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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088178
• Other study ID #: NMCP.2009.0062
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2024
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period

Locations

Country	Name	City	State
United States	Naval Medical Center	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuation Rates of the LNG-IUS when placed postpartum at three time periods	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).	at 6 months
Secondary	Expulsion rate of the LNG-IUS when placed postpartum at three time periods	Determine if there is a difference in expulsion rates at the three different time periods of placement.	at 3 weeks
Secondary	Pain at placement	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.	at 1 minute