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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00540046
Recruitment Status : Completed
First Posted : October 5, 2007
Results First Posted : January 13, 2015
Last Update Posted : February 9, 2015
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Miriam Cremer, NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Device: Copper T 380A IUD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Use of IUD [ Time Frame: 6 months ]
    Number of participants using Copper T380A IUD 6 months after surgery


Secondary Outcome Measures :
  1. Expulsion [ Time Frame: 6 months ]
    IUD was not removed by provider but fell out on its own.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540046


Locations
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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
NYU Langone Health
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Miriam L. Cremer, MD, MPH Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Miriam Cremer, Clinical Assistant Professor, NYU Langone Health
ClinicalTrials.gov Identifier: NCT00540046    
Other Study ID Numbers: Post Abortion Copper T IUD
First Posted: October 5, 2007    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: February 9, 2015
Last Verified: January 2015
Keywords provided by Miriam Cremer, NYU Langone Health:
IUD
Second trimester termination
Contraception
Additional relevant MeSH terms:
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Copper
Trace Elements
Micronutrients
Physiological Effects of Drugs