A Complex Contraception Registry

Cancer Clinical Trial

Official title:

A Complex Contraception Registry - UC Family Planning Collaborative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219269
• Other study ID #: 140166
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: March 13, 2018
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: March 2018
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Cancer
• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Embolism
• Embolism and Thrombosis
• Epilepsy
• Lupus Erythematosus, Systemic
• Migraine
• Nervous System Diseases
• Neurological Disorders
• Organ or Tissue Transplant; Complications
• Other Hematologic Conditions
• Other Venous Embolism and Thrombosis
• Thrombophlebitis
• Thrombosis

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	History of unintended pregnancy	Measured with questionnaire at baseline, 3 months, and 6 months	6 months
Secondary	Change in Medical Condition	Measured with questionnaire at 3 months and 6 months	6 months
Secondary	History of contraceptive methods used	Measured with questionnaire at baseline	6 months
Secondary	If Contraception is Accessed in post-partum or post-abortion setting	Measured with questionnaire at baseline, 3 months, and 6 months	6 months