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

Sponsor

United States Naval Medical Center, Portsmouth (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01088178

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

May 1, 2010

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Postplacental Within 10 minutes from delivery of placenta	Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) Placement of Mirena at given intervals during the postpartum period
Experimental: Early Postpartum After 10 minutes from delivery of placenta but within 48hrs from delivery	Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) Placement of Mirena at given intervals during the postpartum period
Experimental: Interval After 6 weeks postpartum	Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) Placement of Mirena at given intervals during the postpartum period

Arm

Intervention/Treatment

Experimental: Immediate Postplacental

Within 10 minutes from delivery of placenta

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

Placement of Mirena at given intervals during the postpartum period

Experimental: Early Postpartum

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

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

Placement of Mirena at given intervals during the postpartum period

Experimental: Interval

After 6 weeks postpartum

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

Placement of Mirena at given intervals during the postpartum period

Outcome Measures

Primary Outcome Measures

Continuation Rates of the LNG-IUS when placed postpartum at three time periods [at 6 months]
Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum).

Secondary Outcome Measures

Expulsion rate of the LNG-IUS when placed postpartum at three time periods [at 3 weeks]
Determine if there is a difference in expulsion rates at the three different time periods of placement.
Pain at placement [at 1 minute]
Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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