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Trial record 81 of 404 for:    LEVONORGESTREL

Immediate Postpartum Insertion of Contraceptive Intrauterine Devices

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ClinicalTrials.gov Identifier: NCT03657602
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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).

Condition or disease Intervention/treatment Phase
Contraception Drug: Skyla Intrauterine System Drug: Mirena Intrauterine System Early Phase 1

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 Skyla 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 Skyla intrauterine devices.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated one to one to the Skyla or Mirena group and assessment will occur in parallel
Masking: Single (Participant)
Masking Description: Participant will be blinded to group assignment
Primary Purpose: Other
Official Title: Immediate Postpartum Insertion of Skyla vs Mirena Contraceptive Intrauterine Devices
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contraceptive Skyla
Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Skyla Intrauterine System
Drug: Skyla Intrauterine System
Participant will be randomly allocated to this intervention
Other Name: 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 Name: levonorgestrel intrauterine system




Primary Outcome Measures :
  1. Expulsion of intrauterine contraception [ Time Frame: within 10 weeks of placement ]
    IUD string check and ultrasound check


Secondary Outcome Measures :
  1. Discontinuation of intrauterine contraception [ Time Frame: Through study completion, an average of 1 year ]
    Date IUD is removed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657602


Contacts
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Contact: Monica Henning, MD 918-660-8350 Monica-Henning@ouhsc.edu
Contact: Karen Gold, MD 918-660-8352 Karen-Gold@ouhsc.edu

Sponsors and Collaborators
University of Oklahoma
Investigators
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Study Director: Valorie Owens, MSW University of Oklahoma

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03657602     History of Changes
Other Study ID Numbers: 9588
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral