Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial (IUD@CSD)

September 12, 2017 updated by: Erika Levi, MD, MPH, University of North Carolina, Chapel Hill

Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial

This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina, Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women ages 18-45
  • Pregnant and greater than or equal to 24 weeks of estimated gestational age
  • Live Pregnancy
  • States a plan to use an Intrauterine Device (IUD) postpartum for contraception
  • Plan for cesarean delivery
  • Intend to stay in the Chapel Hill area for at least 6 months after birth
  • Fluent in English or Spanish

Exclusion Criteria:

  • known uterine anomalies
  • allergies to any component of the IUD of their choosing
  • known or suspected carcinoma of the breast
  • known acute liver disease or liver tumor (benign or malignant)
  • known or suspected uterine or cervical neoplasia
  • active pelvic inflammatory disease
  • genital bleeding of unknown etiology
  • history of solid organ transplantation
  • positive test for gonorrhea or chlamydia during this pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Interval IUD Placement
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
Experimental: Immediate Postplacental IUD placement
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Device: Immediate Postplacental Placement of an IUD during cesarean delivery
Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IUD Use
Time Frame: 6 months postpartum
The use of an IUD at 6 months postpartum is the primary outcome measure
6 months postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
IUD Expulsion
Time Frame: 0-6 months postpartum
0-6 months postpartum
Women's Satisfaction With IUDs
Time Frame: 0-6 months postpartum
0-6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Erika Levi, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-2477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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