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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01088178
First received: February 25, 2010
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • Continuation Rates of the LNG-IUS when placed postpartum at three time periods [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]
    Determine if there is a difference in expulsion rates at the three different time periods of placement.

  • Pain at placement [ Time Frame: at 1 minute ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: November 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088178

Contacts
Contact: Joshua D Dahlke, MD 757-953-4503 joshua.dahlke@med.navy.mil

Locations
United States, Virginia
Naval Medical Center Recruiting
Portsmouth, Virginia, United States, 23507
Contact: Joshua D Dahlke, MD       joshua.dahlke@med.navy.mil   
Principal Investigator: Joshua D Dahlke, MD         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
  More Information

No publications provided by United States Naval Medical Center, Portsmouth

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LCDR Joshua D. Dahlke MD, Naval Medical Center Portsmouth Virginia
ClinicalTrials.gov Identifier: NCT01088178     History of Changes
Other Study ID Numbers: NMCP.2009.0062
Study First Received: February 25, 2010
Last Updated: September 29, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by United States Naval Medical Center, Portsmouth:
Long-Acting Reversible Contraception
Contraceptive Agents
Therapeutic Uses
Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions
Levonorgestrel

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on July 28, 2014