A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use 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:
NCT01161095
First received: July 12, 2010
Last updated: September 29, 2010
Last verified: September 2010
  Purpose

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
Contraception
Postpartum Period
Device: LNG-IUS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.

  • Postpartum Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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: 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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 23, 2014