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

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Miriam Cremer, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00540046
First received: October 4, 2007
Last updated: April 19, 2013
Last verified: April 2013
  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

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 ]

Secondary Outcome Measures:
  • satisfaction, expulsion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
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
Copper T 380 IUD will be placed immediately following the procedure.
Active Comparator: B
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
Copper T 380 IUD 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
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
Mount Sinai School of Medicine
Investigators
Principal Investigator: Miriam L. Cremer, MD, MPH Mount Sinai School of Medicine
  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
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 20, 2014