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

Not Applicable

Completed

• Conditions: Contraception Behavior
• Interventions: Device: Copper T 380A IUD

• Registration Number: NCT00540046
• Lead Sponsor: NYU Langone Health

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 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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-05
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2015-01
• Results First Submitted: 2015-01-01
• Results First Submitted QC: 2015-01-01
• Results First Posted: 2015-01-13
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A/Immediate	Copper T 380A IUD	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
B/Delayed	Copper T 380A IUD	The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.

Primary Outcome Measures

Name	Time	Method
Use of IUD	6 months	Number of participants using Copper T380A IUD 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Expulsion	6 months	IUD was not removed by provider but fell out on its own.

Trial Locations

Locations (2)

Bellevue Hospital; 🇺🇸 New York, New York, United States

Parkmed Women's Clinic; 🇺🇸 New York, New York, United States