NCT03657602

Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).

Detailed description

Between 40-57% of women report having unprotected intercourse prior to the 6 week postpartum visit. Immediate postpartum long-acting reversible contraception (LARC) is extremely important in preventing short-interval and unintended pregnancies. The postpartum period is an excellent time for intrauterine device (IUD) or implant insertion as women are often highly motivated to prevent unwanted pregnancies at this time. Per the American College of Obstetrics and Gynecology (ACOG), expulsion rates for immediate postpartum IUD insertion are higher than for interval or post-abortion insertion. Despite the higher expulsion rate of immediate postpartum IUD placement over interval placement, cost-benefit analysis data strongly suggest the superiority of immediate placement in reduction of unintended pregnancy, especially for women at greatest risk of not attending the postpartum follow-up visit. This study will randomly allocate participants one to one to the Kyleena or the Mirena IUD group, and participants will be blinded to allocation of groups. Participants will follow up at routine postpartum visit within 4 weeks of delivery, and a second follow up will be performed at 10 weeks. Ultimately, this study will attempt to provide more detailed information on the difference of rates of expulsion and discontinuation of the different-sized Mirena and Kyleena intrauterine devices.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Kyleena Intrauterine System	Participant will be randomly allocated to this intervention
DRUG	Mirena Intrauterine System	Participant will be randomly allocated to this intervention

Timeline

• Start date: 2019-12-15
• Primary completion: 2023-01-15
• Completion: 2023-01-15
• First posted: 2018-09-05
• Last updated: 2023-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study