TerminatedNot Applicable

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

Stopped: Low recruitment

United States42 participantsStarted 2007-05

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Use of the LNG-IUS for Contraception

Timeframe: 12 months after cesarean delivery

Trial details

NCT IDNCT00635362

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01

Results submitted2013-02-22