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A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was:  Recruiting
Information provided by:
United States Naval Medical Center, Portsmouth Identifier:
First received: July 12, 2010
Last updated: September 29, 2010
Last verified: September 2010
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).

Condition Intervention
Postpartum Period
Device: LNG-IUS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Continuation Rates [ Time Frame: 6 months ]

    Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum).

    Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.

Secondary Outcome Measures:
  • Pain at insertion [ Time Frame: 1 minute ]
    Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.

  • Postpartum Depression [ Time Frame: 6 months ]
    Depression history will be determined from the initial data collection sheet upon entry into the study. The Edinburgh Postnatal Depression Scale will be filled out by the participant at their six week postpartum appointment (routine), and also at six months.

  • Breastfeeding Status [ Time Frame: 6 months ]
    We will identify those who plan on breastfeeding their infants prior to discharge from the hospital. We will also determine the number of hours to Lactogenesis II (avg 40-50 hrs) via phone interview within one week from discharge. We will determine discontinuation rates and days to discontinuation of breastfeeding at six weeks and six months. We will also record infant weights at the postpartum appointment and at six months.

  • Postpartum weight retention [ Time Frame: 6 months ]
    We will determine each participant's pre pregnancy BMI, BMI at admission to labor and delivery, and BMI at the postpartum appointment and at 6 months.

  • Sexual Function [ Time Frame: 6 months ]
    We will determine the number of days from delivery to resumption of sexual intercourse. We will also have the participant complete the Female Sexual Function Index questionnaire (FSFI) at the postpartum appointment and at 6 months.

  • Expulsion Rate [ Time Frame: 6 months ]
    Expulsion rate as well as resumption of contraception (whether LNG-IUS is replaced or another form of contraception is initiated) occurs at the postpartum appointment and at six months

  • Bleeding Profile [ Time Frame: 6 months ]
    Each Participant will be asked to complete a monthly menstrual flow calendar to document light, medium, or heavy bleeding. These will be collected at the postpartum appointment and at six months.

  • Infectious morbidity [ Time Frame: 6 months ]
    Postpartum endometritis and pelvic inflammatory disease will be tracked with record review and direct participant questioning at their postpartum appointment and at six months

Estimated Enrollment: 170
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate
LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum
Device: LNG-IUS
Mirena (Bayer)- Levonorgestrel-Intrauterine System
Active Comparator: Interval
LNG-IUS insertion after 6 weeks postpartum
Device: LNG-IUS
Mirena (Bayer)- Levonorgestrel-Intrauterine System

Detailed Description:

The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.

The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.

Secondary outcome measures that we will obtain include:

  • Pain at the time of placement
  • Postpartum Depression
  • Breastfeeding status
  • Postpartum weight retention
  • Expulsion Rates
  • Bleeding Profile
  • Uterine Infection(Endometritis)

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in 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 receiving these forms of contraception in our study.

In addition the following intrapartum findings, the following would exclude the patient:

  • Delivery <37 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 or >1000cc for cesarean delivery)
  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 identifier: NCT01161095

United States, Arkansas
University of Arkansas for the Medical Sciences Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Everett F Magann, MD    501-686-8345   
United States, Virginia
Naval Medical Center Recruiting
Portsmouth, Virginia, United States, 23507
Contact: Joshua D Dahlke, MD    757-953-4503   
Principal Investigator: Joshua D Dahlke, MD         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
  More Information

Responsible Party: LCDR Joshua D. Dahlke MD, United States Navy Identifier: NCT01161095     History of Changes
Other Study ID Numbers: NMCP.2010.0074
Study First Received: July 12, 2010
Last Updated: September 29, 2010

Keywords provided by United States Naval Medical Center, Portsmouth:
Intrauterine Device
Postpartum contraception
Long-acting reversible contraception

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on May 22, 2017