Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

April 5, 2023 updated by: Albert Einstein College of Medicine

Transcesarean IUD Insertion: A Prospective Cohort Study

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

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
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center, Weiler Division

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton gestation
  • greater than 35 weeks gestation
  • speaks English or Spanish
  • desires IUD for contraception
  • undergoing a cesarean delivery

Exclusion Criteria:

  • evidence of chorioamnionitis
  • history of chlamydia within 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Expulsion of IUD
Time Frame: 6 week postpartum
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
6 week postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of IUD Placement
Time Frame: 6 months postpartum
Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD.
6 months postpartum
Number of Participants With Expulsion of IUD
Time Frame: 6 months postpartum
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
6 months postpartum

Collaborators and Investigators

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

Sponsor

Albert Einstein College of Medicine

Investigators

  • Principal Investigator: Amitasrigowri Murthy, MD, NYU School of Medicine

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

August 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (Estimate)

September 23, 2011

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-345-002

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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