Clinical trial NCT02219269: A Complex Contraception Registry
Official title: A Complex Contraception Registry - UC Family Planning Collaborative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Cardiovascular Disease
Epilepsy
Migraine
Neurological Disorders
Cancer
Bariatric Surgery Candidate
Organ or Tissue Transplant; Complications
Lupus Erythematosus, Systemic
Other Hematologic Conditions
Other Venous Embolism and Thrombosis
Keywords: contraception
family planning
complex medical conditions
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, San Francisco
name: University of California, Irvine
name: University of California, Davis
First posted: 2014-08-18
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of women 18-45 years old and seeking contraception with the medical condition listed in inclusion criteria. Participants will be recruited from obstetrics and gynecology clinic at UCSD, UCLA, UCSF, UC Irvine and UC Davis. 250 participants will be enrolled. Approximately 50 cases will be recruited at each site.

Brief summary: The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.

Detailed description: Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.

The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.

Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.

Eligibility criteria: Inclusion Criteria:

1. Ethnic Background: No limitation, will include minorities
2. Sexually Active with men
3. Diagnosis with at least one of the following conditions

   * Diabetes and other endocrine disorders
   * Cardiovascular Disease, such as Ischemic Heart Disease, Valvular disease, hypertension or pulmonary hypertension
   * Epilepsy, Migraine, and other neurologic disorders
   * History of or current cancer
   * History of or planning Bariatric Surgery
   * History of or planning Solid Organ Transplant
   * Systematic Lupus Erythematous and other rheumatologic conditions
   * History of or current Venous Thrombosis Embolism
   * Other Medical Conditions (such as Sickle Cell Disease or Cystic Fibrosis)

Exclusion Criteria:

1. Pregnant at time of recruitment
2. History of hysterectomy, bilateral oophorectomy, or sterilization procedure
3. Unable to provide informed consent
4. Attempting to become pregnant at time of recruitment
5. Not sexually active with men
6. No active telephone number or email for follow up

Women who are pregnant will be excluded from this study. However, no pregnancy testing will be conducted; pregnancy status will be based on self-reporting by subjects.

Primary outcomes:
measure: Contraceptive method continuation and satisfaction
timeFrame: 6 month
Secondary outcomes:
measure: History of unintended pregnancy
timeFrame: 6 months
measure: Change in Medical Condition
timeFrame: 6 months
measure: History of contraceptive methods used
timeFrame: 6 months
measure: If Contraception is Accessed in post-partum or post-abortion setting
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Orange
country: United States
facility: UC Irvine
state: California
city: Sacramento
country: United States
facility: UC Davis
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jody Steinauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Radhika Rible, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Irvine
name: Tabetha Harken, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis
name: Catherine Cansino, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD
name: Sheila Mody, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Centers for Disease Control and Prevention (CDC). U S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Recomm Rep. 2010 Jun 18;59(RR-4):1-86.
citation: Mody SK, Cansino C, Rible R, Farala JP, Steinauer J, Harken T; University of California Family Planning Collaborative. Contraceptive use among women with medical conditions: Factors that influence method choice. Semin Perinatol. 2020 Aug;44(5):151310. doi: 10.1016/j.semperi.2020.151310. Epub 2020 Aug 20.