Antenatal Magnesium Sulphate in High-Risk Preterm Patients

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.

• Inclusion Criteria:

• Pregnant women at high risk of preterm birth between 32 and 35 weeks of gestation
• Birth is planned or expected within 24 hours
• Singleton pregnancy
• No contraindication to antenatal magnesium sulphate
• Able to provide informed consent
• Exclusion Criteria:

• Higher-order multiple pregnancy
• Received antenatal magnesium sulphate during the current pregnancy for hypertension or preeclampsia
• Magnesium sulphate is required for treatment of preeclampsia
• Second stage of labor
• Respiratory rate less than 16 breaths per minute
• Absent patellar reflexes
• Urine output less than 100 mL in the previous 4 hours
• Renal failure
• Hypocalcemia
• Myasthenia gravis
• Magnesium sulphate infusion had to be stopped because of adverse effects