Abortion Clinical Trial
Official title:
Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Therapeutic Abortion - A Randomized Trial
This is a randomized, controlled trial investigating whether immediate versus standard, "Sunday Start", initiation of oral contraceptive pills (OCPs) in post-abortion subjects can improve compliance and the continuation of contraception. Immediate initiation of OCPs has been studied in women seeking contraception when they are not immediately post-abortion, and this "Quick Start" method has been shown to improve the continuation of OCPs into a second pill pack. The primary hypothesis of this study is that immediate initiation of OCPs in post-abortal women will improve the continuation of contraception over delayed initiation on the first Sunday after an abortion.
Status | Completed |
Enrollment | 300 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Any woman aged 13-45 who presents to the Women's Options Clinic and desires to use OCPs for post-abortion contraception. Exclusion Criteria: - Gestational age above 23 weeks and 1 day. - Any absolute contraindication for combination OCP use (smoking > 20 cigarettes a day over age 35, history of venous thromboembolic event or pulmonary embolism, history of or current ischemic heart disease, history of stroke, vascular disease, complicated valvular heart disease [pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis], severe hypertension with blood pressure >160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or benign or malignant liver tumors). - Patients who speak languages other than English or Spanish. - Patients who do not have a phone or who have a phone where any contact might compromise the confidentiality of their abortions. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Women's Options Clinic at San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Continuation of OCPs after abortion | Assessed by phone survey | Two and six months post-enrollment | No |
Secondary | Compliance with OCPs after abortion | assessed by phone survey | Two and six months post-enrollment | No |
Secondary | Bleeding patterns on OCPs after abortion | assessed by phone survey | Two months post-abortion | No |
Secondary | Satisfaction with OCPs after abortion | assessed by phone survey | six months post-enrollment | No |
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