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

This study has been completed.
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Miriam Cremer, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00540046
First received: October 4, 2007
Last updated: January 23, 2015
Last verified: January 2015
  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 Behavior
Device: Copper T 380A IUD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Use of IUD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants using Copper T380A IUD 6 months after surgery


Secondary Outcome Measures:
  • Expulsion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    IUD was not removed by provider but fell out on its own.


Enrollment: 215
Study Start Date: April 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Device: Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Active Comparator: 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.
Device: Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Bellevue Hospital
New York, New York, United States, 10016
Parkmed Women's Clinic
New York, New York, United States, 10017
Sponsors and Collaborators
New York University School of Medicine
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Miriam L. Cremer, MD, MPH Icahn School of Medicine at Mount Sinai
  More Information

No publications provided

Responsible Party: Miriam Cremer, Clinical Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00540046     History of Changes
Other Study ID Numbers: Post Abortion Copper T IUD
Study First Received: October 4, 2007
Results First Received: January 1, 2015
Last Updated: January 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
IUD
Second trimester termination
Contraception

Additional relevant MeSH terms:
Copper
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on September 02, 2015