Status:
TERMINATED
Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion
Lead Sponsor:
University of Chicago
Conditions:
Healthy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00635362
Start Date
May 1 2007
End Date
February 1 2013
Last Update
March 22 2023
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637