Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period
NCT01088178 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-07-20
Summary
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
Conditions
- Contraception
Interventions
- DEVICE
-
Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period
Sponsors & Collaborators
-
United States Naval Medical Center, Portsmouth
lead FED
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2010-05-31
- Completion
- 2010-07-31
Countries
- United States
Study Locations
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