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
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View full resultsBasic Information
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COMPLETED
NA
215 participants
INTERVENTIONAL
2007-04-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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
Copper T 380A IUD
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.
Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Interventions
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Copper T 380A IUD
Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
FEMALE
Yes
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
NYU Langone Health
OTHER
Responsible Party
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Miriam Cremer
Clinical Assistant Professor
Principal Investigators
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Miriam L. Cremer, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Bellevue Hospital
New York, New York, United States
Parkmed Women's Clinic
New York, New York, United States
Countries
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Other Identifiers
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Post Abortion Copper T IUD
Identifier Type: -
Identifier Source: org_study_id
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