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

This study has been completed.

Sponsor:

Collaborator:

Mount Sinai School of Medicine

Information provided by (Responsible Party):

Miriam Cremer, New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT00540046

First received: October 4, 2007

Last updated: April 19, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 4, 2007

Last Updated Date

April 19, 2013

Start Date ^ICMJE

April 2007

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Use of IUD [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Use of IUD [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00540046 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

satisfaction, expulsion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

satisfacttion,expulsion [ Time Frame: 6 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Patients presenting to 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 IUD insertion. The subjects will be seen at a 6 month follow-up visit and IUD placement will be verified by physical exam and subjects will fill out a satisfaction questionnaire.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Contraception Compliance

Intervention ^ICMJE

Device: Copper T 380 IUD
Copper T 380 IUD will be placed immediately following the procedure.
Device: Copper T 380 IUD
Copper T 380 IUD will be placed at the 2-4 week post operative visit.

Study Arm (s)

Active Comparator: A
The patients in the immediate arm will have the IUD inserted within 15 minutes after delivery of the placenta immediately following procedure

Intervention: Device: Copper T 380 IUD
Active Comparator: B
The delayed group will have their IUD inserted in at the post-operative visit within 2-4 weeks following the procedure.

Intervention: Device: Copper T 380 IUD

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

215

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

16 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00540046

Other Study ID Numbers ^ICMJE

Post Abortion Copper T IUD

Has Data Monitoring Committee

Responsible Party

Miriam Cremer, New York University School of Medicine

Study Sponsor ^ICMJE

New York University School of Medicine

Collaborators ^ICMJE

Mount Sinai School of Medicine

Investigators ^ICMJE

Principal Investigator:

Miriam L. Cremer, MD, MPH

Mount Sinai School of Medicine

Information Provided By

New York University School of Medicine

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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