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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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postplacental insertion after cesarean

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)

Group Type EXPERIMENTAL

Levonorgestrel-releasing intrauterine system (LNG-IUS)

Intervention Type DEVICE

Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta

delayed insertion group

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

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

Group Type ACTIVE_COMPARATOR

Levonorgestrel-releasing intrauterine system (LNG-IUS)

Intervention Type DEVICE

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

Interventions

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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

Intervention Type DEVICE

Levonorgestrel-releasing intrauterine system (LNG-IUS)

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery

Intervention Type DEVICE

Other Intervention Names

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Mirena IUD Mirena IUD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes