Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
NCT ID: NCT00014989
Last Updated: 2019-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2136 participants
INTERVENTIONAL
1997-12-31
2007-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Interventions
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magnesium sulfate
Eligibility Criteria
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Inclusion Criteria
* Membrane rupture or delivery definitely planned within 24 hours
* Gestational age \> 24.0 and \< 31.6 wks, viable fetus
Exclusion Criteria
* 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
FEMALE
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER
Responsible Party
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Principal Investigators
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Dwight Rouse, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Menachem Miodovnik
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Locations
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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
Countries
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References
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Nelson KB, Grether JK. Can magnesium sulfate reduce the risk of cerebral palsy in very low birthweight infants? Pediatrics. 1995 Feb;95(2):263-9.
Schendel DE, Berg CJ, Yeargin-Allsopp M, Boyle CA, Decoufle P. Prenatal magnesium sulfate exposure and the risk for cerebral palsy or mental retardation among very low-birth-weight children aged 3 to 5 years. JAMA. 1996 Dec 11;276(22):1805-10.
Hallak M, Berry SM, Madincea F, Romero R, Evans MI, Cotton DB. Fetal serum and amniotic fluid magnesium concentrations with maternal treatment. Obstet Gynecol. 1993 Feb;81(2):185-8.
Aziz K, Vickar DB, Sauve RS, Etches PC, Pain KS, Robertson CM. Province-based study of neurologic disability of children weighing 500 through 1249 grams at birth in relation to neonatal cerebral ultrasound findings. Pediatrics. 1995 Jun;95(6):837-44.
Pinto-Martin JA, Riolo S, Cnaan A, Holzman C, Susser MW, Paneth N. Cranial ultrasound prediction of disabling and nondisabling cerebral palsy at age two in a low birth weight population. Pediatrics. 1995 Feb;95(2):249-54.
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; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med. 2008 Aug 28;359(9):895-905. doi: 10.1056/NEJMoa0801187.
Costantine MM, Weiner SJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Effects of antenatal exposure to magnesium sulfate on neuroprotection and mortality in preterm infants: a meta-analysis. Obstet Gynecol. 2009 Aug;114(2 Pt 1):354-364. doi: 10.1097/AOG.0b013e3181ae98c2.
Buhimschi CS, Jablonski KA, Rouse DJ, Varner MW, Reddy UM, Mercer BM, Leveno KJ, Wapner RJ, Sorokin Y, Thorp JM Jr, Ramin SM, Malone FD, Carpenter MW, O'Sullivan MJ, Peaceman AM, Saade GR, Dudley D, Caritis SN, Buhimschi IA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Cord Blood Haptoglobin, Cerebral Palsy and Death in Infants of Women at Risk for Preterm Birth: A Secondary Analysis of a Randomised Controlled Trial. EClinicalMedicine. 2019 Mar 22;9:11-18. doi: 10.1016/j.eclinm.2019.03.009. eCollection 2019 Mar.
Hirtz DG, Weiner SJ, Bulas D, DiPietro M, Seibert J, Rouse DJ, Mercer BM, Varner MW, Reddy UM, Iams JD, Wapner RJ, Sorokin Y, Thorp JM Jr, Ramin SM, Malone FD, Carpenter MW, O'Sullivan MJ, Peaceman AM, Hankins GD, Dudley D, Caritis SN; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Antenatal Magnesium and Cerebral Palsy in Preterm Infants. J Pediatr. 2015 Oct;167(4):834-839.e3. doi: 10.1016/j.jpeds.2015.06.067. Epub 2015 Aug 5.
Twickler DM, McIntire DD, Alexander JM, Leveno KJ. Effects of magnesium sulfate on preterm fetal cerebral blood flow using Doppler analysis: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):21-25. doi: 10.1097/AOG.0b013e3181c4f7c1.
Related Links
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Click here for more information on the NICHD MFMU Research Network.
Other Identifiers
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NICHD-0800
Identifier Type: -
Identifier Source: org_study_id
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