MAGENTA Trial Information

Magnesium sulphate at 30 to 34 weeks' gestational Age: Neuroprotection Trial

Recruitment for MAGENTA WAS COMPLETED IN FEBRUARY 2018

Objective

Based on high quality evidence, Bi-National Clinical Practice Guidelines recommend the use of antenatal magnesium sulphate for women at risk of imminent, preterm birth at less than 30 weeks for the neuroprotection of their preterm infants (The Antenatal Magnesium Sulphate for Neuroprotection Guideline Development Panel 2010). However there remains uncertainty as to whether these neuroprotective benefits apply at higher gestational ages.

The aim of the MAGENTA randomised controlled trial is to assess whether giving magnesium sulphate, compared with placebo, to women immediately prior to preterm birth between 30 and 34 weeks' gestation reduces the risk of death or cerebral palsy in their children at two years' corrected age.

Study Design

Randomised, multicentre, placebo controlled trial.

Study Population

Women at risk of preterm birth between 30 and 34 weeks' gestation, where birth is planned or definitely expected within 24 hours, with a singleton or twin pregnancy and no contraindications to the use of magnesium sulphate.

Intervention

Eligible women will be randomly allocated to receive either magnesium sulphate or placebo.
Women in the Intervention Group will be administered 50 ml of a 100 ml infusion bag containing 8 g magnesium sulphate heptahydrate (equivalent to 4g magnesium sulphate heptahydrate).
Women in the placebo group will be administered 50 ml of a 100 ml infusion bag containing isotonic sodium chloride solution (0.9% sodium chloride).
Both treatments will be administered through a dedicated intravenous infusion line over 30 minutes.

Outcome Measures

The primary study outcome, measured in the children at follow-up at 2 years’ corrected age, is the incidence of death and cerebral palsy defined as stillbirth, death of live born infant before hospital discharge or death after hospital discharge; or any cerebral palsy (abnormality of tone with motor dysfunction).
Data/power analysis
A trial of 1676 children are required to detect a decrease in the combined outcome of death or cerebral palsy, from 9.6% with placebo to 5.4% with magnesium sulphate (two-sided alpha 0.05, 80% power, 5% loss to follow up, design effect 1.2).

Commencement Date

January 2012

Investigators and Primary Contacts

Chief Investigator: Professor Caroline Crowther

Other Investigators: A/Prof Philippa Middleton, Dr Andrew McPhee, Ms Pat Ashwood, A/Prof Ross Haslam, A/Prof Dominic Wilkinson

Clinical Trial Manager: Ms Pat Ashwood

Australian Research Centre for Health of Women and Babies (ARCH)
The Robinson Research Institute
Discipline of Obstetrics and Gynaecology
School of Medicine
The University of Adelaide
Women’s and Children’s Hospital
King William Road, North Adelaide, SA 5006, Australia
Email: magenta@adelaide.edu.au
Phone: +61 8 8161 7767

Australia New Zealand Clinical Trials Registry (ANZCTR) Trial Registry Number

ACTRN12611000491965