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Completed

NCT Number: NCT03657602

Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

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).

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Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Oklahoma - Tulsa

Tulsa, Oklahoma, 74135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kyleena Intrauterine System

Drug

Participant will be randomly allocated to this intervention

Other names: levonorgestrel intrauterine system

Mirena Intrauterine System

Drug

Participant will be randomly allocated to this intervention

Other names: levonorgestrel intrauterine system

Primary outcomes

  1. Expulsion of intrauterine contraception

    Time frame: within 10 weeks of placement

    IUD string check and ultrasound check

Secondary outcomes

  1. Discontinuation of intrauterine contraception

    Time frame: Through study completion, an average of 1 year

    Date IUD is removed

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2018
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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