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

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ClinicalTrials.gov Identifier: NCT01161095
Recruitment Status : Unknown
Verified September 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was:  Recruiting
First Posted : July 13, 2010
Last Update Posted : September 30, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Contraception Postpartum Period Device: LNG-IUS

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)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161095


Locations
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    efmagann@uams.edu   
United States, Virginia
Naval Medical Center Recruiting
Portsmouth, Virginia, United States, 23507
Contact: Joshua D Dahlke, MD    757-953-4503    joshua.dahlke@med.navy.mil   
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
ClinicalTrials.gov Identifier: NCT01161095     History of Changes
Other Study ID Numbers: NMCP.2010.0074
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: September 30, 2010
Last Verified: September 2010

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

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