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Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Sponsor
University of Oklahoma (Other)
Overall Status
Recruiting
CT.gov ID
NCT03657602
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
35.5
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Kyleena Intrauterine System
  • Drug: Mirena Intrauterine System
 Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallelParticipants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
Masking:
Single (Participant)
Masking Description:
Participant will be blinded to group assignment
Primary Purpose:
Other
Official Title:
Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices
Actual Study Start Date :
Dec 15, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Contraceptive Kyleena

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

Drug: Kyleena Intrauterine System
Participant will be randomly allocated to this intervention
Other Names:
  • levonorgestrel intrauterine system

    		•
    Experimental: Contraceptive Mirena

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

    Drug: Mirena Intrauterine System
    Participant will be randomly allocated to this intervention
    Other Names:
  • levonorgestrel intrauterine system

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Expulsion of intrauterine contraception [within 10 weeks of placement]

      IUD string check and ultrasound check

    Secondary Outcome Measures

    1. Discontinuation of intrauterine contraception [Through study completion, an average of 1 year]

      Date IUD is removed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Oklahoma - Tulsa Tulsa Oklahoma United States 74135

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    • Study Director: Valorie Owens, MSW, University of Oklahoma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT03657602
    Other Study ID Numbers:
    • 9588
    First Posted:
    Sep 5, 2018
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Levonorgestrel

    Study Results

    No Results Posted as of Apr 8, 2021