drugset / Trial / NCT00475228

'Levonorgestrel IUD Insertion After D&E Procedure

NCT00475228

Phase 4 Completed 93 enrolled University of Pittsburgh
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-03
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Levonorgestrel Small molecule Other

Indications

No indication recorded.