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Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study

NCT01309919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-01-29

Study results available
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Summary

The purpose of the study is to determine the feasibility of placing the levonorgestrel-releasing intrauterine system (LNG - IUS, Mirena®) post-delivery. The investigators will gain information about complications at the time of placement; the investigators will also examine the expulsion rate, side effects, bleeding patterns and subject satisfaction at various time periods after insertion.

Conditions

  • Postpartum Period

Interventions

DEVICE

IUD

Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.

OTHER

Diary

Subjects will keep a bleeding diary for three months

Sponsors & Collaborators

  • Baystate Medical Center

    lead OTHER

Principal Investigators

  • Katharine O White, MD, MPH · Baystate Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-12-31
Completion
2012-02-29

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 NCT01309919 on ClinicalTrials.gov