Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

Completed · Phase 3

Conditions studied: Cerebral Palsy, Intraventricular Hemorrhage, Periventricular Leukomalacia, Pulmonary Edema, Abruptio Placentae

In brief

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.

Key facts

Study ID

NCT00014989

Run by

The George Washington University Biostatistics Center

People needed

2136

Starts

1997-12-01

Expected to finish

2007-06-01

Last updated by the study team

2019-07-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Dept of OB/GYN, University of Miami — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Dept of OB/GYN, Hutzel Hospital — Detroit, Michigan, United States
• St. Luke's - Roosevelt Hospital — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Forsyth Memorial Hospital, Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• The University Hospital, University of Cincinnati — Cincinnati, Ohio, United States
• Case Western University — Cleveland, Ohio, United States
• Dept of OB/GYN, Ohio State University — Columbus, Ohio, United States
• MCP Hahnemann University — Philadelphia, Pennsylvania, United States
• Dept of OB/GYN Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Dept of OB/GYN, Southwestern Medical Center, University of Texas — Dallas, Texas, United States
• University of Texas Medical Branch - Galveston — Galveston, Texas, United States
• University of Texas - Houston — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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