Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2023-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

NCT01598662

Contraception

TERMINATED NA

Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery

NCT00476021

Contraception

COMPLETED NA

Immediate Postplacental IUD Insertion

NCT02169869

Contraception

TERMINATED NA

Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

NCT01230242

Estimating Rates of Expulsion

TERMINATED NA

Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

NCT01272960

Postpartum Period

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Participant will be blinded to group assignment

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Contraceptive Kyleena

Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System

Group Type EXPERIMENTAL

Kyleena Intrauterine System

Intervention Type DRUG

Participant will be randomly allocated to this intervention

Contraceptive Mirena

Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System

Group Type EXPERIMENTAL

Mirena Intrauterine System

Intervention Type DRUG

Participant will be randomly allocated to this intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kyleena Intrauterine System

Participant will be randomly allocated to this intervention

Intervention Type DRUG

Mirena Intrauterine System

Participant will be randomly allocated to this intervention

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

levonorgestrel intrauterine system levonorgestrel intrauterine system

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes