Evidence map›Paper›PMID 18753646›Full record

Trial reportThe New England journal of medicine2008

A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy.

Dwight J Rouse, Deborah G Hirtz, Elizabeth Thom, Michael W Varner, Catherine Y Spong, Brian M Mercer, Jay D Iams, Ronald J Wapner, Yoram Sorokin, James M Alexander and 14 more

3 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 177 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
177citing papers in PubMed, 19 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00014989 phase3completednot on this map

Randomized Clinical Trial of the Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)

TypeinterventionalSponsorThe George Washington University Biostatistics CenterRan1997 to 2007Enrolled2,136ConditionsCerebral Palsy, Intraventricular Hemorrhage, Periventricular Leukomalacia, Pulmonary EdemaArmsmagnesium sulfate
NCT01646619 phase3unknown statusnot on this mapstarted 2012, after this paper: background citation

A Multicenter Randomized Controlled Trial of Therapeutic Hypothermia Plus Magnesium Sulphate (MgSO4) Versus Therapeutic Hypothermia Plus Placebo in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy

TypeinterventionalSponsorSajjad RahmanRan2012 to 2014Enrolled300ConditionsSevere Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic EncephalopathyArmsMagnesium Sulphate, Placebo
NCT01709630 completednot on this mapstarted 2012, after this paper: background citation

Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate

TypeobservationalSponsorStanford UniversityRan2012 to 2014Enrolled151ConditionsMagnesium Sulfate Pharmacokinetics and PharmacodynamicsArmsMagnesium sulfate infusion
3 · Its place in the literature

Who cites it

177 citing papers in PubMed, 19 syntheses or guidelines pooled it.

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  7. Antenatal Magnesium Sulfate and adverse gastrointestinal outcomes in Preterm infants-a systematic review and meta-analysis.Journal of perinatology : official journal of the California Perinatal Association · 2023
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  14. Magnesium sulphate for women at term for neuroprotection of the fetus.The Cochrane database of systematic reviews · 2013
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  19. Reducing stillbirths: interventions during labour.BMC pregnancy and childbirth · 2009
    Pooled it
  20. Trial

117 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Dwight J RouseUniversity of Alabama at Birmingham, Birmingham, USA. drouse@uab.edu
Deborah G Hirtz
Elizabeth Thom
Michael W Varner
Catherine Y Spong
Brian M Mercer
Jay D Iams
Ronald J Wapner
Yoram Sorokin
James M Alexander
Margaret Harper
John M Thorp
Susan M Ramin
Fergal D Malone
Marshall Carpenter
Menachem Miodovnik
Atef Moawad
Mary J O'Sullivan
Alan M Peaceman
Gary D V Hankins
Oded Langer
Steve N Caritis
James M Roberts
Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network

Funding

Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research NetU10HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI CLIFTON, REBECCA GERSNOVIEZ · 2009 to 2021
$174.2M
SARS-CoV-2 Vaccine Pregnancy RegistryU24HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI Rebecca Gersnoviez Clifton · 2021 to 2026
$39.2M
MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTRU01HD036801 · NICHD · GEORGE WASHINGTON UNIVERSITY · PI THOM, ELIZABETH ANN · 1998 to 2008
$27.0M
NICHD Maternal Fetal Medicine Units NetworkU10HD034116 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI CASEY, BRIAN M · 1996 to 2015
$19.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD034208 · NICHD · UNIVERSITY OF UTAH · PI VARNER, MICHAEL W. · 1996 to 2015
$16.6M
NICHD Maternal Fetal Medicine Units NetworkU10HD027869 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 1991 to 2015
$12.8M
NICHD Maternal Fetal Medicine Units NetworkU10HD040485 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WAPNER, RONALD · 2001 to 2015
$12.5M
NICHD Maternal Fetal Medicine Units NetworkU10HD040560 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI THORP, JOHN M · 2001 to 2015
$10.3M
NICHD Maternal Fetal Medicine Units NetworkU10HD040512 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GROBMAN, WILLIAM ADAM · 2001 to 2015
$8.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD027917 · NICHD · WAYNE STATE UNIVERSITY · PI GONIK, BERNARD · 1991 to 2015
$8.2M
NICHD Maternal Fetal Medicine Units NetworkU10HD027915 · NICHD · OHIO STATE UNIVERSITY · PI IAMS, JAY · 1992 to 2015
$7.7M
NICHD Maternal Fetal Medicine Units NetworkU10HD040545 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI CHAUHAN, SUNEET P · 2001 to 2015
$7.7M
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6 · The paper itself

Abstract

backgroundResearch suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy.

methodsIn this multicenter, placebo-controlled, double-blind trial, we randomly assigned women at imminent risk for delivery between 24 and 31 weeks of gestation to receive magnesium sulfate, administered intravenously as a 6-g bolus followed by a constant infusion of 2 g per hour, or matching placebo. The primary outcome was the composite of stillbirth or infant death by 1 year of corrected age or moderate or severe cerebral palsy at or beyond 2 years of corrected age.

resultsA total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. Follow-up was achieved for 95.6% of the children. The rate of the primary outcome was not significantly different in the magnesium sulfate group and the placebo group (11.3% and 11.7%, respectively; relative risk, 0.97; 95% confidence interval [CI], 0.77 to 1.23). However, in a prespecified secondary analysis, moderate or severe cerebral palsy occurred significantly less frequently in the magnesium sulfate group (1.9% vs. 3.5%; relative risk, 0.55; 95% CI, 0.32 to 0.95). The risk of death did not differ significantly between the groups (9.5% vs. 8.5%; relative risk, 1.12; 95% CI, 0.85 to 1.47). No woman had a life-threatening event.

conclusionsFetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate or severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. (ClinicalTrials.gov number, NCT00014989.)

Indexed as

AdultCerebral PalsyDouble-Blind MethodFemaleFollow-Up StudiesGestational AgeHumansInfant MortalityInfant, NewbornInfant, PrematureMagnesium SulfateObstetric Labor, PrematurePregnancyTocolytic AgentsMagnesium SulfateTocolytic Agents

Identifiers

PMID18753646
PMCPMC2803083

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.