Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices

Conditions
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Contraception

Intervention / Treatment
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* Drug: Kyleena Intrauterine System
* Drug: Mirena Intrauterine System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contraceptive Kyleena<br>Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System | Drug: Kyleena Intrauterine System<br>* Participant will be randomly allocated to this intervention<br>* Other names: levonorgestrel intrauterine system;|
| Experimental: Contraceptive Mirena<br>Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System | Drug: Mirena Intrauterine System<br>* Participant will be randomly allocated to this intervention<br>* Other names: levonorgestrel intrauterine system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion of intrauterine contraception | IUD string check and ultrasound check | within 10 weeks of placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation of intrauterine contraception | Date IUD is removed | Through study completion, an average of 1 year |