At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immediate Versus Delayed Insertion of the Levonorgestrel-Releasing Intrauterine Device Following Dilation and Evacuation: A Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Levonorgestrel IUD for Contraceptive Usage. Completed, enrolled 93 participants across 1 site.
Detailed Summary
This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation \& evacuation (D\&E) compared to delayed insertion 3-6 weeks post-D\&E. Eighty-eight women undergoing D\&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D\&E procedure than women receiving delayed insertion. Secondary outcomes include the proportion receiving an IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The utility of ultrasonography in predicting expulsion will also be examined. Anticipated problems include poor subject follow-up and coordinating the intra-operative study procedures.
Study Details
Timeline
Interventions
intrauterine insertion for arm 1 immediately after D\&E procedure and for arm 2 at 3-6 weeks post-procedurem