Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Immediate Postpartum Insertion of Kyleena vs Mirena 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).

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Kyleena Intrauterine System; Drug: Mirena Intrauterine System

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Monica Henning, MD; Phone Number: 918-660-8350; Email: Monica-Henning@ouhsc.edu
• Study Contact Backup: Name: Karen Gold, MD; Phone Number: 918-660-8352; Email: Karen-Gold@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • University of Oklahoma - Tulsa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 47 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contraceptive Kyleena; Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System	Drug: Kyleena Intrauterine System; Participant will be randomly allocated to this intervention; Other Names: levonorgestrel intrauterine system
Experimental: Contraceptive Mirena; Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System	Drug: Mirena Intrauterine System; Participant will be randomly allocated to this intervention; Other Names: levonorgestrel intrauterine system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expulsion of intrauterine contraception	IUD string check and ultrasound check	within 10 weeks of placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discontinuation of intrauterine contraception	Date IUD is removed	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Study Director: Valorie Owens, MSW, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 9588 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes