Clinical trial NCT03657602: Immediate Postpartum Insertion of Contraceptive Intrauterine Devices
Official title: Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Contraception
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Expulsion of intrauterine contraception
timeFrame: within 10 weeks of placement
Secondary outcomes:
measure: Discontinuation of intrauterine contraception
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Oklahoma - Tulsa
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Valorie Owens, MSW
role: STUDY_DIRECTOR
References: