Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Contraception Clinical Trial

Official title:

Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657602
• Other study ID #: 9588
• Status: Completed
• Phase: Early Phase 1
• Start date: December 15, 2019
• Est. completion date: January 15, 2023

Study information

• Verified date: April 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Kyleena Intrauterine System
Participant will be randomly allocated to this intervention
• Mirena Intrauterine System
Participant will be randomly allocated to this intervention

Locations

Country	Name	City	State
United States	University of Oklahoma - Tulsa	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expulsion of intrauterine contraception	IUD string check and ultrasound check	within 10 weeks of placement
Secondary	Discontinuation of intrauterine contraception	Date IUD is removed	Through study completion, an average of 1 year