Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

NCT03657602 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 9588
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Expulsion of intrauterine contraception

  IUD string check and ultrasound check

  within 10 weeks of placement

Secondary Outcomes (1)

• Discontinuation of intrauterine contraception

  Through study completion, an average of 1 year

Study Arms (2)

Contraceptive Kyleena

EXPERIMENTAL

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

Drug: Kyleena Intrauterine System

Contraceptive Mirena

EXPERIMENTAL

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

Drug: Mirena Intrauterine System

Interventions

Kyleena Intrauterine System DRUG

Participant will be randomly allocated to this intervention

Also known as: levonorgestrel intrauterine system

Contraceptive Kyleena

Mirena Intrauterine System DRUG

Participant will be randomly allocated to this intervention

Also known as: levonorgestrel intrauterine system

Contraceptive Mirena

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma - Tulsa

Tulsa, Oklahoma, 74135, United States

Location

Study Officials

• Valorie Owens, MSW

  University of Oklahoma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to group assignment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 5, 2018
• Study Start: December 15, 2019
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)