LNG-IUS at 2 Weeks Postpartum (NCT02121067) | Clinical Trial Compass
CompletedPhase 4
LNG-IUS at 2 Weeks Postpartum
United States50 participantsStarted 2014-09
Plain-language summary
This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Desiring a LNG-IUS
✓. Postpartum, ages 18-45 who deliver at a gestational age \> 32 weeks, delivery can be via cesarean or vaginal delivery
✓. Following a viable, singleton pregnancy
✓. Willing to return to UNC for their LNG-IUS insertion and study follow-up
✓. Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits
✓. Fluent in English or Spanish
✓. At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)
Exclusion criteria
✕. No genital bleeding of unknown etiology
✕. No personal history of known or suspected breast carcinoma
✕. No 4th degree vaginal laceration at time of delivery
What they're measuring
1
Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
Timeframe: 6 months postpartum
2
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.