NCT01439802

Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

Transcesarean IUD Insertion: A Prospective Cohort Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intrauterine Device Expulsion

Interventions

Type	Name	Description
DEVICE	Copper IUD placement at time Cesarean Delivery (Copper T 380A)	Placement of Paragard IUD at time of Cesarean Delivery

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-11-01
• Completion: 2010-05-01
• First posted: 2011-09-23
• Last updated: 2023-04-07
• Results posted: 2022-12-29

Locations

2 sites across 1 country: United States