only pill (POP; Minipill), transdermal contraceptive patch, vaginal contraceptive ring, medroxyprogesterone acetate (Depo-Provera®) injection, etonogestrel implant (Implanon®, Nexplanon®), and levonorgestrel intrauterine system (LNG-IUS) (Mirena®, Skyla). Levonorgestrel alone or in a COC pill is used as the emergency contraception pill (ECP). (This should not be used as a regular method of contraception. Ulipristal acetate, an antiprogestin, is the newest option for emergency contraception, and the most effective. ) All of these methods except for Ulipristal contain a form of progestin alone or in combination with an estrogen. The mechanism of contraception is primarily supplied by the progestin, through thickening of the cervical mucus, change in fallopian tube motility, inhibition of ovulation, and prevention of sperm capacitation, and in some cases endometrial atrophy. The addition of estrogen can further inhibit ovulation, and may alter the endometrial lining to prevent implantation. Estrogen helps to prevent breakthrough bleeding and maintain normal cycle patterns (Nelson, Contraceptive T echnology, 2011). Many factors must be weighed in determining if hormonal contraception is appropriate for a patient. Certain medical conditions present contraindications or relative contraindi-cations to hormone use (see U. S. Medical Eligibility Criteria, T able 22-1). Patient compliance and tolerance of side effects are mandatory. Efficacy may be of primary importance to a woman where pregnancy is contraindicated for medical or personal reasons. Time to return of fertility may be impor-tant. Cost may be prohibitive for some patients. High-risk sexual behavior should also be considered, because many patients are less likely to use condoms when using hormonal Lynn Hanson Hormona L Contra C ept I on© Eliks/Shutterstock; © donatas1205/Shutterstock 192 22Chapt Er

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Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Age     Menarche to <40=1Menarche to <18=1Menarche to <18=2Menarche to <18=1Menarche to <20=2Menarche to <20=2   ≥40=2 18-45=1 18-45=1 18-45=1 ≥20=1 ≥20=1     >45=1 >45=2 >45=1     Anatomicabnormalities a) Distorted uterine cavity         4 4 b) Other abnormalities         2 2 Anemias  a) Thalassemia 1 1 1 1 1 2 b) Sickle cell disease‡ 2 1 1 1 1 2 c) Iron-deficiency anemia 1 1 1 1 1 2 Benign ovarian tumors (including cysts) 1 1 1 1 1 1 Breast disease     a) Undiagnosed mass 2* 2* 2* 2* 2 1 b) Benign breast disease 1 1 1 1 1 1 c) Family history of cancer 1 1 1 1 1 1 d) Breast cancer‡             i) current 4 4 4 4 4 1 ii) past and no evidence of current disease for 5 years3 3 3 3 3 1 Breastfeeding(see also Postpartum) a) < 1 month postpartum 3* 2* 2* 2*     b) 1 month or more postpartum 2* 1* 1* 1*     Cervical cancer A waiting treatment 2 1 2 2 4 2 4 2 Cervical ectropion  1 1 1 1 1 1 Cervical intraepithelial neoplasia  2 1 2 2 2 1 Cirrhosis a) Mild (compensated) 1 1 1 1 1 1 b) Severe‡ (decompensated) 4 3 3 3 3 1 (continues)193 Introduction and general background

Clinical Guidelines for Advanced Practice Nursing-1 1.pdf

Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Deep venous thrombosis(DVT)/Pulmonaryembolism (PE)            a) History of DVT/PE, not on anticoagulant therapy            i) higher risk for recurrent DVT/PE 4 2 2 2 2 1 ii) lower risk for recurrent DVT/PE 3 2 2 2 2 1 b) Acute DVT/PE 4 2 2 2 2 2 c) DVT/PE and established on anticoagulant therapy for at least 3 months            i) higher risk for recurrent DVT/PE 4* 2 2 2 2 2 ii) lower risk for recurrent DVT/PE 3* 2 2 2 2 2 d) Family history (first-degree relatives)2 1 1 1 1 1 e) Major surgery             (i) with prolonged immobilization 4 2 2 2 2 1 (ii) without prolonged immobilization2 1 1 1 1 1 f) Minor surgery without immobilization1 1 1 1 1 1 Depressive disorders  1* 1* 1* 1* 1* 1* Diabetes mellitus (DM)     a) History of gestational DM only 1 1 1 1 1 1 b) Non-vascular disease             (i) non-insulin dependent 2 2 2 2 2 1 (ii) insulin dependent‡ 2 2 2 2 2 1 c) Nephropathy/ retinopathy/ neuropathy‡3/4* 2 3 2 2 1 d) Other vascular disease or diabetes of > 20 years' duration‡3/4* 2 3 2 2 1 Endometrial cancer‡  1 1 1 1 4 2 4 2 Endometrial hyperplasia  1 1 1 1 1 1 Endometriosis   1 1 1 1 1 2 Epilepsy‡ (see also Drug Interactions) 1* 1* 1* 1* 1 1(Continued)194 CHAPTER 22 | Hormonal Contraception

Clinical Guidelines for Advanced Practice Nursing-1 1.pdf

Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Gallbladder disease    a) Symptomatic             (i) treated by cholecystectomy 2 2 2 2 2 1 (ii) medically treated 3 2 2 2 2 1 (iii) current 3 2 2 2 2 1 b) Asymptomatic 2 2 2 2 2 1 Gestational trophoblasticdisease a) Decreasing or undetectable ß-h CG levels1 1 1 1 3 3 b) Persistently elevated ß-h CG levels or malignant disease‡1 1 1 1 4 4 Headaches    a) Non-migrainous 1* 2* 1* 1* 1* 1* 1* 1* 1* 1* 1* b) Migraine                       i) without aura, age < 35 2* 3* 1* 2* 2* 2* 2* 2* 2* 2* 1* ii) without aura, age ≥ 35 3* 4* 1* 2* 2* 2* 2* 2* 2* 2* 1* iii) with aura, any age 4* 4* 2* 3* 2* 3* 2* 3* 2* 3* 1* History of bariatricsurgery‡  a) Restrictive procedures 1 1 1 1 1 1 b) Malabsorptive procedures  COCs: 3 3  1 1 1 1 P/R: 1 History ofcholestasisa) Pregnancy-related 2 1 1 1 1 1 b) Past COC-related 3 2 2 2 2 1 History of highblood pressureduring pregnancy  2 1 1 1 1 1 History of pelvic surgery  1 1 1 1 1 1 HIV   High risk 1 1 1* 1 2 2 2 2 HIV infected(see also Drug Interactions)‡1* 1* 1* 1* 2 2 2 2 AIDS(see also Drug Interactions) ‡1* 1* 1* 1* 3 2* 3 2* Clinically well on therapy If on tr eatment, see Drug Interactions 2 2 2 2 Hyperlipidemias   2/3* 2* 2* 2* 2* 1* (continues)(Continued)195 Introduction and general background

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Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Hypertension    a) Adequately controlled hypertension3* 1* 2* 1* 1 1 b) Elevated blood pressure levels (properly taken measurements)            (i) systolic 140-159 or diastolic 90-993 1 2 1 1 1 (ii) systolic ≥ 160 or diastolic ≥ 100‡ 4 2 3 2 2 1 c) V ascular disease 4 2 3 2 2 1 Inflammatory bowel disease(Ulcerative colitis, Crohn's disease) 2/3* 2 2 1 1 1 Ischemic heart disease‡Current and history of 4 2 3 3 2 3 2 3 1 Liver tumors   a) Benign             i) Focal nodular hyperplasia 2 2 2 2 2 1 ii) Hepatocellular adenoma‡ 4 3 3 3 3 1 b) Malignant‡ 4 3 3 3 3 1 Malaria   1 1 1 1 1 1 Multiple risk factors for arterial cardiovascular disease(such as older age, smoking, diabetes, and hypertension)3/4* 2* 3* 2* 2 1 Obesity a) ≥ 30 kg/m 2 body mass index (BMI) 2 1 1 1 1 1 b) Menarche to < 18 years and ≥ 30 kg/m2 BMI2 1 2 1 1 1 Ovarian cancer‡   1 1 1 1 1 1 Parity a) Nulliparous 1 1 1 1 2 2 b) Parous 1 1 1 1 1 1 Past ectopic pregnancy  1 2 1 1 1 1 Pelvic inflammatorydisease   a) Past (assuming no current risk factors of STIs)            (i) with subsequent pregnancy 1 1 1 1 1 1 1 1 (ii) without subsequent pregnancy 1 1 1 1 2 2 2 2 b) Current 1 1 1 1 4 2* 4 2*(Continued)196 CHAPTER 22 | Hormonal Contraception

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Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Peripartum cardiomyopathy‡   a) Normal or mildly impaired cardiac function            (i) < 6 months 4 1 1 1 2 2 (ii) ≥ 6 months 3 1 1 1 2 2 b) Moderately or severely impaired cardiac function4 2 2 2 2 2 Postabortion  a) First trimester 1* 1* 1* 1* 1* 1* b) Second trimester 1* 1* 1* 1* 2 2 c) Immediately post-septic abortion 1* 1* 1* 1* 4 4 Postpartum(see also Breastfeeding)    a) < 21 days 4 1 1 1     b) 21 days to 42 days             (i) with other risk factors for VTE 3* 1 1 1     (ii) without other risk factors for VTE2 1 1 1     c) > 42 days 1 1 1 1     Postpartum (in breastfeeding ornon-breastfeeding women, includingpost-cesareansection)   a) < 10 minutes after delivery of the placenta        2 1 b) 10 minutes after delivery of the placenta to < 4 weeks        2 2 c) ≥ 4 weeks         1 1 d) Puerperal sepsis         4 4 Pregnancy   NA* NA* NA* NA* 4* 4* Rheumatoidarthritis a) On immunosuppressive therapy 2 1 2/3* 1 2 1 2 1 b) Not on immunosuppressive therapy2 1 2 1 1 1 Schistosomiasis a) Uncomplicated 1 1 1 1 1 1 b) Fibrosis of the liver‡ 1 1 1 1 1 1 Severe dysmenorrhea  1 1 1 1 1 2 (continues)(Continued)197 Introduction and general background

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Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Sexually transmitted infections (STIs)  a) Current purulent cervicitis or chlamydial infection or gonorrhea1 1 1 1 4 2* 4 2* b) Other STIs (excluding HIV and hepatitis)1 1 1 1 2 2 2 2 c) V aginitis (including trichomonas vaginalis and bacterial vaginosis)1 1 1 1 2 2 2 2 d) Increased risk of STIs 1 1 1 1 2/3* 2 2/3* 2 Smoking  a) Age < 35 2 1 1 1 1 1 b) Age ≥ 35, < 15 cigarettes/day 3 1 1 1 1 1 c) Age ≥ 35, ≥ 15 cigarettes/day 4 1 1 1 1 1 Solid organtransplantation‡ a) Complicated 4 2 2 2 3 2 3 2 b) Uncomplicated 2* 2 2 2 2 2 Stroke‡ History of cerebrovascular accident 4 2 3 3 2 3 2 1 Superficialvenousthrombosis a) Varicose veins 1 1 1 1 1 1 b) Superficial thrombophlebitis 2 1 1 1 1 1 Systemic lupus erythematosus‡   a) Positive (or unknown) antiphospholipid antibodies4 3 3 3 3 3 1 1 b) Severe thrombocytopenia 2 2 3 2 2 2* 3* 2* c) Immunosuppressive treatment 2 2 2 2 2 2 2 1 d) None of the above 2 2 2 2 2 2 1 1 Thrombogenic mutations‡  4* 2* 2* 2* 2* 1* Thyroid disorders Simple goiter/ hyperthyroid/hypothyroid1 1 1 1 1 1 T uberculosis‡ (see also Drug Interactions) a) Non-pelvic 1* 1* 1* 1* 1 1 b) Pelvic 1* 1* 1* 1* 4 3 4 3 Unexplained vaginal bleeding(suspicious for serious condition) before evaluation2* 2* 3* 3* 4* 2* 4* 2* Uterine fibroids   1 1 1 1 2 2(Continued)198 CHAPTER 22 | Hormonal Contraception

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Table 22-1 Summary Chart of U. S. Medical Eligibility Criteria for Contraceptive Use Key: 1. No r estriction (method can be used) 2. Advantages generally outweigh theor etical or proven risks 3. Theor etical or proven risks usually outweigh the advantages 4. Unacceptable health risk (method not to be used)Updated June 2012. This summary sheet only contains a subset of the recommendations from the US MEC. For complete guidance, see: http://www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm Most contraceptive methods do not protect against sexually transmitted infections (STIs). Consistent and correct use of the male latex condom reduces the risk of STIs and HIV. Condition Sub-condition Combined pill, patch, ring p rogestin-only pill Injection Implant L n G-IUD Copper-IUD     I C I C I C I C I C I C Valvular heart disease a) Uncomplicated 2 1 1 1 1 1 b) Complicated‡ 4 1 1 1 1 1 Vaginalbleedingpatterns a) Irregular pattern without heavy bleeding1 2 2 2 1 1 1 b) Heavy or prolonged bleeding 1* 2* 2* 2* 1* 2* 2* Viral hepatitis  a) Acute or flare 3/4* 2 1 1 1 1 1 b) Carrier/Chronic 1 1 1 1 1 1 1 Drug Inter actions Antiretroviral therapy  a) Nucleoside reverse transcriptase inhibitors1* 1 1 1 2/3* 2* 2/3* 2* b) Non-nucleoside reverse transcriptase inhibitors2* 2* 1 2* 2/3* 2* 2/3* 2* c) Ritonavir-boosted protease inhibitors3* 3* 1 2* 2/3* 2* 2/3* 2* Anticonvulsant therapy a) Certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)3* 3* 1 2* 1 1 b) Lamotrigine 3* 1 1 1 1 1 Antimicrobialtherapy   a) Broad spectrum antibiotics 1 1 1 1 1 1 b) Antifungals 1 1 1 1 1 1 c) Antiparasitics 1 1 1 1 1 1 d) Rifampicin or rifabutin therapy 3* 3* 1 2* 1 1 I = initiation of contraceptive method; C = continuation of contraceptive method; NA = not applicable * Please see the complete guidance for a clarification to this classification: www. cdc. gov/reproductivehealth/unintendedpregnancy/USMEC. htm‡ Condition that exposes a woman to increased risk as a result of unintended pregnancy. This table includes criteria for the copper intrauterine device (IUD) as well as the hormonal methods. Please see the chapter on nonhormonal contraceptive methods for a discussion of the copper IUD. Reproduced from Centers for Disease Control and Prevention. (Updated June 2012). Summary chart of U. S. medical eligibility criteria for contraceptive use. Retrieved from http://www. cdc. gov/reproductivehealth/Unintended Pregnancy/USMEC. htm. (Continued)199 Introduction and general background

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progestational activity. COC pills with greater proges-tational activity may cause weight gain from appetite stimulation, increased varicosities, increased vaginal discharge including moniliasis, and mood changes. Pills with high androgenic activity can cause acne, hirsutism, and increased libido. Appendix 22-1 lists the hormonal contraceptive options available at the time of publication, with comments describing characteristics of each category. Two excellent pocket guides for quick reference for COC pill selection are Managing Contraceptive Pill Patients (Dickey, 2010) and A Pocket Guide to Managing Contraception (Zieman et al., 2010-2012). Additionally, different COC pill combinations have varying effects on high-density lipoprotein and low-density lipoprotein cholesterol, thus affect-ing the potential for serious complications, such as venous thrombosis (VTE) and cardiovascular dis-ease (CVD). This effect is mainly related to the dose of estrogen and only slightly to the type of progestin (Nelson, Contraceptive T echnology, 2011). This should be considered when choosing COCs for users with other risk factors for VTE and CVD (e. g., older age, smoking, diabetes, hypertension, obesity, and family history of VTE or CVD). After COC pills are initiated, patients must be counseled about the symptoms of serious or poten-tially serious side effects, and the possible need for immediate discontinuation. These include: y L oss or distortion of vision (retinal artery throm-bosis) y S evere chest pain (myocardial infarction) y H emoptysis (pulmonary embolism) y S evere unilateral leg pain, swelling, and redness (VTE, thrombosis) y S evere persistent headaches, unilateral numb-ness, weakness or tingling, and slurring of speech (stroke) y A bdominal pain (thrombosis, myocardial infarc-tion, pulmonary embolism, and gallbladder or liver disease) y H eadaches: Patients who develop migraine headaches with aura after starting COC pills should be switched to a progestin-only method. COC pills may be monophasic, with each pill containing the same dose, or multiphasic, with pill weeks containing varying doses of estrogen and progestin. Most COC pills have 21 active pills and 7 inactive or “placebo” pills, allowing for regular menstrual cycling. Several newer formulations extend the active pill days to reduce menstrual flow with a decrease in ectopic pregnancy, pelvic inflamma-tory disease (PID), and benign breast disease. In peri-menopausal women, use of estrogen- c ontaining methods may reduce hot flashes, vaginal dryness, and bone loss. Finally, ovarian, endometrial, and colorectal cancer risk is reduced in users of CHC. Much data has been collected about the safety of the COC pill, and although less is available about the safety of the patch and ring, they seem to have a similar profile. The World Health Organization (WHO) 2015 Medical Eligibility Criteria provide detailed informa-tion on hormonal contraceptive safety and is available on the WHO website (http://apps. who. int/iris/bitstream/10665/181468/1/9789241549158_eng. pdf?ua=1). The U. S. Medical Eligibility Criteria modify these recom-mendations to include situations specific to the U. S. popu-lation, and are listed in this chapter in T able 22-1. 1. C OC pill COC pills have been in use for more than 50 years. When used correctly, the failure rate is 0. 3% in perfect use and 8% in typical use (T russell and Guthrie, Contraceptive T echnology, 2011). There are many different combinations of estrogen-and progestin-containing pills marketed today (for a complete up-to-date list, see Comparison of Hormonal Contraceptive Methods, Appendix 22-1). Most contain ethinyl estradiol, whereas a few of the higher estrogen pills contain mestranol (although 50 mcg is equivalent to only 35 mcg of ethinyl estradiol). Ethinyl estradiol doses range from 20 to 50 mcg, although doses above 35 mcg are rarely used. A new COC pill containing the natural estrogen estradiol is now available under the name Natazia®. This COC contains the progestin dienogest and has been shown to be effective for heavy menstrual bleeding as well as contraception. It has a quadriphasic (four-phase) regimen that necessitates unique “missed pill” instructions (Nelson, 2012). Eight other synthetic progestins are in use in  the United States, ranging in dosage from 0. 1 to 1 mg. The combination of estrogen and progestin determine the efficacy and characteristics of the COC pill. All COC pills have four biologic activities: (1) endometrial activity (defined as the percentage of breakthrough bleeding in the third cycle of use); (2)  estrogenic activity; (3) progestational activ-ity; and (4) androgenic activity (Dickey, 2010). The side effects experienced by many pill users relate to these activities and may be reduced by switch-ing to COC pills with different biologic profiles. For instance, breast swelling and tenderness, nausea, mood changes, and fluid retention resulting in weight gain or headaches are related to the estrogen effect and may be relieved by switching to a pill with greater 200 CHAPTER 22 | Hormonal Contraception

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and related problems. Some have 24 days of active pills and 3 days of placebos. The shortened pill-free interval improves pill efficacy and lessens withdrawal bleeding (Endrikat et al., 2001; Spona et al., 1996). Others have 84 days of active pills, followed by 7 days of placebos. One COC pill formulation is continuous with no placebo days. Extended COC pill use is ideal for women who suffer from menstrual-related (cata-menial) problems or who have conditions, such as endometriosis, that are suppressed by COC pill use. There is no medical necessity for withdrawal bleeding (Miller & Notter, 2001). Women may experience breakthrough bleeding with extended COC pill use and should be counseled that this is not harmful. COC pills offer advantages and disadvantages. COC pills are often preferred by women who feel most comfortable with an oral as opposed to transdermal or vaginal delivery system. However, failure rates are often higher, because timely and consistent dosing requires discipline and motiva-tion. Because of the variety of pill types, more options are available for managing side effects. Most COC pills are now sold generically, thus reducing the cost. A woman may choose to start COC pills in one of three ways:a. Quick s tart allows her to take her first pill on the day she receives the prescription, increasing compliance and reducing the risk of subse-quent pregnancy. A pregnancy test should be performed at the time of her visit, and if indi-cated, emergency contraception should be given, followed by initiation of the first COC pill no later than the next day. She should use a backup method for the first 7 days and return for a urine pregnancy test in 2-3 weeks if pregnancy before starting the COC pill is a possibility. b. F irst day start is another option. The user begins her COC pill on the first day of her menses. This approach reduces the risk of ovarian follicle development in the first cycle, thus reducing the risk of pregnancy. c. S unday start requires the user to start her first pill on the Sunday after her menstrual cycle begins. Many women find it is easier to remember to start a new pill cycle on a Sunday and enjoy the lower likelihood of bleeding on the weekend. However, this approach has the disadvantage of possible ovarian follicle forma-tion, so a backup method should be used for the first 7 days. 2. T ransdermal patch The transdermal patch currently marketed under the name Ortho Evra® is scheduled to be discontinued, but a new generic version, Tulane, is now available. It contains norelgestromin and ethinyl estradiol in a three-layered adhesive polyester patch. The hormonal dose is absorbed through the skin, thus bypassing the liver and gastrointestinal system. A new patch is applied once a week for 3 weeks, followed by a patch-free week, during which withdrawal bleeding will likely occur. The transdermal patch is equivalent to COC pills in efficacy in women who weigh less than 198 pounds (Zieman et al., 2002). Additionally, ease of use improves compliance, although pregnancy rates for women over 90 kg (198 pounds) are slightly higher. Care must be taken to ensure that the patch is completely adhered, because partial or complete separation from the skin has occurred. Although fewer long-term data are available for the patch, it seems to provide similar advantages, risks, and side effects as the COC pill. Serum levels of ethinyl estra-diol are higher in patch users by 60% compared to users of a 35-mcg pill, but epidemiological data are inconsistent as to whether this increases the risk of VTE (Nanda, Contraceptive T echnology, 2011). Some users of the patch have experienced localized reactions, including rash and skin irritation at the site of application. Women with dermatologic conditions may not be candidates for patch use. The same options for starting COC pills are available for patch users; backup methods should be used for quick start and Sunday start options. Management of missed or late patches depends on the week of use; manufacturer instructions should be given to the user. 3. V aginal contraceptive ring The vaginal contraceptive ring (Nuva Ring®) is a soft, flexible ring made of ethylene vinyl acetate that releases ethinyl estradiol and etonogestrel (a metabo-lite of desogestrel) in a low and steady dose. It is worn in the vagina for 3 weeks, and removed for 1 week to allow for withdrawal bleeding. The hormones are absorbed transvaginally, and like the patch, bypass the liver and gastrointestinal system. Circulating levels of hormone are lower than in the transdermal patch or COC pill and do not fluctuate throughout the day. Cycle control is often better than with the COC pill, and there are relatively few side effects (Bjarnadottir, Tuppurainen, & Killick, 2002). Efficacy is comparable to the transdermal patch and COC pill, but similar to patch use, compliance is improved. Users are subject to the same advantages, risks, and side effects as with the other combined hormonal methods; however, some users also experi-ence vaginal discomfort and discharge. The ring may inadvertently be removed with intercourse, so care should be taken to check for its presence postcoitus. 201 Introduction and general background

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11-13 weeks. A subcutaneous dose of 104 mg is also available for self-administration (Depo-sub Q Provera). Medroxyprogesterone acetate is highly efficacious, with a failure rate of 0. 3-3%. It is discreet and convenient and can be used by women with con-traindications to estrogen. Medroxyprogesterone acetate suppresses the follicle-stimulating hormone and luteinizing hormone surge, resulting in ovulation suppression. Additionally, it thickens the cervical mucus, thins the endometrium, and slows tubal motility. Disadvantages include irregular or heavy bleeding; amenorrhea; weight gain; depression; unfa-vorable lipid changes in some women; and decrease in bone density, which is largely reversible (Kaunitz, Arias, & Mc Clung, 2008). Users should be encour-aged to take calcium supplements and exercise regu-larly. Additionally, there can be a delay in return of fertility averaging 10 months from last injection. Medroxyprogesterone acetate is contraindicated in women with breast cancer and should be used with caution in women with CVD and risk factors for CVD, liver disease, and vaginal bleeding with-out explanation. Advantages include convenience; high efficacy; possible decreased menorrhagia and dysmenorrhea; and a reduction in PID, endometrial cancer, fibroids, sickle cell anemia crises, and seizures. Medroxyprogesterone acetate should be initiated any time during the first 7 days of onset of menstrua-tion or at any time if the candidate is not pregnant. A backup method should be used for 7 days if injection occurs outside of the first 7 days of the cycle. 3. I mplants (Implanon®, Nexplanon) Implanon® and Nexplanon are single implants con-taining etonogestrel in an ethylene vinyl acetate capsule. The implant is inserted under the skin of the nondominant upper arm by a trained clinician (train-ing can be obtained through a company-sponsored training session). Nexplanon is the next-generation implant; it is identical to Implanon® with the excep-tion of having a preloaded applicator and the addition of radio-opaque barium sulphate. The implant is the most effective form of birth control, with a 0. 05% failure rate, exceeding tubal ligation efficacy. It is effective for at least 3 years; efficacy is not dependent on user compliance. Its mechanism of action is to thicken the cervical mucus, suppress ovulation, and cause atrophy of the endometrium. It is discrete and can be easily removed at any time with a single inci-sion. Among the advantages of the implant are reduc-tion in menstrual flow and cramping, rapid return of fertility, and high acceptability and continuation. Disadvantages include irregular bleeding, amenor-rhea, pain or infection at implant site postinsertion, When initiating ring use, it is recommended that the first ring be inserted any time within the first 5 days of onset of menses, with backup contraception for the first 7 days. A 1-year vaginal ring containing the progestin Nestorone® and ethinyl estradiol has completed trials and is being prepared for the approval process. A 3-month Nestorone®-only ring is currently in use in some countries and is designed for breastfeeding women. B. Progestin-only contraception Progestin-only contraception is an option for women who cannot take estrogen because of medical contraindications or estrogen-related side effects. Progestin can be taken orally (POP), by injection (medroxyprogesterone acetate), by implant (Implanon®, Nexplanon), or through an intra-uterine system (LNG-IUS; Mirena® and Skyla). Each has its advantages, risks, and potential side effects. The only absolute contraindication to progestin use is current or recent breast cancer, although additional absolute contraindications exist for LNG-IUS (T able 22-1). Relative contraindications to progestin and its delivery systems and conditions that may require monitoring are also listed in T able 22-1 (U. S. Medical Eligibility Criteria guidelines). 1. POP ( Progestin-Only Pill) The POPs contain norethindrone or norgestrel, and no estrogen. The POP has a perfect use failure rate of 0. 3%, and a typical use failure rate of 8%, and requires diligent pill-taking (pill should be taken within 3 hours of same time every day). It is often prescribed during lactation. The main action of the POP is to thicken the cervical mucus; ovulation may or may not be inhibited. Therefore, ovarian cysts are more likely to occur with the POP than with the COC pill (T ayob, Adams, Jacobs, & Guillebaud, 1985). Without the cycle-regulating effect of estrogen, irregular bleeding (breakthrough bleeding, amenor-rhea, or shortened cycles) can occur. There are no placebo pills; active pills are taken every day. If POPs are started within 5 days of the first day of menses, backup contraception is not necessary. If started at other times in the cycle, a pregnancy test should be performed and a backup method used for 2 days. POPs are in general more expensive than COC pills and less effective in controlling medical conditions, such as dysmenorrhea, acne, and hirsutism. POPs protect against uterine and ovarian cancer, PID, and benign breast disease. 2. I njectable progestin (Depo-Provera®) Depo-Provera® (depo medroxyprogesterone acetate), 150 mg, is given by intramuscular injection every 202 CHAPTER 22 | Hormonal Contraception

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and possible weight gain (in clinical studies, mean weight gain in implant users was 2. 8 pounds after 1 year and 3. 7 pounds after 3 years). Implants can be inserted at any time in the cycle, if pregnancy has been ruled out. If inserted within the first 7 days of onset of menses, no additional contraception is needed; otherwise, backup should be used for 7 days. Fertility is restored within 3-6 weeks of removal in 94% of women. Initially cost is high, but if spread out over 3 years of use, it can be less expensive than many other hormonal options. 4. L evonorgestrel intrauterine system (LNG-IUS) LNG-IUS (Mirena®, Skyla®) is an intrauterine system containing levonorgestrel in a capsule molded to a polyethylene T-shaped device. Mirena® releases 20 mcg of levonorgestrel a day for 5 years, and Skyla® releases 14 mcg a day for 3 years. The progestin is released directly into the uterine cavity, with only a small amount of systemic absorption. The amount of plasma concentration is lower than for implants and POPs, but the contraceptive effect remains high. Skyla® is smaller in diameter than Mirena® and has a narrower inserter, making it easier to insert in nulliparous women and better tolerated by teens and perimenopausal women with smaller uterine cavities. LNG-IUS is more than 99% effective in preg-nancy prevention. Two strings are attached to the base, extending through the cervix into the vagina. The strings allow users to check for the presence of the device and facilitate removal. A total of 2-10% are expelled in the first year of use, often without the awareness of the user (it is important to teach the patient to check for her strings regularly). Mechanism of action is through thickening of the cervical mucus, inhibition of sperm capacitation, suppression of the endometrium, and in some cases suppression of ovulation. It is discrete and well tolerated. Noncontraceptive benefits include decrease in menstrual flow and pain and in risk of endometrial cancer. LNG-IUS has been used in the treatment of women with menorrhagia, endometriosis, adeno-myosis, and fibroids, and Mirena® is approved by the Food and Drug Administration (FDA) for the treat-ment of menorrhagia. Disadvantages include pain with and after insertion, especially in nulliparous women; infection postinsertion (0. 1%); perforation of uterus at the time of insertion (less than 0. 1%); spontaneous expulsion; irregular spotting and bleed-ing (usually limited to first 6 months); amenorrhea; ovarian cyst problems; and rare side effects, such as headaches, acne, mood changes, and back and abdominal cramping. The cumulative risk for PID for users of LNG-IUS is 0. 8% over a 5-year period and is higher in women younger than age 25 (Anderson, Odlind, & Rybo, 1994). Cervical cultures for chlamydia and gonorrhea should be performed before insertion in high-risk women, and women should be counseled to use con-doms with new or high-risk partners. The insertion process requires clinician training. It can be inserted immediately after abortion or delivery, and if inserted within the first 7 days of menstrual onset, no backup method is needed. It can be inserted at other times in the menstrual cycle if pregnancy is ruled out. Backup contraception should be used for 7 days. Cost of the LNG-IUS is high, but if it is used for 5 years the overall cost is lower than other hormonal methods. C. ECP ECP provides the only postcoital method of contra-ception (other than the highly effective insertion of a copper-releasing intrauterine device within 5 days of unprotected intercourse). Thus, it is an excellent option after unplanned intercourse, rape, or contraceptive failure (condom breakage, missed COC pills or POPs, delay of more than 14 days in getting medroxyprogesterone acetate injection, delay of 2 or more days in starting a new ring or patch cycle). Prepackaged ECPs containing progestin only (Plan B One-Step, Next Choice, and other generic equivalents) contain 1. 5 mg of levonorgestrel taken once. Ulipristal acetate, a progesterone receptor modulator, is packaged in a 30 mg tablet know as Ella. A third option, CHC pills containing ethinyl estradiol and norgestrel or levonorgestrel, can also be used in two doses taken 12 hours apart (Yuzpe method). ECPs have varying actions depending on the phase of the cycle in which they are taken. They may disrupt normal follicular maturation; interfere with corpus luteal function; or alter the endometrium, cervical mucus, and tubal transport. The first dose should be taken immedi-ately or within 120 hours of unprotected intercourse. Ulipristal is the most effective ECP and is more effective through the fifth day postcoitus than the other ECPs. It may also be more effective in overweight women. Progestin-alone ECPs reduce the risk of pregnancy by 52-100% depending on how soon after coitus they are taken, Ulipristal reduces the risk by an additional 42% up to 72 hours, and 65% in the first 24 hours. Combined estrogen and progesterone pills are less effective than eitherprogestin-only pills or Ulipristal. Efficacy is depen-dent on what phase in the woman's cycle she takes the ECP and how many hours have elapsed since intercourse. Side effects include headache, nausea, and abdominal pain. If a woman vomits within 3 hours of taking ECP she should repeat the dose. ECP may cause early or later menstrual flow. If no bleeding occurs within 3 weeks of taking the dose, a pregnancy test should be performed. 203 Introduction and general background

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j. P revious contraceptive use and satisfaction, compliance, problems k. P reference for and comfort with different hormonal delivery systems (e. g., not fearful of needles and willing to return for repeat injections) (medroxyprogesterone acetate) l. W illingness to undergo a minor procedure (LNG-IUS, implants) m. T olerance of side effects: menstrual cycle dis-turbances, weight gain (medroxyprogesterone acetate), breast tenderness, mood changes, and possible local inflammation and infection (implants) n. F inancial constraints o. C urrent medications p. M enstrual history: age of menarche, character of menses, and date of last menstrual period q. N oncontraceptive benefits: scant or no menses (less anemia), decreased menstrual problems, decreased risk of endometrial and ovarian cancer, decreased risk of PID and fibroids, decreased pain from endometriosis, and fewer seizures and sickle cell crises (medroxyprogesterone acetate) 3. EC P a. A ge b. D ate of last menstrual period c. T ime of unprotected intercourse d. M edical conditions e. C ontraceptive methods used and nature of failure or misuse f. O ccurrence of rape B. Objective (note: the only essential and mandatory components of the exam are blood pressure for combined hormonal contraception and bimanual examination and cervical inspection for IUS insertion. All other components are optional and should be directed by the patient's history) 1. CH C a. B lood pressure and weight b. B reast examination c. S peculum and pelvic examination (not required unless symptomatic) d. P ap smear and testing for sexually transmitted diseases as indicated e. A ssessment for skin conditions (patch use) f. P regnancy test 2. P rogestin-only contraception a. B lood pressure and weight b. B reast examination ECP should not be used as a primary birth control method, because it is less effective than other methods. However, all patients using CHC methods, POP, medroxyprogesterone acetate, and nonhormonal con-traceptives should be advised to obtain ECP as a backup method ahead of need. Pharmacies provide progestin-only ECP to all women without a prescription regardless of age. Ulipristal acetate requires a prescription. II. Database (may include but is not limited to) A. Subjective 1. C ombined hormonal contraceptive (CHC) a. M edical illnesses b. F amily history (especially deep VTE, pulmonary embolism, breast and ovarian cancer) c. P ersonal and social history d. A ge e. P arity and desire for future fertility f. B reastfeeding, postpartum g. P ostabortion h. S moking i. S exual history: recent history of unprotected intercourse, current risk for sexually transmitted disease j. P revious contraceptive use: satisfaction, compli-ance, problems k. P reference for and comfort with different hormone delivery systems l. T olerance of side effects: weight change, breast tenderness, bleeding irregularities, melasma and chloasma, nausea, headaches, libido changes, mood swings, vaginal discharge (vaginal contra-ceptive ring) m. F inancial constraints n. C urrent medication use o. M enstrual history: age of menarche, character of menses, date of last menstrual period 2. P rogestin-only contraception a. M edical illness b. F amily illness c. P ersonal and social history d. A ge e. P arity and desire for future fertility f. B reastfeeding, postpartum g. P ostabortion h. S moking i. S exual history: recent history of unprotected intercourse, current risk for sexually transmitted disease204 CHAPTER 22 | Hormonal Contraception

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c. S peculum examination with Pap smear and cultures for gonorrhea and chlamydia (LNG-IUS), assess for cervical stenosis (LNG-IUS) d. P elvic examination (required for LNG-IUS and if symptomatic) e. P regnancy test 3. EC P 4. P regnancy test III. a ssessment A. CHC 1. N o medical contraindications to estrogen or progestin 2. N onsmoker (if older than age 35) 3. N ot breastfeeding 4. N oncontraceptive benefits: decreased acne and hirsutism; less endometrial and ovarian cancer; decreased benign breast disease; improved cycle control; suppression of endometriosis; less gonorrheal PID; improvement in premenstrual syndrome and perimenopausal symptoms; decreased anemia; fewer ovarian cyst problems; possible reduction in such diseases as polycystic ovary syndrome, rheumatoid arthritis, uterine fibroids, seizure and asthma episodes, colorectal cancer, and osteoporosis; possible improvement of lipid profile 5. N ormotensive 6. N o breast masses 7. N o lifestyle barriers: need for discretion, difficulty remembering to use method, difficulty with storage or access, need for protection against sexually transmitted infections, financial constraints, desire for rapid return to fertility (delayed in some COC users) 8. N o skin rashes (patch) 9. N o physical or psychologic limitations with vaginal insertion or removal (ring) 10. W illing to tolerate side effects B. Progestin-only contraception 1. N o medical contraindications to progestin or vehicle for progestin 2. N oncontraceptive benefits: reduction in menstrual flow and pain, migraine headaches, and ovarian cyst formation (implants) 3. A ppropriate when estrogen contraindicated (smoker, hypertension, lactation, or migraine headache) 4. N o breast masses5. N o lifestyle barriers: need for discretion (POP), difficulty remembering to use method (POP), difficulty with storage or access, need for protection against sexually transmitted infections, financial constraints, desire for rapid return to fertility (medroxyprogesterone acetate), and intolerance of irregular bleeding 6. Obe sity (medroxyprogesterone acetate and trans-dermal patch) 7. H igh efficacy desired (medroxyprogesterone acetate, implants, and LNG-IUS) 8. N o PID, chlamydia, gonorrhea, or cervical or uterine anomalies (LNG-IUS) 9. W illing to tolerate discomfort of delivery (implants and medroxyprogesterone acetate) 10. W illing to tolerate side effects C. ECP 1. W ithin window of effective use (120 hours from unprotected intercourse) 2. W illing to tolerate side effects IV. Goals of clinical management A. Screen for contraindications to contraceptive method B. Management and patient adherence 1. S elect appropriate contraceptive method; discuss risks, benefits, and costs. 2. P rovide counseling and tools to increase compliance. Discuss smoking cessation and prevention of sexually transmitted infections with all methods of contraception. V. p lan A. Screening and diagnostic tests In addition to Pap smear and sexually transmitted infection testing, may include mammogram, pelvic ultrasound (rule out fibroids or other anomalies), lipid testing (if family history of premature CVD), fasting blood sugar (if family history of diabetes), Leiden factor V. B. Management and patient adherence 1. C OC pills a. C hoose any low-dose (≤ 35 mcg) pill. If patient has polycystic ovary syndrome, hirsutism, or acne, choose pill with low androgenic activity. Choose monophasic pill if cycle suppression planned. 205 Plan

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b. W hen possible, have patient insert and remove ring at time of examination to demonstrate com-fort and ease of insertion. c. R ing is usually worn during intercourse but can be removed before intercourse if replaced within 3 hours. If worn with intercourse, check for pres-ence in vagina postcoitus. d. Di spose of used ring in product package. e. Di scuss side effects and warning signs (ACHES). f. Di scuss compliance, tips for remembering insertion and removal dates, what to do if dates missed (ring offers 1 extra week of efficacy), and backup. g. R ecommend ECP be purchased in advance as backup method. 4. POP a. Be gin first pill at any time during the first 5 days of menses, or begin at any time if not pregnant (use backup for 2 days). b. Di scuss compliance, tips for remembering to take pills, what to do if pill missed or late by 3 or more hours (use backup for at least 48 hours). c. M anage side effects: for amenorrhea, rule out pregnancy, then reassure. For irregular bleed-ing, rule out underlying pathology, then reassure. Explain that bleeding is likely to improve within 3 months. For heavy bleeding, nonsteroidal anti-inflammatory medications (NSAIDs) for 3-day course may be beneficial. d. Di scuss interactions with medications (see COC pills). e. R ecommend ECP be purchased in advance as backup method. 5. I njectable progestin (medroxyprogesterone acetate) a. P rovide first injection within 7 days of onset of menses (no backup method needed) or at any time if not pregnant (use backup for 7 days). b. I nject 150 mg intramuscularly deeply into de ltoid or gluteus maximus. c. S chedule subsequent injections every 11-12 weeks. If more than 13 weeks from previous injection, test for pregnancy. Assess for weight gain and depression. d. R eview potential side effects: weight gain, depression, severe headaches, heavy bleeding, and amenorrhea. e. M anage bleeding problems. For heavy bleeding, rule out underlying pathology, then may pro-vide NSAIDs (800 mg ibuprofen every 8 hours for 3 days) or conjugated estrogen (2. 5, 1. 25, or 0. 625 mg one to four times a day for 4-6 days), or COC pills for 1-2 months. For spotting or breakthrough bleeding, rule out underlying b. S elect starting option (first day, quick start, Sunday start) based on patient desire, compli-ance, and willingness to use backup. c. S elect cycling pattern based on patient desire and medical indications (endometriosis, dysmenor-rhea, and menstrual migraines). d. M ay choose prepackaged extended cycle pills or skip placebo pills. e. Di scuss possible side effects and option for changing pill type, breakthrough bleeding, and lack of withdrawal bleeding. f. R eview warning signs (ACHES): i. A bdominal pain ii. C hest pain iii. H eadaches iv. E ye problems v. S evere leg pain g. Di scuss compliance (take at same time every day), tips for remembering pills (e. g., set alarm, put near toothbrush), what to do if pill missed, when to use backup. h. R ecommend ECP be purchased in advance as backup method. i. Di scuss interactions with medications (certain antiretroviral therapy, certain anticonvulsant therapy, rifampicin, St. John's Wort may inter-fere with efficacy; most antibiotics do not lower effectiveness). 2. T ransdermal patch a. S elect starting option (same as for COC pills). b. Di scuss patch placement. i. P lace on clean, dry, skin of lower abdomen, buttock, upper arm, or upper back without rash or abrasion; rotate sites ii. A void use of body lotions and oils; can be worn in shower and bath, during exercise and swimming c. Di scuss compliance including daily patch inspection, tips for remembering patch removal and replacement dates, what to do if dates missed (patch effective for 2 extra days), when to use backup. d. Di scuss side effects, warning signs (ACHES). e. P rovide prescription for replacement patch if patch dislodged. f. R ecommend ECP be purchased in advance as backup method. g. Di spose of used patch in product package to avoid environmental contamination. 3. V aginal contraceptive ring a. I nstruct to insert first ring within first 5 days of onset of menses or at any time if not pregnant (use backup for 7 days). 206 CHAPTER 22 | Hormonal Contraception

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pathology, reassure, or treat as for heavy bleed-ing. For amenorrhea, test for pregnancy if indicated and reassure. f. Di scuss delayed return to fertility of up to 1. 5 years. g. Di scuss bone health, recommend 1,000-1,200 mg of calcium daily and 1,000 IU of vitamin D3 daily, discuss weight-bearing exercise. h. R ecommend ECP be purchased in advance as back up method. 6. I mplants a. I mplants should be inserted by a trained practi-tioner according to manufacturer guidelines. It may be inserted within 7 days of onset of menses (no backup method needed) or at any time in the cycle if not pregnant (backup should be used for 7 days). b. Di scuss possible side effects: irregular bleeding and infection or abscess at insertion site. c. M anage side effects: for amenorrhea, perform pregnancy test, then reassure. For spotting or breakthrough bleeding, rule out underlying pathology, then treat as for medroxyprogester-one acetate. For arm pain and swelling, rule out infection, then treat with icepacks and NSAIDs. For infection without abscess, treat with oral anti-biotics, and recheck in 24-48 hours. For abscess, treat with antibiotics, drain pus, and remove implant. d. R emove implant according to manufacturer guidelines after 3 years or as desired by patient. Discuss rapid return to fertility with patient. 7. LNG-IUS a. I nsertion of LNG-IUS should be performed by a trained clinician, according to manufacturer guidelines. The system can be inserted within the first 7 days of onset of menses; no backup meth-od is needed. It may be inserted at other times if pregnancy is excluded; use backup for 7 days. b. C ervical dilation may be necessary, either with graduated dilators, or misoprostol, 200-μg tablet placed in the vagina or buccal cavity 1-2 hours before insertion. Patients can be premedicated with ibuprofen or with a paracervical block. c. P atients should be observed postinsertion for adverse events, including signs of perforation and vasovagal reaction. d. Adv ise NSAIDs for postinsertion pain. e. P atients may be scheduled for a follow-up visit in 2 months to assess for presence of strings and for side effects; return sooner if problems. f. Di scuss side effects, including menstrual changes and warning signs of expulsion and infection. T each patient how to check for strings. g. Di scuss signs of PID, including prolonged heavy bleeding, unusual discharge, pelvic pain, fever and chills, and dyspareunia. If PID is diagnosed, treat with antibiotics. 8. EC P a. All women who are using COC pills and POPs, rings, and patch should be advised to have ECP available. b. Adv ise patients to purchase ECP in advance. c. P rovide ECP to all patients if unprotected inter-course has occurred within 120 hours; review directions for taking ECP. d. Di scuss possible side effects (nausea and vomit-ing with COC pills; may prescribe antiemetic to take 1 hour before first dose). e. Di scuss possible changes in menstrual cycle post-ECP (early or delayed menses). Recommend pregnancy test if no menses in 3 weeks. f. R eport rape; provide or refer for trauma services. g. Di scuss prevention of sexually transmitted disease, offer testing. h. Adv ise no teratogenic effect if pregnancy occurs. i. Adv ise no prolonged contraceptive effect after ECP dose, may begin new cycle of CHC or POC immediately. j. Di scuss contraceptive compliance, reason for contraceptive failure if indicated. referen Ce S Anderson, K., Odlind, V., & Rybo, G. (1994). Levonorgestrel-releasing and copper releasing (Nova-T) intrauterine devices during five years of use: A randomized comparative trial. Contraception, 49, 56-72. Bjarnadottir, R. I., Tuppurainen, M., & Killick, S. R. (2002). Comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel/ethinyl estradiol. American Journal of Obstetrics and Gynecology, 186, 389-395. Centers for Disease Control and Prevention. (2012). Update to U. S. medical eligibility criteria for contraceptive use. Morbidity and Mortality Weekly Report (MMWR), 61(24), 449-452. Dickey, R. P. (2010). Managing contraceptive pill patients (14th ed. ). New Orleans, LA: EMIS Medical Publishers. Endrikat, J., Cronin, M., Gerlinger, C., Ruebig, A., Schmidt, W., & Düsterberg, B. (2001). Open, multicenter comparison of efficacy, cycle control, and tolerability of a 23-day oral contraceptive regimen with 20 microg ethinyl estradiol and 150 microg desogestrel. Contraception, 64(3), 201-207. Gavin, L., Moskosky, S., Carter, M., Curtis, K., Glass, E., Godfrey, E. et al. (2014). Providing quality family planning services: Recommendations of CDC and the U. S. Office of Population Affairs recommendations and reports. Morbidity and Mortality Weekly Report, 63(RRO4), 1-29. Hatcher, R. A., T russell, J., Nelson, A. L., Cates, W., Jr., Kowal, D., & Policar, M. S. (2011). Contraceptive technology (20th rev. ed. ). New Y ork, NY: Ardent Media, Inc.. Kaunitz, A. M., Arias, R., & Mc Clung, M. (2008). Bone density recovery after depot medroxyprogesterone acetate injectable contraception use. Contraception, 77, 67-76. 207 References

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Miller, L., & Notter, K. M. (2001). Menstrual reduction with extended use of combination oral contraceptive pills: Randomized controlled trial. Obstetrics and Gynecology, 98(5, Pt. 1), 771-778. Nelson, A. L. (2012). New developments in oral contraception: Clinical utility of estradiol valerate/dienogest (Natazia) for contraception and treatment of heavy menstrual bleeding: Patient considerations. Open Access Journal of Contraception, 2012:3, 49-63. Pharmacist's Letter/Prescriber's Letter. (2013). Comparison of oral contraceptives and non-oral alternatives. Stockton, CA: Therapeutic Research Center. Spona, J., Elstein, M., Feichtinger, W., Sullivan, H., Lüdicke, F., Müller, U., et al. (1996). Shorter pill-free interval in combined oral contra-ceptives decreases follicular development. Contraception, 54(2), 71-77. T ayob, Y., Adams, J., Jacobs, H. S., & Guillebaud, J. (1985). Ultrasound dem-onstration of increased frequency of functional cysts in women using progestogen-only oral contraception. British Journal of Obstetrics and Gynaecology, 92, 1003-1009. World Health Organization, Department of Reproductive Health and Research. (2015). Medical eligibility criteria for contraceptive use (5th ed. ). Geneva: Author. Zieman, M., Guillebaud, J., Weisberg, E., Shangold, G. A., Fisher, A. C., & Creasy, G. W. (2002). Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: The analysis of pooled data. Fertility and Sterility, 77(Suppl. 2), S13-S18. Zieman, M., Hatcher, R. A., Cwiak, C., Darney, P. D., Creinin, M. D., & Stosur, H. R. (2010-2012). A pocket guide to managing contraception. Tiger, GA: Bridging the Gap Foundation. 208 CHAPTER 22 | Hormonal Contraception

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appen DIx 22-1: C ompar IS on of H ormona L C ontra C ept IV e met H o DS Table 22-2 Comparison of Oral Contraceptives products m anufacturer e strogen p rogestin Comments LOW-DOSE MONOPHASIC PILLS Aviane-28 Falmina Lessina Lutera Orsythia Sronyx Teva Novast Teva Actavis Qualitest Actavis EE 20 mcg Levonorgestrel 0. 1 mg Low estrogen; low progestin; low androgen. Low estrogen dose may cause more spotting and less margin of error for missed pills. Good choice to minimize risk of estrogen side effects like nausea, breast tenderness, etc. Gildess Fe 1/20Junel 1/20Junel Fe 1/20Loestrin-21 1/20Loestrin Fe 1/20Microgestin 1/20Microgestin Fe 1/20Qualitest Teva Teva Warner Chilcott Warner Chilcott Actavis Actavis EE 20 mcg Norethindrone 1 mg Low estrogen; high progestin; medium androgen. Low estrogen dose may cause more spotting and less margin of error for missed pills. Good choice to minimize risk of estrogen side effects like nausea, breast tenderness, etc. Generess Fe Chewable Actavis EE 25 mcg Norethindrone 0. 8 mg High progestin, low estrogen, high androgen. Good choice to minimize estrogen side effects like nausea, breast tenderness, etc. Altavera Kurvelo Levora Marlissa Nordette-28Portia-28Sandoz Lupin Actavis Glenmark Duramed/Teva Teva EE 30 mcg Levonorgestrel 0. 15 mg Low estrogen; medium progestin; medium/high androgen. Good choice to minimize estrogen side effects like nausea, breast tenderness, etc. Good choice to minimize spotting and/or breakthrough bleeding. Cryselle-28Elinest Low-Ogestrel-21Low-Ogestrel-28Lo/Ovral-28Teva Novast Actavis Actavis Wyeth EE 30 mcg Norgestrel 0. 3 mg Low estrogen; medium progestin; medium/high androgen. Good choice to minimize estrogen side effects like nausea, breast tenderness, etc. and to minimize spotting and/or breakthrough bleeding. Gildess Fe 1. 5/30Junel 1. 5/30Junel Fe 1. 5/30Loestrin 1. 5/30-21Loestrin Fe 1. 5/30Microgestin 1. 5/30Microgestin Fe 1. 5/30Qualitest Teva Teva Warner Chilcott Warner Chilcott Actavis Actavis EE 30 mcg Norethindrone acetate 1. 5 mg Low estrogen; high progestin; high androgen. Good choice to minimize estrogen side effects like nausea, breast tenderness, etc. (continues)209 Appendix

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Table 22-2 Comparison of Oral Contraceptives products m anufacturer e strogen p rogestin Comments Apri Desogen Emoquette Ortho-Cept Reclipsen Solia Teva Organon Qualitest Ortho Actavis Prasco EE 30 mcg Desogestrel 0. 15 mg Low estrogen; high progestin; low androgen. Increased risk of DVT with desogestrel over other progestins (controversial data). Good choice to minimize spotting and/or breakthrough bleeding and to minimize androgenic effects. Has favorable lipid profile. Levonorgestrel/ethinyl estradiol Ocella Safyral Syeda Zarah Yasmin Lupi n T eva Bayer Sandoz Activis Bayer EE 30 mcg Drospirenone 3 mg Low estrogen; progestin potency unclear; antiandrogenic and antimineralocorticoid activity. Does not appear to cause cyclic fluid retention. May be good choice for women with premenstrual syndrome, premenstrual dysphoric disorder, acne, hirsutism, or PCOS. Can increase potassium: avoid in renal/hepatic dysfunction or renal insufficiency. Check potassium during first cycle if another potassium-sparing drug (NSAID, ACE inhibitor, angiotensin receptor blocker, potassium-sparing diuretic, aldosterone antagonist) is given. Safyral contains folate. Kelnor 1/35Zovia 1/35Teva Actavis EE 35 mcg Ethynodiol diacetate 1 mg Medium estrogen; high progestin; low androgen. Good choice to minimize androgenic effects. Mono-Linyah Ortho-Cyclen-28Mono Nessa Norgestimate/ethinyl estradiol Previfem Sprintec Novast Ortho Actavis Glenmark Qualitest Teva EE 35 mcg Norgestimate 0. 25 mg Medium estrogen; low progestin; low androgen. Good choice to minimize spotting and/or breakthrough bleeding and to minimize androgenic effects. Has favorable lipid profile. Necon 1/50Norinyl 1+50Actavis Actavis Mestranol 50 mcg Norethindrone 1 mg Medium estrogen; medium progestin; medium androgen. Ovcon-35Balziva Briellyn Femcon Fe chewable Gildagia Philith Zenchent Zeosa chewable Warner Chilcott Teva Glenmark Warner Chilcott Qualitest Novast Actavis Teva EE 35 mcg Norethindrone 0. 4 mg; total of 8. 4 mg/cycle Medium estrogen; low progestin; low androgen. Good choice to minimize androgenic effects. Has favorable lipid profile. (Continued)210 CHAPTER 22 | Hormonal Contraception

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Table 22-2 Comparison of Oral Contraceptives products m anufacturer e strogen p rogestin Comments Brevicon-28 Modicon-28Necon 0. 5/35Nortrel 0. 5/35Wera Actavis Ortho Actavis Teva Novast EE 35 mcg Norethindrone 0. 5 mg; total of 10. 5 mg/cycle Medium estrogen; low progestin; low androgen. Good choice to minimize androgenic effects. Has favorable lipid profile. Alyacen 1/35Cyclofem 1/35Dasetta 1/35Necon 1/35-28Norinyl 1+35-28Nortrel 1/35-28Ortho-Novum 1/35-28Glenmark Qualitest Novast Actavis Actavis Teva Ortho EE 35 mcg Norethindrone 1 mg; total of 21 mg/cycle Medium estrogen; medium/high progestin; medium androgen. HIGH-DOSE MONOPHASIC PILLS Ovcon-50 Warner Chilcott EE 50 mcg Norethindrone 1 mg High estrogen; medium progestin; medium androgen. Ogestrel 0. 5/50-28 Actavis EE 50 mcg Norgestrel 0. 5 mg High estrogen; high progestin; high androgen. Zovia 1/50-28 Actavis EE 50 mcg Ethynodiol diacetate 1 mg High estrogen; high progestin; medium/high androgen. BIPHASIC PILLS Azurette Mircette Kariva Viorele Actavis Teva Teva Glenmark EE 20 mcg × 21 days, placebo × 2 days, 10 mcg × 5 days Desogestrel 0. 15 mg × 21 days Low estrogen; high progestin; low androgen. Shorter hormone-free interval may help menstrual migraine, dysmenorrhea, PMS. Increased risk of deep vein thrombosis (DVT) with desogestrel over other progestins. Necon 10/11 Actavis EE 35 mcg Norethindrone 0. 5 mg × 10 days, 1 mg × 11 days High estrogen; medium progestin; low/medium androgen. Poor cycle control compared with levonorgestrel triphasic pill. TRIPHASIC PILLS Estrostep Fe Tilia Tilia Fe Tri-Legest Fe Warner Chilcott Actavis Actavis Teva EE 20 mcg × 5 days, 30 mcg × 7 days, 35 mcg × 9 days Norethindrone 1 mg × 21 days Low estrogen; high progestin; medium androgen. FDA-labeled for acne. Good choice to minimize estrogen side effects like nausea, breast tenderness, etc. and to minimize spotting and/or breakthrough bleeding. Norgestimate/ethinyl estradiol Ortho Tri-Cyclen Lo Tri-Lo Sprintec Lupin Ortho Actavis EE 25 mcg × 21 days Norgestimate 0. 18 mg × 7 days, 0. 215 mg × 7 days, 0. 25 mg × 7 days Low estrogen; low progestin; low androgen. Good choice to minimize spotting, breakthrough bleeding, and androgenic effects. Has favorable lipid profile. (Continued) (continues)211 Appendix

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Table 22-2 Comparison of Oral Contraceptives products m anufacturer e strogen p rogestin Comments Caziant Cesia Cyclessa Velivet Actavis Prasco Schering-Plough Teva EE 25 mcg × 21 days Desogestrel 0. 1 mg × 7 days, 0. 125 mg × 7 days, 0. 15 mg × 7 days Low estrogen; high progestin; low androgen. First triphasic pill with desogestrel. Increased risk of DVT with desogestrel over other progestins. Better cycle control and less weight gain than Ortho-Novum 7/7/7. Enpresse Levonest Myzilra Trivora Teva Novast Qualitest Actavis EE 30 mcg × 6 days, 40 mcg × 5 days, 30 mcg × 10 days Levonorgestrel 0. 05 mg × 6 days, 0. 075 mg × 5 days, 0. 125 mg × 10 days. Total of 1. 925 mg/cycle. Medium estrogen; low progestin; low/medium androgen. Better cycle control than with norethindrone biphasic pill (Ortho-Novum 10/11). Ortho Tri-Cyclen Tri-Estarylla Tri-Linyah Tri Nessa Tri-Previfem Tri-Sprintec Ortho Sandoz Novast Actavis Qualitest Teva EE 35 mcg × 21 days Norgestimate 0. 18 mg × 7 days, 0. 215 mg × 7 days, 0. 25 mg × 7 days Medium estrogen; low progestin; low androgen. FDA-labeled for treatment of acne. Aranelle Leena Tri-Norinyl Teva Actavis Actavis EE 35 mcg × 21 days Norethindrone 0. 5 mg × 7 days, 1 mg × 9 days, 0. 5 mg x 5 days. Total of 15 mg/cycle. Medium estrogen; medium progestin; low/medium androgen. Alyacen 7/7/7Cyclafem 7/7/7Dasetta 7/7/7Ortho-Novum 7/7/7Nortrel 7/7/7Necon 7/7/7Glenmark Qualitest Novatest Ortho Teva Actavis EE 35 mcg × 21 days Norethindrone 0. 5 mg × 7 days, 0. 75 mg × 7 days, 1 mg x 7 days. Total of 15. 75 mg/cycle. Medium estrogen; medium progestin; low/medium androgen. FOUR-PHASIC Natazia Bayer Estradiol valerate 3 mg x 2 days, then 2 mg x 22 days, then 1 mg x 2 days, then 2-day pill-free interval Dienogest none x 2 days, then 2 mg x 5 days, then 3 mg x 17 days, then none x 4 days Strong endometrial effect, low androgen effect. Four-phase regimen with minimal effect on lipid profile, fewer metabolic changes. Good choice for heavy menstruation. EXTENDED-CYCLE PILLS Lo Loestrin Fe Warner Chilcott EE 10 mcg x 26 days Norethindrone 1 mg x 24 days High progestin, ultra-low estrogen, medium androgen. Good choice for women with endometriosis, perimenopause, migraine with higher dose estrogen (without aura), smoker < 35 years old. (Continued)212 CHAPTER 22 | Hormonal Contraception

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Table 22-2 Comparison of Oral Contraceptives products m anufacturer e strogen p rogestin Comments Loestrin-24 Fe Warner Chilcott EE 20 mcg × 24 days Norethindrone 1 mg × 24 days Low estrogen; high progestin; medium androgen. Low estrogen dose may cause more spotting and less margin of error for missed pills. Good choice to minimize risk of estrogen side effects like nausea, breast tenderness, etc. 24/4-day cycle combination may be helpful for women wanting to stay on a 28-day cycle, but minimize duration of withdrawal bleeding and menstrual-related symptoms. Amethia Lo Ethinyl estradiol/levonorgestel Lo Seasonique Actavis Lupin Teva EE 20 mcg × 84 days, 10 mcg × 7 days Levonorgestrel 0. 1 mg × 84 days A low dose version of Seasonique. Introvale Jolessa Levonorgestrel/ethinyl estradiol Quasense Seasonale Sandoz Teva Lupin Actavis Teva EE 30 mcg × 84 days Levonorgestrel 0. 15 mg × 84 days84-day active pills then 7-day pill-free interval. More intermenstrual bleeding and/or spotting than with 28-day cycle; total days of bleeding and/or spotting similar. May allow women to experience menstruation-related symptoms less frequently. Amethia Seasonique Actavis Teva EE 30 mcg × 84 days, 10 mcg × 7 days Levonorgestrel 0. 15 mg × 84 days84-day active pills then 7-day low-dose estrogen instead of placebo pills. Extended cycle and lack of hormone-free interval may help menorrhagia, dysmenorrhea, menstrual migraine, and PMS. Beyaz Gianvi Loryna Vestura Yaz Bayer Teva Sandoz Actavis Bayer EE 20 mcg × 24 days Drospirenone 3 mg × 24 days FDA-approved for premenstrual dysphoric disorder and moderate acne. Follows 24/4-day cycle and contains ingredients of Yasmin, but with lower estrogen dose (20 mcg EE compared to 30 mcg EE in Yasmin). Also see Yasmin comments. Beyaz contains folate. CONTINUOUS-CYCLE PILLS Amethyst Actavis EE 20 mcg Levonorgestrel 90 mcg Active pill taken every day (NO pill-free interval). Breakthrough bleeding/spotting common initially and decreases with continued use. May allow women to experience menstruation-related symptoms less frequently. (Continued) (continues)213 Appendix

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Table 22-2 Comparison of Oral Contraceptives products m anufacturer e strogen p rogestin Comments PROGESTIN-ONLY PILLS—"Mini-pill" Camila Errin Heather Jolivette Micronor Nor-QDNora-BETeva Teva Glenmark Actavis Ortho Actavis Actavis Not applicable Norethindrone 0. 35 mg Irregular menses, but overall blood loss reduced. Preferred over COCs in women who are breastfeeding. EMERGENCY CONTRACEPTION Levonorgestrel Ella Plan BNext Choice Perrigo Rand DActavis Teva Actavis Not applicable Ella: Not applicable Levonorgestrel 0. 75 mg tablets × 2 Ella: Ulipristal 30 mg tablet (progesterone receptor modulator)For prevention of pregnancy for women who present within 72 hours of unprotected intercourse or contraceptive failure. Traditional FDA-approved regimen consists of two tablets with the first tablet taken as soon as possible within 72 hours and the second tablet taken 12 hours later. Alternatively, taking both tablets at once is equally effective and is recommended by some experts. Plan B can be considered for a woman who presents within 5 days of unprotected or inadequately protected sexual intercourse; however, it is more effective the earlier it is taken. Plan B is about 89% effective if used within 3 days after sex. Ella: Most effective ECP, may be more effective in overweight women, requires prescription Next Choice One Dose Plan B One-Step Actavis Teva Not applicable Levonorgestrel 1. 5 mg tablet One tablet for prevention of pregnancy for women who present within 72 hours of unprotected intercourse or contraceptive failure. Similar efficacy and adverse effects as Plan B. Data from Therapuetic Research Center. (2013). Pharmacist's Letter / Prescriber's Letter. (Continued)214 CHAPTER 22 | Hormonal Contraception

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Table 22-3 Hormonal Alternatives to Oral Contraception Brand Name Manufacturer Estrogen Progestin Failure Rate Comments Depo-Provera® CI Medroxyprogesterone Acetate Injection Pfizer Sicor None Medroxyprogesterone acetate 150 mg0. 3% Intramuscular injection once every 3 months. Long duration of action may be inappropriate for some women. Noncontraceptive benefits in women with sickle cell disease. May decrease risk of seizures in women with epilepsy. May decrease bone mineral density. Depo-Sub Q Provera 104Pfizer None Medroxyprogesterone acetate 104 mg N/A Subcutaneous injection once every 3 months. FDA approved for use as a contraceptive in December 2004 and for management of pain associated with endometriosis in March 2005. Efficacy similar to Depo-Provera® and medroxyprogesterone injections, but at lower doses. Long-term adverse effects similar to Depo-Provera. Nexplanon® Schering-Plough None Etonogestrel (release rate varies over time)N/A Implantable (subdermal) rod. Provides contraception for up to 3 years. Failure rate = < 1 pregnancy per 100 women using Implanon for 1 year. Effectiveness rate in very overweight women unknown. Mirena® Bayer None Levonorgestrel 20 mcg/day for 5 years0. 1% Intrauterine device (IUD). In October 2009, approved to treat heavy menstrual bleeding in women who use IUDs for contraception. Skyla (IUS) Bayer None Levonorgestrel 14 mcg/day (after first 24 days of insertion) for up to 3 years  Smaller in diameter, narrower inserter, easier to insert in nulliparous women, better tolerated in teens and perimenopausal women. (continues)215 Appendix

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Table 22-3 Hormonal Alternatives to Oral Contraception Brand Name Manufacturer Estrogen Progestin Failure Rate Comments Nuva Ring® Schering-Plough Ethinyl estradiol 15 mcg/day Etonogestrel (active form of desogestrel) 0. 12 mg/day0. 3% Vaginal ring that is left in for 3 weeks and removed for 1 week. May have higher incidence of vaginal discharge than pills. Ortho Evra® Ortho Ethinyl estradiol 35 mcg/day (Release rate extrapolated from Canadian product monograph, which shows identical pharmacokinetic data for Evra [Canada] and Ortho Evra® [U. S. ])Norelgestromin (active form of norgestimate) 200 mcg/day (Release rate extrapolated from Canadian product monograph, which shows identical pharmacokinetic data for Evra [Canada] and Ortho Evra® [U. S. ])0. 3% Transdermal patch applied weekly (for 3 weeks, then week 4 is patch free). Application site reactions. Cycle control poor in 20% of women in first cycle. More breast discomfort in first two cycles than with combined oral contraceptive. Body weight > 90 kg may increase risk of unintended pregnancy. Has been used continuously with nine active patches in a row followed by 7-day patch-free interval. Compliance may improve compared with combined oral contraceptive. Data from Therapuetic Research Center. (2013). Pharmacist's Letter / Prescriber's Letter. (Continued)216 CHAPTER 22 | Hormonal Contraception

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Cartwright, 2012). Previously, the condition was referred to as premature ovarian failure. B. Symptoms 1. V asomotor changes a. D efinition and overview: Symptoms range from flushing or warmth in the face and upper body to sweating and chills lasting about 1-5 minutes (Kronenberg, 1990). Hot flashes can lead to severe sleep disturbances in some women. Hot flashes typically begin when cycles become irregu-lar. Unfortunately, emerging research suggests that women with hot flashes may have an increased risk for cardiovascular disease especially if they have other risk factors (Thurston et al., 2011). b. E tiology: Hot flashes stem from declining levels of estradiol affecting the hypothalamic tempera-ture regulating center. This results in altered ther-moregulation, although the exact mechanism is unknown. In addition, genetic polymorphisms may play a role in how estradiol is synthesized and metabolized, thus affecting vasomotor symptoms (Rebbeck et al., 2010). c. P revalence and incidence: Sixty to eighty percent of women will have vasomotor symp-toms at some point during the menopause tran-sition (Gold et al., 2007). African-American women are more likely to report bothersome vasomotor symptoms and Asian women are least likely to report them (Thurston et al., 2008). They commonly occur up to 5 years after the last menstrual period but about one-third of women have them for up to 10 years (Freeman, Sammel, & Sanders, 2014). 2. Ge nitourinary syndrome of menopause (GSM) a. E tiology and definition: Decreasing estrogen levels lead to a decrease in the production of vaginal lubrication and loss of vaginal elasticity and thickness of the epithelium (Speroff & I. Intr oduction and general background Menopause is the result of the natural decline in the hormones produced in the ovaries. As hormone levels decrease, a num-ber of symptoms may emerge, although their presentation and severity varies greatly from woman to woman. Menopause is a retrospective diagnosis made after complete cessation of the menstrual period for 12 consecutive months (Speroff & Fritz, 2005). The average age of menopause is 51. 4 years old. Women who smoke reach menopause 1. 74 years earlier than non-smokers (Mc Kinlay, Bifano, & Mc Kinlay, 1985). The Stages of Reproductive Aging Workshop (STRAW) +10 (Harlow et al., 2012) is an updated version of the original STRAW criteria developed to more precisely describe the reproductive aging process in women (Soules et al., 2001). Menopause usually occurs between the mid-40s and the mid-50s. The menopause transition is not only marked by physiologic changes; there are also important developmental changes that occur at this time of life. During this transition, women face such issues as the meaning of midlife and aging, role and purpose in life, and changes in interpersonal relationships (children, spouse, and parents) (Deeks, 2002). The experience of the menopause transition is influenced by sociocultural background. Women with a negative attitude toward menopause seem to report more symptoms (Forshaw & Hunter, 2010). This chapter addresses the management of the major symptoms experi-enced by women during the menopause transition. A. Types of menopause 1. S urgical menopause occurs when both ovaries are surgically removed (bilateral oophorectomy). 2. M edical menopause can be induced by the use of certain drugs, such as gonadotropin-releasing hor-mone antagonists, or treatments, such as chemo-therapy or radiation therapy. 3. P remature ovarian insufficiency is the loss of ovar-ian function before the age of 40 years (Davies & Priscilla Abercrombie Meno PAuse Tr A ns ITI on© Eliks/Shutterstock; © donatas1205/Shutterstock 21723Chapt Er

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(Morrison, Brinton, Schmidt, & Gore, 2006). More research is needed to determine whether estrogen may be beneficial when initiated after surgical menopause or early in the menopause transition to prevent cognitive decline. 4. S exual functioning The most common sexual complaints during meno-pause are vaginal dryness and painful sex, low desire, and poor orgasm and satisfaction (Nappi & Lachowsky, 2009). Population-based studies show a decline in many aspects of sexual functioning in con-junction with a decline in estradiol levels, not andro-gen levels (Dinnerstein, 2003). In one Australian study, scores indicating sexual dysfunction rose from 42% to 88% during perimenopause. Sexual function in midlife women is a complex issue that is affected not only by hormonal changes but also by many other fac-tors, such as premorbid sexual functioning, personal-ity, educational level, stress, physical and psychological health status, partner health status, and the woman's feelings toward her partner. The level of distress experi-enced as a result of the sexual problems should also be assessed. Sexual dysfunction can be categorized into disorders of desire, arousal, orgasm, or pain. a. H ypoactive sexual desire disorder is a lack of desire for sexual activity and lack of responsive-ness to sexual stimulation. Decreased sexual desire is a relatively common problem for women. About 24-43% of women complain of low sexual desire. It can become particularly problematic for women during life transitions, such as pregnancy, postpartum, and menopause. b. S exual aversion disorder: intermittent or persis-tent avoidance of sexual contact with a partner because of fear or loathing of such an experience. c. S exual arousal disorder: intermittent or per-sistent inability to attain or maintain adequate sexual excitement. Sexual thoughts that typically produce somatic changes, such as vaginal lubri-cation or swelling, are absent. d. Or gasmic disorder: intermittent or persistent difficult or inability to attain orgasm after suffi-cient stimulation and arousal. e. S exual pain disorder: dyspareunia, vaginismus, noncoital sexual pain. 5. S leep disturbance During the menopause transition, many women suffer from poor sleep and it can have a severe impact on quality of life. a. The pr evalence of sleep disturbance is higher in perimenopausal, postmenopausal, and surgical menopausal women than in premenopausal women (Xu & Lang, 2014). Fritz, 2005). GSM is a new term endorsed by the North American Menopause Society and International Society for the Study of Women's Sexual Health to describe changes in the genital tract associated with a decrease in sex hormones. It includes symptoms of vaginal dry-ness, burning, and irritation; lack of lubrication, discomfort, impaired function or pain during intercourse; and urinary urgency, dysuria and recurrent urinary tract infections (Portman, Gass, & Vulvovaginal Atrophy T erminology Consensus Conference Panel, 2014). b. P revalence and incidence: In a cohort study involving over 1,000 women, 50% experienced problematic vaginal dryness and 40% of the sexu-ally active women had dyspareunia (Huang et al., 2010). In a large online survey of women with vul-vovaginal symptoms 55% experienced dryness, 44% had dyspareunia, and 37% reported irrita-tion (Kingsberg, Wysocki, Magnus, & Krychman, 2013). Vulvovaginal atrophy symptoms affected enjoyment of sex in 59% of participants. 3. M ood and cognition Women are at increased risk for depressive symp-toms and depressive disorders during perimenopause (Bromberger & Kravitz, 2011). Women who experi-ence vasomotor symptoms and insomnia are more at risk for depression (Gyllstrom, Schreiner, & Harlow, 2007). Women with a history of depression especially during reproductive events may be more vulnerable to relapse during perimenopause. a. Di fficulty thinking, forgetfulness, and other cognitive disturbances are frequently reported during the menopause transition. b. Es trogens not only act as hormones but as neurosteroids and neuromodulators that influ-ence cognition (Luine, 2014). The Women's Health Initiative (WHI) Memory study con-cluded that hormone therapy (HT) did not improve cognitive function (Rapp et al., 2003) and increased the risk for dementia in women 65 years and older (Shumaker et al., 2003). c. The “critical period hypothesis” suggests that in order for estrogens to exert positive benefits on the brain they should be given early in the meno-pause transition (Luine, 2014). There is some evidence that giving only short-term HT during perimenopause may have long-term benefits. d. Es tradiol has differing effects on the brain than conjugated equine estrogen used in the WHI studies. There is some evidence that estrogen may reduce the risk of Alzheimer's disease, a devastating disease that largely affects women 218 CHAPTER 23 | Menopause Transition

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hyperlipidemia, thyroid disease, depression or anxiety, liver disease, obesity, prolactinoma, and anorexia. 2. S urgical history: hysterectomy with bilateral oophorectomy. 3. G ynecological history a. Obs tetric history: pregnancies, deliveries, abor-tions, and postpartum issues b. C ontraception and family planning: current and past use, experience with hormonal contraception c. U rinary: recurrent cystitis, interstitial cystitis, overactive bladder, and urinary incontinence d. G ynecological: vulvar disease, vulvar pain disorders, abnormal uterine or vaginal bleed-ing, cervical cancer screening, uterine fibroids, endometriosis, and ovarian cysts e. A natomic issues: organ prolapse, stenosis, scar-ring, cervical mass and Asherman syndrome 4. S exually transmitted infections 5. C ancer: gynecological and breast malignancies; history of treatment with surgery, radiation, chemo-therapy, and/or drugs 6. S exual history a. S exual experience or inexperience b. S exual orientation and gender identity c. B aseline and current receptivity to sex play d. A ssess current pattern and explore if pattern has changed e. Di scuss disparity between patient and partner's desire f. A ssess nonpartner initiated sexual expression (masturbation, erotic dreams, and sexual thoughts) g. A ssess sexual trauma history 7. E xposure history: environmental exposures that affect hormone production. 8. M edication history: medications that affect hormone production (antipsychotics, contraceptives, gonadotropin-releasing hormone antagonists, and so forth) platelet function, liver or kidney function, or sexual function. 9. F amily history: age of menopause, breast and ovarian cancer, and osteoporosis. 10. O ccupational and environmental history: workplace stress. 11. P ersonal social history: religious or cultural considerations, current or past relationship issues, and perception of menopause. 12. R eview of systems. a. C onstitutional signs and symptoms: fatigue, mood, and hot flashesb. S everity of insomnia is associated with frequency of moderate to severe hot flashes (Ensrud et al., 2009). c. HT has been shown to improve perceived sleep quality and sleeping problems better than placebo ( Joffe, Massler, & Sharkey, 2010). d. S leep disturbance is associated with anxiety and depression, aging, primary sleep disorders, medical conditions, and medications. e. P sychosocial and behavioral factors also contribute to sleep issues, making it difficult to treat. A multi-modal approach to treatment is preferred. C. Menstrual cycle disturbances Disturbances in the menstrual cycle are a hallmark of the menopausal transition. Fluctuations in hormone levels lead to variations in cycle length and menstrual flow. Periods of amenorrhea caused by anovulatory cycles can be followed by heavy and prolonged menstrual bleeding. Menstrual cycle length eventually increases especially in the year pre-ceding cessation of menses. During the perimenopause transition follicle-stimulating hormone (FSH) and estra-diol levels rise (Speroff & Fritz, 2005), whereas luteinizing hormone (LH) levels remain normal. Although FSH levels can be high, ovarian follicular development is unpredict-able; thus the use of contraceptive methods is encouraged to prevent unwanted pregnancy. In the postmenopause, FSH and LH levels remain high and estrogen is low. Dysfunctional uterine bleeding may occur because of hor-monal fluctuations. Abnormal menstrual bleeding may be a symptom of endometrial hyperplasia or cancer, and further evaluation with endometrial biopsy may be warranted. 1. M enorrhagia is excessive or prolonged bleeding. Gynecological conditions, such as fibroids, endome-trial polyps, adenomyosis, and anovulation, contrib-ute to menorrhagia. 2. M enometrorrhagia is irregular or frequent excessive bleeding. 3. I ntermenstrual bleeding is bleeding that occurs between menstrual periods. It may be a symptom of endometrial hyperplasia or cancer. 4. P ersistent abnormal vaginal bleeding, suspected ovu-lation resulting in unopposed estrogen, and any post-menopausal bleeding should be investigated further. II. Database (may include but is not limited to) A. Subjective: menopause transition 1. P ast medical history: cardiovascular disease, stroke, venous thromboembolism (VTE), hypertension, 219 Database

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b. Ge nitourinary: heavy menses or amenorrhea, intermenstrual bleeding, dysuria, urinary incon-tinence, dyspareunia, vaginal dryness, decreased sexual arousal or orgasm, and postcoital bleeding c. M usculoskeletal: joint stiffness or pain, myalgias d. N eurologic: lethargy, depressed mood, moodi-ness, decreased libido, and poor short-term memory B. Objective 1. P hysical examination findings a. V asomotor changes: may witness flushing b. U rogenital atrophy (Castelo-Branco, Cancelo, Villero, Nohales, & Julia, 2005). i. V isual inspection changes seen in vaginal epithelium is the most common diagnostic indicator ii. V aginal p H greater than 4. 5 iii. P ale dry vaginal tissues with decreased rugae iv. S hrinkage of labia minora, check for lesions, inflammation, and friability v. I nspect for urethral caruncle, prolapse, or polyps vi. T ightening of introitus secondary to atro-phic changes or other vulvar conditions c. Thinnin g of pubic hair d. C ystocele or rectocele and/or genital prolapse e. M enstrual cycle disturbances: menstrual flood-ing at time of examination, intermenstrual spotting on examination, cervical mass or ste-nosis, uterine fibroids, and ovarian cysts and adnexal mass f. M ood and cognition: inappropriate affect, depressed or anxious affect, crying, and poor cognition during interview g. C otton swab Q-tip test to assess for vulvodynia h. A ssess pelvic floor muscles to rule out pelvic floor muscle dysfunction i. V ulvar lesions III. Assessment A. Determine the diagnosis Menopause transition is diagnosed based on chronologic age, menstrual cycle history, and menopausal symptoms B. Other conditions to consider based on symptoms and examination findings 1. V asomotor symptoms a. C ardiovascular disease b. H yperthyroidism c. P heochromocytomad. C ancere. Effe ct of medications 2. U rogenital atrophy a. U rinary incontinence b. U rinary tract infection c. V ulvar disease d. A trophic vaginitis 3. M enstrual cycle disturbances a. C auses of secondary amenorrhea: hyperprolac-tinemia or prolactinoma, pregnancy, hypothalam-ic dysfunction, thyroid disease, and Asherman syndrome (see Chapter 19 on amenorrhea). b. A bnormal vaginal bleeding: endometrial hyper-plasia and unopposed estrogen, endometrial or cervical cancer, endometrial polyps, adenomyo-sis, pregnancy, thyroid disease, and spontaneous abortion (SAB) (see Chapter 18 on abnormal uterine bleeding). 4. M ood and cognition a. D epression and anxiety disorders b. D ementia and Alzheimer's disease c. S leep disorders 5. S exual dysfunction a. A nxiety and depression disorders and relation-ship issues b. V ulvar disease, vulvar pain disorder, and pelvic floor muscle dysfunction, vaginal atrophy c. S exual trauma history C. Severity Assess the severity of the symptoms and transition 1. The me nopausal rating scale can be found at http:// www. menopause-rating-scale. info/ 2. S ee the review of instruments to measure quality of life during the menopause transition (Shin & Shin, 2012). D. Significance Assess the significance of the transition to the patient and significant others IV. Goals of clinical management A. Alleviate symptoms of the menopause transition that affect quality of life B. Rule out abnormalities C. Prevent major causes of morbidity and mortality 1. O steoporosis 2. C ardiovascular disease and stroke 3. C ancer: lung, breast, and colorectal220 CHAPTER 23 | Menopause Transition

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The addition of a progestogen has not shown a benefit for CHD. Vaginal estrogen should be used for women with vaginal dryness or related dyspareunia. Estrogen can be used alone in women post hysterectomy; otherwise, it should be used with a progestogen to protect against increased risk of endometrial cancer. MHT is an individual decision based on quality of life, health priorities, and risk fac-tors such as age, time since menopause, risk for venous thromboembolism, stroke, isch-emic heart disease, and breast cancer. Oral MHT increases the risk of venous thromboembolism and ischemic stroke. The increased risk of breast cancer with MHT is small. It is primarily associated with the progestogen and the duration of use. The risk decreases once treatment stops. The dose and duration of MHT should be individualized based on goals and safety issues. The use of custom compounded bioidenti-cal hormone therapy is not recommended. Safety data do not support the use of MHT in breast cancer survivors. a. Be nefits: HT is the most effective treatment for vasomotor symptoms and is recommended for women who are experiencing moderate to severe hot flashes. It is also beneficial for the symptoms of genitourinary syndrome. It may improve overall quality of life. The “timing hypothesis” suggests that there may be some cardiovascular disease (CVD) protection when estrogen is started near the onset of menopause (Grodstein, Manson, & Stampfer, 2006). b. C ontraindications (Al-Safi & Santoro, 2014): i. H istory of breast or endometrial cancer, cardiac disease ii. Thr omboembolic disease, uncontrolled hypertension iii. Ac ute liver disease iv. Act ive gallbladder disease v. M igraine headache with aura vi. U ndiagnosed vaginal bleeding c. R isks: there is an increased risk of ischemic stroke, VTE, and breast cancer with HT. The “gap theory” suggests that the risk of breast cancer may be highest when HT is started near menopause (Bhupathiraju & Manson, 2014). Women should not take HT to prevent CVD or to treat heart disease. V. Plan A. Screening 1. C onsult guidelines on healthcare maintenance of the adult for age-appropriate physical exam and screening test recommendations. B. Diagnostic testing based on symptoms 1. F or abnormal bleeding: endometrial biopsy, pelvic ultrasound, complete blood count, and thyroid-stimulating hormone (see Chapter 18 on abnormal uterine bleeding for a more in-depth discussion). 2. F or amenorrhea: pregnancy test, prolactin, thyroid-stimulating hormone, and FSH (see Chapter 19 on amenorrhea for more in-depth discussion). 3. F or mood and cognition symptoms: screen for depression, anxiety, and dementia. 4. F or sexual dysfunction symptoms: consider baseline free testosterone level, lipid profile, and liver enzyme levels, especially important before initiating testosterone therapy. C. Management 1. H ormone therapy (Note: as with prescribing any drug be aware of drug interactions, contraindications for use, and side effects) The results of two large clinical trials, the Women's Health Initiative and the Heart and Estrogen/Progestin Replacement Study in 2002, greatly influenced HT prescribing practices. In 2013 the Global Consensus Statement on Menopausal Hormone Therapy was released (de Villiers et al., 2013). This consensus statement was created by an international panel and is endorsed by many pro-fessional organizations including the Endocrine Society, American Menopause Society, and the American Society for Reproductive Medicine. Key points include: Menopause hormone therapy (MHT) is the most effective treatment for vasomo-tor symptoms and the benefits outweigh the risks before age 60 or within 10 years of menopause. MHT is effective for the prevention of osteoporosis-related fractures before age 60 or within 10 years of menopause. Estrogen-alone MHT may decrease the risk of coronary heart disease (CHD) and all-cause mortality in women younger than 60  or within 10 years of menopause. 221 Plan

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d. Es trogen therapy: there are multiple types of estrogen available in many doses and formu-lations including pills, creams, lotions, and patches. T ransdermal administration of estrogen has been associated with a decreased risk of deep vein thrombosis, stroke, and MI in observational studies (North American Menopause Society, 2012). It may also be more advantageous in the setting of hypertension, gallbladder disease, and diabetes but more research is needed. Start at the lowest effective dose for the shortest dura-tion possible. For examples of preparations and starting doses, see T able 23-1. Of note, vaginal preparations are for the treatment of vaginal symptoms and do not require progesterone for endometrial protection. e. P rogestogen therapy: women with an intact uterus should receive progestogen in addition to estrogen to prevent endometrial hyperpla-sia. Progestins seem to attenuate the beneficial Table 23-1 Estrogen Therapy Oral preparations Starting dose and frequency estradiol 0. 5 mg per day ethinyl estradiol 2. 5 mcg per day conjugated estrogen 0. 3-0. 45 mg per day Transdermal preparation Starting dose and frequency estradiol patch0. 025-0. 0375 mg changed once or twice weekly depending on product Intramuscular preparations Starting dose and frequency estradiol cypionate 1-5 mg every 3-4 weeks estradiol valerate 10-20 mg every 4 weeks Topical preparations Starting dose and frequencyestradiol: gel 0. 06% pump 0. 75 mg/1. 25 g per day estradiol: 0. 06% spray emulsion 1. 53 mg/spray per day Vaginal preparations Starting dose and frequency estradiol 0. 01%1 g one to three times per week after daily use of 2 g for 1-2 weeks conjugated estrogen0. 25-2 g one to three times per week after daily use for 2 weeks estradiol tablet10 mcg/tab twice weekly after daily use for 2 weeks estradiol ring 2 mg ring every 3 months Table 23-2 Progestogen Therapy Oral preparations for cyclic use Starting dose medroxyprogesterone acetate 5-10 mg norethindrone acetate 2. 5-5 mg micronized progesterone 100-200 mg Intrauterine system for long-term uselevonorgestrel-releasing intrauterine system* *A levonorgestrel-releasing intrauterine system appears to offer adequate endometrial protection according to a meta-analysis, but further study is warranted (Somboonporn, Panna, Temtanakitpaisan, Kaewrudee, & Soontrapa, 2011)effects of estrogen on lipids. Oral micronized progesterone may be more advantageous because it appears to have little or no effect on lipids (Writing Group for the PEPI T rial, 1995). Note: Progestogens may worsen depression. For examples of preparations and starting doses, see T able 23-2. f. C ombination therapies: See T able 23-3. g. D osing considerations: advantages, disadvan-tages, and the patient's preferences should be taken into account when prescribing HT. Options are:i. D aily administration of both estrogen and progestogen. ii. I ntermittent progestogen with daily estro-gen. The progestogen could be given on days 1-14 each month. At this time there are inadequate data to support the use of long-cycle regimens, such as a progestogen, every 3 months, vaginal administration of progesterone, or ultralow-dose estrogen without progestogen (North American Menopause Society [NAMS], 2012). h. Di scontinuing therapy: There is a 50% risk of symptoms recurring after HT is discontinued (NAMS, 2008). Recurrence of vasomotor symp-toms is similar whether tapered or if cessation is abrupt. i. B ioidentical HT: bioidentical hormones are thought to more closely mimic the hormones normally found in the female body. There are three different types of estrogen produced in the body: (a) E 2 or estradiol is produced primarily during the reproductive years, (b) E1 or estrone is produced primarily after meno-pause, and (c) E3 or estriol is produced primarily during pregnancy. Each form of estrogen works differently throughout the body. It is thought that estriol may be protective against 222 CHAPTER 23 | Menopause Transition

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endometrial protection (Miles et al., 1994) though this needs to be studied further. ii. The re are Food and Drug Administration (FDA)-approved bioidentical hormones available by prescription. Estradiol comes in many different forms including pills, patches, creams, lotions, and vaginal products. Oral micronized progesterone is also available. iii. C ompounded hormones are non-FDA approved prescription hormones that are prepared by a compounding pharmacist. By compounding the hormones, pharmacists are able to provide a wide range of types of hormones, dosages, and formulations that are not available from pharmaceutical companies. In 2008, the FDA sent warning letters to seven compounding pharmacies for making false claims about the safety and effectiveness of bioidentical hormonal replacement therapy. iv. The re is no evidence that salivary or blood hormone testing should be used to adjust hormone levels (Boothby & Doering, 2008). NAMS has made a statement against the use of compounded hormones and salivary testing (NAMS, 2012). 2. N onhormonal drug (Note: as with prescribing any drug, be aware of drug interactions, contraindications for use, and side effects. ) These drugs include selective serotonin reup-take inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, clonidine, and gabapentin. These drugs are less effective than HT but are a good alterna-tive for women who are not candidates for HT. Most of these drugs have been studied in women with breast cancer, not women experiencing naturally occurring menopause, and were found to be safe for use. a. S SRIs: paroxetine, citalopram, escitalopram, venlafaxine, and desvenlafaxine are all effective in reducing the number and severity of hot flashes (Handley & Williams, 2014). Fluoxetine and sertraline appear to be less effective. Side effects of selective serotonin reuptake inhibi-tors include dry mouth, insomnia, sedation, decreased appetite, constipation, and decreased libido. Severe withdrawal syndrome if discon-tinued abruptly. i. P aroxetine: 10-25 mg daily. The FDA-approved drug for menopause is Brisdelle 7. 5 mg. ii. V enlafaxine: 37. 5 or 75 mg daily. May cause heavy uterine bleeding, galactorrhea, or mastodynia. Table 23-3 Combination Therapies Progesterone and Estrogen Combinations Starting dose and frequency estradiol/levonorgestrel transdermal patch 0. 045/0. 015 mg once weekly estradiol/norethindrone acetate transdermal patch 0. 05/0. 14 mg. twice weekly conjugated estrogen/ medroxyprogesterone oral preparation0. 3/1. 5, 0. 45/1. 5, 0. 625/2. 5, 0. 625/5 mg per day Estrogen and Aldosterone Antagonist Starting dose and frequency estradiol/drospirenone oral preparation 0. 5/0. 5 mg per day Estrogen and Selective Estrogen Receptor Modulator Starting dose and frequency conjugated estrogen/bazedoxifene oral preparation 0. 45/20 mg per day breast cancer but it has not been well studied. Progesterone is the progestogen naturally found in the body. Counseling women about bioidentical hormone therapy can be chal-lenging because terms such as compounded and bioidentical are often times confused. An evidence-based guide for counseling women about bioidentical hormone therapy can be found in the Journal of the American Board of Family Medicine (Sood, Shuster, Smith, Vincent, & Jatoi, 2011). i. The re is mounting evidence that estradiol and micronized progesterone may have some beneficial effects over other synthetic hormones (Holtorf, 2009; Moskowitz, 2006). There is evidence from animal mod-els and observational studies that micron-ized progesterone may pose less risk for breast cancer than medroxyprogesterone acetate (Gadducci, Biglia, Cosio, Sismondi, & Genazzani, 2009). One of the side effects of the breakdown of oral progesterone is sedation; therefore, it can be very helpful for women with insomnia when it is given before bed. Unfortunately, the bioavail-ability of progesterone is low when given orally (< 2%); thus, it may not offer ade-quate endometrial protection (Stanczyk, Hapgood, Winer, & Mishell, 2013). When given per vagina it probably affords better 223 Plan

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b. G abapentin: 900 mg daily. Side effects include somnolence, fatigue, dizziness, and palpitations. May be especially helpful in women with poor sleep and night sweats. c. C lonidine: 0. 025-0. 075 mg twice daily. Side effects include drowsiness, dry mouth, constipa-tion, insomnia, postural hypotension, and reac-tion to skin patch. Discontinue slowly to reduce dose to avoid rebound hypertension, headaches, and agitation. d. Only p aroxetine is FDA approved for the treat-ment of hot flashes. 3. A lternative treatments (Note: as with prescribing any drugs, be aware of drug interactions, contraindications for use, and side effects of any herbal supplements. ) a. P hytoestrogens (red clover, soy isoflavones, etc. ): according to a Cochrane review there is no conclusive evidence that they decrease vaso-motor symptoms (Lethaby et al., 2013). In con-trast, a meta-analysis found an improvement in hot flushes but not the Kupperman Index when compared to placebo (Chen, Lin, & Liu, 2014). No serious side effects were noted. b. B lack cohosh: A Cochrane review of the evidence for the use of black cohosh (Cimicifuga racemosa) was insufficient to support its use for the treatment of menopausal symptoms though other reviewers of the scientific literature found benefit and challenge the Cochrane conclusions (Beer et al., 2013). i. S tudy doses ranged from 20 to 80 mg twice daily. ii. M echanism of action is unknown but unlike-ly hormonal. A systematic review of the clini-cal evidence for the safety of black cohosh found that clinical studies suggest that it is safe, although case reports including liver toxicity have been reported (Borrelli & Ernst, 2008). The U. S. Pharmacopeia also reviewed the case reports and concluded that dietary supplements containing black cohosh should have a cautionary statement on the label: One should discontinue use and consult a healthcare practitioner if there is a liver dis-order or if symptoms of liver trouble develop, such as abdominal pain, dark urine, or jaun-dice (Mahady et al., 2008). Baseline and periodic evaluations of liver enzymes when prescribing black cohosh may be prudent. c. A me ta-analysis found that acupuncture reduced hot flash frequency and severity and improved menopause-related symptoms and quality of life (Chiu, Pan, Shyu, Han, & T sai, 2014). d. M aca (Lepidium meyenii) has been found to have some positive effects on menopausal symptoms but the quality of studies has been poor and there is little safety data (Lee, Shin, Yang, Lim, & Ernst, 2011). Typical doses in studies were 2-3. 5 grams. A review of its use for sexual func-tion also showed mixed results (Shin, Lee, Yang, Lim, & Ernst, 2010). e. Othe r herbs: Maritime pine bark (Pycnogenol®) and flaxseed show some promise in the treat-ment of vasomotor symptoms but more research is needed (Depypere & Comhaire, 2014). 4. M ultiple lifestyle strategies are suggested but there has been little research done to support their efficacy. a. R egulation of core body temperature b. R egular exercise c. R elaxation techniques d. P aced breathing e. W eight loss f. S moking cessation 5. U rogenital atrophy a. V aginal dryness or dyspareunia related to atrophy i. V aginal estrogen a. L ow-dose vaginal tablets, rings, and creams are equally effective (see T able 23-1). b. L ess systemic and endometrial effects with low-dose vaginal estradiol tablets and estriol-containing formulations. Low-dose vaginal estrogen therapy does not generally require a progestogen (NAMS, 2012). c. M ay be of some benefit for women with urge incontinence (NAMS, 2010). d. M ay reduce the risk of recurrent uri-nary tract infection (Perrotta, Aznar, Mejia, Albert, & Ng, 2008). e. Es triol is a weaker estrogen that is well absorbed from vaginal mucosa and improves vaginal atrophy (Griesser, Skonietzki, Fischer, Fielder, & Suesskind, 2012) but must be ordered from a compounding pharmacist in the United States. It is usually given as 1 mg/g nightly for 2 weeks then twice weekly. ii. Es trogen receptor agonist/antagonist: ospemifene is a selective estrogen receptor modulator (SERM) that has been FDA approved for the treatment of dyspareunia related to vaginal atrophy. Side effects include hot flashes. 224 CHAPTER 23 | Menopause Transition

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function and activity among postmenopausal women (Davis & Braunstein, 2012). Specifically, the addition of an androgen to estrogen therapy has demonstrated a sig-nificant positive incremental effect on sex-ual functioning in women (Somboonporn et al., 2005). ii. The us e of testosterone in women with disorders of sexual desire is controversial. The role of testosterone therapy in post-menopausal women: position statement of The North American Menopause Society (2005) states that postmenopausal women who are distressed by decreased sexual desire and have no other known cause (physical or psychological) are candidates for testosterone therapy. iii. S ide effects: decreased high-density lipo-protein and increased low-density lipo-protein, acne, and hirsutism (Elraiyah et al., 2014). In addition, there is a potential for clitoral enlargement, voice deepening, weight gain, menstrual irregularities, and possibly an increased risk of breast cancer. There are inadequate long-term safety data for the use of testosterone. iv. Be nefits: increased clitoral sensitivity, vagi-nal lubrication, and libido v. C ontraindications: history of breast or uter-ine cancer, liver disease, and cardiovascular disease vi. C onsider initiating therapy if below nor-mal or low normal free testosterone. T ransdermal use preferred. Counsel regard-ing risks and benefits of therapy. The use of testosterone in women is off label; there are no FDA-approved products for women. The use of products designed for men may lead to supraphysiologic levels of testoster-one in women. vii. T estosterone 0. 5-2 mg/g cream compounded: apply 2-3 times per week to lower abdomen, mons pubis, inner thigh, or buttocks. Results seen in 6-12 weeks, may first experience erotic dreams. Reevaluation at 3  months: monitor testosterone levels before and after therapy for supraphysiologic levels, lipid pro-file, and liver enzymes; monitor symptoms and side effects. Goal: free testosterone levels in upper normal range. Continued therapy: taper to lowest effective dose, monitor lipids and liver enzymes at 3 months then one to two times per year. iii. V aginal moisturizers a. L ubricants for sexual intercourse iv. M aintain sexual activity: women who are sexually active have less vaginal atrophy v. The re is mounting evidence that DHEA suppositories improve vaginal atrophy, sexual pain, and sexual desire. It is usually given as 12. 5 mg ovule (Archer, 2015). 6. U rinary frequency, urgency, or incontinence (see Chapter 25 on urinary incontinence in women). a. The se symptoms may not be related to estrogen deficiency and often are not relieved with the administration of estrogen alone. b. R efer for urogynecology assessment. 7. M ood and cognition a. D epression i. HT m ay be particularly useful in treating new onset of depression during the meno-pausal transition. HT may play a role in alleviating depressive symptoms during the menopause transition either alone or in combination with antidepressants (T offol, Heikinheimo, & Partonen, 2014). Progestogens may counteract the beneficial effects of estrogen on mood. ii. P sychotherapy referral iii. A ntidepressants iv. R egular physical activity and optimum nutrition avoiding stimulants and sugar b. C ognition: consider referral for neuropsychiatric assessment, physical activity, cognitive stimula-tion through games, languages, new activities, etc. 8. S exual dysfunction: See Al-Azzawi et al. (2010) for a review of therapeutic options for postmenopausal women with sexual dysfunction. Hypoactive sexual desire disorder (HSDD) is a complex condition that is poorly understood among women. Consider hormone therapy. HT (estrogen alone or with a progestogen) given during the perimenopause or early postmenopause has been associated with a mild to moderate improvement in sexual function, particularly pain (Nastri et al., 2013). For decreased desire: a. T reat contributing psychological (e. g., depression or relationship issues) or underlying medical conditions. b. C hange or discontinue medication contributing to decreased desire. c. R efer to a sex therapist or sexologist. d. T estosterone deficiency may be considered one of the underlying causes of HSDD. i. A review of clinical trials has demonstrated that transdermal testosterone improves sexual 225 Plan

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e. Di scuss sexual issues when a new medication is prescribed, presurgery and postsurgery for bilateral oophorectomy f. C onsider lifestyle issues: boredom with sexual routine (give permission for experimentation); stress (importance of relaxation); and children (privacy and relationship time) g. Dir ected resexualization: take 20 minutes three times a week for erotic literature; exercises that increase blood flow to genitals, such as biking; masturbation; and be aware of sexual cues h. H erbal alternatives include American ginseng (Panax quinquefolius ), damiana (Turnera aphrodisiaca ), maca (Lepidium meyenii), and wild oats milky seed (Avena sativa). Although there is a long history of traditional use of herbs for decreased sexual desire, there is little research evidence to support their use. 9. Di sorders of arousal a. O ver-the-counter products include L-arginine (oral), Zestra b. E nhance stimulation and eliminate routine: use erotic materials, masturbation, encourage com-munication during sex; use vibrators, varying positions, times of day or places, and make a date for sex 10. S exual pain disorder a. P rovide distraction techniques (helps with anxiety, increasing relaxation): erotic or nonerotic fantasy, Kegel exercises with sex, background music, or videos or television b. E ncourage noncoital behaviors: sensual massage, sensate-focus exercises, oral or noncoital stimu-lation with or without orgasm D. Client education 1. C oncerns and feelings: discuss menopause transition as a normal physiologic and developmental process that affects each woman uniquely. 2. I nformation: provide verbal and preferably written information regarding the menopause transition, diagnostic tests, and management strategies 3. N utrition a. S even to nine servings of fresh fruits and vegetables b. P lentiful use of grains and beans for 25-30 g of fiber daily c. H ealthy fats: monounsaturated (olive oil, canola oil, avocados, and so forth) and polyunsatu-rated fats and omega-3 fatty acids (flaxseed, fish, walnuts, and so forth) d. P rotein primarily from fish, poultry, and beanse. C alcium from dark green vegetables and nonfat dairy to meet the need of 1,200 mg/day f. A void exposure to plastics, pesticides, and other potential endocrine disruptors. See University of California San Francisco (2015) for more information. 4. P hysical activity a. W eight-bearing exercise for bone strength: walking, dancing, and jump rope b. 30 min utes of aerobic exercise at least 5 days per week c. Flex ibility training, such as yoga, to decrease falls two to three times per week d. S trength training to improve muscle mass two to three times per week 5. S piritual life a. P articipate in activities that bring purpose and meaning to life b. T ake time for reflection i. J ournaling ii. W omen's group iii. W alks in nature iv. R eligious activities: prayer, meditation, and ritual v. R eflective questioning: What keeps you going? What sustains you? Where do you find meaning and purpose in life? Where do you find joy? What or whom do you turn to when you get down? VI. s elf-management resources and tools A. North American Menopause Society: http://www . menopause. org/Consumers. aspx B. American College of Obstetricians and Gynecologists: http://www. acog. org/Patients C. Association of Reproductive Health Professionals: http://www. arhp. org/topics/menopause VII. Clinical pr actice guidelines A. American Association of Clinical Endocrinologists: https://www. aace. com /publications/guidelines226 CHAPTER 23 | Menopause Transition

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Davies, M. C., & Cartwright, B. (2012). What is the best management strategy for a 20-year-old woman with premature ovarian failure? Clinical Endocrinology, 77(2), 182-186. Davis, S. R., & Braunstein, G. D. (2012). Efficacy and safety of testosterone in the management of hypoactive sexual desire disorder in postmeno-pausal women. Journal of Sexual Medicine, 9(4), 1134-1148. de Villiers, T. J., Gass, M. L., Haines, C. J., Hall, J. E., Lobo, R. A., Pierroz, D. D., et al. (2013). Global consensus statement on menopausal hormone therapy. Climacteric: The Journal of the International Menopause Society, 16(2), 203-204. Deeks, A. (2002). Is this menopause? Women in midlife—psychosocial issues. Australian Family Physician, 33(11), 889-893. Depypere, H. T., & Comhaire, F. H. (2014). Herbal preparations for the menopause: Beyond isoflavones and black cohosh. Maturitas, 77(2), 191-194. Dinnerstein, L., Alexander, J., & Kotz, K. (2003). The menopause and sexual functioning: A review of population-based studies. Annual Review of Sex Research, 14, 64-82. Elraiyah, T., Sonbol, M. B., Wang, Z., Khairalseed, T., Asi, N., Undavalli, C., et al. (2014). Clinical review: The benefits and harms of systemic testosterone therapy in postmenopausal women with normal adrenal function: A systematic review and meta-analysis. The Journal of Clinical Endocrinology and Metabolism, 99(10), 3543-3550. Ensrud, K. E., Stone, K. L., Blackwell, T. L., Sawaya, G. F., T agliaferri, M., Diem, S. J., et al. (2009). Frequency and severity of hot flashes and sleep disturbance in postmenopausal women with hot flashes. Menopause (New York, N. Y. ), 16(2), 286-292. Forshaw, M., & Hunter, M. (2010). The impact of attitudes towards the menopause on women's symptom experience: A systematic review. Maturitas, 65, 28-36. Freeman, E. W., Sammel, M. D., & Sanders, R. J. (2014). Risk of long-term hot flashes after natural menopause: Evidence from the Penn Ovarian Aging Study cohort. Menopause (New York, N. Y. ), 21(9), 924-932. Gadducci, A., Biglia, N., Cosio, S., Sismondi, P., & Genazzani, A. R. (2009). Progestagen component in combined hormone replacement therapy in postmenopausal women and breast cancer risk: A debated clinical issue. Gynecological Endocrinology : The Official Journal of the International Society of Gynecological Endocrinology, 25(12), 807-815. Gold, E. B., Lasley, B., Crawford, S. L., Mc Connell, D., Joffe, H., & Greendale, G. A. (2007). Relation of daily urinary hormone patterns to vasomotor symptoms in a racially/ethnically diverse sample of midlife women: Study of Women's Health Across the Nation. Reproductive Sciences (Thousand Oaks, Calif. ), 14(8), 786-797. Griesser, H., Skonietzki, S., Fischer, T., Fielder, K., & Suesskind, M. (2012). Low dose estriol pessaries for the treatment of vaginal atrophy: A double-blind placebo-controlled trial investigating the efficacy of pessaries containing 0. 2mg and 0. 03mg estriol. Maturitas, 71(4), 360-368. Grodstein, F., Manson, J. E., & Stampfer, M. J. (2006). Hormone therapy and coronary heart disease: The role of time since menopause and age at hormone initiation. Journal of Women's Health (2002), 15(1), 35-44. Gyllstrom, M. E., Schreiner, P. J., & Harlow, B. L. (2007). Perimenopause and depression: Strength of association, causal mechanisms and treatment recommendations. Best Practice & Research Clinical Obstetrics & Gynaecology, 21(2), 275-292. Handley, A. P., & Williams, M. (2014). The efficacy and tolerability of SSRI/SNRIs in the treatment of vasomotor symptoms in menopausal women: A systematic review. Journal of the American Association of Nurse Practitioners, 27(1), 54-61. B. NAMS: http://www. menopause . org/for-women/-i-menopro-i-mobile-app. They have a mobile application called Meno Pro for health professionals and consumers. In addition, see the NAMS clinical guidelines (Shifren et al., 2014). C. Obstetrics and Gynaecology of Canada Guidelines: Managing Menopause (Reid et al., 2014). referen Ces Al-Azzawi, F., Bitzer, J., Brandenburg, U., Castelo-Branco, C., Graziottin, A., Kenemans, P., et al. (2010). Therapeutic options for postmenopausal female sexual dysfunction. Climacteric, 13(2), 103-120. Al-Safi, Z. A., & Santoro, N. (2014). Menopausal hormone therapy and menopausal symptoms. Fertility and Sterility, 101(4), 905-915. Archer, D. (2015). Dehydroepiandrosterone intra-vaginal administration for the management of postmenopausal vulvovaginal atrophy. Journal of Steroid Biochemistry and Molecular Biology, 145, 139-143. Beer, A. M., Osmers, R., Schnitker, J., Bai, W., Mueck, A. O., & Meden, H. (2013). Efficacy of black cohosh (cimicifuga racemosa) medicines for treatment of menopausal symptoms-comments on major statements of the Cochrane Collaboration report 2012 “Black Cohosh (Cimicifuga spp. ) for Menopausal Symptoms (Review). ” Gynecological Endocrinology: The Official Journal of the International Society of Gynecological Endocrinology, 29(12), 1022-1025. Berlin Center of Epidemiology and Health Research (2008). MRS—the Menopause Rating Scale. Retrieved from http://www. menopause-rating-scale. info/about. htm. Bhupathiraju, S. N., & Manson, J. E. (2014). Menopausal hormone therapy and chronic disease risk in the Women's Health Initiative: Is timing everything? Endocrine Practice: Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 20(11), 1201-1213. Boothby, L. A., & Doering, P. L. (2008). Bioidentical hormone therapy: A panacea that lacks supportive evidence. Current Opinion in Obstetrics and Gynecology, 20(4), 400-407. Borrelli, F., & Ernst, E. (2008). Black cohosh (Cimicifuga racemosa): A systematic review of adverse events. American Journal of Obstetrics and Gynecology, 199(5), 455-466. Bromberger, J. T., & Kravitz, H. M. (2011). Mood and menopause: Findings from the Study of Women's Health Across the Nation (SWAN) over 10 years. Obstetrics and Gynecology Clinics of North America, 38(3), 609-625. Castelo-Branco, C., Cancelo, M., Villero, J., Nohales, F., & Julia, M. (2005). Management of post-menopausal vaginal atrophy and atrophic vaginitis. Maturitas, 525, 546-552. Chen, M. N., Lin, C. C., & Liu, C. F. (2014). Efficacy of phytoestrogens for menopausal symptoms: A meta-analysis and systematic review. Climacteric: The Journal of the International Menopause Society, 18(2), 260-269. Chiu, H. Y., Pan, C. H., Shyu, Y. K., Han, B. C., & T sai, P. S. (2014). Effects of acupuncture on menopause-related symptoms and quality of life in women on natural menopause: A meta-analysis of randomized controlled trials. Menopause (New York, N. Y. ), 22(2), 234-244. 227 References

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Harlow, S. D., Gass, M., Hall, J. E., Lobo, R., Maki, P., Rebar, R. W., et al. (2012). Executive summary of the stages of reproductive aging workshop + 10: Addressing the unfinished agenda of staging reproductive aging. Fertility and Sterility, 97(4), 843-851. Holtorf, K. (2009). The bioidentical hormone debate: Are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgraduate Medicine, 121(1), 73-85. Huang, A., Moore, E. E., Boyko, E. J., Scholes, D., Lin, F., Vittinghoff, E., et al. (2010). Vaginal symptoms in postmenopausal women: Self reported severity, natural history, and risk factors. Menopause, 17(1), 121-126. Joffe, H., Massler, A., & Sharkey, K. M. (2010). Evaluation and management of sleep disturbance during the menopause transition. Seminars in Reproductive Medicine, 28(5), 404-421. Kingsberg, S. A., Wysocki, S., Magnus, L., & Krychman, M. L. (2013). 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United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause, 15(4), 628-638. Mc Kinlay, S. M., Bifano, N. L., & Mc Kinlay, J. B. (1985). Smoking and age at menopause in women. Annals of Internal Medicine, 103(3), 350-356. Miles, R. A., Paulson, R. J., Lobo, R. A., Press, M. F., Dahmoush, L., & Sauer, M. V. (1994). Pharmacokinetics and endometrial tissue levels of progesterone after administration by intramuscular and vaginal routes: A comparative study. Fertility and Sterility, 62(3), 485-490. Morrison, J. H., Brinton, R. D., Schmidt, P. J., & Gore, A. C. (2006). Estrogen, menopause, and the aging brain: How basic neuroscience can inform hormone therapy in women. Journal of Neuroscience: The Official Journal of the Society for Neuroscience, 26(41), 10332-10348. Moskowitz, D. (2006). A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks. Alternative Medicine Review, 11(3), 208-223. Nappi, R. E., & Lachowsky, M. (2009). Menopause and sexuality: Prevalence of symptoms and impact on quality of life. Maturitas, 63(2), 138-141. Nastri, C. O., Lara, L. A., Ferriani, R. A., Rosa-E-Silva, A. C., Figueiredo, J. B., & Martins, W. P. (2013). Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database of Systematic Reviews, 6, CD009672. North American Menopause Society. (2005). The role of testosterone therapy in postmenopausal women: Position statement of the North American Menopause Society. Menopause, 12(5), 496-511; quiz 649. North American Menopause Society. (2008). Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society. Menopause, 15(4 Pt 1), 584-602. North American Menopause Society. (2012). The 2012 hormone thera-py position statement of: The North American Menopause Society. Menopause (New York, N. Y. ), 19(3), 257-271. Perrotta, C., Aznar, M., Mejia, R., et al. (2008). Oestrogens for preventing recurrent urinary tract infection in postmenopausal women. The Cochrane Database of Systematic Reviews, (2), CD005131-. Portman, D. J., Gass, M. L., & Vulvovaginal Atrophy T erminology Consensus Conference Panel. (2014). Genitourinary syndrome of menopause: New terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause (New York, N. Y. ), 21(10), 1063-1068. Rapp, S. R., Espeland, M. A., Shumaker, S. A., Henderson, V. W., Brunner, R. L., Manson, J. E., et al. (2003). Effect of estrogen plus progestin on global cognitive function in postmenopausal women: The Women's Health Initiative Memory Study: A randomized controlled trial. JAMA, 289(20), 2663-2672. Rebbeck, T. R., Su, H. I., Sammel, M. D., Lin, H., T ran, T. V., Gracia, C. R., et al. (2010). Effect of hormone metabolism genotypes on steroid hormone levels and menopausal symptoms in a prospective population-based cohort of women experiencing the menopausal transition. Menopause (New York, N. Y. ), 17(5), 1026-1034. Reid, R., Abramson, B. L., Blake, J., Desindes, S., Dodin, S., Johnston, S., et al. (2014). Managing menopause. Journal of Obstetrics and Gynaecology Canada: JOGC = Journal d'Obstetrique et Gynecologie du Canada: JOGC, 36(9), 830-833. Shifren, J., Gass, M., & NAMS Recommendations for Clinical Care of Midlife Women Working Group 2014. The North American Menopause Society recommendations for clinical care of midlife women. Menopause, 21(10), 1038-1062. Shin, B. C., Lee, M. S., Yang, E. J., Lim, H. S., & Ernst, E. (2010). Maca (L. meyenii) for improving sexual function: A systematic review. BMC Complementary and Alternative Medicine, 10, 44-6882-10-44. Shin, H., & Shin, H. S. (2012). Measurement of quality of life in menopausal women: A systematic review. Western Journal of Nursing Research, 34(4), 475-503. Shumaker, S. A., Legault, C., Rapp, S. R., Thal, L., Wallace, R. B., Ockene, J. K., et al. (2003). Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: The Women's Health Initiative Memory Study: A randomized controlled trial. JAMA, 289(20), 2651-2662. Somboonporn, W., Davis, S., Seif, M., & Bell, R. (2005). T estosterone for peri-and postmenopausal women. Cochrane Database of Systematic Reviews, 19(4), CD004509. Somboonporn, W., Panna, S., T emtanakitpaisan, T., Kaewrudee, S., & Soontrapa, S. (2011). Effects of the levonorgestrel-releasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women: Systematic review and meta-analysis. Menopause (New York, N. Y. ), 18(10), 1060-1066. Sood, R., Shuster, L., Smith, R., Vincent, A., & Jatoi, A. (2011). Counseling postmenopausal women about bioidentical hormones: T en discussion points for practicing physicians. Journal of the American Board of Family Medicine, 24(2), 202-210. Soules, M. R., Sherman, S., Parrott, E., Rebar, R., Santoro, N., Utian, W., et al. (2001). Executive summary: Stages of reproductive aging workshop (STRAW). Climacteric: The Journal of the International Menopause Society, 4(4), 267-272. 228 CHAPTER 23 | Menopause Transition

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T offol, E., Heikinheimo, O., & Partonen, T. (2014). Hormone therapy and mood in perimenopausal and postmenopausal women: A narrative review. Menopause (New York, N. Y. ), 22(5), 564-578. University of California San Francisco, Program on Reproductive Health and the Environment (2015). Information for families. Retrieved from http://www. prhe. ucsf. edu/prhe/toxicmatters. html. The Writing Group for the PEPI T rial. (1995). Effects of estrogen or estrogen/ progestin regimens on heart disease risk factors in postmenopausal women. The Postmenopausal Estrogen/Progestin Interentions (PEPI) T rial. JAMA, 273(3), 199-208. Xu, Q., & Lang, C. P. (2014). Examining the relationship between subjective sleep disturbance and menopause: A systematic review and meta-analysis. Menopause (New York, N. Y. ), 21(12), 1301-1318. Speroff, L., & Fritz, M. (2005). Menopause and perimenopause transition. In L. Speroff & M. Fritz, Clinical gynecologic endocrinology and infertility (7th ed., pp. 621-688). Philadelphia, PA: Lippincott Williams & Wilkins. Stanczyk, F. Z., Hapgood, J. P., Winer, S., & Mishell, D. R., Jr. (2013). Progestogens used in postmenopausal hormone therapy: Differences in their pharmacological properties, intracellular actions, and clinical effects. Endocrine Reviews, 34(2), 171-208. Thurston, R. C., Bromberger, J. T., Joffe, H., Avis, N. E., Hess, R., Crandall, C. J., et al. (2008). Beyond frequency: Who is most bothered by vasomotor symptoms? Menopause (New York, N. Y. ), 15(5), 841-847. Thurston, R. C., Sutton-Tyrrell, K., Everson-Rose, S. A., Hess, R., Powell, L. H., & Matthews, K. A. (2011). Hot flashes and carotid intima media thickness among midlife women. Menopause (New York, N. Y. ), 18(4), 352-358. 229 References

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rates. T erms used to identify these rates are “perfect use” and “typical use. ” Perfect use (reported as a percentage) refers to the number of women out of 100 who prevent pregnancy in 1 year with correct and consistent use of the method. Typical use refers to the percentage of women out of 100 who do not use the method consistently or correctly each time and over 1 year still avoid pregnancy (T russell, 2008). A. Barrier methods A barrier method of contraception is one that is designed to physically prohibit sperm from entering the vagina or the uterus during intercourse. The current barrier methods available in the United States include the male condom, the female condom, the diaphragm, the Fem Cap, and the sponge. Effectiveness rates increase when combined with a spermicidal agent, such as nonoxynol-9, discussed in a later section. 1. M ale condom The condom is a barrier method of contraception designed to prevent sperm from entering the vagina. Made of latex, polyurethane, or lambskin, male condoms come in a variety of textures, colors, and sizes, and with or without spermicide and with or without lubrication, each intended to improve user acceptance of the method. Additionally, they are avail-able with or without reservoir tips, designed to help prevent spillage of the ejaculate; therefore, reservoir tips are usually recommended. Male condoms are placed on a man's erect penis before genital contact with a partner. Condom use instructions should be carefully followed because correct placement and removal are essential to avoid pregnancy. Perfect use efficacy rate for the male condom is 98%, whereas typical use rate is 85% (T russell, 2008). One of the major advantages of using either latex or polyurethane male condoms for contraception is that they also help prevent sexually transmitted infections (STIs) including HIV (NIAID, 2011). However, although lambskin condoms protect equally as well I. Intr oduction and general background Nonhormonal contraception is a form of family planning used by couples during coitus or postcoitally to prevent preg-nancy without the use of exogenous hormones. It includes barrier methods that can be used by either the male or female partner and placed before genital contact; spermicides, placed inside the vagina moments or minutes before genital contact; the Para Gard® intrauterine contraceptive (IUC), placed inside a woman's uterus by her provider in advance or in some cases up to 5 days after unprotected intercourse as emergency contraception (EC); and natural family planning (NFP) methods, which are learned behaviors and include fertility awareness methods (FAM) and the lactational amenorrhea method (LAM). Nonhormonal contraception can be an appropriate option for most women, although most of the methods, excluding the IUC and strict NFP, have effectiveness rates that are lower than those containing hormones. Still, many women or couples prefer to use nonhormonal methods for a variety of reasons including but not limited to contraindication to hor-mones, reduced side effect profile, past experience, religious beliefs, and personal values. Advantages of nonhormonal contraception include few or no side effects for most meth-ods, low long-term cost, no clinic visit required for several of the methods, and in all cases near immediate effective-ness and an immediate return to fertility once the method is stopped. With all of the methods discussed in this chapter, a patient should also be offered the EC pill or a prescription as a backup in case of user or method failure. The EC pill is discussed in a separate chapter. Choosing a method of family planning is a multifaceted process. Patients need current, factual information about all methods of contraception and must be allowed to participate fully in the decision-making process. Efficacy rate is an important component in choosing a contraceptive method. In this chapter, efficacy rates are reported rather than failure Kimberley Chastain No Nhormo Nal Co N tra C ept I o N© Eliks/Shutterstock; © donatas1205/Shutterstock 230 24Chapt Er

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minimum of 6 hours after intercourse to ensure that all sperm are immobilized. The sponge should not be left in the vagina longer than 30 hours because of the risk of toxic shock syndrome. Perfect use efficacy rates for the contraceptive sponge are 91% for nulliparous women and 80% for parous women, whereas typical use yields efficacy of 84% for nulliparous and 68% for parous women (T russell, 2008). Advantages to using the sponge are that it is readily available over the counter and does not require a prescription or examination. Disadvantages include risk of sensitivity or allergy to nonoxynol-9 and the fact that it must be moistened with water before insertion, requiring advance preparation. The only absolute contraindications to use are current cervical cancer or women at high risk for HIV (WHO, 2009) because of the nonoxynol-9 component (see the section on spermicides). 4. Di aphragm The diaphragm is one of the first female-worn bar-rier methods to be used in the United States. The dia-phragm is a physical barrier made of silicone in the shape of a dome surrounded by a flexible “spring” rim, designed to be placed deep inside the vagina blocking the cervix entirely. Diaphragms are available in several different rim styles and diameters ranging from 55 to 95 mm. Because of the wide range of female anatomic differences, the diaphragm style and size must be fit for the patient during a pelvic examination by a trained provider. T o use the diaphragm, a woman should check for integrity before insertion. A dime-sized amount of spermicidal jelly or cream is placed in the cup side of the dome and extra spermicide is placed around the rim. Pinching the diaphragm in half, the user places it deep inside her vagina making sure to completely cover the entire cervix, requiring both education and practice. The diaphragm must be kept in the vagina for at least 6 but no more than 24 hours after intercourse. Spermicide must be reinserted vaginally with every new act of intercourse while the diaphragm is in place. Perfect use effectiveness rate for the diaphragm is 94%, whereas typical use is 84% (T russell, 2008). Advantages to the diaphragm are that it is nonlatex, it can be placed well in advance of sexual intercourse (≤ 24 hours), it is discrete, and it is relatively inex-pensive considering that each one lasts up to 2 years, with the only additional cost being extra spermicide. Additionally, it has been observed that the diaphragm may reduce the risk of human papillomavirus transmis-sion (by blocking the cervix) and therefore lower the risk of cervical dysplasia (Cates & Raymond, 2007). Disadvantages are that it is available by prescrip-tion only and must be fit in the clinic by a provider. against pregnancy as other condoms, they do not protect against most STIs or HIV. Other advantages to condoms include cost (male condoms are relative-ly inexpensive compared with other methods), the ability to offer men a role in contraception, the lack of physical examination or prescription requirement, ready availability over the counter, and a low side effect profile. Additionally, they can be used simul-taneously with every other available birth control method except the female condom. Disadvantages include possible allergies or sensitivities to latex, reduction in sexual spontaneity, need for coopera-tion by the partner, and the possibility for breakage or slipping off, resulting in method failure. 2. F emale condom Currently, there is only one female condom approved by the Food and Drug Administration (FDA) for use in the United States. Formerly known as the “Reality,” the second-generation female condom is called the FC2®, and is produced by the Female Health Company. Made of synthetic nitrile, the FC2® has a flexible inner ring that facilitates insertion into the vagina, with a sec-ond outer ring designed to hold it in place and cover part of the vulva. Perfect use of the female condom confers a 95% efficacy rate, compared with 79% with typical use in the first year (T russell, 2008). Advantages to using the female condom include the fact that it is relatively inexpensive (although more expensive than the male condom) and is available over the counter without an examination or prescription. Additionally, it reduces the risk of STIs including HIV in laboratory testing (French et al., 2003), giving women an opportunity to actively play a role in preventing HIV and STI transmission during intercourse. Disadvantages are that it can be somewhat awkward to place correctly and can become dislodged easily. Of note is that the female condom should not be used simultaneously with a male condom, because they can stick to one another, causing one or both to slip off or tear. 3. C ontraceptive sponge The contraceptive sponge was first introduced to the U. S. market as the T oday® Sponge in 1983. However, after multiple production stops and starts, it was reintroduced most recently in May 2009 by Mayer Laboratories. The polyurethane sponge acts as a physical barrier to sperm by trapping them within the sponge before they can enter the cervix. Additionally, the sponge contains the spermicide nonoxynol-9 for added protection. Before insertion, the sponge must be moistened with water to activate the sper-micide. It is then placed deep inside the vagina, with the concave side toward the cervix, up to 24 hours before intercourse. The sponge must be left in place a 231 Introduction and general background

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cancer or women at high risk for HIV (WHO, 2009) because of the use of a spermicide. Patients must be given a prescription for the Fem Cap, which they can use to order it online through www. femcap. com. B. Spermicides Contraceptive spermicides are formulations of a gel, foam, cream, suppository, or film base that have an added surface-active chemical to kill sperm. The only currently approved spermicidal chemical in the United States is nonoxynol-9. If a spermicidal formulation is correctly inserted into the vagina before intercourse, the efficacy rate for perfect use is 85%, whereas typical use is 71% (T russell, 2008). Following package instructions is essential because of the fact that each formulation may require different amounts of time to dissolve or disperse to be effective. Spermicidal formulations require reinsertion after 1 hour and after each act of intercourse. They are commonly used with barrier methods, such as male and female condoms; come already imbedded in the sponge; and are recommended as stan-dard practice with diaphragms and the Fem Cap to achieve full efficacy rates. Advantages of spermicides are that no examination or prescription is required, they are readily available over the counter, they are relatively inexpensive, they provide lubrica-tion during sex, and they increase efficacy of other methods. Disadvantages are that they can be somewhat messy, sup-positories or film may require up to 15 minutes to dissolve, and some people experience allergies or irritation with use. Additionally, studies have shown that there is a possible increased risk of genital ulceration or epithelial disrup-tion from the use of nonoxynol-9, which could actually facilitate STI transmission including HIV, especially in frequent users (considered more than two times per day) (WHO, 2002). For women who are at low risk for STIs, spermicides remain a good contraception option. C. Copper T 380-A intrauterine contraceptive (Para Gard ®) 1. I UC as long-acting reversible contraceptive Approved by the FDA in 1984, the Copper T 380-A, also known as the Para Gard®, is an IUC made of poly-ethylene shaped like a “T,” wrapped in fine copper wire. Placed inside a woman's uterine cavity through the cervix by a trained provider, the IUC is consid-ered a long-acting reversible contraceptive (LARC) and is highly effective at preventing pregnancy. Two monofilament threads (strings) are attached to the base of the device, extending through the cervix into the vaginal cavity. The strings are provided to facilitate removal but are also a convenient way for the patient to check for the presence of her IUC monthly by feel-ing for them with her finger. Because there is nothing for the patient to do after receiving the IUC to activate It should normally be replaced every 2 years, but refit-ting is required after any full-term pregnancy, second-trimester abortion, or a weight gain or loss of 20% or more. Although not contraindicated, diaphragms should be used with caution in women with a history of repeated urinary tract infections. Absolute contrain-dications include women with current cervical cancer and those women at high risk for HIV (WHO, 2009) because of the necessary spermicide use. In 2014, Janssen, the manufacturer of Ortho Flex diaphragms, discontinued their manufacture due to low usage. Only Omniflex diaphragms are currently available in the United States, and providers can order these directly for their patients through their customer service department, as pharmacies typically do not stock them. 5. F em Cap Because former contraceptive cervical caps, such as the Prentif and Lea's Shield®, have gone by the way-side, the Fem Cap is currently the only cap available on the U. S. market. Approved by the FDA in March 2003, the current version is a small silicone device shaped similarly to a sailor's cap, designed to cover the cervix and be held in place by the muscular walls of the vagina. The major difference between the cur-rent and original Fem Cap device introduced in 1999 is that it now includes a strap for easier removal. The Fem Cap comes in three diameter sizes: small (22 mm) for nulligravida women, medium (26 mm) for women with prior pregnancies that resulted in only abortion or cesarean delivery, and large (30 mm) for parous women with a history of vaginal delivery. Although not required, fit is best determined by a provider to check sizing in the clinic because of differ-ences in female anatomy regardless of parity. Fem Cap must be used along with a spermicidal jelly, placed both in the “bowl” of the cap and around its “brim. ” It is then placed by the user with its concave side directly over her cervix up to 40 hours before intercourse and ideally at least 15 minutes before any female sexual arousal. Effectiveness data for the first generation Fem Cap showed a failure rate of 14% among nulliparous women and 29% among women who have had a vaginal delivery (Fem Cap, 2015). Like the diaphragm and sponge, the Fem Cap must be left in place at least 6 hours after intercourse; however, it can be left in place for a full 48 hours if necessary. Advantages of the Fem Cap are that it is nonlatex, is discrete, and can be placed well ahead of sexual inter-course. Disadvantages are that it requires a prescrip-tion, sizing and fit are best done by an experienced provider, and it must be replaced every year or after any new pregnancy. The only absolute contraindi-cations to use of the Fem Cap are current cervical 232 CHAPTER 24 | Nonhormonal Contraception

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it, perfect use and typical use efficacy rates are similar at 99. 4% and 99. 2%, respectively (T russell, 2008). This difference results from a perfect user checking her “strings” regularly at home and being more aware of spontaneous expulsion than a typical user. The Para Gard® works primarily by preventing sperm from fertilizing an egg by increasing copper ions, enzymes, prostaglandins, and macrophages in uterine fluid, both altering transport and affecting the sperm and egg, ultimately preventing fertilization (Grimes, 2007). There is renewed interest in intrauterine contracep-tion in the United States (Hubacher, Finer, & Espey, 2011). Although IUCs that were on the market before the 1980s had a design flaw that caused an increased prevalence of pelvic infection, current studies of today's IUCs show no increased incidence or only a slight increased incidence of infection in the first 30  days after and related to insertion. Additionally, IUCs decrease the risk of ectopic pregnancy and are safe in nulliparous women (Grimes, 2007). An ideal candidate for the IUC is any woman look-ing for a highly effective, long-term, reversible method and who is able to tolerate minor discomfort with insertion. Absolute contraindications to the use of the Para Gard® according to the WHO (category 4) include current untreated chlamydia or gonorrhea; current pelvic inflammatory disease (or infection within the last 3 months); known cervical cancer that has yet to be treated; known endometrial cancer; known pelvic tuberculosis; persistent gestational tro-phoblastic disease; endometritis or septic abortion in the past 3 months; physical distortion of the uter-ine cavity, such as fibroids that would prevent proper placement; and undiagnosed suspicious, abnormal vaginal bleeding (WHO, 2009). Allergy to copper or history of Wilson disease is also a contraindication. Advantages of the IUC include high effectiveness, reversibility, and relatively low long-term cost. Although initial cost may seem high, if used for at least 2 years, the Para Gard® is the most cost-effective con-traceptive on the U. S. market (T russell et al., 1995). Currently, the Para Gard® IUC is approved for use up to 10 years, at which time it can be removed and replaced immediately by another, if desired. Insertion can be done at any time during a woman's menstrual cycle (including the postpartum period) as long as pregnancy is reliably excluded. It has been shown to be highly safe and effective when inserted immedi-ately post aspiration abortion (Goodman et al., 2008). Another advantage of the IUC is that there is nothing for the patient to remember at home other than check-ing her strings. Disadvantages include an increase in menstrual bleeding and cramping in the first several cycles, rare insertion risks including perforation and infection, and possible spontaneous expulsion. 2. I UC as EC First reported in 1976, the Para Gard® IUC is the most highly effective method of postcoital EC avail-able today. When placed within 5 days of unpro-tected intercourse, the Para Gard® has an efficacy rate of over 99% compared with only 75-89% for the EC pills (T russell et al., 1995). It is recommended as an appropriate method of EC for all women who meet the standard criteria for Para Gard® IUC insertion and have none of the contraindications as listed in the previous section (American College of Obstetricians and Gynecologists, 2005). Once an existing pregnancy has been ruled out by a good history and a high-sensitivity urine pregnancy test, the patient may have the Para Gard® IUC placed immediately by a trained provider in the same normal manner. Aside from the fact that it is highly effective as an EC, a great advantage to this method is that it is excellent for women who also desire long-term contraception, because it can confer up to another 12 years of protection. Disadvantages are the same as listed for Para Gard® as a LARC method. D. Natural family planning (NFP) NFP methods are for the most part behavioral methods of contraception requiring body awareness, self-control, education, and commitment. Methods include FAM and the LAM. Coitus interruptus (or withdrawal) and absti-nence can also be considered methods of NFP, and both can be incorporated into the other methods, although neither is discussed in this chapter. 1. F ertility awareness method (FAM) FAM is the practice of detecting and interpreting a woman's fertile ovulation period and avoiding all intercourse during that time. Two ways of identifying this fertile window are through either calendar-based or symptom-based methods. Simple periodic absti-nence based on misinformation or guesswork with-out formal instruction regarding “safe” times yields an overall typical use rate of only about 75% (T russell, 2008). However, actual FAMs depend on careful instruction, understanding, and strict adherence. If a specific method is adhered to correctly, perfect use rates have been shown to be very successful. Calendar methods involve keeping track of the menstrual cycle and include the calendar rhythm method, with a 91% perfect use rate, and the stan-dard days method, with a 95% perfect use rate. The calendar rhythm method involves tracking menstrual cycles for 6-12 months and using a simple mathe-matical formula to calculate fertile days, whereas the 233 Introduction and general background

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II. Database (may include but is not limited to) A. Subjective 1. B arrier methods a. M edical illnesses: current cervical cancer (Fem Cap) and history of urinary tract infections (diaphragm) b. P ersonal and social history i. Gr avida and para (Fem Cap and sponge) ii. A llergies: (male and female) latex, non-oxynol-9 (condoms, Fem Cap, diaphragm, sponge, and spermicide) iii. S exual history: recent history of unprotected intercourse and current risk of STI iv. P revious contraceptive use and satisfaction, compliance, or problems v. P reference for and comfort with method vi. T olerance of side effects: potential allergy or sensitivity to latex or nonoxynol-9 vii. F inancial constraints 2. S permicides a. P ersonal and social history i. A llergies: (male and female) nonoxynol-9 ii. S exual history: current risk of STI iii. P revious contraceptive use and satisfaction, compliance, or problems iv. P reference for and comfort with method v. T olerance of side effects: potential skin irri-tation or ulceration 3. C u T380-A IUC a. M edical illnesses (cervical or endometrial cancer, history of Wilson disease, pelvic tuberculosis, pelvic inflammatory disease, endometritis or septic abortion in past 3 months, or persistent gestational trophoblastic disease) b. P ersonal and social history i. A llergies (to copper) ii. P ostpartum (first 48 hours best, or wait 4 weeks after delivery for insertion) iii. P ostabortion (immediate insertion appro-priate) iv. S exual history: recent history of unpro-tected intercourse (last 5 days for EC) and current risk for STI v. P revious contraceptive use and satisfaction, compliance, or problems vi. P reference for and comfort with method (i. e., can tolerate insertion process including minor pain or discomfort)standard days method uses a tool called Cycle Beads® for keeping track of fertile days and is ideal for low-literacy patients (T russell, 2008). It is now also avail-able online and as a smartphone app. These methods along with the basal body temperature method, for which there are no reliable data for effectiveness rate, have been largely replaced in favor of newer methods that use other physical signs of fertility, such as cervi-cal secretions (Pallone & Bergus, 2009). The “2-day method” and the “ovulation method” confer a 96% and 97% effectiveness, respectively (T russell, 2008), whereas the “symptothermal method,” using a combi-nation of basal body temperature and cervical mucus, has a perfect use rate of 98% (T russell, 2008). T eaching these methods can take considerably more time than teaching other methods of contra-ception, with an estimated 4-6 hours for a woman to learn the necessary skills ( Jennings, Arevalo, & Kowal, 2007). Therefore, it is important that refer-rals to specialized instructors be provided if none are available in the clinical setting, or that literate couples be encouraged to read at least one or two books on the method of choice before beginning. Advantages of FAMs are that there are no health risks or side effects, they can be acceptable for couples with religious concerns about other contraceptive methods, they can increase body awareness, and they are either free or very low cost. Additionally, some of the methods can be used in reverse for couples wanting to plan a pregnancy. Disadvantages are primarily that learning a method takes time and effort and using it requires considerable commitment and self-control. Additionally, many of the methods cannot be reliably used by women with irregular cycles or a vaginal infection, those who have recently reached menarche, those approaching menopause, those in the immediate postpartum period or while breastfeeding, or women who have recently discon-tinued hormonal contraceptive. Finally, there is no protection against STIs with FAM. 2. L actational amenorrhea method (LAM) LAM is a very effective method of NFP but is limited to the 6 months postpartum period for women meeting specific criteria. A woman must have had no return to menses since giving birth; be breast-feeding almost exclusively, with less than 10% of infant calories from supplements; feed at least every 4 hours during the day and at least every 6 hours at night; and not be “pumping” for an effectiveness rate of 98% to be achieved. However, if she pumps even part of her milk, the rate is reduced to 95% (Pallone & Bergus, 2009). 234 CHAPTER 24 | Nonhormonal Contraception

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vii. T olerance of side effects: possible increased bleeding or menstrual cramping in first several cycles viii. F inancial constraints 4. NFP a. M edical illnesses b. P ersonal and social history i. P ostpartum ii. B reastfeeding iii. S exual history: current risk for STI iv. P revious contraceptive use and satisfaction and compliance problems v. P reference for, comfort with, and expressed ability to learn and strictly adhere to chosen FAM or LAM c. M enstrual history and problems: length and regularity of cycles, recent menarche, or approaching menopause d. C urrent and recent medications (i. e., hormonal contraceptives) B. Objective 1. B arrier methods a. S creening or testing for STIs as indicated b. S peculum examination with screening Pap if not up to date to rule out cervical cancer c. P elvic examination and sizing for diaphragm; fitting for Fem Cap 2. S permicides Screening and testing for STIs as indicated 3. C u T 380-A IUC as LARC or EC a. P regnancy test b. S creening for STIs c. S peculum examination with Pap if not up to date to rule out cervical cancer d. P elvic examination to determine size, shape of uterus, and position of fundus; “sounding” to measure length of uterine cavity (minimum 6 cm required) 4. NFP S creening and testing for STIs as indicated III. a ssessment A. Needs Determine the current and future childbearing plans of the patient. B. Significance Determine the significance of an unplanned pregnancy to the patient. C. Motivation and ability Determine the patient's willingness and ability to correctly and consistently use the method of choice. D. Meets criteria No contraindications to the method of choice. IV. Goals of clinical management A. Desired outcomes met 1. P atient provided with methods that support his or her family planning needs; pregnancy prevention, planning, and spacing as desired 2. S creening, diagnosis, and treatment of any STIs or other infections B. Patient adherence Select an approach that maximizes patient adherence and satisfaction. V. p lan A. Screening for all methods 1. S TI, human papilloma virus, and Pap screening as indicated. Major authorities including the United States Preventative Services T ask Force recommend chlamydia and gonorrhea screening for all sexually active women 25 years of age and younger and men and women in geographically high-risk areas (Meyers et al., 2008). Additionally, screening for HIV and syphilis is recommended for all men and women engaging in high-risk sexual behavior (U. S. Department of Health and Human Services, 2014). B. Management (includes treatment, consultation, referral, and follow-up care) 1. B arrier methods a. P rovide method of choice in office or by prescription b. F ollow-up for resizing of diaphragm after weight gain or loss of 20 pounds or more, or after vaginal childbirth c. F ollow-up for refitting of new Fem Cap after any pregnancy beyond first trimester 2. S permicides a. P rovide in office or direct patient to convenient locations for purchase b. H ave patient return to clinic for evaluation if vaginal or penile ulceration noted to rule out pathology c. P rovide EC pills or a prescription235 Plan

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refere NCes American College of Obstetricians and Gynecologists. (2005). ACOG practice bulletin no. 59. Obstetrics & Gynecology, 105, 223-232. Cates, W., & Raymond, E. (2007). Vaginal barriers and spermicides. In R. A. Hatcher, J. T russell, A. L. Nelson, W. Cates, F. H. Stewart, & D. Kowal (Eds. ), Contraceptive technology (19th ed., pp. 317-335). New Y ork, NY: PDR Network, LLC. Fem Cap. (2015). Natural birth control for health-conscious women. Retrieved from http://www. femcap. com/ French, P. P., Latka, M., Gollub, E. L., Rogers, C., Hoover, D. R., & Stein, Z. A. (2003). Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sexually Transmitted Disease, 30, 433-439. Goodman, S., Hendlish, C., Benedict, M., Reeves, M., Pera-Floyd, A., & Foster-Rosales, S. (2008). Increasing intrauterine contraception use by reducing barriers to post-abortal and interval insertion. Contraception, 78(2), 136-142. Grimes, D. (2007). Intrauterine devices (IUDs). In R. A. Hatcher, J. T russell, A. L. Nelson, W. Cates, F. H. Stewart, & D. Kowal (Eds. ), Contraceptive technology (19th ed., pp. 117-143). New Y ork, NY: PDR Network, LLC. Hubacher, D., Finer, L. B.,& Espey, E. (2011). Renewed interest in intra-uterine contraception in the United States: Evidence and explanation. Contraception, 83(4), 291-294. Jennings, V., Arevalo, M., & Kowal, D. (2007). Vaginal barriers and spermi-cides. In R. A. Hatcher, J. T russell, A. L. Nelson, W. Cates, F. H. Stewart, & D. Kowal (Eds. ), Contraceptive technology (19th ed., pp. 317-335). New Y ork, NY: PDR Network, LLC. Meyers, D., Wolff, T., Gregory, K. Marion, L., Moyer, V., Nelson, H., & USPSTF. (2008). USPSTF recommendations for STI screening. Originally published in American Family Physician, 77, 819-824. Rockville, MD: Agency for Healthcare Research and Quality. National Institute of Allergy and Infectious Disease. Workshop Summary: Scientific Evidence on Condom Effectiveness for Sexually T ransmitted Disease (STD) Prevention, July 20, 2011. Pallone, S., & Bergus, G. (2009). Natural family planning. Journal of the American Board of Family Medicine, 22, 147-157. T russell, J. (2008). Contraceptive efficacy. In R. A. Hatcher, J. T russell, A. L. Nelson, W. Cates, F. H. Stewart, & D. Kowal (Eds. ), Contraceptive technology (19th ed., pp. 747-826). New Y ork, NY: PDR Network, LLC. T russell, J., & Ellerston, C. (1995). Efficacy of emergency contraception. Fertility Control Review, 4, 8-11. T russell, J., Leveque, J. A., Koenig, J. D., London, R., Borden, S., Henneberry, J., & Wysocki, S. (1995). The economic value of contraception: A comparison of 15 methods. American Journal of Public Health, 85, 494-503. U. S. Department of Health and Human Services. (2014). The guide to clinical preventive services. Retrieved from http://www. ahrq. gov /clinic/pocketgd1011/gcp10s1. htm. World Health Organization. (2002). Nonoxynol-9 ineffective in preventing HIV infection. Retrieved from http://www. who. int/mediacentre/news /releases/who55/en/index. html World Health Organization. (2009). Medical eligibility criteria for contraceptive use (4th ed. ). Geneva, Switzerland: Department of Reproductive Health and Research. Retrieved from http://www. who. int/reproductivehealth/publications/family_planning/MEC-5/en/. 3. C u T 380-A IUC a. I nsert IUC at office visit per protocols b. F ollow-up with clinic visit in 2 to 3 months after insertion to check for expulsion and trim strings if desired by patient c. R eturn to clinic for evaluation if experiencing extended, heavy menses or amenorrhea 4. NFP a. R efer to well-trained individuals for instruction if not experienced or comfortable with teaching methods b. E ncourage follow-up to reinforce learning c. S upport and encourage breastfeeding moms who choose LAM and refer to lactation specialist if necessary d. P rovide EC pills or prescription C. Client education 1. I nformation: provide verbal and written information regarding a. R isk reduction and screening b. Act ion, use, side effects, associated risks, and importance of adherence 2. C ounseling a. E ncourage full client participation in the con-traceptive selection process; ideally meet with both patient and partner b. Di scuss benefits and risks of all available methods c. Di scuss possible outcomes and choices if user or method failure occurs d. Di scuss risk factors for STIs e. D ocument discussion on patient records VI. s elf-management resources and tools A. Patient and client education Both of these sites have excellent patient information and interactive tools that allow the user to filter and search through different options to find the right method for them. 1. P lanned Parenthood Federation of America website at www. plannedparenthood. org has full-color pictures and detailed information about all available contraception. They also have an interactive tool called “My Method” that can be reached directly: https://www. plannedparenthood. org/all-access/my-method. 2. The A ssociation of Reproductive Health Professionals (ARHP) site at www. arhp. org has patient information and an interactive tool at http://www. arhp. org /methodmatch. 236 CHAPTER 24 | Nonhormonal Contraception

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abdominal pressure from coughing, sneezing, strain-ing, or exercise. 2. U rge incontinence and overactive bladder a. U rge incontinence (UUI) describes the loss of urine associated with a strong urge or need to void. Urinary frequency and nocturia are a frequent part of the clinical presentation of this condition. Some patients report nocturnal enuresis. b. W omen with overactive bladder (OAB) can be characterized as having wet or dry OAB. Wet OAB includes episodes of UUI. Women with dry OAB experience frequency, urgency, or nocturia but manage to avoid accidents with various behavioral strategies (e. g., limiting fluids, voiding often, and avoiding dietary bladder irritants). 3. M ixed incontinence Women with mixed incontinence have symptoms of both stress and urge incontinence, although one or the other condition may predominate. 4. O verflow incontinence Bladder outlet obstruction or hypocontractility of the detrusor muscle can cause incomplete bladder emptying. An abnormally full bladder can overspill resulting in overflow incontinence. This is a less common bladder dysfunction in women. I. Intr oduction and general background Involuntary loss of urine, or urinary incontinence (UI), affects more than 13 million American women, including 25% of reproductive age women, 44-57% of middle-age and postmenopausal women, and 75% of those aged 75 and older (Anger, Saigal, Litwin, & Urologic Diseases of America Project, 2006; Melville, Katon, Delaney, & Newton, 2005; Qaseem et al. for the Clinical Guidelines Committee of the American College of Physicians, 2014). The condition is associated with a profound adverse impact on quality of life and a higher risk of falls, fractures, nursing home admissions, and social isolation. Each year, consumers spend more than $30 billion on incontinence, including $20 billion in out-of-pocket costs for incontinence management. Y et, UI among adult women is a frequently unrecognized and undertreated problem. A. Types of UI UI classification is based on clinical presentation and severity. The primary circumstances leading to leakage of urine determine the type of incontinence. Most patients seen in the ambulatory care setting with UI present with stress, urge, or mixed UI (T able 25-1). 1. S tress UI Stress UI (SUI) is defined as the involuntary loss of urine as a result of physical stress or increased Janis Luft Ur Inary Incont Inence I n Women© Eliks/Shutterstock; © donatas1205/Shutterstock Table 25-1 Dif ferential Diagnosis of Urinary Incontinence in Women type Pr esentation timing V olume Stress Leakage associated with greater abdominal pressure from coughing, sneezing, straining, or exercise Immediate Small to moderate Urge Leakage occurs with a strong urge or need to void Delayed Drops to large Mixed Combination of stress and urge incontinence; one or the other may predominate Varies Varies 23725Chapt Er

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2-year remission rate (i. e., the percentage of women who reported leaking at least once a month at baseline and no leaking on follow-up) was 13. 9% (T ownsend et al., 2007). This surprising result underscores the dynamic nature of UI as a clinical condition. C. Risk factors 1. N onmodifiable: age, race or ethnicity, and possibly genetics. 2. P otentially modifiable: pregnancy, vaginal delivery, other obstetric events, and hysterectomy. 3. M odifiable or preventable: obesity, diabetes, smoking, chronic cough, and constipation. II. Initial evaluation Initial evaluation of UI begins with a thorough medical, surgical, obstetric, and gynecological history and a complete list of the patient's medications. Clinicians can use a three-part screening tool to determine the type of incontinence (T able 25-2). These questions reliably correlate with clinical findings. 5. F unctional incontinence Functional incontinence is defined as urine loss that occurs because of factors exogenous to the lower urinary tract, such as diminished cognition or limited ambulation. 6. R eflex incontinence or neurogenic bladder Reflex incontinence, also known as neurogenic bladder, is incontinence associated with neurologic dysfunction (e. g., multiple sclerosis or spinal cord injury). This can occur without warning or sensory awareness. B. Prevalence The prevalence of UI types varies according to age and underlying health status. Stress incontinence is more common in younger, ambulatory women, whereas urge and mixed incontinence increase with age and other health conditions. The proportion of women with UI varies widely (from 2% to 55%) depending on the definitions researchers used and the populations they surveyed. Researchers in the United States followed 64,000 women for at least 2 years in the Nurses' Health Study. The 2-year incidence of UI was 13. 7%, but the Table 25-2 Initial Screening for Urinary Incontinence 1. During the last 3 months, have you leaked urine (even a small amount)? ❑ Yes ❑ No 2. During the last 3 months, did you leak urine ( check all that apply): ❑ When you were performing some physical activity, such as coughing, sneezing, lifting, or exercise? ❑ When you had the urge or the feeling that you needed to empty your bladder, but you could not get to the toilet fast enough? ❑ Without physical activity and without a sense of urgency? 3. During the last 3 months, did you leak urine most often ( check only one): ❑ When you were performing some physical activity, such as coughing, sneezing, lifting, or exercise? ❑ When you had the urge or the feeling that you needed to empty your bladder, but you could not get to the toilet fast enough? ❑ Without physical activity and without a sense of urgency? ❑ About equally as often with physical activity as with a sense of urgency? T ype of Urinary Incontinence Is Based on Responses to Question 3 Responses to Question 3 Type of Incontinence a. Most often with physical activity Stress only or stress predominant b. Most often with the urge to empty the bladder Urge only or urge predominant c. Without physical activity or a sense of urgency Other cause only or other cause predominant d. About equally with physical activity and a sense of urgency Mixed Reproduced from Brown, J. S., Bradley, C. S., Subak, L. L., Richter, H. E., Kraus, S. R., Brubaker, L., et al. (2006). The sensitivity and specificity of a simple test to distinguish between urge and stress urinary incontinence. Annals of Internal Medicine, 144, 715-723. Reprinted with permission. 238 CHAPTER 25 | Urinary Incontinence in Women

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A. Subjective 1. U rinary symptoms a. T iming, frequency, severity, and precipitants of incontinence episodes b. N umber of daytime and nighttime urinations c. U rinary diary (T able 25-3) 2. A mount and nature of fluid intake 3. Bo wel habits (e. g., constipation, diarrhea, or straining) B. Objective 1. A lthough not a prerequisite to diagnosis and the initiation of nonsurgical treatment for UI, the fol-lowing may provide data that aid in individualiza-tion of treatment or assist in the management of UI refractory to treatment a. A ssess for genital atrophyb. Dir ected pelvic examination to assess for uter-ine prolapse or other pathology, such as a pelvic mass 2. S imple neurologic examination: mental status and sensory and motor function of the perineum and lower extremities III. a ssessment A. Determine the diagnosis The screening tool found in T able 25-2 can be used to determine the initial diagnosis of UI type (T able 25-1). B. Severity Assess the severity of the condition. 1. N umber and types of pads or hygienic products used Table 25-3 Urinary Diary*   Fluid Intake time Urinate in  toilet Leaking a ccident r eason for a ccident type a mount 6 a. m.           7 a. m.           8 a. m.           9 a. m.           10 a. m.           11 a. m.           12 noon           1 p. m.           2 p. m.           3 p. m.           4 p. m.           5 p. m.           NOTES INSTRUCTIONS 1. In the first column, mark an (x) every time you urinate into the toilet. 2. In the second column, mark an (x) every time you accidentally leaked urine. 3. If an accident occurred, indicate the reason or circumstances surrounding the accident, for example, “coughed, bent over, sudden urge. ” 4. Under “Fluid Intake” describe the type (cof fee, tea, juice, etc. ) and amount (a cup, 1 quart, etc). 5. Circle the time when you went to bed and when you got up in the morning. 6. Record number and type of pads used. 7. Under “Notes” write any additional information you would like to include. For example, type and dose of medication you may be on for your urinary incontinence. *Actual diary contains 24 rows labeled for each hour. 239 Assessment

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2. P sychological distress and depression associated with the condition (e. g., limitation to travel, time with family, social isolation, fear of odor or accidents, restriction of exercise) 3. Di sruption of sleep C. Significance Assess the significance of the problem to the patient and significant others. D. Motivation and ability 1. D etermine the patient's goals for treatment (e. g., reduction in incontinent episodes vs. complete dryness, less daytime urination, or less nocturia). 2. D etermine the patient's preferences for treatment (e. g., behavioral modification, medication, combina-tion of these, or other treatment options). 3. D etermine the patient's willingness and ability to follow the treatment plan. IV. Goals of clinical management A. Screening or diagnosing UI Choose a cost-effective approach for screening or diagnosing UI that is compatible with the patient's goals and preferences. B. Treatment Select a treatment plan that achieves the patient's objec-tives for bladder control in a safe and effective manner. C. Patient adherence Select an approach that maximizes patient adherence. V. Plan A. Screening Although an extremely common chronic condition in women, UI is underreported by patients and unaddressed by many clinicians (Brown et al., 1999). Primary or wom-en's healthcare providers can effectively screen patients by simply asking about issues of bladder control or using the simple questionnaire provided in T able 25-2. B. Diagnostic tests (Table 25-2) 1. I ncontinence Questionnaire 2. A ur inary diary that the patient keeps for 1-3 days (T able 25-3) 3. A d ipstick urinalysis to rule out underlying infection4. P ostvoid residual urine to rule out overflow incontinence. This can be done by catheterizing or bladder ultrasonography within 15 minutes of urination. 5. U rodynamic testing measures detrusor function, bladder capacity and compliance, and sensation to void. Although such testing may be useful in evaluating patients with complex symptoms or voiding dysfunction, it is not necessary for all patients with incontinence before proceeding to treatment based on clinical presentation. C. Management (includes treatment, consultation, referral, and follow-up care) 1. N onpharmacologic management a. B ladder training helps patients reestablish vol-untary bladder control. Patients learn how to void on a set schedule, beginning with about 30-60 minutes between voids and then slowly increasing the interval to 3 or 4 hours (T able 25-4) b. R elaxation and urge suppression techniques effectively suppress the strong urge to void that is associated with urge UI (T able 25-5). c. P elvic floor muscle exercises or Kegel exercises strengthen the muscles of the pelvic floor and improve urethral pressure and inhibit involun-tary detrusor contractions (T able 25-5). d. B iofeedback uses electromyography or manome-try to help patients learn pelvic floor muscle exer-cises through directed instructions as they receive feedback in the form of dynamic graphs or tones that reinforces their actions. This modality can help women isolate pelvic muscles and improve the efficacy of pelvic floor muscle exercises. e. W eight loss has been shown to improve conti-nence symptoms (Subak et al., 2005; Subak et al., 2009). Weight loss as little as 3-5% has been shown to reduce weekly incontinence episodes by 50-60%. f. Die t modification can be helpful. Some patients find that reduction or elimination of “bladder triggers,” such as caffeine, alcohol, spicy foods, and concentrated citrus, can improve urinary urgency and frequency. Overhydration and underhydration should be discouraged. Fluid intake sufficient to maintain “lemon juice” col-ored urine is ideal. 2. P harmacologic treatment options A growing number of medications are available to treat UUI, urgency, frequency, and nocturia (T able 25-6). Generally, these agents, which inhibit 240 CHAPTER 25 | Urinary Incontinence in Women

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the bladder's contractile activity, have an anticholin-ergic and/or antimuscarinic effect. Although they provide excellent symptom relief and reduce weekly incontinent episodes by 15-60%, they may also cause bothersome side effects, such as dry mouth, con-stipation, drowsiness, and blurred vision (Nygaard & Heit, 2004). Sustained-release medications may cause fewer side effects. A newer type of overactive bladder medication is now available. Mirabegron (Myrebetriq®) is the only FDA-approved β3-adrenergic receptor agonist. It acts to relax the smooth muscle that surrounds the blad-der and helps to increase the bladder's ability to store urine. A review of studies evaluating the use of vaginal estrogen in postmenopausal women for the treatment of genitourinary symptoms, including UUI and SUI concluded that such vaginal estrogen creams, tablets, and rings can be safe and a helpful adjunct to treat-ment (Rahn et al., 2014). Medical treatment of SUI has been largely unsuc-cessful. There are no pharmaceutical agents for the treatment of SUI on the U. S. market. T reatment of incontinence with oral or transdermal estrogen is not recommended. Two large randomized controlled trials (the Women's Health Initiative and the Heart and Estrogen Replacement Study) demonstrated an increase in the prevalence of UI with the use of both estrogen-only and combined hormone-replacement therapy on stress, urge, and mixed UI (40-50% over a 4-year period and 20-60% at 12 months) (Grady et al., 2001; Hendrix et al., 2005). Table 25-4 Bladder Retraining Bladder retraining is a behavioral treatment for urinary incontinence that uses scheduled toileting to help you relearn normal bladder function. The purpose of bladder retraining is to a. increase the amount of time between emptying your bladder. b. increase the amount of fluids your bladder can hold. c. diminish the sense of urgency and/or leakage associated with your problem. Keeping the diary of your bladder activity is very important. This helps us to determine the correct starting interval for you and to monitor your progress throughout your program. INSTRUCTIONS 1. Empty your bladder as soon as you get up in the morning. This begins your retraining schedule. 2. Go to the bathroom every _______________________________________ W ait the full amount of time before you urinate again AND when it is your scheduled time, be sure to empty your bladder even if you feel no urge to urinate. Follow the schedule during waking hours ONLY. During the night time go to the bathroom only if you awaken and find it necessary. 3. A helpful hint: When the urge to urinate is felt before the next designated time, use the “urge suppression” technique described on the pink handout, or try relaxation techniques like deep breathing. Focus on relaxing all other muscles. If possible, sit down until the sensation passes. If the urge is suppressed, adhere to the schedule. If you cannot suppress the urge, wait 5 minutes then slowly make your way to the bathroom; then reestablish the schedule. Repeat this process each time an urge is felt. 4. When you have accomplished this goal, gradually increase the time between emptying your bladder by 15-minute intervals. T ry to increase your interval each week, but you will be the best judge of how quickly you can advance to the next step. The time between each urination is increased until you reach a 3-to 4-hour voiding interval. 5. It should take between 6 and 12 weeks to accomplish your goal. Don' t be discouraged by setbacks. You may find you have good days and bad days. As you continue bladder retraining you will start to notice more and more good days, so keep practicing. 6. Y ou will hasten your success by doing your pelvic muscle exercises faithfully every day. Your diaries will help you see your progress and identify your problem times. 7. If you need more help, medication or other treatments are available and may be useful. 241 Plan

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Table 25-5 Urge Suppression Urge incontinence is the loss of urine when you have a strong desire to urinate and are unable to reach a bathroom in time. The urge is a signal that it is time to urinate. Your goal is to maintain bladder control until you reach a toilet. A normally functioning bladder can wait until the appropriate opportunity to empty; an unstable bladder cannot. For a person with urge incontinence, rushing to the bathroom when you have a strong urge to urinate is the worst thing you can do. Rushing actually causes bladder irritability to increase and interferes with your ability to concentrate on controlling your bladder. When urgency strikes, you should use the “urge suppression” technique to maintain control. 1. Stop all movement immediately and stand still. Sit down if possible. Remaining still increases your ability to stay in control. 2. Squeeze your pelvic floor muscles quickly and tightly several times. Do not relax the muscles fully between these very quick squeezes. Squeezing your pelvic floor muscles this way signals the bladder to relax and increases your feeling of being in control. 3. T ake a deep breath and relax. Shrug your shoulders and let them go limp. Release the tension in the rest of your body. 4. Concentrate on suppressing the urge feeling. Some women find distraction an ef fective technique. 5. When the strong urgency subsides, walk slowly and calmly to the bathroom. If the urge begins to build again, repeat these steps. You can also try contracting your muscles as you walk to the bathroom. Remember: going to the bathroom is not an emergency! Table 25-6 Medications for Overactive Bladder Short-acting oral anticholinergics/muscarinic receptor antagonists   Oxybutynin (Ditropan ®), 5 mg 0. 50-1 tablet two to four times a day Tolterodine (Detrol®), 1 and 2 mg1 tablet twice daily (start with 2 mg and decrease to 1 mg if severe side effects) Trospium chloride (Sanctura®), 20 mg 1 tablet twice daily on an empty stomach Extended-release oral anticholinergics/MRAs     Oxybutynin ER (Ditropan XL ®), 5-15 mg 1 tablet daily Tolterodine ER (Detrol LA®), 2 and 4 mg1 capsule daily (start with 4 mg and decrease to 2 mg if severe side effects) Darifenacin (Enablex®), 7. 5 and 15 mg 1 tablet daily Solifenacin (Vesi Care®), 5 and 10 mg 1 tablet daily Fesoterodine (Toviaz®), 4 and 8 mg 1 tablet daily Transdermal anticholinergics/MRAs  Oxybutynin transdermal patch (Oxytrol) ®, 3. 9 mg/day (OTC—no Rx needed)1 patch on dry skin (hip, abdomen, or buttocks) every 3-4 days Oxybutynin transdermal gel 10% (Gelnique®), 100 mg/g1 sachet daily to dry, intact skin on the abdomen, upper arms or shoulders, or thighs Nonanticholinergic medications Mirabegron (Myrbetriq ®) 25 and 50 mg 1 tablet daily Notes for anticholinergic/muscarinic receptor antagonist (MRA) medications Contraindications: Narrow-angle glaucoma or severe liver or kidney disease. Side effects: Dry mouth and constipation are the most common. Adjust dose to balance drug effectiveness versus side effects. Alternative: Imipramine, 10 mg, at bedtime and adjust as often as weekly. Adjust per the patient's urinary diary and symptoms to a maximum of 100 mg at bedtime. Use with caution in the elderly because of hypotension or cognitive impairment. Notes for Mirabegron This is a β3-adrenergic receptor agonist. Monitor changes in blood pressure after initiation of medication. 242 CHAPTER 25 | Urinary Incontinence in Women

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in your lower leg and connected to the battery-powered stimulator. These gentle impulses travel up the tibial nerve to the sacral nerve plexus to modify the bladder's activity. Each treatment lasts about 30 minutes. An initial series of 12 treatments are scheduled, each about a week apart. The entire procedure is carried out in the comfort of our office, and following the initial series of treatments you are evaluated by your doctor to assess your response to treatment. d. S urgical treatments i. M ultiple surgical options are available to treat stress incontinence. The most com-mon sling procedure is the midurethral syn-thetic sling, in which the surgeon places a narrow piece of polypropylene mesh under the midurethra; this can be done by either a retropubic (passed behind the pubic bone through the anterior abdominal wall) or transobturator (passed through the obtura-tor foramen) approach. ii. P atients whose stress incontinence results from intrinsic sphincter deficiency may benefit from urethral bulking agents, such as Coaptite® and Macroplastique®, which are injected transurethrally as an outpatient surgery (Ghoniem & Boctor, 2014). iii. S acral nerve stimulation, also called sacral nerve neuromodulation (Inter Stim®) therapy, is a reversible treatment for people with UUI caused by OAB who do not respond to behavioral treatments or medication. Inter Stim® is a surgically implanted neuro-stimulation system that sends mild electrical pulses to the S3 sacral nerve root, a nerve that influences bladder control. iv. Bot ox® (botulinum toxin A) injection into the detrusor muscle is an option for neurogenic or idiopathic UUI unrespon-sive to conservative measures. Botox® is injected into numerous sites in the bladder wall using a cystoscope. The toxin works by inactivating proteins involved in neu-rotransmitter release from nerve terminals. As neurotransmitter levels decrease, under-lying muscle spasm may be diminished or ablated. The Food and Drug Administration approved Botox® for the treatment of OAB in June 2013. v. B ladder augmentation is infrequently used and reserved for people with UUI who do not benefit from bladder retraining or medication. This procedure increases the 3. T reatment requiring referral to a continence specialty practice a. P essaries: well-fit incontinence ring or inconti-nence dish pessaries can relieve the symptoms of S UI. The pessary compresses the urethra against the upper posterior portion of the sym-physis pubis and elevates the bladder neck. This causes an increase in outflow resistance and corrects the angle between the bladder and the urethra. b. Ele ctrical stimulation i. V aginal or rectal electrical stimulation uses an internal sensor to deliver electrical currents at preset frequencies. Higher fre-quency causes involuntary levator ani con-tractions that improve pelvic floor tone and assist in learning to contract these muscles at will. Lower frequencies are used to block-ade the sacral nerve plexus, reducing detru-sor irritability. ii. P ercutaneous tibial nerve stimulation is used to treat OAB. A fine-needle electrode is inserted into the lower, inner aspect of the leg, slightly cephalad to the medial malleo-lus. The goal is to send stimulation through the tibial nerve. The needle electrode is connected to an external pulse generator that delivers an adjustable electrical pulse that travels to the sacral plexus via the tibi-al nerve. The treatment protocol requires once-a-week treatments for 12 weeks, roughly 30 minutes per session. c. P ercutaneous tibial nerve stimulation Patient Instructions:Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive treatment for overactive bladder symptoms. Although many options are available for the treatment of OAB, including behavioral modification, pelvic floor muscle rehabilitation (PFMR), and medication, not all patients have success with these. PTNS works by gentle electrical stimulation of the nerves of the sacral nerve plexus to modify the bladder's activity, sometimes referred to as neuromodu-lation. The tibial nerve, located in the lower leg, can be accessed with a sensor placed through the skin, the impulses then travel along the tibial nerve and to the sacral nerve plexus. After your clinician determines that you may benefit from PTNS, you return for an initial evaluation with our nurse practitioner who spe-cializes in urinary incontinence. A small needle electrode is inserted adjacent to the tibial nerve 243 Plan

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capacity of a small, hyperactive, or nonre-silient bladder by adding bowel segments or by reducing the muscle-squeezing ability of the bladder. D. Client education 1. I nformation Provide verbal and, preferably, written information regarding:a. P revalence, morbidity, cost, and available treat-ments for UI. b. M odifiable risk factors for UI, such as obesity, diabetes, and smoking. c. M anagement rationale, action, use, side effects, associated risks, and cost of therapeutic inter-ventions; and the need for adhering to long-term treatment plans. 2. C ounseling a. W eight loss counseling and advice as needed. b. M anagement of diabetic glucose levels. c. A voidance of constipation. d. D ecision making regarding elective pelvic surgery. VI. Self-management r esources and tools A. Patient and client education 1. N ational Institute for Diabetes, Digestive and Kidney Diseases (NIDDK) The NIDDK is a division of the National Institutes of Health. According to their website, “the NIDDK conducts and supports research on many chronic and costly diseases affecting the public health. Several diseases studied by the NIDDK are among the lead-ing causes of disability and death in the Nation; all affect seriously the quality of life of those suffering from them. ” Both patient and provider literature is available on their website (www2. niddk. nih. gov). 2. UC SF Women's Continence Center website (http:// coe. ucsf. edu/wcc/) The UCSF Women's Continence Center website provides information about women's UI, pelvic floor prolapse, and treatment options. Downloadable dia-ries and handouts are available for public use. B. Community support groups 1. N ational Association for Continence (NAFC) Founded in 1982, the NAFC was originally known as Help for Incontinent People. T oday, the renamed National Association for Continence is the largest private consumer organization dedicated to educating and advocating for people with bladder and pelvic floor dysfunction. The NAFC provides educational resources, healthcare referrals, public education, and personal support for those with incontinence (www. nafc. org or 1-800-BLADDER). 2. The S imon Foundation for Continence The mission statement of the Simon Foundation is that of “bringing the topic of incontinence out into the open, removing the stigma surrounding inconti-nence, and providing help and hope for people with incontinence, their families, and the health profes-sionals who provide their care. ” The organization provides public education materials (www. simon-foundation. org). re Ference S Anger, J. T., Saigal, C. S., Litwin, M. S., & Urologic Diseases of America Project. (2006). The prevalence of urinary incontinence among community dwelling adult women: Results from the National Health and Nutrition Examination Survey. Journal of Urology, 175(2), 601-604. Brown, J. S., Bradley, C. S., Subak, L. L., Richter, H. E., Kraus, S. R., Brubaker, L., et al. (2006). The sensitivity and specificity of a simple test to distin-guish between urge and stress urinary incontinence. Annals of Internal Medicine, 144, 715-723. Brown, J., Grady, D., Ouslander, J. G., Herzog, A. R., Varner, R. E., & Posner, S. F. (1999). Prevalence of urinary incontinence and associated risk factors in postmenopausal women. Heart & Estrogen/Progestin Replacement Study (HERS) Research Group. Obstetrics & Gynecology, 94(1), 66-70. Ghoniem, G., & Boctor, N. (2014). Update on urethral bulking agents for female stress urinary incontinence due to intrinsic sphincter deficiency. Journal of Urology and Research, 1(2), 1009. Grady, D., Brown, J. S., Vittinghoff, E., Applegate, W., Varner, E., Snyder, T., & HERS Research Group. (2001). Postmenopausal hormones and incontinence: The Heart and Estrogen/Progestin Replacement Study. Obstetrics & Gynecology, 97(1), 116-120. Hannestad, Y. S., Rortveit, G., Sandvik, H., & Hunskaar, S. (2000). A community-based epidemiological survey of female urinary incontinence: The Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-T røndelag. Journal of Clinical Epidemiology, 53(11), 1150-1157. Hendrix, S., Cochrane, B., Nygaard, I.., Handa, V., Barnabei, V., Iglesia, C., et al. (2005). Effect of estrogen with and without progestin on urinary incontinence. Journal of the American Medical Association, 293(8), 935-948. Melville, J. L., Katon, W., Delaney, K., & Newton, K. (2005). Urinary incon-tinence in U. S. women: A population-based study. Archives of Internal Medicine, 165, 537-542. Nygaard, I., & Heit, M. (2004). Stress urinary incontinence. Obstetrics & Gynecology, 104, 607-620. Qaseem, A., Dallas, P., Forciea, M., Starkey, M., Denber, T. & Shekelle, P. for the Clinical Guidelines Committee of the American College of Physicians. (2014). Nonsurgical management of urinary incontinence in women: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 161(6), 429-440. 244 CHAPTER 25 | Urinary Incontinence in Women

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Subak, L., Wing, R., West, D., Franklin, F., Vittinghoff, E., Creasman, J., et al. for the PRIDE Investigators. (2009). Weight loss to treat urinary incontinence in overweight and obese women. New England Journal of Medicine, 360(5), 481-490. T ownsend, M., Danforth, K., Lifford, K., Rosner, B., Curhan, G.. Resnick, N., et al. (2007). Incidence and remission of urinary incontinence in middle-aged women. American Journal of Obstetrics & Gynecology, 197(2), 167. e1-e5. Rahn, D., Carberry C., Sanses, T., Mamik, M., Ward, R., Meriwether, K., et al. for the Society of Gynecologic Surgeons Systemic Review Group. (2014). Vaginal estrogen for genitourinary syndrome of menopause: A  systematic review. Obstetrics & Gynecology, 124(6), 1147-1156. Subak. L. L., Whitcomb, E., Shen, H., Saxton, J., Vittinghoff, E., & Brown, J. S. (2005). Weight loss: A novel and effective treatment for urinary incontinence. Journal of Urology, 174(1), 190-195. 245 References

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Section i V o BStet Ric He ALt H MA inten A nce A n D PR o M otionstudies as indicated by findings of history, physical and/or gestational age. II. Database (may include, but is not limited to) A. Subjective 1. H istory of the current pregnancy a. P regnancy symptoms: e. g., nausea, vomiting, fatigue, sore breasts, headache, and fetal movement b. P roblems: e. g., vaginal bleeding, excessive vomiting c. F eelings about pregnancy: e. g., unplanned but wanted, anxious, happy 2. I nformation for dating of pregnancy (Box 26-1) a. P ast menstrual history: menarche, cycle interval, length and amount of flow b. F irst day of last normal menstrual period: sure-ness of date, length of flow, previous menstrual period if last period abnormal and any factors that potentially interfere with duration of cycle or ovulation (e. g., hormonal contraceptives) c. D ates and results of home pregnancy testing d. I nformation related to conception—dates of intercourse, use of ovulation predictor, use of reproductive technology e. S ymptoms of pregnancy including onset and evolution, and fetal movement if present f. P revious ultrasound if done 3. Obs tetric history a. T otal number of pregnancies including ectopic, abortions (spontaneous and therapeutic) and number of term, preterm, and living children b. D eliveries: date, mode of delivery (vaginal birth, cesarean, vacuum or forceps assisted and indication if operative birth), gestational age, gender, birth weight, length of labor, I. Definition and backgr ound Pregnancy is a time of great physical and emotional changes in a woman's life. Careful, regular monitoring during pregnancy can reassure the mother-to-be and detect variations from a normal pregnancy. Ideally prenatal care begins before conception. The basic components of prenatal care include early and continuing risk assessment, health promotion and education, and medical and psychosocial interventions and follow-up. Not only is preg-nancy a time when most women are unusually open to making positive lifestyle changes, but prenatal care offers the clinician an opportunity to develop a relationship with women over the duration of the pregnancy. Current evidence does not show that the standard model of individual prenatal care visits improves birth outcomes including the rates of low-birth-weight infants or preterm delivery. However, the various components of prenatal care may allow practitioners to identify risks for a woman and her family in many aspects of her life and initiate appropriate interventions (Fiscella, 1995; Lu et al., 2003; Vintzileos, Ananth, Smulian, Scorza, & Knuppel, 2002). The guiding principles prenatal care should include: Nonintervention: the reproductive cycle is a normal and essentially healthy process. Consideration of the patient as a member of the health-care team. Provision of education appropriate to age, culture, and needs including anticipatory guidance and nutrition. Promotion of self-esteem and empowerment. Individualization of care: respecting cultural back-ground, sexual orientation, and patient priorities (Walker, Mc Cully, & Vest, 2001). The initial prenatal visit includes a health and psychosocial history and physical exam with a special focus on establishing a due date and identifying women and/or fetuses at risk for complications. Additional data are gathered through routine laboratory tests and additional ultrasound or diagnostic Rebekah Kaplan The In ITIal P Rena Tal V I s IT© Eliks/Shutterstock; © donatas1205/Shutterstock 246 26Chapt Er

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f. N eonatal or newborn complications such as prolonged hospitalization including diagnosis, jaundice, congenital anomalies 4. G ynecological history a. S exually transmitted infections including HIV and genital herpes simplex virus of patient or partner b. F ibroids or reproductive tract malformations c. G ynecological surgery, particularly uterine d. A bnormal Pap smears and related loop electro-surgical excision procedure or cone procedures e. V ulvovaginal disorders or vaginismus 5. M edical history a. P resent medications: prescriptions, over the counter, supplements b. S ignificant illnesses: asthma, diabetes, hyperten-sion, frequent urinary tract infections, cardiovas-cular, thyroid, hepatitis, anemia, tuberculosis, seizures, psychiatric illnesses c. A llergies: medications, latex, foods, environmental d. S urgeries, hospitalizations, blood transfusions 6. F amily history a. S ignificant illnesses with genetic risk: diabe-tes, hypertension, renal disease, cardiovascular disease, blood disorders, multiple gestation. b. S ignificant illnesses with risk for fetal outcomes: congenital or chromosomal abnormalities, cys-tic fibrosis, intellectual disability, substance dependence. 7. S ocial history a. C ountry of origin (recent immigrant) b. C urrent living situation c. S upports d. F inancial stability, healthcare coverage e. F ood access f. O ccupation and work safety (exposure to haz-ards: chemical, biologic, or physical) g. I ntimate partner violence h. H istory of violence or sexual abuse i. S ubstance use (cigarettes, alcohol, narcotics, current and past use) j. H IV risk factors k. E ducational history (reading level, years of schooling, how they learn best) 8. N utritional history a. P repregnancy weight and body mass index (BMI) b. W eight gain or loss c. C urrent diet: restrictions (vegetarian or lactose intolerant), adequate protein, calcium, grains, fruits and vegetablesanesthesia, pregnancy weight gain, spontaneous or induced labor c. P regnancy complications such as preterm labor, gestational diabetes, preeclampsia, gestational hypertension, cholestasis, small or large for gestational age newborn d. D elivery complications such as: shoulder dys-tocia, postpartum hemorrhage, third-or fourth-degree laceration e. P ostpartum complications such as blood trans-fusion, infection, wound issues, depression, or mastitis Box 26-1 establishing a Due Date Dating the pregnancy is an essential part of the first prenatal visit. The practitioner must take into consider-ation all the information for dating the pregnancy and establish a best estimate of the delivery date (EDD). For most women a sure and “normal” last menstrual period (LMP) is the most useful method. Calculate the EDD based on LMP by using a gestational wheel, one of many apps, or Naegle's rule (LMP + 7 days-3 months, based on 28-day cycle). Use an ultrasound EDD if first-trimester ultrasound dates differ by more than 5-7 days or second-trimester dates differ by more than 10 days. Accuracy of Dating In vitro fertilization ± 1 day Ovulation indication ± 3 days Single intercourse record/insemination ± 3 days Basal body temperature record ± 4 days Ultrasound 6-9 weeks (crown-rump length) ± 5 days Ultrasound 9-14 weeks (crown-rump length) ± 7 days “Regular” and certain LMP with 28-day cycle ± 10-14 days Second-trimester ultrasound 10-14 days Third-trimester ultrasound 14-28 days First-trimester physical examination ± 2 weeks Second-trimester physical examination ± 4 weeks Third-trimester physical examination ± 6 weeks Data from Hunter, L. A. (2009). Issues in pregnancy dating: Revisiting the evidence. Journal of Midwifery & Women's Health, 54(3), 184-190; ACOG. (2014). Committee Opinion No 611: Method for Estimating Due Date. Obstetrics and Gynecology, 124(4), 863. 247 Database

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C. Anticipatory guidance related to pregnancy, birth, parenting, and medical care D. Individualize care to meet both the family and medical needs and maximize maternal and fetal well-being V. Plan A. Discuss and order diagnostic and laboratory screening (see Boxes 26-2 and 26-3) B. Discuss and recommend therapeutic interventions and medications 1. P renatal vitamins 2. Othe r vitamins or supplementation as indicated by history or nutritional assessment may include: a. I ron, 325 mg daily if anemic (hemoglobin < 10, hematocrit < 32) (Graves & Barger, 2001; Grieger & Clifton, 2014) b. C alcium if dietary intake less than 1,200 mg daily (Grieger & Clifton, 2014; Hofmeyr, Lawrie, Atallah, & Duley, 2014) c. V itamin D3 (Harvey et al., 2014; Wei, Qi, Luo, & Fraser, 2013) d. F ish oil: omega-3 fatty acids (Mozurkewich & Klemens, 2012) 3. P rescriptions (assess safety in pregnancy): clinicians need to be mindful of the U. S. Food and Drug Administration risk category for drugs during pregnancy when prescribing medications for the pregnant woman (Box 26-4). 4. V accines: a. I nfluenza vaccine recommended for all pregnant women (seasonal). b. T etanus/diphtheria/pertussis (T dap) recommended for all pregnant women with each pregnancy, between 27-36 weeks, gestation. c. H epatitis A and B if at risk (Bridges, Woods, & Coyne-Beasley, 2013). C. Patient education includes (Figure 26-1 ): 1. P renatal care and compliance 2. C ommon discomforts 3. P hysiologic and emotional changes 4. F etal growth and development 5. O ptions for prenatal screening and diagnosis offered, reviewed, and discussed 6. N utrition and exercise B. Objective 1. B aseline data: height, weight, basal metabolic index, and blood pressure 2. C omplete physical examination: for many women pregnancy is their only contact with medical care, hence an opportunity for overall health assessment. a. H ead, ears, eyes, nose, and throat, teeth b. S kin, neck, and thyroid c. B reasts, heart, chest, and lungs d. A bdomen: including uterine size or fundal height and fetal heart tones (after 10 weeks) e. N eurologic: deep tendon reflexes, extremities f. P elvic examination i. E xternal genitalia ii. V agina: discharge iii. C ervix: polyps, dilation of os, length, con-sistency, and position iv. U terus: size, position, and symmetry v. Adnex a: difficult to palpate after 12 weeks vi. R ectum: note hemorrhoids III. a ssessment A. Estimated gestational age and date of delivery: Size (S)/Dates (D) relationship (S = D, S < D, or S > D) B. Creation of a “problem list” that will guide future care based on issues/risk factors identified from history and physical examination or existing laboratory data—could include: 1. U nknown LMP 2. P rior cesarean delivery 3. B MI: 41 4. R h-negative blood type C. Role assessment: need for consultation or collaborative management (see Chapter 30 for guidelines for medical consultation and referral during pregnancy) IV. Goals of clinical management A. Establish a date of delivery B. Identify medical, nutritional, and psychosocial problems and risk factors and a plan of care for each problem248 CHAPTER 26 | The Initial Prenatal Visit

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Box 26-2 laboratory Data Initial screening “routine” Complete blood count with platelets and mean corpuscular volume (MCV) Maternal blood type with antibody screen Hepatitis B surface antigen Rubella immunity Syphilis serology HIV antibody with consent Urine culture with sensitivities Pap smear if due Initial scr eening “risk based” based on population served or individual risk may include: Hepatitis C antibody Varicella antibody if immunity is unknown Purified protein derivative (PPD tuberculosis skin test) T oxoplasmosis (Ig G, Ig M) Early glucose load test Hemoglobin A1c Tay-Sachs carrier status Cystic fibrosis Hemoglobin electrophoresis Wet mount Gonorrhea and chlamydia Thyroid function tests Box 26-3 T iming of e lective Genetic Diagnostic and s creening Tests Offered to Women Before 20 Weeks This may vary by location and what is available Screening tests: First-trimester blood screen (10 weeks-13 weeks and 6 days) Nuchal translucency screening ultrasound (11 weeks and 2 days-14 weeks and 2 days weeks) Second-trimester or quadruple marker blood screen (15-20 weeks) Noninvasive prenatal testing/cell-free DNA blood test (after 10 weeks) Fetal survey/screening ultrasound (18-20 weeks, routine in many practices) Diagnostic tests Chorionic villus sampling (10-14 weeks) Amniocentesis (15-20 weeks) Box 26-4 F ood and Drug a dministration (FDa ) Prescription Drug s afety Categories A. No risk of harm to the fetus B. No risk seen in animals, but no controlled studies in women; probably little risk C. Animal studies may show some risk to fetus; studies in women unavailable. Give only if benefit outweighs risk D. Positive evidence of human fetal risk, but benefits may be acceptable in life-threatening situation (D) E. Known fetal abnormalities7. O ver-the-counter medications 8. S ubstance use and abuse 9. F ood safety (e. g., listeria, mercury, and pasteurization) 10. T eratogens 11. W orkplace safety and exposure 12. S afer sex 13. D anger signs (specific to gestational age) 14. C ommunity resources 15. S exuality during pregnancy D. Consultation and referrals (could include) 1. Ge netic counseling for advanced maternal age; family history of genetic disorder, developmental delays, and cardiovascular defects; as indicated by ethnic background, multiple miscarriages, consanguinity, and exposure to potential teratogens (Box 26-5)2. A ncillary services: social worker, nutritionist, health educator, prenatal classes, psychiatry as needed or desired 3. C ommunity resources (e. g., Women, Infants, Children nutritional program, public health nurse, smoking cessation, community-based organizations, support groups) 4. M edical consultation and referral E. Follow-up 1. P atient should return per the return visit schedule guideline. This should be flexible, individualized, and depend on parity and risk (Box 26-6). 249 Plan

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FIGu Re 26-1 OB Pr ovider e ducation Flow s heet First and Second Trimester ❑ Centering Offered ❑ Accepted ❑ Declined Why? ❑ Orientation to clinic/service ❑ Dental referral Common Discomforts:Back pain N/V Constipation Dizziness HA Round ligament pain SOB Urinary frequency Other: Food and drug safety Fetal growth and development Dating/sonogram Fetal movement Exercises (back care, stretching, yoga, keeping fit) Additional Education: Method of infant feeding: ❑ breast ❑ bottle ❑ both Breastfeeding:❑ Received Breastfeeding class info Breastfeeding experience ❑ Benefits of breastfeeding ❑ Exclusive Breastfeeding 6 mo Method of contraception ❑ Consent signed ❑ Attended TL class S/sx Preterm Labor (UCs, VB, LOF or ROM, pelvic pressure) Danger signs (fever, VB, severe abd pain, dysuria) Danger signs: preeclampsia (H/A, scotoma, RUQ or epigastric pain) Third Trimester❑ Gave childbirth class info ❑ Attended childbirth class ❑ Tdap vaccination Danger signs: general (VB, ROM, severe abdominal pain, decreased FM, fever) Labor and Delivery Birth plan ❑ Relaxation techniques ❑ Pain control options ❑ Fetal monitoring methods ❑ ❑ Signs/Symptoms labor (UCs, bloody show, ROM) Early labor comfort measures ❑ Support people in labor (continues)250 CHAPTER 26 | The Initial Prenatal Visit

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Breastfeeding: ❑ Attended breastfeeding class ❑ Early initiation of breastfeeding ❑ Skin to skin/rooming in ❑ Infant feeding cues ❑ Latch ❑ Colostrum/milk production ❑ Breastfeeding and returning to work ❑ Breastfeeding resources Baby Care:❑ Experience with baby care ❑ Help with baby at home ❑ Sibling rivalry ❑ Preparing for baby at home ❑ Calming your baby ❑ Car seat Additional Education: ❑ Fetal movement ❑ Kick counts Developed by San Francisco General Hospital Nurse-Midwifery Service Box 26-5 Medical Conditions Requiring Transfer of Care to h igh-Risk Clinic (These may differ in different settings) Maternal Conditions Chronic hypertension diagnosed before pregnancy Active or uncontrolled seizure disorder Severe asthma (hospitalization or requiring systemic steroids during pregnancy) Cardiac disease (except asymptomatic mitral valve prolapse) Pulmonary hypertension Platelet count less than 100,000 Deep vein thrombosis Sickle cell disease Lupus, scleroderma, or any connective tissue disease Cancer Active tuberculosis Active viral hepatitis HIV positive Hyperthyroidism Diabetes: type 1 and type 2 Multiple gestation Box 26-6 Visit s chedule Guidelines Frequency of prenatal visits 1-28 weeks—every 4 weeks 28-36 weeks—every 2-3 weeks 36+ weeks—every week Reduced visit schedule One visit during each gestational age or age range (approximately eight visits) 6-8 weeks 14-16 weeks 24-28 weeks 32 weeks 36 weeks Weekly from 38 weeks 2. P atient should return to a physician if she is assessed to be high risk per guidelines or for consul-tation around a specific problem (see Chapter  30 on guidelines for medical consultation during pregnancy). FIGu Re 26-1 OB Pr ovider e ducation Flow s heet (Continued)251 Plan

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VI. Internet r esources A. American College of Nurse-Midwives Consumer Education website: There is information regarding pregnancy, labor and birth, parenting, and women's health including easy to use patient education handouts (some in Spanish) from the “Share with Women Series” (http://www. mymidwife. org/). B. March of Dimes: Information is available for providers and patients in both written and audio-video formats in English and Spanish on pregnancy, birth, and newborn development and care(http://www. marchofdimes. com/). C. National Women's Health Information Center: This is a U. S. Department of Health and Human Services women's health information website. There are numerous fact sheets on all aspects of women's health including pregnancy in both Spanish and English (http://www . womenshealth. gov). D. Childbirth Connection: This organization promotes evidenced-based maternity care and helps women and providers to make informed decisions. There are numerous patient education, preg-nancy, and childbirth resources (http://www. childbirth connection. org/). E. American College of Obstetricians and Gynecologists: There are limited numbers of patient education handouts available by provider request (http://www. acog. org/). Re Fe Ren Ces American College of Obstetricians and Gynecologists. (2014). Committee opinion No. 611: Method for estimating due date. Obstetrics and Gynecology, 124(4), 863-866. Bridges, C. B., Woods, L., & Coyne Beasley, T. (2013). Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule for adults aged 19 years and older—United States, 2013. MMWR. Surveillance Summaries, 62(Suppl. 1), 9-19. Dowswell, T., Carroli, G., Duley, L., Gates, S., Gülmezoglu, A. M., Khan-Neelofur, D., et al. (2010). Alternative versus standard packages of antenatal care for low-risk pregnancy. Cochrane Database of Systematic Reviews, 10, CD000934. Fiscella, K. (1995). Does prenatal care improve birth outcomes? A critical review. Obstetrics & Gynecology, 85(3), 468-479. Graves, B. W., & Barger, M. K. (2001). A conservative approach to iron supplementation during pregnancy. Journal of Midwifery and Women's Health, 45(3), 163-166; 159-163 (for N282A). Grieger, J. A., & Clifton, V. L. (2014). A review of the impact of dietary intakes in human pregnancy on infant birthweight. Nutrients, 7(1), 153-178. Harvey, N. C., Holroyd, C., Ntani, G, Javid, K., Cooper, P., Moon, R., et al. (2014). Vitamin D supplementation in pregnancy: A systematic review. Health T echnology Assessment, 18(45), 1-190. Hofmeyr, G. J., Lawrie, T. A., Atallah, A. N., & Dully, L. (2014). Calcium sup-plementation during pregnancy for preventing hypertensive disorders and related problems. Cochrane Database of Systematic Reviews, 6, CD001059. Hunter, L. A. (2009). Issues in pregnancy dating: Revisiting the evidence. Journal of Midwifery & Women's Health, 54(3), 184-190. Lu, M. C., T ache, V., Alexander, G. R., Kotelchuck, M., & Halfon, N. (2003). Preventing low birth weight: Is prenatal care the answer? Journal of Maternal-Fetal & Neonatal Medicine, 13(6), 362-380. Mozurkewich, E. L., & Klemens, C. (2012). Omega-3 fatty acids and pregnancy: Current implications for practice. Current Opinion in Obstetrics & Gynecology, 24(2), 72-77. Vintzileos, A., Ananth, C. V., Smulian, J. C., Scorza, W. E., & Knuppel, R. A. (2002). The impact of prenatal care on neonatal deaths in the presence and absence of antenatal high-risk conditions. American Journal of Obstetrics and Gynecology, 186(5), 1011-1016. Walker, D. S., Mc Cully, L., & Vest, V. (2001). Evidence-based pre-natal care visits: When less is more. Journal of Midwifery and Women's Health, 46(3), 146-151. Wei, S. Q., Qi, H. P., Luo, Z. C., & Fraser, W. D. (2013). Maternal vitamin D status and adverse pregnancy outcomes: A systematic review and meta-analysis. Journal of Maternal, Fetal, and Neonatal Medicine, 26, 889-899. 252 CHAPTER 26 | The Initial Prenatal Visit

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patients with information about all screening and diagnostic options. Included in counseling are the benefits, limitations, and risks of prenatal genetic testing, individualized genetic information, options, and assistance with interpretation and understanding of test results. A. Prenatal genetic screening for trisomies 21, 18, 13; neural tube defects (NTD); abdominal wall defects; and Smith-Lemli-Opitz syndrome (SLOS) Several optional first and second trimester screening strategies are available to assess risk for trisomy 21 (Down syndrome), trisomy 18 (Edward syndrome), open neural tube defects (NTD), abdominal wall defects, and Smith-Lemli-Opitz syndrome (SLOS). The tests use serum biochemical markers and fetal ultrasound to refine and improve risk assessment beyond standard population-based risk assessments. Combining these first-and second-trimester screening strategies to assess risk, rather than using them as single-method testing, improves accuracy and detection rates for Down syn-drome and trisomy 18 (California Department of Public Health, 2014). See T able 27-1 for detection rates and timing of these genetic screening strategies. 1. C ombined first-trimester screening: first-trimester maternal serum and fetal nuchal translucency (NT) Combined first-trimester screening is performed in two steps and determines risk for trisomies 21 and 18. Maternal serum testing for pregnancy-associated plasma protein A (PAPP-A) and human chorionic gonadotropin (h CG) is obtained; the serum analyte values are combined with ultrasound examination of fetal NT to determine risk. Nuchal translucency refers to a measurement of a clearly demarcated fluid-filled space behind the fetal neck that is present in all fetuses. Skill at obtain-ing NT measurement requires training for a stan-dardized method of measurement; therefore, this screening tool may not be available in all communi-ties. NT measurement alone has a detection rate for I. Intr oduction and general background Recent scientific advances in human genetics, combined with new prenatal screening and diagnostic technologies, have resulted in a proliferation of genetic testing options and a con-comitant change in the landscape of prenatal genetic testing. All pregnant women now have the option of numerous genetic screening and diagnostic tests. T raditionally, genetic tests such as hemoglobin electropho-resis for hemoglobinopathies, cystic fibrosis carrier screen-ing, and first and second-trimester serologic screening with fetal ultrasound to determine risk for aneuploidy and selected structural defects are routinely offered to all pregnant women (Minkoff & Berkowitz, 2014). When patients test positive for these screening tests, or have genetic risk factors such as a family history of inherited disorders, advanced maternal age, a history of offspring with anomalies, or an ethnicity-based risk for autosomal recessive disorders, they are referred for genetic counseling and possible genetic diagnostic testing. The recent introduction and acceptance of new technolo-gies such as noninvasive prenatal testing (NIPT) for fetal aneuploidy (also known as cell-free fetal DNA) and expanded carrier gene panels offer benefits such as early genetic screen-ing, improved specificity and sensitivity for aneuploidy, and capacity to identify genetic carrier status for over 100 recessive diseases. The limitations of these tests underlie current debate about how and when to best incorporate these new tests into established prenatal genetic testing algorithms (Han & Platt, 2014; Langlois, Benn, & Wilkins-Haug, 2015; Wienke, Brown, Farmer, & Strange, 2014). Nevertheless, incorporation of these tests is already beginning to alter testing paradigms. In 2014, for example, Larion, Warsof, and Romary reported that an increased use of NIPT was associated with a decrease in chronic villus sampling and amniocentesis procedures. As more and more screening and diagnostic tools become available, genetic counselors with requisite knowledge about the multitude of optional genetic tests are key to providing Deborah Anderson Pren At A l Genet I c Screen I n G A n D D IAG no SIS© Eliks/Shutterstock; © donatas1205/Shutterstock 25327Chapt Er

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Table 27-1 Selected Prenatal Screening Strategies, Detection Rates, and T iming of Screening timing of Scr eening ( l aboratory dependent) Screening Strategy Detection r ate c linical Application First-trimester serum: 10-13 weeks 6 days First-trimester serum There are no risk assessments for the first trimester as a stand-alone test. (May vary with screening program. ) The test combines with the NT and/or the quad marker. First-trimester serum: 10-13 weeks 6 days Nuchal translucency: 11 weeks 2 days-14 weeks 2 days Combined first-trimester screen (Combines maternal serum testing results and NT results)Trisomy 21: 85% Trisomy 18: 60%Test performed in two steps. If results are positive, first-trimester screening allows for the option of early diagnostic testing and decision making regarding the course of the pregnancy. > 10 weeks Noninvasive prenatal testing or cell-free fetal DNA testing (Maternal serum)Trisomy 21: 99% Trisomy 18: 99%Trisomy 13: 92%Offered to women at high risk for aneuploidy 15-20 weeks (Optimal time 16-18 weeks)Quadruple or quad marker screen (Maternal serum)Trisomy 21: 80% Trisomy 18: 67%Anencephaly: 97%Open spina bifida: 80%Abdominal wall defects: 85%Smith-Lemli-Opitz: 60%Can be used alone or combined with first-trimester serum or combined first-trimester screen. Detection rates for trisomy 21 and 18 are improved when combined. May be used in women with late entry to prenatal care. First-trimester serum: 10-13 weeks 6 days Second-trimester serum: 15-20 weeks Serum integrated screen (Combines first-trimester maternal serum with quad marker)Trisomy 21: 85% Trisomy 18: 79%Anencephaly: 97%Open spina bifida: 80%Abdominal wall defects: 85% Smith-Lemli-Opitz: 60%Test is performed in two steps. First-trimester serum: 10-13 weeks 6 days Nuchal translucency: 11 weeks 2 days-14 weeks 2 days Second-trimester serum: 15-20 weeks Sequential integrated screen (Combines first-trimester serum and NT with quad marker test results)Trisomy 21: 90% Trisomy 18: 81%Anencephaly: 97%Open spina bifida: 80%Abdominal wall defects: 85%Smith-Lemli-Opitz: 60%Test is performed in three steps. Data from California Department of Public Health Prenatal Screening Program. (2014). trisomy 21 of 64-70% with a 5% false-positive rate (California Department of Public Health, 2014). Detection rates improve and can modify risk assess-ment when combined with first-trimester serum testing and the quadruple marker serum screen. An increased NT measurement (> 3 mm) is associated with fetal chromosomal abnormalities and cardiac defects. NT measurement of 3. 5 mm or greater is associated with fetal structural anomalies, such as congenital hydrocephalus; agenesis, hypoplasia, and dysplasia of the lung; atresia and stenosis of the small intestine; osteodystrophies; genetic disorders such as Noonan syndrome; and diaphragm anoma-lies (Baer et al., 2014). As such, women with an NT greater than or equal to 3 mm should be offered genetic counseling and diagnosis, targeted ultra-sound, and fetal echocardiogram. 2. Qua druple (quad) marker serum examination The quad marker estimates the risk for trisomies 21 and 18, open NTD, abdominal wall defect, and 254 CHAPTER 27 | Prenatal Genetic Screening and Diagnosis

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a prior pregnancy with a trisomy, positive test result for aneuploidy (including first-trimester, sequential, integrated screen, or quadruple screen), and parental balanced robertsonian translocation. The California Prenatal Screening Program recommends offering the option of NIPT or chorionic villus sampling (CVS) when the first-trimester combined screen-ing (first-trimester serum and NT) is positive for trisomy 21 or 18. B. Carrier screening for recessive conditions Carrier screening is available to individuals and couples who are at risk of conceiving children affected by reces-sive diseases. Currently, all pregnant women are rou-tinely screened for hemoglobinopathies (hemoglobin electrophoresis and mean corpuscular volume [MCV]) and are offered carrier screening for cystic fibrosis (ACOG Committee on Genetics, 2011). The American College of Medical Genetics and Genomics (ACMG) recommends the option of general population screen-ing for spinal muscular atrophy, as well, although this is unsupported by ACOG (ACOG Committee on Genetics, 2009). Additionally, parents with personal or family his-tories of inherited disorders such as T ay-Sachs disease, Canavan disease, familial dysautonomia, fragile-X syn-drome, sickle cell anemia, α-thalassemia, β-thalassemia, and cystic fibrosis are offered carrier testing along with genetic counseling. In the absence of family history, ethnicity-based carrier screening is offered to women who are at risk of targeted genetic diseases that are found to have increased preva-lence in certain ethnic groups. T able 27-2 lists ACOG recommendations (ACOG Committee on Genetics, 2005, 2009, 2010, 2011; ACOG Committee on Obstetrics, 2007) for genetic diseases for which carrier screening is recommended and the patient populations that carry an increased risk for these disorders. Limitations of ethnicity-based carrier screening include difficulty assigning a spe-cific ethnicity in individuals with mixed racial ancestry, patient preferences against use of racial and ethnic cat-egorization in medicine, and noninclusion of groups with lower risks for the diseases. Recent research demonstrated SLOS. Four biochemical markers are assessed: alpha fetoprotein (AFP), human chorionic gonadotropin (h CG), unconjugated estriol (u E3), and dimeric inhibin-A (DIA). It can be used alone, combined with first-trimester serum, or combined with first-trimester screen to improve detection rates. 3. S erum integrated screening: first-and second-trimester serum testing Serum integrated screening combines first-trimester blood test results with quad marker blood test results. This test may be useful when NT measurements can-not be obtained because of timing, patient wishes, or where NT programs are not available. 4. S equential integrated screening: first-and second-trimester serum testing, and NT Sequential integrated screening combines three tests: first-and second-trimester serum screening, and NT. It provides higher detection rates for aneuploidy when compared to combined first-trimester screen or serum integrated screening. 5. N oninvasive prenatal testing (NIPT) or cell-free fetal DNA testing Noninvasive prenatal testing screens for trisomy 21 (Down syndrome), trisomy 18 (Edward syn-drome), trisomy 13 (Patau syndrome), and some sex chromosome abnormalities have been avail-able for clinical use since 2011. NIPT can also determine fetal Rhesus status and fetal sex. The test analyzes maternal serum cell-free fetal DNA frag-ments circulating in maternal plasma and has been shown to be highly sensitive and specific, with a > 99. 1% detection rate for Down syndrome and a low false-positive rate (< 1%) (Bianchi et al., 2013; Gil et al., 2015; Norton et al., 2012). The American College of Obstetricians and Gynecologists (ACOG Committee on Genetics, 2012) currently recom-mends offering NIPT to women who are at high risk for aneuploidy: women with maternal age of 35 years or older at delivery, fetal ultrasonographic findings indicating an increased risk of aneuploidy, history of Table 27-2 Ethnicity-Based Recommendation for Carrier Screening ethnic Group/Geographic Ancestry Disease All ethnicities Cystic fibrosis Cajun, French-Canadian T ay-Sachs disease Ashkenazi Jewish Tay-Sachs, Canavan disease, familial dysautonomia African, African-American Sickle cell anemia Southeast Asian, Mediterranean Alpha-or beta-thalassemia255 Introduction and general background

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that ethnicity-based approaches to genetic screening are not aligned with the current distribution of carrier frequen-cies of severe genetic disease and suggested that new carrier screening guidelines are needed (Lazarin et al., 2013). Recent advances in genetic technology now make it possible to screen for hundreds of causal mutations for genetic disease (Lazarin et al., 2013). Expanded prenatal carrier screening panels are currently available to the public and medical providers through commercial labo-ratories. Evidence-based guidelines are not yet available to guide practitioners about how to best incorporate expanded prenatal carrier screening panels into current screening algorithms. When consumers request expand-ed prenatal carrier panels from commercial laboratories, formal genetic counseling prior to and after the test will provide patients with support and information for under-standing the test's benefits, limitations, and interpretation. Current controversies related to expanded carrier screen-ing include questions about which diseases to include in the prenatal carrier screening panel and implications of the test results in reproductive decision making. The American College of Medical Genetics and Genomics (Grody et al., 2013) position statement on prenatal/preconception expanded carrier screening provides criteria to laborato-ries for the selection of appropriate tests to be included in prenatal carrier screening panels. II. Database A. Subjective 1. A ll women regardless of age should have the option for genetic screening or diagnostic testing (ACOG Committee on Obstetrics, 2007). Advanced maternal age (35 years old) alone is no longer used as a deter-mining factor for who is offered prenatal screening or diagnostic testing. 2. L ast menstrual period. If unsure or unreliable, order an ultrasound to determine gestational age. Screening tests for aneuploidy and neural tube defects are sensitive to gestational age. 3. E thnicity 4. Ge netic, obstetric, and family history. Identify any genetic risk factors such as chromosome abnor-malities, inherited genetic disorders, unexplained mental retardation or developmental delay, primary ovarian insufficiency of unknown etiology, autism, or congenital malformation. 5. D etermine whether the patient desires prenatal testing. Factors to be considered if women choose to have or decline testing includea. Ge stational age at entry into prenatal careb. E thnicity-based risk factors c. P ersonal, family, genetic, and obstetric history d. N umber of fetuses e. N T availability f. T est sensitivity and limitations g. D esire for testing h. R isks of diagnostic procedures i. O ptions for early termination j. I nsurance coverage B. Objective 1. Es tablish expected date of delivery (EDD). Because first and second-trimester testing is sensitive to gestational age, ultrasound dating of pregnancy reduces rates of false-positive and false-negative results caused by incorrect dating. If the expected date of delivery is changed (≥ 10 days difference) after submission of screening tests, the laboratory must be informed of the new EDD for reinterpretation of test results. 2. R outine laboratory: complete blood count (CBC) with mean corpuscular volume and hemoglobin electrophoresis to screen for hemoglobinopathies and cystic fibrosis carrier testing if desired by the patient. 3. R outine ultrasound to assess fetal anatomy at approximately 18-20 weeks' gestation 4. W eight III. Assessment Patient desires/declines prenatal genetic screening tests (specify test) or carrier testing. IV. Goals for clinical management A. Identify infants with specific genetic and/ or neural tube disorders previous to birth in requesting families. B. Establish inherited and/or historical risk for genetic disorders. C. Establish patient desires for genetic screening using principals of informed consent and shared decision making. D. Allow for identification of increased risk for neural tube defects and genetic disorders and give families the option of diagnostic screening. 256 CHAPTER 27 | Prenatal Genetic Screening and Diagnosis

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refer to a genetic counselor for further counseling regarding interpretation of results, recommendations for follow-up examinations, possible confirmatory diagnostic testing, and supportive counseling. I. Pr enatal genetic diagnosis: Introduction and general background Invasive prenatal diagnosis allows for the identification of multiple genetic disorders and provides parents with the information necessary to help make well-informed reproduc-tive decisions. Although all women have the option of prena-tal diagnosis, it is most often performed in women who have known risk factors for heritable genetic diseases or in women whose prenatal screening tests return positive. Chorionic villus sampling and amniocentesis permit a multitude of genetic diag-noses to be made in early pregnancy; preimplantation genetic diagnosis provides genetic diagnosis in an embryo obtained through in vitro fertilization prior to implantation. A patient's decision to choose prenatal genetic diagnosis includes consideration of the anticipated risk that the fetus will have an abnormality, gestational age of the fetus, previ-ous obstetric history, risk of pregnancy loss from an invasive procedure, feelings about having a child with a chromosomal abnormality, desire for a definitive diagnosis, and beliefs about termination. A. Chorionic villus sampling Under ultrasound guidance, a small sample of the placenta is obtained through a transcervical or transabdominal route. 1. T iming of test: 10-14 weeks of gestation 2. Be nefits a. C VS tests for aneuploidy. If there is an indication, it can also test for biochemical abnormalities, single gene conditions, and collagen abnormali-ties. Microarray analysis can be performed to test for microdeletions and duplications. b. Be cause CVS is generally performed in the first trimester, it allows for early diagnosis and decision making about reproductive choices. c. R esults are usually available 1-2 weeks after the procedure. 3. R isks a. R isk rates approach or may be the same as amniocentesis (see amniocentesis). b. A mniotic fluid leak or infection, vaginal bleed-ing, or cell culture failure. c. M osaicism that may or may not be confined to the placenta. When mosaicism is detected on CVS, amniocentesis is recommended. V. Plan A. Counseling regarding tests and results 1. A ll patients are offered first and second-trimester serologic screening, NT ultrasound examination, and cystic fibrosis carrier status testing. The option of NIPT and expanded carrier screening will vary with practice site. 2. I f personal, family, or obstetric history are positive for genetic risk factors such as aneuploidy, inherited genetic disorder, offspring with birth defects, or consanguinity, offer referral to a genetic counselor or a perinatal specialist for counseling and possible prenatal diagnosis. 3. P rovide information regarding screening tests in a nondirective, sensitive, and nonjudgmental manner. Include information about the difference between risk assessment and diagnosis, the limitations of the screening tests, the rates and meaning of false positives and negatives, and the difference between carrier traits and diseases. Offer unbiased support for their decisions (Sheets et al., 2011). 4. D ocument acceptance or refusal of genetic screening tests. Some state-run programs require a standardized signed accept/decline form for first-trimester serum screen, NT, or quad marker. 5. W hen reviewing combined first-trimester, quad marker, or sequential integrated screen results with women, it is preferred to communicate the numerical risk assess-ment of the final analysis rather than a “positive” or “negative” result. Numerical risk of a genetic condition can be communicated in both ratio and percentages and may include the chances of having or not having the genetic condition. For example, “There is a 1:50 chance of Down syndrome, which means there is a 49:50 chance that there is not Down syndrome. That equates to a 2%  chance of Down syndrome or a 98% chance there is not Down syndrome. ” It may also be useful to compare their screening risk to their age-related risk. B. Laboratory 1. S ee T able 27-1 for timing of genetic screening tests. Timing of the first-trimester serum screen, NT, and quad marker testing is limited by gestational age. 2. F ill out the appropriate laboratory forms including the best dating parameter, current weight, number of fetuses, race, diabetes, and tobacco use. Additional data are used to adjust interpretation of test results. C. Consultation and referral If the risk is screen positive, or if the risk is higher than the procedure-related risk of loss from diagnostic testing, 257 Prenatal genetic diagnosis: Introduction and general background

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B. Amniocentesis Under ultrasound guidance a small amount of amniotic fluid is aspirated via a transabdominal puncture of the uterus and amnion. 1. T iming of test: 15-20 weeks' gestation 2. Be nefits a. A mniocentesis tests for aneuploidy and neu-ral tube defects. If indicated, it can test for fetal blood type and selected inherited diseases. Microarray analysis can be performed to test for microdeletions and duplications. b. R esults are usually available 1-2 weeks after the procedure. c. C ytogenetic diagnostic accuracy is greater than 99%. 3. R isks a. P rocedure-related loss is 1 in 300-500, depending on provider (ACOG Committee on Obstetrics, 2007). b. A mniotic fluid leakage or rupture, transient vaginal spotting, chorioamnionitis, rare needle injury to fetus, and failure of amniotic fluid cell culture. C. Preimplantation genetic diagnosis Preimplantation genetic diagnosis is performed on cells removed from preimplantation embryos conceived through in vitro fertilization. Single gene or chromosomal abnormalities can be identified in the embryo, allowing for transfer of only unaffected embryos back to the uterus. 1. Be nefits a. T ests for aneuploidy, single gene disorders, and chromosomal abnormalities, such as deletions and translocations (ACOG, 2014). b. A llows for very early reproductive decision mak-ing, prior to the establishment of pregnancy. 2. R isks a. R equires in vitro fertilization with its associated risks and expense. b. F alse-positive and-negative test results leading to misdiagnosis. Confirmatory CVS or amnio-centesis is recommended for pregnancies con-ceived after prenatal diagnosis. c. M ay decrease the chance of pregnancy depend-ing on type of testing. II. Database A. Subjective 1. I dentify genetic indications for prenatal diagnosis. a. C hromosomal abnormality in previous off-spring, parent, or close relative b. S tructural anomalies identified by ultrasound examination c. H istory of previous fetus or child with any chro-mosome abnormality d. P arental carrier of chromosome translocation or chromosome inversion e. P arental aneuploidy or mosaicism for aneuploidy f. A bnormal prenatal screening test results g. P arents are carriers of mendelian conditions, such as cystic fibrosis, hemophilia, muscular dystrophy, T ay-Sachs disease, inborn errors of metabolism, or hemoglobinopathies h. A ll women regardless of age should have the option for genetic screening or diagnostic testing. B. Objective 1. Ge stational age 2. R esults of prenatal screening tests for aneuploidy, ultrasound evaluations, and carrier screening status of parents 3. R h status, hemoglobin electrophoresis, MCV III. Assessment Patient desires/declines CVS, amniocentesis, or preimplanta-tion genetic diagnosis IV. Goals for c linical Management A. Establish patient desires for genetic testing using principles of informed consent and shared decision making. B. Identify infants with specific genetic defects and neural tube disorders previous to birth in requesting families. C. Give families information in order to prepare for an affected child or allow for pregnancy termination. V. Plan A. Diagnosis 1. R efer patient for preimplantation genetic diagnosis, CVS, or amniocentesis during appropriate testing window. 258 CHAPTER 27 | Prenatal Genetic Screening and Diagnosis

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Baer, R. J., Norton, M., Shaw. G., Flessel, M. C., Goldman, S., Currier, R. J., et al. (2014). Risk of selected structural abnormalities in infants after increased nuchal translucency measurement. American Journal of Obstetrics and Gynecology, 211(6), 675-719. Bianchi, D. W., Prosen, T., Platt, L. D., Goldberg, J. D., Abuhamad, A. Z., Rava, R. P., et al. (2013). Massively parallel sequencing of maternal plasma DNA in 113 cases of fetal nuchal cystic hygroma). Obstetrics and Gynecology, 121(5), 1057-1062. California Department of Public Health. (2014). California Prenatal Screening Program. Retrieved from www. cdph. ca. gov/pns. Gil, M M, Quezada, M S, Revello, R, Akolekar, R. & Nicolaides, K. H. (2015). Analysis of cell-free DNA in maternal blood in screening for fetal aneuploidies: Updated meta-analysis. Ultrasound in Obstetrics & Gynecology, 45(3), 249-66. Grody, W., Thompson, B., Gregg, A., Bean, L. H., Monaghan, K. G., Schneider, A., et al. (2013). ACMG position statement on prenatal/preconception expanded carrier screening. Genetic Medicine, 15(6), 482-483. Han, C. S., & Platt, L. D. (2014). Noninvasive prenatal testing: Need for informed enthusiasm. American Journal of Obstetrics and Gynecology, 211(6), 577-580. Langlois, S., Benn, P., & Wilkins-Haug, L. (2015). Current controversies in prenatal diagnosis 4: Pre-conception expanded carrier screening should replace all current prenatal screening for specific single gene disorders. Prenatal Diagnosis, 35(1), 23-28. Larion, S., Warsof, S. L., & Romary, L. (2014). Uptake of noninvasive pre-natal testing at a large academic referral center. American Journal of Obstetrics and Gynecology. 211(6), 651-657. Lazarin, G. A., Haque, I. S., Nazareth, S., Iori, K., Patterson, A. S., Jacobson, J. L., et al. (2013). An empirical estimate of carrier frequencies for 400+ causal mendelian variants: Results from an ethnically diverse clinical sample of 23,453 individuals. Genetics in Medicine, 15(3), 178-186. Minkoff, H., & Berkowitz, R. (2014). The case for universal prenatal genetic counseling. Obstetrics and Gynecology, 123(6), 1335-1338. Norton, M. E., Brar, H., Weiss, J., Karimi, A., Laurent, L. C., Caughey, A. B., et al. (2012). Non-invasive chromosomal evaluation (NICE) study: Results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. American Journal of Obstetrics and Gynecology, 207(2), 137-138. Sheets, K., Crissman, B., Feist, C., Sell, S. L., Johnson, L. R., Donahue, K. C., et al. (2011). Practice guidelines for communicating a prenatal or postnatal diagnosis of down syndrome: Recommendations of the national society of genetic counselors. journal of genetic counseling. Journal of Genetic Counseling, 20(5), 432-441. Wienke, S., Brown, K., Farmer, M., & Strange, C. (2014). Expanded carrier screening panels-does bigger mean better? Journal of Community Genetics, 5(2), 191-198. B. Education and Counseling 1. R eview the risks and benefits of procedures; include comparisons to screening tests. 2. P rovide genetic counseling prior to testing; patients should return to their genetic counselors for reporting and interpretation of test results. 3. A posit ive diagnosis result is delivered to the patient by a knowledgeable healthcare provider. Provide accurate and balanced information as soon as possible, in the patient's preferred language, and in a private setting. Use neutral language, in a sensitive and caring manner while avoiding value judgments (Sheets et al., 2011); offer in-person follow-up. 4. C onsider referral to social workers, parent support networks, clergy, and therapeutic counselors for further support and information. C. Medication 1. R h-negative nonsensitized women need Rh (D) immune globulin (Rhogam) administration after CVS or amniocentesis. reference S ACOG Committee on Genetics. (2005). ACOG committee opinion. Number 318, October 2005. Screening for T ay-Sachs disease. Obstetrics and Gynecology, 106(4), 893-894. ACOG Committee on Genetics. (2009). ACOG committee opinion no. 442: Preconception and prenatal carrier screening for genetic diseases in individuals of Eastern European Jewish descent. Obstetrics and Gynecology, 114(4), 950-953. ACOG Committee on Genetics. (2010). ACOG committee opinion no.  469: Carrier screening for fragile X syndrome. Obstetrics and Gynecology, 116(4), 1008-1010. ACOG Committee on Genetics. (2011). ACOG committee opinion no. 486: Update on carrier screening for cystic fibrosis. Obstetrics and Gynecology, 117(4), 1028-1031. ACOG Committee on Genetics. (2012). Noninvasive prenatal testing for fetal aneuploidy. Committee opinion no. 545: Noninvasive prenatal testing for fetal aneuploidy. Obstetrics and Gynecology, 120(6), 1532-1534. ACOG Committee on Obstetrics. (2007). ACOG practice bulletin no. 78: Hemoglobinopathies in pregnancy. Obstetrics and Gynecology, 109(1), 229-237. American College of Obstetricians and Gynecologists. (2014). ACOG technology assessment no. 11: Genetics and molecular diagnostic testing. Obstetrics and Gynecology, 123(2, Pt. 1), 394-413. 259 References

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2. Es timated delivery date: review dating 3. P roblems or concerns since her last visit (e. g., uterine activity, change in vaginal discharge, or psychosocial issues) 4. F ollow-up on problems from previous visit (e. g., nausea, back pain, fetal position, psychosocial issues) 5. F ollow-up on problems from “problem list” (e. g., Was medication taken for urinary tract infection? Is housing issue resolved?) 6. D anger signs (e. g., signs of spontaneous abortion, preterm labor, urinary tract infection, preeclampsia, or intimate partner violence) (T able 28-2) 7. H istory and health screening review (current pregnancy, obstetric, medical, family, psychosocial-including depression and violence, and nutrition). The Family Violence Prevention Fund recommends screening for intimate partner violence and abuse at each prenatal visit (T able 28-3). 8. C onsults: Results and management plans (physician, social worker, public health nurse, and so forth) B. Objective 1. V ital signs and urine a. W eight b. B lood pressure c. U rinalysis: if indicated to screen for preeclampsia or urinary tract infection (evidence does not sup-port routine urine screening in low-risk women [Alto, 2005; Siddique, Lantos, Vander Weele, & Lauderdale, 2012]) 2. L aboratory data a. R esults for current problems (e. g., urine dip or wet mount) b. A re laboratory values up to date? (e. g., chest radiograph after a positive purified protein deriv-ative, third-trimester testing for group B strepto-coccus) (T able 28-4)I. Definition and backgr ound The purpose of return prenatal visits is to evaluate the pregnancy through ongoing health, nutritional, and psycho-social assessments. Referrals within the healthcare system and assistance with movement toward positive health behavior changes are also integral parts of the prenatal care process. The frequency and content of prenatal visits can be tailored to the specific needs of each client (medical risk factors, psychoso-cial needs, and parity). The format of care delivery may also vary depending on the site. Although most prenatal care in the United States is still structured around one-to-one visits with a medical care provider, there is increasing use of group-based prenatal care models, most notably Centering Pregnancy. For sites using Centering Pregnancy, care is moved out of the examination room and into a group space, and cohorts of 8-12 women go through pregnancy together. Each of the 10 Centering sessions includes three components: Women receive medical assessment, health education with interactive learning, and social support within the group space. Randomized controlled trial research has shown that women who participate in Centering Pregnancy, when compared with women in one-to-one care, are less likely to have a premature birth, more likely to be satisfied with care, and feel more prepared for labor and childbirth (Ickovics et al., 2007). Numerous other studies support these findings and suggest other positive health out-comes associated with Centering Pregnancy (Baldwin, 2006; Tilden, Hersh, Emeis, Weinstein, & Caughey, 2014). For more information on the Centering Pregnancy model, go to www. centeringhealthcare. org/. T able 28-1 provides a summary of the Essential Elements of Centering Pregnancy. II. Database A. Subjective 1. Ge stational age Rebekah Kaplan and Margaret Hutchison THe Re Tu Rn PRena Tal V I s IT© Eliks/Shutterstock; © donatas1205/Shutterstock 260 28Chapt Er

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Table 28-1 Centering Pregnancy®: Essential Elements The following are what are considered to be the “Essential Elements” of Centering Pregnancy, with a brief description of the significance of each element. These function as the guiding precepts that make prenatal care conducted in a group setting “centering. ” 1. Health assessment occurs within the group space. Normalizes pregnancy and prenatal care 2. Participants are involved in self-care activities. Promotes sense of self-ef ficac y 3. A facilitative leadership style is used. Promotes sense of self-ef ficacy, supports community building 4. The group is conducted in a circle. Supports open, nonhierarchic communications 5. Each session has an overall plan. There is an agenda for each session 6. Attention is given to the core content, although emphasis may vary. The facilitative leadership model supports flexibility in discussion content, as dictated by the needs of the group 7. There is stability of group leadership. Group leaders (a provider/nonprovider team) become trusted members of the group 8. Group conduct honors the contributions of each member. Creating a safe group environment supports group cohesion and learning 9. The composition of the group is stable but not rigid. Supports community-building and development of trust among participants 10. Group size is optimal to promote the process. 8-12 pregnant participants are recommended; supports optimal engagement by of participants, sustainable use of staf f 11. Involvement of family support people is optional. Support people included as determined by site 12. Opportunity for socializing within the group is provided. Supports community building 13. There is ongoing evaluation of outcomes. Given challenges inherent in prenatal care system redesign, supports sustainability Modified from materials developed by the Centering Healthcare Institute (used with permission). 3. P hysical examination a. Ge neral appearance (e. g., new striae or signs of depression) b. A bdominal examination i. F undal height: measure by landmarks before 22-24 weeks, then with measuring tape (from the superior border of the sym-physis pubis to the fundus) ii. L eopold's maneuvers (position and presen-tation) after 32-36 weeksiii. Es timated fetal weight after 36 weeks c. F etal heart rate i. D oppler 9-12 weeks ii. F etoscope 18-20 weeks iii. U ltrasound after 6-7 weeks (if indicated) d. Othe r physical examination as indicated by client problems or concerns (e. g., costovertebral angle tenderness or vaginal discharge)261 Database

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III. a ssessment A. Gestational age/fetal size: 1. Es tablish due date using best criteria if not previously done (T able 26-5) 2. I dentify any size and date discrepancy Table 28-2 Signs of Pregnancy Complications First Trimester Vaginal bleeding Fever, chills, dysuria Persistent nausea and vomiting Second and Third Trimesters Vaginal bleeding Fever, chills, dysuria, flank pain Uterine cramping or contractions Leaking of amniotic fluid Decreased fetal movement Severe headache without relief from analgesics Visual changes (blurry vision or seeing spots) Pelvic pressure Continuous pruritus without rash (with affected palms and soles) Table 28-3 Abuse Assessment Screen 1. Have you ever been emotionally or physically abused by your partner or someone important to you? q YES q NO 2. Within the last year, have you been hit, slapped, kicked, or otherwise physically hurt by someone?q YES q NO If YES, by whom? Total number of times: 3. Since you've been pregnant, were you hit, slapped, kicked, or otherwise physically hurt by someone? q YES q NO If YES, by whom? Total number of times: Adapted from Centers for Disease Control and Prevention. (2007). Intimate partner violence and sexual violence victimization assessment instruments. Retrieved from http://www. cdc. gov/violenceprevention /pdf/ipv/ipvandsvscreening. pdf Table 28-4 T iming of Testing/Procedures for Women Without Significant Medical Risk Factors Initial visit (see Chapter 26, Obstetric Health Maintenance and Promotion: The Initial Prenatal Visit) 8-20 weeks 10-136 weeks: offer first-trimester serum genetic screening test 112-142 weeks: offer ultrasound for nuchal translucency 15-20 weeks: offer second-trimester serum genetic screening test Diagnostic/screening testing and vaccines as indicated 10+ weeks: noninvasive prenatal testing (cell-free DNA) 10-14 weeks: chorionic villi sampling 15-20 weeks: amniocentesis 18-20 weeks: fetal survey screening ultrasound 26-28 weeks: complete blood count, 1-hour glucose load test, antibody screen if rhesus factor negative; if indicated, venereal disease reference laboratory, HIV 27-36 weeks: Tdap vaccine (American College of Obstetricians and Gynecologists [ACOG], 2013b) 32-36 weeks: if indicated, repeat sexually transmitted infection testing 35-37 weeks: group B Streptococcus (GBS) culture Table 28-5 When to Redate a Pregnancy by Ultrasound Findings Gestational a ge Range (Based on l MP)Method of Measurement Discrepancy Between u ltrasound Dating and l MP Dating That s upports Redating ≤ 8 6/7 wk 9 0/7 to 13 6/7 wk CRLCRLMore than 5 days More than 7 days 14 0/7 to 15 6/7 BPD, HC, AC, FL More than 7 days 16 0/7 wk to 21 6/7 wk BPD, HC, AC, FL More than 10 days 22 0/7 wk to 27 6/7 wk BPD, HC, AC, FL More than 14 days 28 0/7 wk and beyond BPD, HC, AC, FL More than 21 days Abbreviations: AC, abdominal circumference; BPD, biparietal diameter; CRL, crown-rump length; FL, femur length; HC, head circumference; LMP, last menstrual period. Reproduced from ACOG. (2014). ACOG committee opinion No 611: Method for estimating due date. Obstetrics and Gynecology, 124(4), 863-866. 262 CHAPTER 28 | The Return Prenatal Visit

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B. Differential diagnosis: 1. Es tablish for identified abnormal physical examina-tion or laboratory findings (e. g., anemia, preterm labor, or urinary tract infection) C. Determine appropriateness of weight gain and nutritional status (Tables 28-6 and 28-7 ) D. Determine prenatal educational needs E. Identify psychosocial issues (e. g., food insecurity, violence, immigration problems, housing, or social isolation) F. Role assessment: identify the need for consultation or collaborative management with other health team members IV. Goals of clinical management A. Identify medical, nutritional, and psychosocial problems and risk factors and develop a plan of care for each problem B. Anticipatory guidance related to pregnancy, birth, parenting, and medical care C. Individualize care to meet both the family and medical needs and maximize maternal and fetal well-being V. Plan (Figur e 28-1) A. Laboratory 1. L aboratory or diagnostic testing (T able 28-4) 2. Othe r laboratory tests needed related to physical examination findings (e. g., urine culture, chlamydia test, or anemia work-up) 3. F ollow-up on any previous abnormal laboratory studies B. Medication 1. R efill prenatal vitamins as necessary 2. S upplementation: calcium, fish oil, vitamin D3, and iron if deficient 3. T reatment of specific problems (e. g., urinary tract infection or vaginitis) C. Education and counseling 1. C lient concerns2. C urrent laboratory data 3. W eight gain and diet 4. T eaching appropriate to gestational age and client needs (Figures 28-1 and 26-1) 5. D anger signs of pregnancy (e. g., spontaneous abortion, preterm labor, and preeclampsia) 6. E motional preparation for motherhood 7. E xercise, stress management, and behavior modification D. Refer for consultation or antepartum fetal evaluation 1. R efer any clients as indicated for physician consultation or transfer of care (see Chapter 30 on guidelines for medical consultation and referral Table 28-6 Recommended Pattern of W eight Gain for Pregnancy First trimester 1. 1-4. 4 lb Rates for second and third trimesters by body mass index (BMI) Underweight—BMI less than 18. 5: 1 lb/wk (1-1. 3): TWG 28-40 lbs Normal weight—BMI 18. 5-24. 9: 1 lb/wk (0. 8-1): TWG 25-35 lbs Overweight—BMI 25-29. 9: 0. 6 lb/wk (0. 5-0. 7): TWG 15-25 lbs Obese (all classes)—BMI 30 or greater: 0. 5 lb/wk (0. 4-0. 6): TWG 11-20 lbs Abbreviation: TWG, total weight gain. Data from Institute of Medicine. (2009). Report brief. Weight gain during pregnancy: Reexamining the guidelines. Washington, DC: National Academies Press; ACOG. (2013a). ACOG committee opinion no. 548: Weight gain during pregnancy. Obstetrics and Gynecology, 121(1), 210-212. Table 28-7 Daily Dietary Needs for Normal-W eight Women Second and third trimesters: Approximately 300 additional calories a day (e. g., 8 oz 1% milk, one hardboiled egg, and one apple) Protein: 60 g (teenagers, 75-80 g) Grains: 6 oz Vegetables: 2. 5 cups Fruit: 2 cups Calcium: 1,000 mg263 Plan

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FIGu Re 28-1 Pr enatal Care Flow s heet 8-14 Weeks 15-20 Weeks 20-28 Weeks Labs/Tes Ts Sono/dating Blood type, Rh, antibody screen complete blood count (CBC), Hgb electrophoresis Rapid plasma reagin (RPR), rubella, varicella (by hx or titers), HIV, purified protein derivative (PPD), hepatitis B surface antigen Urine culture + sensitivity (C+S), urine dip screening Pap (if due), GC/Chlamydia First-trimester diagnostic screen Nuchal translucency Labs/Tes T s/Va CCI nes Quadruple marker screen Sono fetal survey (18-20 weeks)Flu vaccine (Oct-May)Labs/Tes T s CBC, glucose load test (26-28 weeks) HIV, RPR (if indicated) se L e CTIV e T es TI n G Early glucose load test, fasting glucose and/or hemoglobin A1C Hepatitis CUrine toxicology screen Chorionic villus sampling, noninvasive DNA testing Cystic fibrosis, Ashkenazi screening Genetic screening based on family medical history/ethnicity Refusal of blood products consentse L e CTIV e T es TI n G Amniocentesis Early glucose load test or hemoglobin A1c Urine toxicology screen Chest x-ray (if + PPD)Urine C+SHepatitis B vaccine (high-risk behaviors) Level 2 ultrasound, fetal echose L e CTIV e T es TI n G 3-hour glucose tolerance test Antibody screen Rhogam at 28 weeks (or with any vaginal bleeding) in Rh-negative woman e DUC a TIO n Orientation to clinic/service Prenatal Classes referral Danger signs Common discomforts Nutrition, weight gain, and exercise Genetic testing options OTC/Rx med use Drug, tobacco, and alcohol use Dental services informatione DUC a TIO n Breastfeeding (BF) benefits Exclusive breast milk 6 months BF class referral Fetal movement and quickening Exercise in pregnancy Common discomforts Danger signse DUC a TIO n Signs/symptoms preterm labor (PTL)Contraception Danger signs Fetal movement V aginal birth after cesarean/trial of labor (VBAC/TOL) discussion Postpartum tubal ligation (PPTL) class referral (PPTL papers can be signed after 17 weeks) Breastfeeding benefits Exercise in pregnancy Attended breastfeeding class Attended Prenatal Classes264 CHAPTER 28 | The Return Prenatal Visit (continues)

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  28-32 Weeks 32-37 Weeks 37-41 Weeks Labs/Tes Ts/Va CCI nes Optional/Indicated Antenatal testing Kick counts Tdap (recommended between 27-36 weeks)L abs /T es T s /Va CCI nes GBS (35-37 weeks)Tdap Optional/Indicated Antenatal testing Disability L abs /T es T s Optional/Indicated Antenatal testing: NST/AFI (after 41 weeks) e DUC a TIO n Contraception Birth control method Consent signed q Attended PPTL class q VBAC/TOL consent q Signs and symptoms of PTLOther danger signs Newborn procedures Referral to birth prep class qe DUC a TIO n Early initiation of breastfeeding Skin to skin and rooming in Latch, infant feeding cues BF and returning to work Colostrum and milk production BF resources Circumcision Danger signs Signs and symptoms labor Infant car seat and baby supplies Choosing a pediatric provider Last chance for PPTL paperse DUC a TIO n Labor comfort measures Pain management options Signs and symptoms labor Managing early labor at home Fetal monitoring options Birth plan Danger signs Going past due date (induction 41-42 weeks) Attended labor prep class Pain control preference Support system Pediatric provider Courtesy of Community Health Network of San Francisco, Department of Public Health. during pregnancy) or for genetics, nutrition, or social services. 2. I nitiate and refer for fetal evaluation and antenatal testing if indicated (T able 28-8) E. Update problem list 1. Add or r esolve any outstanding problems or concerns F. Follow-up visit 1. Thi s should be flexible and individualized based on client needs, parity, and risk following a standard or reduced visit schedule reviewed in Chapter 26, Obstetric Health Maintenance and Promotion: The Initial Prenatal Visit. 2. P ostterm pregnancy (see T able 28-9)265 Plan

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Table 28-8 Antepartum Fetal Evaluation Conditions posing risk for fetal compromise include, but are not limited to: Postterm pregnancy; hypertensive disease; fetal growth restriction; diabetes; previous unexplained stillbirth; decreased fetal movement; abnormal analytes on serum genetic screening tests; increased serum human chorionic gonadotropin; cholestasis of pregnancy; twins with discordant growth; BMI greater than or equal to 40; preterm premature rupture of membranes; oligohydramnios; unexplained severe polyhydramnios; rhesus factor isoimmunization; active substance abuse; lupus; gastroschisis; and medical problems (e. g., cardiac disease, hyperthyroidism) Management Review of dating criteria Leopold's for good estimation of fetal weight Initiation of testing Begin testing at the gestational age at which the provider is willing to intervene to save the life of the fetus balanced with the age at which one would expect to detect abnormal testing (generally 34-36 weeks) Methods of testing Fetal movement assessments (kick counts) Nonstress test Amniotic fluid index Vibroacoustic stimulation Biophysical profile Contraction stress test First line: No consistent evidence suggests that formal kick counts decrease incidence of intrauterine fetal demise, although the method is widely used in practice for higher-risk pregnancies (Darby-Stewart, Strickland, & Jamieson, 2009). Second line: Modified biophysical profile: nonstress test plus amniotic fluid index. If modified biophysical profile is not reassuring, consult for biophysical profile, Doppler flow studies, and induction of labor after a contraction stress test. Table 28-9 Postterm Pregnancy Definitions Term delivery is considered between 37-42 weeks. Early Term: 37 wks + 0 days to 38 wks + 6 days Full Term: 39 wks + 0 days to 40 wks + 6 days Late Term: 41 wks + 0 days to 41 wks + 6 days Postterm: 42 wks + Management Examine cervix; Bishop's score greater than 5 is favorable for induction of labor Consider sweeping membranes at 38-41 weeks Consider alternative methods of induction Education Counsel risks and benefits of induction versus expectant management Follow-up Biweekly antenatal testing (nonstress test [NST], amniotic fluid index [AFI]) by 41 weeks, gestation Kick counts should be initiated at 40-41 weeks Offer induction of labor between 41-42 weeks Data from ACOG. (2013c). ACOG committee opinion no. 579: Definition of term pregnancy. Obstetrics and Gynecology, 122(5), 1139-1140. Re Fe Ren Ces Alto, W. A. (2005). No need for glycosuria/proteinuria screen in pregnant women. Journal of Family Practice, 54(11), 978-983. American College of Obstetricians and Gynecologists. (2013a). ACOG committee opinion no. 548: Weight gain during pregnancy. Obstetrics and Gynecology, 121(1), 210-212. American College of Obstetricians and Gynecologists. (2013b). ACOG committee opinion no. 566: Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Obstetrics and Gynecology, 121(6), 1411-1414. American College of Obstetricians and Gynecologists. (2013c). ACOG committee opinion no. 579: Definition of term pregnancy. Obstetrics and Gynecology, 122(5), 1139-1140. American College of Obstetricians and Gynecologists. (2014). ACOG committee opinion no. 611: Method for estimating due date. Obstetrics and Gynecology, 124(4), 863-866. Baldwin, K. A. (2006). Comparison of selected outcomes of centering pregnancy versus traditional prenatal care. Journal of Midwifery & Women's Health, 51(4), 266-272. Centers for Disease Control and Prevention. (2007). Intimate partner violence and sexual violence victimization assessment instruments. Retrieved from http://www. cdc. gov/violenceprevention/pdf/ipv/ipvandsvscreening. pdf. Darby-Stewart, A. L., Strickland, C. & Jamieson, B. (2009). Do abnormal fetal kick counts predict intrauterine death in average-risk pregnancies? Journal of Family Practice, 58(4), 220a-220c. 266 CHAPTER 28 | The Return Prenatal Visit

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Siddique, J., Lantos, J. D., Vander Weele, T. J., & Lauderdale, D. S. (2012). Screening tests during prenatal care: Does practice follow the evidence? Maternal and Child Health Journal, 16(1), 51-59. Tilden, E. L., Hersh, S. R., Emeis, C. L., Weinstein, S. R., & Caughey, A. B. (2014). Group prenatal care: Review of outcomes and recommendations for model implementation. Obstetrical and Gynecological Survey, 69(1), 46-55. Ickovics, J. R., Kershaw, T. S., Westdahl, C., Magriples, U., Massey, Z., Reynolds, H., et al. (2007). Group prenatal care and perinatal outcomes: A randomized controlled trial. Obstetrics & Gynecology, 110(2, Pt. 1), 330-339. Institute of Medicine. (2009). Report brief. Weight gain during pregnancy: Reexamining the guidelines. Washington, DC: National Academies Press. 267 References

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New mothers commonly appreciate opportunities to discuss their experience of childbirth and early parenting, although there are few data to guide the format or content of these conversa-tions. Women may desire to review clinical details and ask ques-tions to “fill in the blanks” in their childbirth memories (Rowan, Bick, & Bastos 2007). They may not have anticipated the inten-sity of the experience and benefit from reassurance that their coping behaviors and choices were respected. Postpartum care providers can prioritize sensitive and effective therapeutic com-munications because vulnerability, changes in self-perception, uncertainty, and disequilibrium are common during the postpar-tum role transition (Association of Women's Health, Obstetric and Neonatal Nurses [AWHONN], 2006). Ideally, women are provided an opportunity for a postpartum visit conducted by the provider who attended their labor and birth after visits in preg-nancy, to extend or facilitate new continuity of care, exchange of information, and feedback (Barimani, Oxelmark, Johansson & Highland; Sandall, Soltani, Gates, Shennan, & Devane, 2015). This chapter uses the SOAP (subjective, objective, assess-ment, and plan) note format to outline essential elements of postpartum care, which should be customized for individual women. The timing, number, and content of postpartum visits vary (Haran, van Driel, Mitchell, & Brodribb, 2014). Women are typically followed daily during their inpatient postpartum stay and scheduled for outpatient follow-up one or more times 1-8  weeks later (Declerq et al., 2013; Haran et al., 2014), per individual risk factors and recommenda-tions by the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) (2012). The timing of the standard 6-week postpar-tum visit may be based on tradition as much as research, as well as the understanding that uterine involution is typically complete then (Speroff & Mishell, 2008). Six weeks may be too late to detect or prevent some postpar-tum complications or to provide optimal contraceptive coun-seling because many women resume sexual intercourse before this time ( Jackson & Glasier, 2011; Speroff & Mishell, 2008). Women may be examined earlier or more frequently, or visits may be supplemented with telephone encounters (Lavender, I. Intr oduction and general background The postpartum period is a time of tremendous physical and emotional change for new mothers. Although childbearing women experience the most profound adaptations during this 6-8 week period, their partners, older children, extended family, and community may also experience significant transi-tions (Declerq, Sakala, Corry, Applebaum, & Herrlich, 2013). The goals of family-centered postpartum care include skilled support for optimal health during the transition with the pre-vention, identification, management, and resolution of abnor-mal physical, psychologic, and psychosocial adaptations. Postpartum visits include monitoring and education related to parturition complications with short-term or lifelong health implications. They serve as a transition from obstetric to primary health care with opportunities to initiate or resume routine screening and health maintenance activities. There is little research on optimal postpartum care, and no evidence to support some routine counseling and recommen-dations often made by healthcare providers in the postpartum period, e. g., stair climbing and lifting restrictions (Minig et al., 2006). However, accurate health education and promotion activities may be particularly effective in the postpartum period because many new mothers have knowledge deficits (Declerq et al., 2013) and most are highly motivated to make lifestyle and other changes to improve their health and that of their growing family. The postpartum period is also a key time for interven-tions because perinatal care is often the entry point into health care for marginalized populations whose healthcare access and use may decrease between pregnancies (Di Bari, Yu, Chao, & Lu, 2014) and who experience disparate adverse perinatal out-comes with lifelong implications for survivors. Postpartum edu-cation may include self-and infant care, symptoms that require immediate evaluation, and recommendations for primary care and health promoting activities such as exercise, healthful nutri-tion, breastfeeding, immunizations, sleep hygiene, child safety, contraception, and sexually transmitted infection prevention. Jenna Shaw-Battista and Holly Cost THe Po STPar T um V ISIT© Eliks/Shutterstock; © donatas1205/Shutterstock 268 29Chapt Er

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b. E ndocrine disorders (e. g., thyroid disorder and preexisting or gestational, type 1, or type 2 diabetes mellitus) c. H ypertension (e. g., chronic or gestational hyper-tension or preeclampsia-eclampsia) d. I nfectious processes such as sexually transmitted infections, latent tuberculosis, or chronic hepatitis infection e. Body mass index (BMI) outside the normal range f. T obacco exposure, either first or second hand g. S ubstance use disorders h. I ntimate partner or family violence i. P sychosocial stressors including housing and food insecurity j. A ny other primary care issues that may need to be addressed 2. D escription of the woman's intrapartum experience, including: a. D ate and type of birth and hospital postpartum course with information about any clinical variants or complications including perineal lacerations b. H er understanding and feelings about her labor and the birth of her infant; note and explore any traumatic feelings expressed about her experience, which may be most likely after obstetrical emergen-cies and unplanned cesarean or forceps-assisted vaginal birth (Andersen et al., 2012; Gamble & Creedy, 2009; Rowlands & Redshaw, 2012). 3. Ge neral health, well-being, and psychological status should be assessed screening for: a. R eport of feeling generally unwell or specific symptoms, which may indicate primary health concerns or parturition complications including mood disorders (Cerimele et al., 2013). b. S elf-care: i. W hat is the woman doing to care for herself? ii. D oes she have the opportunity to get exer-cise and leave the house? iii. C an she nap/sleep when the baby sleeps? iv. I f she sustained a perineal laceration, is she using sitz baths at home? How often? c. Ad justment, capabilities, and satisfaction with parenting d. P erinatal mood disorders, the most common postpartum complicationi. W omen with depression and/or anxiety fre-quently present with physical symptoms in primary care oriented visits during the first 12 months postpartum, which should prompt careful screening for risk factors and psycho-logic symptoms (Cerimele et al., 2013). Richens, Milan, Smyth, & Dowswell, 2013), to follow-up on birth complications, when significant risk factors for adverse postpartum conditions are present or for other reasons such as breastfeeding difficulties, management of chronic or perinatal health conditions, or optimal timing of birth control initiation. For example, women who gave birth by cesarean section may be evaluated 1-2 weeks postpartum with targeted assessments for postoperative complications including trauma, excessive blood loss, anemia, thrombophlebitis, oliguria, and infection, e. g., sur-gical wound infections that most commonly present 3-8 days postpartum (AWHONN, 2006). A 1-2 week postpartum visit may also be helpful to evaluate mother-infant bonding, mood, risks for discontinuing breastfeeding, and family support and integration (Y onemoto, Dowswell, Nagai, & Mori, 2013). Appointment reminders or incentives may increase postpar-tum visit attendance and prove particularly useful in the care of high-risk populations, e. g., women with a history of mood dis-orders or adolescent mothers (Stevens-Simon, O'Connor, & Bassford, 1994). Perinatal outcomes may also be improved in vulnerable and high-risk populations with home visits, phone calls, web-based programs, and referrals to postpartum educa-tion, fitness classes, and peer support groups, among other inter-ventions (T eychenne & Y ork, 2013; Thomson, Dykes, Hurley, & Hoddinott, 2012). Counseling, social support facilitation, rein-forcement of healthful coping strategies, and discussion of role transition and self-perception alterations may help to reestablish psychologic equilibrium (Mac Arthur et al., 2003; Ruchat & Mottola, 2012), particularly for women who experienced unan-ticipated obstetrical procedures, emergencies or trauma related to pregnancy and childbirth (Andersen, Melvaer, Videbech, Lamont, & Joergensen, 2012; Gamble & Creedy, 2009; Shaw, Levitt, Wong, & Kaczorowski, 2006). Women who experienced perinatal loss, had an infant removed from their custody by child protective services, placed their infant with an adoptive family, or served as a surrogate mother may require unique or additional supports during their postpartum transition. In addition to con-siderations of women's health status and risk factors, the time elapsed since childbirth informs the type of screening, interven-tion, education, and referrals provided in postpartum visits. II. Database (may include but is not limited to) Data may be gleaned from postpartum patient interviews and review of medical records when available. A. Subjective data 1. H istory of medical conditions, antenatal, intrapartum, or postpartum complications requiring follow-up, including: a. M ental health conditions including mood and anxiety disorders269 Database

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v. D oes she have information about milk col-lection and storage? Does she need a breast pump? b. I f formula feeding, does she have information on how to properly make and store formula and how to properly clean bottles and nipples? 6. N utrition status, including a. D aily nutritional intake including adequacy of protein, calcium sources, and fruits and vegetables b. D oes she require additional support or educa-tion to obtain diet appropriate for lactation, iron deficiency, or other common postpartum circumstances? c. Othe r nutritional risk factors such as BMI out-side of the normal range, gestational diabetes, or eating disorders that would benefit from ongoing nutritional support d. A ny use of vitamins, minerals, herbs, or other supplements e. Ade quate water intake 7. M edications with dosage and indication, if any 8. S exual health, including a. A ltered self-perception b. L ibido and satisfaction c. R esumption of sexual activity and need for contraception 9. F amily, social, and community integration and support a. Bond ing with infant b. W hat types of physical and emotional support and daily help does she have? c. H ousing and economic status: Does she have what she needs to care for self and infant? d. A ny plans to start or return to work outside the home, with impact on infant care and feeding and self-care e. R elationship conflict or interpersonal violence f. P artner adjustment g. S ibling, grandparent, extended family, and social support network adjustment h. C ultural or religious practices in the postpartum period (Dennis et al., 2007) 10. R eview of systems (screen for) a. B reasts i. B reast or nipple pain ii. M asses or erythema noted iii. C oncerns about insufficient breast milk or infant feeding b. A bdomen i. A bdominal or uterine pain or cramping that has increased since delivery or is unrelieved with pain medicationii. R isk factors: History of depression or anxiety, perinatal loss, complications of pregnancy, hyperemesis, multiple gestation, major life events unrelated to pregnancy and child-birth, lack of support or resources, and social stigma, e. g., single or adolescent motherhood (Tharp & Farley, 2013). iii. S ymptoms: Inability to cope with demands of new role, disorganized daily routine, poor sleep hygiene, excessive fatigue that inter-feres with self-or infant care, depression or mania, anhedonia, frequent crying, insom-nia, anxiety, hypervigilance, or thoughts of harming self or infant (Cerimele et al., 2013). e. P ostpartum psychosis, a medical emergency characterized by disorganized behavior, visual or auditory hallucination, and delusions (Tharp & Farley, 2013). f. P osttraumatic stress disorder, which may recur due to childbirth-related stressors among women with a prior diagnosis or present for the first time as a consequence of trauma experienced during pregnancy and childbirth. Risk factors for new postpartum onset of posttraumatic stress disorder include subjective report of distress during labor, obstetrical emergencies, and unplanned mode of delivery (Andersen et al., 2012; Gamble  & Creedy, 2009; Rowlands & Redshaw, 2012). g. S ubstance use or abuse, which frequently co-occurs with perinatal mood disorders and inti-mate partner violence (AWHONN, 2006). 4. H ow is her infant? a. A ny health or growth issues? b. D oes the infant have pediatric care? c. I s the infant in a safe sleeping environment at home and/or in other care situations d. U sing a car seat? e. A sk about methods being used to soothe the infant—skin to skin, swaddling, movement, sounds 5. I nfant feeding a. I f infant is nursing, determine if breastfeeding is exclusive or if there is formula supplementation. i. I f supplementation, how much and why? ii. H ow is nursing going—any questions or concerns? Does the woman have support for nursing from her partner/family/friends? iii. D oes she feel her milk supply is adequate? iv. H ow long does she plan to nurse? Does she plan to return to work, and if so, when? Will she have support for pumping and milk storage at work?270 CHAPTER 29 | The Postpartum Visit

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ii. R eport of pain, redness, odor, or discharge at the site of a cesarean incision c. P elvis, genitals, and lochia i. P elvic pain, particularly over the symphysis pubis or coccyx, which may result from injury during childbirth ii. V aginal, vulvar, or perineal pain that has increased since delivery or is unrelieved by pain medication, with or without edema iii. A bnormal, excessive or prolonged bleeding (e. g., fills pad in < 1-2 hours, large recurrent clots, lochia serosa or alba that reverts to lochia rubra, or lochia that persists beyond 6 weeks postpartum) iv. F oul-smelling lochia v. R esumption of menses d. El imination i. U rinary, fecal, or flatus incontinence ii. U rinary retention iii. D ysuria iv. H istory of intrapartum or postpartum bladder catheterization, or other risk factors for urinary tract infection v. C onstipation e. E xtremities i. C alf pain, heat, or redness ii. E dema that increases or persists beyond 7 days postpartum, particularly if unilateral B. Objective data 1. Ge neral well-being and psychologic status: Observe affect, eye contact, and appearance 2. F amily integration: Observe interactions between mother, child, and family members present 3. W eight and vital signs 4. H ead and neck a. Th yroid gland: palpate for size and nodularity b. L ymph nodes: palpate for size and tenderness 5. B reasts a. Obs erve size, color, and symmetry b. P alpate for tenderness, masses, and warmth c. E xamine the nipples for cracks, fissures, bleed-ing, lesions, and compression stripes d. I f possible, observe infant position and latch during breastfeeding 6. A bdomen a. I nspect and palpate for masses, tenderness, uterine involution, hernias, diastasis recti, and muscle tone b. C heck surgical site for closure, pain, masses, exu-date, and erythema if applicable, e. g., cesarean or postpartum tubal ligation7. P elvis, genitals, and lochia a. P alpate over symphysis pubis and coccyx if report of pain b. E xternal genitalia and perineum i. I nspect for symmetry, excoriation, and varicosities ii. A ssess any lacerations for approximation, exudate, and healing iii. V isualize the amount and appearance of lochia iv. A ssess for leakage of urine c. P elvic examination as indicated i. V agina: assess for uterine prolapse, cystocele, or rectocele; check the strength of pelvic musculature during a Kegel exercise ii. U terus: assess position, size, and tenderness iii. C ervix: assess os appearance and closure d. R ectal exam: Assess for hemorrhoids, fissures, fistulas, masses, and sphincter tone 8. E xtremities a. A ssess for calf pain, heat, or redness on inspec-tion and palpation b. A ssess for edema that increases or persists beyond 7 days postpartum or is unilateral III. a ssessment Assessment should incorporate subjective and objective data and address the woman's physical, emotional, and social post-partum adaptation along with any complications noted. IV. Goals for clinical management The goals of family-centered postpartum care include skilled support for optimal health during the transition with the pre-vention, identification, management, and resolution of abnor-mal physical, psychologic, and psychosocial adaptations. A. Identify women at risk for postpartum complications including mood disorders and individualize care to promote health and minimize harm. B. Assess postpartum adjustment and support families during the postpartum transition period; provide care and referrals as needed. C. Screen for dangers to the mother, baby, and family. D. Breastfeeding support: Provide lactation care, anticipatory guidance, and nutritional counseling. 271 Goals for clinical management

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