Actively Recruiting
Assessment of the Role of Antenatal Magnesium Sulphate in High-Risk Preterm Patients With Cerebral Palsy: a Randomized Clinical Trial
Led by Cairo University · Updated on 2026-04-13
138
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Cairo University
Lead Sponsor
S
Suez Canal University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving magnesium sulphate to pregnant women at high risk of preterm birth can reduce the chance of cerebral palsy in their infants. This trial focuses on women between 32 and 35 weeks of pregnancy who are expected to deliver within 24 hours. The study also aims to assess the safety of magnesium sulphate for both mothers and newborns by comparing it to a placebo. Participants will be randomly assigned to receive either intravenous magnesium sulphate or a placebo. The magnesium sulphate is given as a 4 gram loading dose over 20 minutes, followed by a maintenance infusion of 1 gram per hour until delivery or for up to 24 hours. The placebo group receives an intravenous sodium chloride solution following the same schedule. Both groups will receive standard obstetric and neonatal care throughout the study. During the study, mothers will be monitored for side effects while receiving the infusion. Newborns will have routine assessments and cranial ultrasound screenings when needed. After discharge, infants will be followed up with neurodevelopmental evaluations to check for cerebral palsy. The main outcome measured is the combined rate of death or cerebral palsy at 6 months corrected age. The study will also track maternal side effects up to 48 hours after infusion and neonatal health up to 4 weeks after birth.
CONDITIONS
Brief Title
Antenatal Magnesium Sulphate in High-Risk Preterm Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 hours or until delivery
Participants receive an intravenous infusion of magnesium sulphate or placebo for fetal neuroprotection, starting with a loading dose followed by a maintenance infusion until delivery or for up to 24 hours. Maternal monitoring is performed during the infusion to observe for any side effects.
1 to 2 visits depending on delivery timing
Duration - Up to 6 months after birth
After birth, infants undergo routine neonatal assessments including cranial ultrasound when indicated, and neurodevelopmental evaluation at 6 months corrected age to assess for cerebral palsy.
1 follow-up visit at 6 months corrected age
Trial Site Locations
Total: 1 location
1
Suez Canal University
Ismailia, Ismailia Governorate, Egypt, 8366004
Actively Recruiting
Research Team
M
mohamed shaaban, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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