Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-07-31

Brief Summary

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The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Postplacental

Within 10 minutes from delivery of placenta

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)

Intervention Type DEVICE

Placement of Mirena at given intervals during the postpartum period

Early Postpartum

After 10 minutes from delivery of placenta but within 48hrs from delivery

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)

Intervention Type DEVICE

Placement of Mirena at given intervals during the postpartum period

Interval

After 6 weeks postpartum

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)

Intervention Type DEVICE

Placement of Mirena at given intervals during the postpartum period

Interventions

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Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)

Placement of Mirena at given intervals during the postpartum period

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study.

Exclusion Criteria

* Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study.
* Delivery \<36 weeks
* Intrapartum chorioamnionitis (defined as maternal fever \>100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
* Postpartum Hemorrhage (defined as \>500cc EBL for spontaneous vaginal delivery)
* Cesarean delivery if randomized to IPP or EP placement

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No