NCT01161095

A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: United States Naval Medical Center, Portsmouth · Federal
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).

Detailed description

The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement. The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement. Secondary outcome measures that we will obtain include: * Pain at the time of placement * Postpartum Depression * Breastfeeding status * Postpartum weight retention * Expulsion Rates * Bleeding Profile * Uterine Infection(Endometritis)

Conditions

• Contraception
• Postpartum Period

Interventions

Type	Name	Description
DEVICE	LNG-IUS	Mirena (Bayer)- Levonorgestrel-Intrauterine System

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-05-28
• Completion: 2014-05-28
• First posted: 2010-07-13
• Last updated: 2025-07-20

Locations

2 sites across 1 country: United States