Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

Phase 4

Completed

• Conditions: Postpartum Contraception
• Interventions: Drug: Levonorgestrel-releasing intrauterine system

• Registration Number: NCT01555931
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-07-14
• Results First Submitted QC: 2014-08-21
• Last Update Submitted: 2014-08-21
• Results First Posted: 2014-08-25
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Levonorgestrel-releasing intrauterine system	Placement 4-8 weeks after delivery
Immediate	Levonorgestrel-releasing intrauterine system	Placement within 48 hours of delivery

Primary Outcome Measures

Name	Time	Method
Breastfeeding	6 months	Reported any breastfeeding at the final 6 month visit

Secondary Outcome Measures

Name	Time	Method
LNG-IUS Expulsion or Removal	up to 6 months	Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study

Trial Locations

Locations (1)

University of North Carolina Women's Hospital; 🇺🇸 Chapel Hill, North Carolina, United States