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

NYU Langone Health

Status: Completed

Conditions: Contraception Behavior

Treatments: Device: Copper T 380A IUD

Study type: Interventional

Funder types: Other

Identifiers

NCT00540046

Post Abortion Copper T IUD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

215 participants in 2 patient groups

A/Immediate

Active Comparator group

Description:

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

Treatment:

Device: Copper T 380A IUD

B/Delayed

Active Comparator group

Description:

The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.

Treatment:

Device: Copper T 380A IUD