Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

University of Oklahoma (OU)

Status and phase: Completed; Early Phase 1

Conditions: Contraception

Treatments: Drug: Mirena Intrauterine System; Drug: Kyleena Intrauterine System

Study type: Interventional

Funder types: Other

Identifiers

NCT03657602

9588 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Contraceptive Kyleena

Experimental group

Description:

Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System

Treatment:

Drug: Kyleena Intrauterine System

Contraceptive Mirena

Experimental group

Description:

Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System

Treatment:

Drug: Mirena Intrauterine System