NCT00997932

A Pilot Study of Early Postpartum Intrauterine Contraception

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months. The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.

Detailed description

This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery. Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant. Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital. Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.

Conditions

• Unplanned Pregnancy

Interventions

Type	Name	Description
DRUG	Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration	Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-10-01
• Completion: 2012-11-01
• First posted: 2009-10-20
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study