Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Early Phase 1

Completed

• Conditions: Contraception
• Interventions: Drug: Mirena Intrauterine System; Drug: Kyleena Intrauterine System

• Registration Number: NCT03657602
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Study Start: 2019-12-15
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• 18 years or older
• desire an intrauterine device as postpartum contraception
• want to avoid pregnancy for at least 1 year
• are currently pregnant
• desire immediate postpartum IUD insertion.

Exclusion Criteria

• known uterine or cervical anomaly
• untreated cervical infection
• untreated cervical infection
• pelvic infection within 3 months of the study
• recent (within last 3 months) or active intrauterine infection
• genital bleeding of unknown etiology
• history of postpartum or postabortal sepsis
• cervical cancer or carcinoma in suit
• plan to leave Tulsa area within 10 weeks postpartum
• allergy to device ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contraceptive Mirena	Mirena Intrauterine System	Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System
Contraceptive Kyleena	Kyleena Intrauterine System	Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System

Primary Outcome Measures

Name	Time	Method
Expulsion of intrauterine contraception	within 10 weeks of placement	IUD string check and ultrasound check

Secondary Outcome Measures

Name	Time	Method
Discontinuation of intrauterine contraception	Through study completion, an average of 1 year	Date IUD is removed

Trial Locations

Locations (1)

University of Oklahoma - Tulsa; 🇺🇸 Tulsa, Oklahoma, United States