NCT07524972

Antenatal Magnesium Sulphate in High-Risk Preterm Patients

Assessment of the Role of Antenatal Magnesium Sulphate in High-Risk Preterm Patients With Cerebral Palsy: a Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether antenatal magnesium sulphate reduces the risk of cerebral palsy in infants born to women at high risk of preterm birth. It will also assess the safety of magnesium sulfate for both the mother and the neonate. The main question it aims to answer is whether magnesium sulphate given before anticipated preterm delivery decreases the incidence of cerebral palsy without causing significant maternal or neonatal adverse effects. Researchers will compare magnesium sulphate with a placebo in women at high risk of preterm birth between 32 and 35 weeks of gestation. Participants will be randomly assigned to receive either intravenous magnesium sulphate or a placebo before delivery, and maternal and neonatal outcomes will be followed after birth, including neurodevelopmental assessment of the infant.

Detailed description

Preterm birth is strongly associated with adverse neonatal outcomes, including cerebral palsy, which remains one of the most important long-term neurodevelopmental complications among preterm infants. Antenatal magnesium sulphate has been proposed as a fetal neuroprotective therapy because of its potential to reduce neuronal injury through anti-inflammatory, anti-excitotoxic, and membrane-stabilising effects. Although previous trials and systematic reviews support its neuroprotective role, further evaluation is needed in women at high risk of preterm delivery to assess its effectiveness and safety in routine obstetric practice. This study is a randomised, placebo-controlled clinical trial conducted at Suez Canal University Hospital. Eligible pregnant women at high risk of preterm birth between 32 and 35 weeks of gestation, in whom delivery is planned or expected within 24 hours, will be randomised to receive either intravenous magnesium sulphate or placebo. The magnesium sulphate regimen consists of a loading dose followed by a maintenance infusion for up to 24 hours or until delivery. The placebo group will receive an isotonic sodium chloride solution administered in the same volume and schedule. Allocation concealment and blinding procedures are used so that participants and outcome assessors remain unaware of treatment assignment. All participants will receive standard obstetric and neonatal care in addition to the assigned study treatment. Maternal monitoring during infusion will include clinical assessment and observation for adverse effects. Neonatal follow-up will include routine postnatal assessment and cranial ultrasound screening when indicated. Infants will undergo follow-up after discharge, with neurodevelopmental evaluation at corrected age to assess for cerebral palsy. The trial is designed to determine whether antenatal magnesium sulphate provides fetal neuroprotection in women at risk of preterm birth while maintaining acceptable maternal and neonatal safety.

Conditions

• Cerebral Palsy
• Magnesium Sulfate Overdose

Interventions

Type	Name	Description
DRUG	Magnesium sulfate	Intravenous magnesium sulphate administered for fetal neuroprotection in women at high risk of preterm birth. Treatment is given as a loading dose followed by continuous maintenance infusion, with maternal monitoring during administration. The intervention is used for neuroprotection and not for tocolysis.
DRUG	Placebo	Intravenous placebo infusion using isotonic sodium chloride 0.9%, administered in the same volume and schedule as the active treatment to maintain blinding. Maternal monitoring during infusion is performed in the same manner as in the active treatment group.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-04-30
• Completion: 2028-05-30
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Egypt