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Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery

NCT00476021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2016-06-24

Study results available
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Summary

This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.

Conditions

  • Contraception

Interventions

DEVICE

Levonorgestrel-releasing IUD (Mirena)

levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Beatrice A Chen, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476021 on ClinicalTrials.gov