Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion
Condition: Abortion
Study type: Interventional

Summary: 
      This is a randomized, controlled trial investigating whether immediate versus standard,
      "Sunday Start", initiation of transdermal hormonal contraception (the patch) in post-abortion
      subjects can improve compliance and the continuation of contraception. Immediate initiation
      of the patch 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
      the patch into a second month. The primary hypothesis of this study is that immediate
      initiation of the patch 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. Hormonal contraception is the most common method of 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 contraception use. Several
      recent studies have examined the "Quick Start", or initiation of hormonal contraception (OCPs
      and patch) in front of the provider while still at the clinic, regardless of time in the
      cycle. These studies have shown that women who placed the first patch in the clinic were more
      likely to continue the patch 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 patch 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 the patch is 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 place the first patch while still in the
      clinic after their abortion may improve compliance and continuation of patch 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 month's worth of the patch
      and a one-year prescription after their TAB. The women in the immediate start arm will then
      place their first patch in the clinic, observed by clinic staff, before leaving. The controls
      will be instructed to place the first patch 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 patch. Measurements of continuation will be determined by telephone
      interviews administered at two and six months after the subjects' abortion.
    

Intervention name(s): timing of initiation of transdermal patch after an abortion
Intervention type(s): Behavioral
Intervention description(s): the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: abortion; randomized; contraception; pregnancy; compliance; continuation; contraceptive patch; transdermal hormonal contraception