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Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

NCT01272960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2017-12-02

Study results available
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Summary

In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.

We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.

Conditions

  • Postpartum Period

Interventions

DEVICE

Post-Placenta Mirena Insertion

Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

DEVICE

Interval Insertion

Insertion of Mirena 4-8 weeks post partum after vaginal delivery

Sponsors & Collaborators

Principal Investigators

  • Lorie M Harper, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT01272960 on ClinicalTrials.gov