Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

February 21, 2023 updated by: University of Chicago

Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial

The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.

Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant at time of enrollment
  • Planning to undergo a scheduled cesarean delivery
  • Desires to use the LNG-IUS for contraception
  • Willing and able to sign an informed consent in English
  • Willing to comply with the study protocol
  • Age greater than or equal to 18 years
  • English speaking

Exclusion Criteria:

  • Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
  • Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
  • Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
  • Uterine anomaly which would not allow placement of the LNG-IUS
  • Current cervical cancer or carcinoma in-situ
  • Desire for repeat pregnancy in less than 12 months
  • History of postabortal or postpartum sepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: postplacental insertion after cesarean

Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta

Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Other Names:
  • Mirena IUD
Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Other Names:
  • Mirena IUD
Active Comparator: delayed insertion group

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Other Names:
  • Mirena IUD
Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Other Names:
  • Mirena IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of the LNG-IUS for Contraception
Time Frame: 12 months after cesarean delivery
12 months after cesarean delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Expulsion of the LNG-IUS
Time Frame: 12 months after cesarean delivery
12 months after cesarean delivery
Perforation Rates
Time Frame: 12 months after cesarean delivery
12 months after cesarean delivery
Satisfaction With LNG-IUS
Time Frame: 6 months after cesarean delivery
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
6 months after cesarean delivery
Satisfaction With LNG-IUS
Time Frame: 12 months after cesarean delivery
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
12 months after cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Melissa Gilliam, MD MPH, University Of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15148A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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