Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation

January 23, 2015 updated by: Miriam Cremer, NYU Langone Health

Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation

The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.

Study Type

Interventional

Enrollment (Actual)

215

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
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital
      • New York, New York, United States, 10017
        • Parkmed Women's Clinic

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women 16 years of age and older
  • intrauterine pregnancy > 14 weeks gestation
  • desires termination of pregnancy
  • desires IUD for contraception
  • ability to give informed consent
  • no contraindication for D+E

Exclusion Criteria:

  • unable to give informed consent
  • less than 16 years of age
  • congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
  • acute pelvic inflammatory disease (PID)
  • known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear
  • untreated acute cervicitis or vaginitis, until infection treated/controlled
  • confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days
  • acute liver disease or liver tumor (benign or malignant)
  • woman or partner currently with multiple sexual partners
  • history of Wilson's disease
  • hypersensitivity to any component of Copper T IUD

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A/Immediate
The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
Device: Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Active Comparator: B/Delayed
The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.
Device: Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of IUD
Time Frame: 6 months
Number of participants using Copper T380A IUD 6 months after surgery
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expulsion
Time Frame: 6 months
IUD was not removed by provider but fell out on its own.
6 months

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Miriam L. Cremer, MD, MPH, Icahn School of Medicine at Mount Sinai

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

April 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

October 4, 2007

First Posted (Estimate)

October 5, 2007

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

January 23, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Post Abortion Copper T IUD

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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