Intrauterine Device (IUD) Placement at the Time of Cesarean Section

December 20, 2016 updated by: University of Kentucky

Pilot Study of Copper IUD Placement at the Time of Cesarean Section

To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women ages 18-40 who are undergoing a scheduled cesarean section, or women who are attempting to VBAC and want an IUD post partum will be eligible.

Description

Inclusion Criteria:

  • Desire an IUD post-partum and are willing to use the copper IUD.
  • They will also need to be patients at one of our OBGYN clinics at the university of Kentucky.

Exclusion Criteria:

  • Post-partum hemorrhage,
  • Chorioamnionitis (or a fever >101 at the time of cesarean),
  • Women on antibiotic or immunosuppressive therapies,
  • Cervical dilation > 5 cm at the time of c-section, OR
  • Excessive intraoperative blood loss.
  • Also women with contraindications to a copper IUD: Wilson's disease, unusual uterine shape or known uterine anomaly.

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

Cohorts and Interventions

Group / Cohort
women who have an IUD placed at the time of c-section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continuation at one year
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
satisfaction with placement at time of cesarean
Time Frame: 4-6 months and 1 year
4-6 months and 1 year
bleeding profile
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

University of Kentucky

Collaborators

Duramed Research

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

August 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-0938-F6A

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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