Antenatal Magnesium Sulphate in High-Risk Preterm Patients

Sponsor
Cairo University
Study ID
NCT07524972
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Magnesium Sulfate Overdose

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnesium sulfate — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Magnesium Sulphate
    Participants in this arm will receive intravenous magnesium sulfate for fetal neuroprotection, given as a 4 g loading dose (8 mL) over 20 minutes followed by a maintenance infusion of 1 g/hour (2 mL/hour) until delivery or for up to 24 hours.
  • Placebo Comparator: Placebo
    Participants in this arm will receive placebo as isotonic sodium chloride 0.9%, given intravenously as 8 mL over 20 minutes followed by a maintenance infusion of 2 mL/hour until delivery or for up to 24 hours, using the same schedule as the active treatment arm.

Primary Outcome Measure

Combined incidence of death or cerebral palsy [ Time Frame: By 6 months corrected age ]

Central Contacts

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