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Antenatal Magnesium Sulphate in High-Risk Preterm Patients

RecruitingPhase 3Ages 18 Years - 45 YearsFemaleCairo University
NCT07524972 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
* 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
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What it tests

  • Magnesium sulfate
  • Placebo
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Where

1 site
Suez Canal University
Ismailia, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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