Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion
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.
Behavioral: Immediate initiation of OCPs
Behavioral: Delayed initiation of OCPs
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Therapeutic Abortion - A Randomized Trial|
- Continuation of OCPs after abortion [ Time Frame: Two and six months post-enrollment ] [ Designated as safety issue: No ]Assessed by phone survey
- Compliance with OCPs after abortion [ Time Frame: Two and six months post-enrollment ] [ Designated as safety issue: No ]assessed by phone survey
- Bleeding patterns on OCPs after abortion [ Time Frame: Two months post-abortion ] [ Designated as safety issue: No ]assessed by phone survey
- Satisfaction with OCPs after abortion [ Time Frame: six months post-enrollment ] [ Designated as safety issue: No ]assessed by phone survey
|Study Start Date:||October 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Experimental: Immediate start
Initiate selected birth control method before leaving the clinic at the time of the abortion procedure.
|Behavioral: Immediate initiation of OCPs|
Active Comparator: Sunday start
Begin birth control the first Sunday after leaving the clinic
|Behavioral: Delayed initiation of OCPs|
The United States has a higher rate of unintended pregnancy than Canada or any other developed nation in Europe. OCPs are the most common method of hormonal contraception used in this country. Perfect use can lead to failure rates as low as 0.1% per year. Actual failure rates are much higher, often due to non-compliance with OCP use. Several recent studies have examined the "Quick Start", or initiation of OCPs in front of the provider while still at the clinic, regardless of time in the cycle. These studies have shown that women who swallowed the first OCP in the clinic were more likely to continue the OCP into the second month. Women who are seen in clinics for a therapeutic abortion (TAB) are often at extremely high risk for another unintended/unwanted pregnancy. If compliance in OCP use could be improved in this group of women, unintended/unwanted pregnancy rates could be reduced. One concern about the "Quick Start" technique is that women may have already ovulated or conceived when OCPs are initiated mid-cycle. In the post-abortal setting, this is not a concern. Applying the "Quick Start" technique to post-abortion patients and having women take the first of their OCPs while still in the clinic after their abortion may improve compliance and continuation of OCP use.
This is a prospective, randomized, controlled trial in post-abortal women, and will last approximately 24 months. All of the study subjects will receive a single pack of combination OCPs and a one-year prescription after their TAB. The women in the immediate start arm will then take their first OCP in the clinic, observed by clinic staff, before leaving. The controls will be instructed to begin the OCPs on the first Sunday following their abortion. All subjects will receive the same medication with the only difference being the timing of initiation of the OCPs. Measurements of continuation will be determined by telephone interviews administered at two and six months after the subjects' abortion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235534
|United States, California|
|Women's Options Clinic at San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Jody E Steinauer, MD, MAS||University of California, San Francisco|
|Study Director:||Sarah W Prager, MD||University of California, San Francisco|