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

United States Naval Medical Center, Portsmouth

Status: Withdrawn

Conditions: Contraception

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01088178

NMCP.2009.0062

Details and patient eligibility

About

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.

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Immediate Postplacental

Experimental group

Description:

Within 10 minutes from delivery of placenta

Treatment:

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

Early Postpartum

Experimental group

Description:

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

Treatment:

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

Interval

Experimental group

Description:

After 6 weeks postpartum

Treatment:

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