NCT01293760

Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion

Immediate Post-placental Insertion of the Copper T 380A After Cesarean Delivery Versus 6 Week Post-cesarean Insertion: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Planned Parenthood League of Massachusetts · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine, in a pilot setting, if this study is feasible in terms of recruitment, willingness to be randomized, provision of contraceptive methods, and follow-up. The investigators hypothesize that this pilot study will be feasible in terms of recruitment, provision of care, and follow-up. The study will be a pilot randomized controlled trial comparing outcomes of immediate post-placental insertion of the Copper T 380A (Group 1) to outcomes of interval insertion of the Copper T 380A performed 6 weeks after delivery (Group 2) for patients undergoing scheduled cesarean delivery at Mulago Hospital in Kampala, Uganda. This study will not be powered to detect a difference, but rather the investigators will enroll all eligible and interested women during the three-month enrollment period. Potential participants who do not choose an IUD or who choose not to participate will be offered an anonymous opt-out survey.

Conditions

• Contraception

Interventions

Type	Name	Description
OTHER	Immediate insertion	Insertion of Copper T 380A immediately after c-section delivery of baby and placenta
OTHER	6 weeks interval insertion	Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-02-11
• Last updated: 2012-05-10

Locations

1 site across 1 country: Uganda