Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion
Condition: Abortion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Immediate initiation of OCPs; Delayed initiation of OCPs
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: abortion; randomized; contraception; pregnancy; compliance; continuation; oral contraceptive pills