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
Cairo University
138 participants
May 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria11
- 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
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07524972