Contraception
Conditions
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.
Interventions
DRUGKyleena Intrauterine System
Participant will be randomly allocated to this intervention
DRUGMirena Intrauterine System
Participant will be randomly allocated to this intervention
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participant will be blinded to group assignment
Intervention model description
Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion of intrauterine contraception | within 10 weeks of placement | IUD string check and ultrasound check |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discontinuation of intrauterine contraception | Through study completion, an average of 1 year | Date IUD is removed |
Countries
United States
Outcome results
None listed