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You can access this
clinical trial
if you have
Contraception
and you are a woman who is
between 15 and 45
years old
Phase
-
The phase for this study is not defined.
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The purpose

This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.

Provided treatments

  • Device: Mirena (levonorgestrel-releasing intrauterine system)
Tris trial is registered with FDA with number: NCT01598662. The sponsor of the trial is University of Louisville and it is looking for 70 volunteers for the current phase.
Official trial title:
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial