A Complex Contraception Registry
1 other identifier
observational
97
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Shorter than P25 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 14, 2018
March 1, 2018
1 year
August 11, 2014
March 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contraceptive method continuation and satisfaction
Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.
6 month
Secondary Outcomes (4)
History of unintended pregnancy
6 months
Change in Medical Condition
6 months
History of contraceptive methods used
6 months
If Contraception is Accessed in post-partum or post-abortion setting
6 months
Study Arms (1)
Medically complex contraception users
Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.
Eligibility Criteria
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.
You may qualify if:
- Ethnic Background: No limitation, will include minorities
- Sexually Active with men
- 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)
You may not qualify if:
- Pregnant at time of recruitment
- History of hysterectomy, bilateral oophorectomy, or sterilization procedure
- Unable to provide informed consent
- Attempting to become pregnant at time of recruitment
- Not sexually active with men
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- University of California, Los Angelescollaborator
- University of California, San Franciscocollaborator
- University of California, Irvinecollaborator
- University of California, Daviscollaborator
Study Sites (5)
UCLA
Los Angeles, California, 90095, United States
UC Irvine
Orange, California, 92868, United States
UC Davis
Sacramento, California, 95817, United States
UCSD
San Diego, California, 92103, United States
UCSF
San Francisco, California, 94117, United States
Related Publications (2)
Center for Disease Control and Prevention. U.S Medical Eligibility Criteria for Contraceptive Use, 2010.MMWR 2010;59 (No.RR-4).76-81
BACKGROUNDMody 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.
PMID: 32888723DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jody Steinauer, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Radhika Rible, MD MS
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Tabetha Harken, MD MPH
UC Irvine
- PRINCIPAL INVESTIGATOR
Catherine Cansino, MD MPH
UC Davis
- PRINCIPAL INVESTIGATOR
Sheila Mody, MD MPH
UCSD
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 18, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 14, 2018
Record last verified: 2018-03