Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00014989
First received: April 17, 2001
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

As many more premature infants survive, the numbers of these infants with health problems increases. The rate of cerebral palsy (CP) in extremely premature infants is approximately 20%. Magnesium sulfate, the most commonly used drug in the US to stop premature labor, may prevent CP. This trial tests whether magnesium sulfate given to a woman in labor with a premature fetus (24 to 31 weeks out of 40) will reduce the rate of death or moderate to severe CP in the children at 2 years. The children receive ultrasounds of their brains as infants and attend three follow-up visits over two years to assess their health and development.


Condition Intervention Phase
Cerebral Palsy
Intraventricular Hemorrhage
Periventricular Leukomalacia
Pulmonary Edema
Abruptio Placentae
Drug: magnesium sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Composite outcome of death or moderate to severe cerebral palsy

Secondary Outcome Measures:
  • Maternal
  • Chorioamnionitis
  • Endometritis
  • Other infectious morbidity
  • Pulmonary edema
  • Placental abruption
  • Neonatal
  • Stillbirth and neonatal death
  • Intraventricular hemorrhage
  • Neonatal infectious morbidity
  • Neonatal noninfectious morbidity
  • Birth weight
  • Days in NICU

Enrollment: 2136
Study Start Date: December 1997
Study Completion Date: June 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The prevalence of cerebral palsy is increasing as the survival rate of extremely premature infants is improving. Studies have suggested an apparent association between maternal magnesium sulfate administration and a reduced risk of cerebral palsy. Other studies have suggested a possible association between magnesium sulfate and a reduction in neonatal cranial ultrasound abnormalities which may be markers for subsequent development of cerebral palsy.

This multicenter trial tests whether prophylactic magnesium sulfate given to women, for whom preterm delivery is imminent, reduces the risk of death or moderate to severe cerebral palsy in their children. Women presenting from 24.0 to 31.6 weeks gestation with advanced preterm labor or premature rupture of the membranes (pPROM) and no recent exposure to magnesium sulfate are randomized to receive either intravenous magnesium sulfate or masked study drug placebo. The study drug is administered as a 6 gram loading dose followed by a 2 gram/hour infusion (or equivalent rate for placebo). If after 12 hours, delivery has not occurred and is not anticipated, the infusion is stopped. No other parenteral tocolytics other than the IV medication may be used. Retreatment with study medication is given any time labor recurs or delivery is anticipated until gestational age is > 34.0 wks. Standard clinical management and therapy is to be maintained for all study patients. Patients are assessed for signs of intolerance to the study medications and maternal data are collected up to hospital discharge. A sample of venous blood is collected and neonatal cranial ultrasounds are performed. Up to three follow-up visits are scheduled over two years where certified examiners, masked to study group assignment, collect physical and neurological data, including a modified Gross Motor Function Classification Scale. The Bayley Scales of Infant Development is also administered. Cranial ultrasounds are reviewed centrally.

The primary outcome is a composite outcome of death or moderate to severe cerebral palsy. Secondary outcomes include maternal infectious morbidity, pulmonary edema and placental abruption, neonatal stillbirth and death, intraventricular hemorrhage, periventricular leukomalacia, neonatal infectious and noninfectious morbidity.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant with diagnosis of preterm labor
  • Membrane rupture or delivery definitely planned within 24 hours
  • Gestational age > 24.0 and < 31.6 wks, viable fetus

Exclusion Criteria:

  • Prior IV magnesium sulfate therapy within 12 hours of screening
  • Delivery expected <2 hrs
  • Cervical dilation > 8 cm
  • More than 2 fetuses
  • Known major fetal anomalies
  • Hypertension or preeclampsia
  • Maternal medical complications contraindicating magnesium sulfate treatment
  • Participation in any intervention study which influences infant neurological outcome
  • Previous participation in this trial
  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: NCT00014989

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Florida
Dept of OB/GYN, University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Dept of OB/GYN, Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, New York
St. Luke's - Roosevelt Hospital
New York, New York, United States, 10019
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Forsyth Memorial Hospital, Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
The University Hospital, University of Cincinnati
Cincinnati, Ohio, United States, 45267-0794
Case Western University
Cleveland, Ohio, United States, 44109
Dept of OB/GYN, Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
MCP Hahnemann University
Philadelphia, Pennsylvania, United States, 19102
Dept of OB/GYN Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905-2499
United States, Texas
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, United States, 75235-9032
University of Texas Medical Branch - Galveston
Galveston, Texas, United States, 77555
University of Texas - Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Investigators
Principal Investigator: Dwight Rouse, MD University of Alabama at Birmingham
  More Information

Additional Information:
Publications:
Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM, for the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. New England Journal of Medicine, 359:895-905, 2008.
Costantine M, Weiner S, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network. Effects of Antenatal Exposure to Magnesium Sulfate on Neuroprotection and Mortality in Preterm Infants: A Meta-analysis. Obstetrics & Gynecology, 114(2, Part 1):354-364, 2009.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Y Spong, Chief, Pregnancy and Perinatology Branch, NICHD, NIH
ClinicalTrials.gov Identifier: NCT00014989     History of Changes
Other Study ID Numbers: NICHD-0800, U10-HD40473, U10-HD21410, U10-HD27905, U10-HD27917, U10-HD27860, U10-HD27915, U10-HD34116, U10-HD34208, U10-HD34136, U10-HD40462
Study First Received: April 17, 2001
Last Updated: May 12, 2010
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Preterm delivery
Cerebral palsy
Magnesium sulfate

Additional relevant MeSH terms:
Leukomalacia, Periventricular
Cerebral Palsy
Hemorrhage
Pulmonary Edema
Cerebral Hemorrhage
Abruptio Placentae
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014