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

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

• Registration Number: NCT00635362
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Primary Completion: 2011-01
• Study Completion: 2013-02
• Results First Submitted: 2013-02-22
• Results First Submitted QC: 2013-04-01
• Results First Posted: 2013-05-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed insertion group	Levonorgestrel-releasing intrauterine system (LNG-IUS)	Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
postplacental insertion after cesarean	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 Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Primary Outcome Measures

Name	Time	Method
Use of the LNG-IUS for Contraception	12 months after cesarean delivery

Secondary Outcome Measures

Name	Time	Method
Satisfaction With LNG-IUS	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.
Rates of Expulsion of the LNG-IUS	12 months after cesarean delivery
Perforation Rates	12 months after cesarean delivery

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States