MedTrace Logo

Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

NCT01598662 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-09-25

Study results available
· View outcomes & findings →

Summary

This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.

Conditions

  • Contraception

Interventions

DEVICE

Mirena (levonorgestrel-releasing intrauterine system)

The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Mary E Stauble, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-03-21
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01598662 on ClinicalTrials.gov