Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception Behavior
- Sponsor
- NYU Langone Health
- Enrollment
- 215
- Locations
- 2
- Primary Endpoint
- Use of IUD
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
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.
Investigators
Miriam Cremer
Clinical Assistant Professor
NYU Langone Health
Eligibility 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
Outcomes
Primary Outcomes
Use of IUD
Time Frame: 6 months
Number of participants using Copper T380A IUD 6 months after surgery
Secondary Outcomes
- Expulsion(6 months)