Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    200
  • sponsor
    University of Oklahoma
Updated on 15 April 2021
mirena
insertion of intrauterine contraceptive device
kyleena

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).

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.

Details
Condition Contraception, Birth Control, contraceptive method, birth control method
Treatment Skyla Intrauterine System, Mirena Intrauterine System, Kyleena Intrauterine System
Clinical Study IdentifierNCT03657602
SponsorUniversity of Oklahoma
Last Modified on15 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 49 yrs?
Are you female?
Do you have any of these conditions: Birth Control or Contraception or birth control method or contraceptive method?
Do you have any of these conditions: contraceptive method or Contraception or Birth Control or birth control method?
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
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