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Randomized, open-label, controlled trial of immediate postpartum versus interval insertion of Mirena® to increase the usage at 6 months after delivery

David Eisenberg, Washington University in St. Louis School of Medicine, 2010

Project abstract

In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placental insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, participants will be randomized to receive either immediate post-placental insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 6 months post-partum to confirm the LNG-IUS is still in the uterus.

This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.

The primary outcome of this sub-study is the number of LNG-IUS in place at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants.

We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation at 6-months due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placental insertion focus on expulsion rates and do not report on continuation, symptoms and satisfaction rates.

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