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Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial

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@article{236ac38ece9c499ca69dedd06321532b,
title = "Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial",
abstract = "Objective: To study the effect of antenatal magnesium sulphate (MgSO 4) on cerebral palsy (CP) in a manner that also provides adequate power for a linked trial sequential analysis. Design: Double-blind, randomised, placebo-controlled, multi-centre trial. Setting: Fourteen Danish obstetric departments. Population: In total, 560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018. Those women gave birth to 680 children. Methods: Women were randomised to receive either a loading dose of 5 g MgSO 4 followed by 1 g/hour or a placebo in identical volumes. The children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire. Main outcome measure: The primary outcome measure was moderate to severe CP. Secondary outcomes included mortality, neonatal morbidity, blindness and mild CP. Results: The crude rates of moderate to severe CP in the MgSO 4 group and the placebo group were 2.0% and 3.3%, respectively. The adjusted odds of moderate to severe CP were lower in the MgSO 4 group than in the placebo group (odds ratio 0.61; 95% CI 0.23–1.65). Conclusions: Antenatal MgSO 4 before 32 weeks of gestation decreases the likelihood of moderate to severe CP; these results are entirely consistent with other randomised evidence summarised in the linked trial sequential analysis. Tweetable abstract: Antenatal magnesium sulphate may decrease the risk of moderate to severe cerebral palsy in children born before 32 weeks of gestation. ",
keywords = "Cerebral palsy, magnesium sulphate, MgSO, mortality, neonatal morbidity, neuroprotection, preterm birth",
author = "Wolf, {Hanne Trap} and Jesper Brok and Henriksen, {Tine Brink} and Gorm Greisen and Salvig, {Jannie Dalby} and Ole Pryds and Morten Hedegaard and Tom Weber and Hegaard, {Hanne Kristine} and Anja Pinborg and Huusom, {Lene Drasbek} and {MASP research group} and Svare, {Jens Anton}",
note = "{\textcopyright} 2020 Royal College of Obstetricians and Gynaecologists.",
year = "2020",
month = sep,
day = "1",
doi = "10.1111/1471-0528.16239",
language = "English",
volume = "127",
pages = "1217--1225",
journal = "BJOG: An International Journal of Obstetrics and Gynaecology",
issn = "1470-0328",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "10",

}

RIS

TY - JOUR

T1 - Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm

T2 - a double-blind, randomised, placebo-controlled, multi-centre trial

AU - Wolf, Hanne Trap

AU - Brok, Jesper

AU - Henriksen, Tine Brink

AU - Greisen, Gorm

AU - Salvig, Jannie Dalby

AU - Pryds, Ole

AU - Hedegaard, Morten

AU - Weber, Tom

AU - Hegaard, Hanne Kristine

AU - Pinborg, Anja

AU - Huusom, Lene Drasbek

AU - MASP research group

A2 - Svare, Jens Anton

N1 - © 2020 Royal College of Obstetricians and Gynaecologists.

PY - 2020/9/1

Y1 - 2020/9/1

N2 - Objective: To study the effect of antenatal magnesium sulphate (MgSO 4) on cerebral palsy (CP) in a manner that also provides adequate power for a linked trial sequential analysis. Design: Double-blind, randomised, placebo-controlled, multi-centre trial. Setting: Fourteen Danish obstetric departments. Population: In total, 560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018. Those women gave birth to 680 children. Methods: Women were randomised to receive either a loading dose of 5 g MgSO 4 followed by 1 g/hour or a placebo in identical volumes. The children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire. Main outcome measure: The primary outcome measure was moderate to severe CP. Secondary outcomes included mortality, neonatal morbidity, blindness and mild CP. Results: The crude rates of moderate to severe CP in the MgSO 4 group and the placebo group were 2.0% and 3.3%, respectively. The adjusted odds of moderate to severe CP were lower in the MgSO 4 group than in the placebo group (odds ratio 0.61; 95% CI 0.23–1.65). Conclusions: Antenatal MgSO 4 before 32 weeks of gestation decreases the likelihood of moderate to severe CP; these results are entirely consistent with other randomised evidence summarised in the linked trial sequential analysis. Tweetable abstract: Antenatal magnesium sulphate may decrease the risk of moderate to severe cerebral palsy in children born before 32 weeks of gestation.

AB - Objective: To study the effect of antenatal magnesium sulphate (MgSO 4) on cerebral palsy (CP) in a manner that also provides adequate power for a linked trial sequential analysis. Design: Double-blind, randomised, placebo-controlled, multi-centre trial. Setting: Fourteen Danish obstetric departments. Population: In total, 560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018. Those women gave birth to 680 children. Methods: Women were randomised to receive either a loading dose of 5 g MgSO 4 followed by 1 g/hour or a placebo in identical volumes. The children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire. Main outcome measure: The primary outcome measure was moderate to severe CP. Secondary outcomes included mortality, neonatal morbidity, blindness and mild CP. Results: The crude rates of moderate to severe CP in the MgSO 4 group and the placebo group were 2.0% and 3.3%, respectively. The adjusted odds of moderate to severe CP were lower in the MgSO 4 group than in the placebo group (odds ratio 0.61; 95% CI 0.23–1.65). Conclusions: Antenatal MgSO 4 before 32 weeks of gestation decreases the likelihood of moderate to severe CP; these results are entirely consistent with other randomised evidence summarised in the linked trial sequential analysis. Tweetable abstract: Antenatal magnesium sulphate may decrease the risk of moderate to severe cerebral palsy in children born before 32 weeks of gestation.

KW - Cerebral palsy

KW - magnesium sulphate

KW - MgSO

KW - mortality

KW - neonatal morbidity

KW - neuroprotection

KW - preterm birth

UR - http://www.scopus.com/inward/record.url?scp=85083997684&partnerID=8YFLogxK

U2 - 10.1111/1471-0528.16239

DO - 10.1111/1471-0528.16239

M3 - Journal article

C2 - 32237024

VL - 127

SP - 1217

EP - 1225

JO - BJOG: An International Journal of Obstetrics and Gynaecology

JF - BJOG: An International Journal of Obstetrics and Gynaecology

SN - 1470-0328

IS - 10

ER -

ID: 59656468