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

Study 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.

Official Title
-----------------
Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation

Conditions
-----------------
Contraception Behavior

Intervention / Treatment
-----------------
* Device: Copper T 380A IUD


Participation Criteria
=================
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 hypersensitivity to any component of Copper T IUD

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A/Immediate<br>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<br>* Copper T 380A IUD will be placed at the 2-4 week post-operative visit.<br>|
| Active Comparator: B/Delayed<br>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<br>* Copper T 380A IUD will be placed at the 2-4 week post-operative visit.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of IUD | Number of participants using Copper T380A IUD 6 months after surgery | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion | IUD was not removed by provider but fell out on its own. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUD, Second trimester termination, Contraception