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

The University of Chicago

Status: Terminated

Conditions: Healthy

Treatments: Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00635362

15148A

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

postplacental insertion after cesarean

Experimental group

Description:

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)

Treatment:

Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

delayed insertion group

Active Comparator group

Description:

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Treatment:

Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)