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

Contraception Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540046
• Other study ID #: Post Abortion Copper T IUD
• Status: Completed
• Phase: N/A
• First received: October 4, 2007
• Last updated: January 23, 2015
• Start date: April 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

Device:
• Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.

Locations

Country	Name	City	State
United States	Bellevue Hospital	New York	New York
United States	Parkmed Women's Clinic	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of IUD	Number of participants using Copper T380A IUD 6 months after surgery	6 months	No
Secondary	Expulsion	IUD was not removed by provider but fell out on its own.	6 months	No