A Complex Contraception Registry

NCT ID: NCT02219269

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sheila Mody

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jody Steinauer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Radhika Rible, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Tabetha Harken, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Catherine Cansino, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Sheila Mody, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCLA

Los Angeles, California, United States

UC Irvine

Orange, California, United States

UC Davis

Sacramento, California, United States

UCSD

San Diego, California, United States

UCSF

San Francisco, California, United States

Countries

United States

References

Center for Disease Control and Prevention. U.S Medical Eligibility Criteria for Contraceptive Use, 2010.MMWR 2010;59 (No.RR-4).76-81

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 32888723 (View on PubMed)

Other Identifiers

140166

Identifier Type: -

Identifier Source: org_study_id