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

NCT ID: NCT00540046

Last Updated: 2015-02-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Copper T 380A IUD

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Copper T 380A IUD

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Copper T 380A IUD

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Miriam Cremer

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Miriam L. Cremer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bellevue Hospital

New York, New York, United States

Site Status

Parkmed Women's Clinic

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Post Abortion Copper T IUD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.