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Clinical Trials/NCT00635362
NCT00635362
Terminated
Not Applicable

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

University of Chicago1 site in 1 country42 target enrollmentMay 2007
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ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Chicago
Enrollment
42
Locations
1
Primary Endpoint
Use of the LNG-IUS for Contraception
Status
Terminated
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
February 2013
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Use of the LNG-IUS for Contraception

Time Frame: 12 months after cesarean delivery

Secondary Outcomes

  • Satisfaction With LNG-IUS(12 months after cesarean delivery)
  • Rates of Expulsion of the LNG-IUS(12 months after cesarean delivery)
  • Perforation Rates(12 months after cesarean delivery)

Study Sites (1)

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