CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Levonorgestrel-releasing intrauterine systemdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01555931
NCT01555931Phase 4Completed
CompareCT.gov

Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)

University of North Carolina, Chapel Hill·interventional·Posted Mar 16, 2012·Updated Aug 25, 2014

In Brief

A Phase 4 clinical trial evaluating Levonorgestrel-releasing intrauterine system for Postpartum Contraception. Completed, enrolled 61 participants across 1 site.

Detailed Summary

This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Contraception
CountriesUnited States
CollaboratorsSociety of Family Planning

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2012
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago

Interventions

Levonorgestrel-releasing intrauterine systemdrug

Placement within 48 hours of delivery