Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

Phase 4

Completed

• Conditions: Intrauterine Device Expulsion

• Registration Number: NCT01439802
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

Detailed Description

This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-11
• Study Completion: 2010-05
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Results First Submitted: 2022-10-31
• Results First Submitted QC: 2022-12-06
• Results First Posted: 2022-12-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• singleton gestation
• greater than 35 weeks gestation
• speaks English or Spanish
• desires IUD for contraception
• undergoing a cesarean delivery

Exclusion Criteria

• evidence of chorioamnionitis
• history of chlamydia within this pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Expulsion of IUD	6 week postpartum	Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of IUD Placement	6 months postpartum	Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD.
Number of Participants With Expulsion of IUD	6 months postpartum	Number of participants with Expulsion of IUDs placed at time of cesarean delivery.

Trial Locations

Locations (2)

Jacobi Medical Center; 🇺🇸 Bronx, New York, United States

Montefiore Medical Center, Weiler Division; 🇺🇸 Bronx, New York, United States