Dataset Information

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

ABSTRACT:

Background

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

Methods

In 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.

Results

A 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.

Conclusions

Fetal 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.)

SUBMITTER: Rouse DJ

PROVIDER: S-EPMC2803083 | biostudies-literature | 2008 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Rouse Dwight J DJ Hirtz Deborah G DG Thom Elizabeth E Varner Michael W MW Spong Catherine Y CY Mercer Brian M BM Iams Jay D JD Wapner Ronald J RJ Sorokin Yoram Y Alexander James M JM Harper Margaret M Thorp John M JM Ramin Susan M SM Malone Fergal D FD Carpenter Marshall M Miodovnik Menachem M Moawad Atef A O'Sullivan Mary J MJ Peaceman Alan M AM Hankins Gary D V GD Langer Oded O Caritis Steve N SN Roberts James M JM

The New England journal of medicine 20080801 9

<h4>Background</h4>Research suggests that fetal exposure to magnesium sulfate before preterm birth might reduce the risk of cerebral palsy.<h4>Methods</h4>In 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 stillbi ...[more]

PMID: 18753646

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Project description:BackgroundMagnesium sulfate is used topically to reduce the duration of labor in some regions of the country. However, there is insufficient evidence about its effectiveness. This study aimed to determine whether topical magnesium sulfate reduces labor duration and improves childbirth experience (primary outcomes).MethodsIn this randomized controlled trial, the participants were 98 women with low-risk, singleton, and full-term pregnancies admitted to a teaching hospital in Iran. They were randomly assigned to the intervention group (receiving 50% magnesium sulfate) or the control group (receiving distilled water) stratified by parity and onset of labor. The participants, interventionists, and data collectors were blinded. During the vaginal examination at the beginning of the active phase of labor, 10 mL of magnesium sulfate or distilled water was poured on the cervix of the uterus. Data collection was performed by the researcher with continuous monitoring up to two hours post-delivery and follow-up at 4-5 weeks postpartum. The Childbirth Experience Questionnaire 2.0 was used to examine childbirth experience. We performed a modified intention-to-treat analysis, excluding those whose outcome of interest could not be assessed. Independent-samples t-tests were used to compare the groups in terms of the mean of the primary outcomes.ResultsParticipant recruitment took place between December 2021 and December 2022. Thirty-three percent were primiparous and 37% had induced labor. Three women in the intervention group and seven in the control group underwent emergency cesarean sections. All 49 women assigned to each group were included in the analysis of labor duration outcome, while one and two women were excluded from the analysis of childbirth experience score due to loss to follow-up. In the intervention group, compared to the control group, the mean duration of the intervention until delivery was significantly shorter (1.59 vs. 2.93 h; MD -1.34, 95% CI [-1.88 to -0.79]) and the childbirth experience score was higher (3.1 vs. 2.3, MD 0.84; 95% CI [0.59 to 1.08]).ConclusionsAccording to the results of this trial, pouring 10 mL of 50% magnesium sulfate on the cervix at the beginning of the active phase of labor probably reduces labor duration and improves the childbirth experience.Trial registrationEthics Committee of Tabriz University of Medical Sciences: IR.TBZMED.REC. 1400.726. Iranian Registry of Clinical Trials: IRCT20100414003706N40 Registration date: 21/11/2021 ( https://en.irct.ir/trial/58323 ).

Project description:BackgroundRecent research indicates that intensive rehabilitation tends to be effective for children with cerebral palsy (CP). Intensive Neurophysiological Rehabilitation System (INRS) is a multi-component approach that combines various interventions and addresses different functional goals.. This study aimed to examine the effectiveness of the INRS treatment in children with bilateral CP.MethodsIn this quasi-randomized controlled study, 48 children with spastic bilateral CP (age 5-12 years, GMFCS Levels I-IV, MACS Levels I-IV) were assigned to an experimental or control group in order they have been enrolled. The experimental group underwent INRS treatment in the tertiary care facility for about four hours daily for ten days and continued routine home treatment for four weeks. After the first evaluation, participants from the control group stayed on the waiting list for four weeks receiving home treatment and then starting the INRS treatment. Thereby, all participants were assessed three times. The primary outcome measure was a Gross Motor Function Measure 66 Item Set (GMFM). The secondary outcome measures included the Jebsen-Taylor Hand Function test, Box and Blocks test, ABILHAND-Kids Questionnaire, Self-care and Mobility domain of the Pediatric Evaluation of Disability Inventory, and the ankle dorsiflexion passive range of motion.ResultsThere was a statistically significant increase in the GMFM score after the INRS treatment in both the experimental group (mean difference (MD) 2.0, P < 0.01) and control group (MD 1.5, P < 0.05), with a large size effect (partial eta squared (η2) = 0.21 and η2 = 0.14). The mean difference between groups during the first study period was 2.89 points (p < 0.01) in the GMFM score with a medium effect size (η2 = 0.12). Statistically significant superiority of the INRS treatment over home treatment was also obtained by Jebsen-Taylor Hand Function Test and the Box and Blocks Test in both dominant and non-dominant hands.ConclusionsThe study indicates that the INRS treatment can be beneficial for improving both gross motor functions and hand function in children with bilateral CP. Further longitudinal studies are required to evaluate the effects of the INRS treatment on the participation level of children with CP.Trial registrationThe study protocol was registered on ClinicalTrials.gov under the identifier: NCT04093180 on 17/09/2019.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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