bluuebunny/crossref_metadata_2025_split huggingface dataset:
Five-Year Efficacy and Safety of the Liletta® Levonorgestrel Intrauterine System [13F]
Authors: Teal Stephanie B. , Turok David K. , Jensen Jeffrey T. , Chen Beatrice A. , Kimble Thomas D. , Creinin Mitchell D. 
Published: April 2018

INTRODUCTION:
Liletta is a levonorgestrel 52 mg contraceptive intrauterine system (IUS) currently approved for contraception for up to four years based on an ongoing multicenter trial currently planned to continue for up to eight years of use. We evaluated the five-year efficacy and safety data for Liletta.

METHODS:
Women aged 16-45 years were enrolled; those women aged 36-45 years received the IUS for safety evaluation only. We followed 1,568 women aged 16-35 years and 146 women aged 36-45 years after successful IUS placement. We assessed five-year pregnancy rates and safety outcomes.

RESULTS:
The 16-35 year old subjects included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these women, nine pregnancies occurred including four in nulliparous women and one in an obese woman. One pregnancy occurred following perforation and one following expulsion. Six (67%) pregnancies were ectopic. The Pearl Index in the first year was .15 (95% CI .02-.55). Cumulative life-table pregnancy rates through years three and five were .59 (95% CI .28-1.25) and .92 (95% CI .46-1.82), respectively. Perforation following IUS placement occurred in two (0.1%) women; both were diagnosed within the first year. Expulsion occurred in 63 (3.7%) participants, most (50 [80.6%]) during the first year of use. Pelvic infection was diagnosed in 11 (.6%) women. Only 39 (2.3%) women discontinued due to bleeding complaints, primarily (n=29 [74.3%]) in the first year.

CONCLUSION:
Liletta is highly effective and has an excellent safety profile over five years of use; most expulsions and discontinuation for bleeding occur during the first year of use.
Contraceptive Usage in Female Survivors of Young Adult Cancers [17F]
Authors: Shandley Lisa M. , Spencer Jessica B. , McKenzie Laurie J. , Mertens Ann C. , Howards Penelope P. 
Published: April 2018

INTRODUCTION:
Cancer survivors may be less likely than the general population to use effective methods of contraception, but prior studies were small.

METHODS:
In a population-based study, we recruited reproductive-aged (22-45 years) women, diagnosed with cancer between the ages of 20-35 years and at least 2 years post-diagnosis. Women with no cancer history were recruited for comparison. Exclusion criteria included having a hysterectomy or bilateral oophorectomy. Women reported on contraceptive use (pills, patch, ring, mini-pills, Depo Provera, implant, hormonal and non-hormonal intrauterine device, and tubal ligation) in the past year.

RESULTS:
Among survivors (n=960), 38.4% reported using a WHO Tier I/II contraceptive method in the past year compared to 47.5% of comparison women (n=992). Long-acting reversible contraceptive (LARC) was more common among contracepting survivors (30.9%) than among contracepting comparison women (23.4%). Among cancer survivors contraceptive use was associated with being younger than 35 years at interview (odds ratio [OR]: 2.04, 95% confidence interval [CI] 1.55, 2.67), being younger than 30 years at diagnosis (OR 1.81, 95% CI 1.38, 2.37), identifying as white (OR 1.54, 95% CI 1.13, 2.10), not having chemotherapy (OR 1.43, 95% CI 1.10, 1.86), and being nulligravid at cancer diagnosis (OR 1.31, 95% CI 1.01, 1.69). Breast cancer survivors were less likely to have used birth control in the past year (OR 0.46, 95% CI 0.34, 0.62) compared with all other cancer types.

CONCLUSION:
While the overall rate of contraceptive use was lower among cancer survivors than among comparison women, survivors using contraception were more likely to use LARC methods.
Cost-Effectiveness of Offering Contraceptives to Incarcerated Women Prior to Release from Prison [20F]
Authors: Toffey David E. , Allen Allison , Caughey Aaron B. 
Published: April 2018

INTRODUCTION:
Incarcerated women face numerous barriers to consistent and affordable contraception, and experience high rates of unintended pregnancy with associated individual, institutional, and societal costs. We sought to determine the benefits of providing contraceptive services to this high-risk patient population.

METHODS:
A decision-analytic model using TreeAge software was designed to compare offering contraceptive counseling and methods prior to release from prison with providing no such services. Our study included long- and short-acting reversible contraception methods and included rates of discontinuation and method switching. All probabilities and utilities were derived from the literature. Utilities were included with a discounted life expectancy rate of 3% to produce quality adjusted life years (QALYs). The cost-effectiveness threshold was set at $100,000 per QALY. Outcomes include unintended pregnancies, ectopic pregnancy, spontaneous and therapeutic abortion, and preterm and term births.

RESULTS:
Offering contraception prior to release is cost-effective for all methods assessed. In a theoretical cohort of 56,000 incarcerated women of reproductive age not intending to get pregnant over a 12-month interval, offering contraception would prevent 18,251 unintended pregnancies, 644 preterm births, 6,045 term births, 180 ectopic pregnancies, 8,310 therapeutic abortions, and save $85 million. Sensitivity analysis demonstrated cost-effectiveness when services are utilized at a rate 25% of that modeled based on reported rates. Additionally, these services are cost-saving up to 9-times the costs modeled for counseling and office visits, and cost-effective up to 32-times these costs.

CONCLUSION:
Offering incarcerated reproductive-age women contraception prior to release is cost-effective, cost-saving, and reduces the rate of unintended pregnancy and associated obstetric complications.
Maternal and Neonatal Outcomes Following Methadone Taper for Opiate Detoxification [24F]
Authors: Smallwood Pamela Tess , Williams Corrine M. , McQuerry Kristen J. , Critchfield Agatha S. 
Published: April 2018

INTRODUCTION:
Several models have been studied for treatment of opioid dependence during pregnancy. The purpose of our study is to examine maternal and neonatal outcomes following a methadone taper for medication-assisted withdrawal (MAW) for opioid dependent pregnant women.

METHODS:
A retrospective chart review of pregnant women undergoing inpatient MAW using a methadone taper and delivering at the study institution was performed. At our institution, methadone taper is performed over approximately six days beginning with a total of 30mg of methadone on Day 1. As needed doses are available to the patient, however this does not affect the overall taper length. “Success” of MAW was defined as appropriate urine drug screen (UDS) on admission to Labor and Delivery (LDR).

RESULTS:
Among study participants (n=32) 47% had an appropriate UDS at admission to LDR. Among those who were successful vs those who were not, mean length of stay (6.20 vs. 4.18days p=0.0150) and the incidence of opiate maintenance at time of delivery (93% vs. 23%, p<.0001) were significantly different. Differences in neonatal outcomes included number of neonates treated for neonatal abstinence syndrome (33% vs. 47% p=0.4905) and mean maximum morphine dose (0.05 vs. 0.08mg p=0.3985), however none were significant.

CONCLUSION:
MAW (as performed at our institution) results in a less than 50% success rate. Success rates are higher when the taper is performed more slowly and when maintenance therapy is utilized. Therefore, if MAW is preferred by the patient, completion of the entire taper should be encouraged and maintenance therapy should be discussed following MAW completion.
Characteristics of Referred Patients With Twin-Twin Transfusion Syndrome (TTTS) Who Did Not Undergo Fetal Therapy [29F]
Authors: Sasso Elizabeth B. , Hardley Macy T. , Bottura Isabela , Korst Lisa M. , Ouzounian Joseph G. , Chmait Ramen H. 
Published: April 2018

INTRODUCTION:
Abundant research has been conducted regarding patients with TTTS who underwent fetal therapy, i.e., laser surgery, amnioreduction, and umbilical cord occlusion. Here, we describe patients referred for TTTS who did not undergo fetal therapy.

METHODS:
TTTS gestations at 16-26 weeks referred between 1/2006 and 3/2017 were reviewed. Those who did not undergo fetal therapy comprised the final study population. Based on initial consultation data, patients were grouped as non-surgical vs. surgical candidates. TTTS progression and perinatal outcomes were assessed.

RESULTS:
734 TTTS patients were evaluated. Of these, 68 (9.3%) did not undergo intervention; 42 non-surgical candidates (62%) and 26 surgical candidates (38%). Of the non-surgical candidates, 21 were ineligible because of fetal demise and 21 were ineligible because of maternal factors (12: preterm labor or preterm premature rupture of membranes, 7: placental abruption, 2: severe membrane separation). Of the surgical candidates, 11 underwent expectant management without subsequent intervention, 8 elected pregnancy termination, and 7 planned fetal intervention but had a complication before the procedure. Of 66 untreated cases, 10 (15.2%) had TTTS disease progression. Neonatal outcomes were available in 64 untreated cases: 41 (64%) had no survivors, 11 (17.2%) had one survivor and 12 (18.8%) had two survivors.

CONCLUSION:
9% of referred TTTS patients did not undergo fetal therapy, with many ineligible because of the development of fetal demise or labor onset between referral and consultation. To avoid bias, studies tracking outcomes of TTTS should routinely acknowledge this subgroup and the circumstances leading to lack of treatment.
Fetal and Maternal Responses to Yoga in the Third Trimester [30F]
Authors: Gavin Nicole R. , Kogutt Benjamin K. , Fletcher William , Szymanski Linda M. 
Published: April 2018

INTRODUCTION:
The goal is to examine the practical and real-time maternal and fetal responses to a moderate intensity yoga session in the third trimester of pregnancy. Unlike previous studies, our study examines a typical 1-hour, moderate intensity prenatal yoga session.

METHODS:
This is a prospective observational study in low-risk, pregnant participants. Exclusion criteria included hypertension, IUGR, preterm labor, or contraindications to exercise. Wireless fetal monitors were used to monitor fetal beat-to-beat variability, accelerations, and decelerations as well as maternal heart rate and uterine activity. For analysis, fetal and maternal heart rates were continuously recorded over the entire yoga session, and pre- and post NST tracings were analyzed for loss of fetal heart rate variability and decelerations.

RESULTS:
Twenty participants were enrolled; 19 completed the session. Mean gestational age was 35 weeks and 6 days with an average participant age of 32 years. While fetal heart rates fluctuated over the course of the yoga session, there were no significant fetal heart rate decelerations or changes in beat-to-beat variability to suggest deleterious fetal effects. The fetal heart rate averaged 135.3 bpm (SD±12.2) regardless of activity level . Maternal heart rate also fluctuated from a mean resting heart rate of 88.7 bpm (SD±9.7), increasing to an average heart rate of 104.8 bpm (SD±18.6) during the session, reaching a maximum of 154.9 bpm (SD±12.8), and subsequently decreasing to 88.7 bpm (SD±11.2) during meditation,.

CONCLUSION:
Yoga can be recommended for low-risk women during pregnancy as no adverse fetal heart rate effects were observed during a realistic, continuous yoga session.
Educating Patients on Preeclampsia and the Effect of Different Methods of Education on Patient Anxiety [33F]
Authors: Fisher Sarah M. , Strassberg Emmie R. , Mackeen Awathif , Paglia Michael J. 
Published: April 2018

INTRODUCTION:
To determine whether the exposure to two different methods of patient education regarding preeclampsia increased anxiety.

METHODS:
A randomized controlled trial was conducted of singleton primigravid patients at a tertiary care center between 18-25 weeks gestation. Patients were randomized to preeclampsia education with a graphic card or an educational video. Patients completed the validated State Trait Anxiety Short version 6 (STAI-6) anxiety assessment tool before and after exposure to the assigned educational tool. The change in score was compared to evaluate if patient anxiety level changed after education.

RESULTS:
A total of 101 patients were randomized with 56 to graphic card and 45 to educational video. The average STAI-6 scores before and after intervention for all groups were nearly within normal range (34-36). There were no significant differences in anxiety score before and after the intervention for those exposed to either the graphic card (p = 0.739) or the video (p = 0.121).

CONCLUSION:
Patient anxiety does not appear to be impacted by preeclampsia education with a graphic card or an educational video on preeclampsia.
Cost-Effectiveness of Detoxification vs. Methadone in Pregnancy [36F]
Authors: Seymour-Willey Alicia , Sargent James , Toffey David E. , Caughey Aaron B. 
Published: April 2018

INTRODUCTION:
Management of opiate-dependence in pregnancy can include detoxification and maintenance therapy with methadone or buprenorphine. Traditionally, detoxification was associated with higher rates of fetal and neonatal death but recent studies have challenged this relationship. The purpose of this study is to assess the cost-effectiveness of detoxification compared to methadone maintenance therapy.

METHODS:
A decision-analytic model using TreeAge Pro was designed to compare detoxification with methadone maintenance therapy. All probabilities and utilities were derived from the literature. Utilities were included with a discounted life expectancy rate of 3% to produce quality adjusted life years (QALYs). The cost-effectiveness threshold was set at $100,000 per QALY. Prenatal outcomes examined included intrauterine fetal demise (IUFD), neonatal demise (NND), perinatal deaths, neonatal abstinence syndrome (NAS), major neurodevelopmental disorder (MNDD), and preterm delivery (PTD). The maternal outcome measured was opioid relapse rate.

RESULTS:
We found that that detoxification was the dominant methodology for all outcomes assessed. In a theoretical cohort of 10,000 opiate-dependent pregnant woman, detoxification resulted in 59 fewer treatment failures, 26 fewer perinatal deaths, 4282 fewer cases of NAS, 137 fewer cases of MNDD, 224 fewer PTDs, and savings of $3,363 per pregnancy. Sensitivity analysis demonstrated that detoxification was the dominant strategy up to a detoxification price of $14,750, and remained cost-effective to a detoxification price of $26,357.

CONCLUSION:
Detoxification in pregnancy results in improved maternal and fetal outcomes, and is the cost-effective strategy when compared to methadone maintenance therapy.
Are Women Aware of FDA-510K Lubricant Clearance? [40F]
Authors: Krychman Michael 
Published: April 2018

INTRODUCTION:
Vaginal products have come under greater scrutiny with the consumer awareness campaign that has focused on additives and potential chemical irritants, acid base balance, chemicals or carcinogens in these products. Class II medical device 510(k) clearance is a premarket submission, made directly to the FDA that includes sufficient evidence to demonstrate that the lubricant/device is safe and effective.

METHODS:
An in office observational survey was completed to investigate whether lubricant consumers were aware if the lubricant they were using was 510(k) cleared. Fifty popular lubricant products were reviewed as to if they designated 510(k) clearance on their home page.

RESULTS:
Fifty women, (mean age 48) were assessed. Ninety six percent of the woman were not aware if their lubricant was 510(k) cleared. Ninety-six percent of the women did not have understanding of what the 510(k)-clearance specified. All women were unaware if their lubricant contained additives such as bactericides, or other caustic chemical. A total of 50 lubricants (30 water; 20 silicone products) were assessed. Fifty percent of (water based) were deemed to be 510(k) cleared by the FDA whereas only 14% of those mentioned this designation on their website. Fifty percent of the silicone lubes were 510(k) cleared and only 5% of them mentioned it on their websites.

CONCLUSION:
Most women are not aware of the 510(k) designations nor are they familiar with its significance and meaning. Companies are remiss in educating women about this important safety, efficacy and product designation.
The Association Between Depo-Provera and Postpartum Depressive Symptoms [2G]
Authors: Ross Carolyn , Shim Jessica , Stark Elisabeth , Miller Emily Stinnett 
Published: April 2018

INTRODUCTION:
Prior studies investigating the effects of Depo-Provera (DMPA) on mood have demonstrated conflicting results. We hypothesize that receipt of DMPA during the immediate postpartum period is associated with the development of postpartum depressive symptomatology.

METHODS:
We conducted a retrospective cohort study of women who presented to an academic outpatient clinic associated with Northwestern University for prenatal care between January 1, 2008 and December 31, 2014 who underwent a routine postpartum depression screen using the Patient Health Questionnaire-9 (PHQ-9) at their 6-week postpartum visits. A score of at least 10 defined a positive screen. Bivariable and multivariable analyses were performed to examine the relationship between DMPA receipt and postpartum depressive symptomatology.

RESULTS:
Of the 5103 women that met inclusion criteria, 410 (8.0%) received DMPA prior to being discharged from the hospital after delivery. Receipt of DMPA was not associated with a difference in the frequency of a positive depression screen at the postpartum visit (4.5% vs 6.1%, P=.25). This remained true after controlling for potential confounders (positive antenatal depression screen, age, BMI at delivery, gestational diabetes, nulliparity, public insurance, race, and preterm birth). Using an alpha of .05 and a beta of .20, this study had 80% power to detect a two-fold increase in the frequency of postpartum depressive symptomatology.

CONCLUSION:
Receipt of DMPA immediately postpartum is not associated with increased postpartum depressive symptomatology at the 6-week postpartum visit.
Contraceptive Practices in Women With Medical Conditions in the Clinics at the University Hospital of the West Indies [3G]
Authors: Hunter-Greaves Tiffany , Tate Nastassia , Medley-Singh Natalie , Simms-Stewart Donnette 
Published: April 2018

INTRODUCTION:
Women with medical comorbidities should optimize their health prior to conception with the consistent use of effective contraceptives. The objective of this study is to assess the contraceptive use among women with chronic diseases at the University Hospital.

METHODS:
A cross-sectional study was done among 260 participants identified from the medical clinics at the University Hospital, with an interviewer-administrated questionnaire. Candidates were recruited by convenience sampling and those who fit the inclusion criteria were enrolled. Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, USA) was used for data management and statistical analysis.

RESULTS:
The majority of the patients (200, 76.9%) were between 25-45 years old, employed (114, 43.9%), single (107, 41.2%), nulliparous (24,12.3%) and sexually active (176, 67.7%). Ten persons were pregnant however, only 3 (30%) were planned. The largest representation were in women with Systemic Lupus Erythematous (50, 19.2%), Diabetes Mellitus (48, 18.5%) and Hypertension (45, 17.5%), with the least among those receiving chemotherapy (7, 2.7%). 161 (62%) of the participants were currently using contraceptives. The methods included barrier methods (117, 45%) and oral contraceptive methods (36, 14%). Individuals with sickle cell disease were more likely to be using contraceptives (r=8.14, p=.004). Only 26 (10%) of patients used long acting reversible contraceptives

CONCLUSION:
Most women with chronic medical illness at the clinics at the University hospital reported current contraceptive use. Mainly short-term methods were used compared to the preferred long acting reversible counterparts. Greater efforts should be made in offering long-term contraception to women with chronic medical disorders.
Contraception Counseling in College Student Health Centers: A Survey of Healthcare Providers [13G]
Authors: Carr Audrey V. , Raker Christina , Clark Melissa A. , Khan Unab , Allen Rebecca H. 
Published: April 2018

INTRODUCTION:
Many of the 20 million college students in the U.S. access contraception through student health centers, but little is known about how college health providers approach contraceptive counseling and provision.

METHODS:
We surveyed 87 New England college health providers about contraceptive counseling practices and on site availability of contraceptives, especially intrauterine devices and subdermal implants (long-acting reversible contraception= LARC). Providers were also surveyed about their IUD/implant training and comfort level with insertion. Descriptive statistical analyses were conducted using STATA 13.2.

RESULTS:
Most respondents (57%) were nurse practitioners, 17% were registered nurses, and 11% were medical doctors. Providers ranked oral contraceptive methods as most popular with students and reported that students chose LARC methods less than 10% of the time. Providers felt that IUDs and implants were appropriate methods for this population, however few (<15%) provided LARC methods themselves. Most students had to be referred off-campus for further services. Providers had some experience with LARC training. 75% of providers reported classroom training with IUDs and implants, while 30-50% had hands-on insertion training. Despite these training experiences, nearly all providers reported they were uncomfortable with IUD and implant insertion. Barriers to LARC uptake included insufficient volume or experience, institutional policies, and student unfamiliarity with the methods.

CONCLUSION:
While college student healthcare providers are enthusiastic about LARC methods, few have insertion experience or are comfortable with follow-up care. Further research should address whether increased on-campus accessibility would increase student uptake as well as development of supplemental college healthcare provider training to increase comfort with LARC insertion.