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

This study is currently recruiting participants.

Verified by New York University School of Medicine, August 2007

Sponsored by:	New York University School of Medicine
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00540046

Purpose

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.

Condition	Intervention
Contraception Compliance	Device: Copper T 380 IUD

MedlinePlus related topics: Birth Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Use of IUD [ Time Frame: 6 months ]

Secondary Outcome Measures:

satisfacttion,expulsion [ Time Frame: 6 months ]

Estimated Enrollment:	157
Study Start Date:	April 2007

Arms	Assigned Interventions
A: Active Comparator The patients in the immediate arm will have the IUD inserted within 15 minutes after delivery of the placenta immediately following procedure	Device: Copper T 380 IUD Device will be placed immediately following the procedure.
B: Active Comparator The delayed group will have their IUD inserted in at the post-operative visit within 2-4 weeks following the procedure.	Device: Copper T 380 IUD Device will be placed at the 2-4 week post operative visit.

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540046

Locations

United States, New York
Bellevue Hospital	Recruiting
New York, New York, United States, 10016
Contact: Miriam L Cremer, MD MPH 212-263-6291 mlcremer@hotmail.com

Sponsors and Collaborators

New York University School of Medicine

Investigators

Study Director:

Carli Pitchford

NYU School of Medicine

More Information

Study ID Numbers:	Post Abortion Copper T IUD
Study First Received:	October 4, 2007
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00540046
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

IUD
Second trimester termination
Compliance
Contraception

Study placed in the following topic categories:

Copper

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009