Antenatal magnesium sulphate to lower the risk of cerebral palsy in preterm babies
Official title: Assessment of the Role of Antenatal Magnesium Sulphate in High-Risk Preterm Patients With Cerebral Palsy: a Randomized Clinical Trial
Run by Cairo University · NCT07524972 · Data updated 2026-11-12
It tests whether giving pregnant people at high risk of delivering between 32 and 35 weeks an IV dose of magnesium sulphate before birth can lower their baby's chance of cerebral palsy without causing significant harm to mother or baby.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 138 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Ismailia, Ismailia Governorate) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | April 30, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07524972 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with a singleton pregnancy between 32 and 35 weeks gestation who are judged to be at high risk of delivery within 24 hours, can provide informed consent, and have no contraindications to magnesium sulphate.
✕Probably not a fit
Women already receiving magnesium sulphate for preeclampsia, with contraindications to magnesium (such as myasthenia gravis or renal failure), in active second-stage labor, or with higher-order multiple pregnancies are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled Phase 3 trial enrolls women at high risk of preterm birth between 32 and 35 weeks and assigns them to receive either intravenous magnesium sulphate or an identical-volume saline placebo before delivery. Participants and outcome assessors are blinded, and all receive standard obstetric and neonatal care while maternal and neonatal safety are closely monitored during and after infusion. The main outcome is the incidence of cerebral palsy in the infant, with follow-up including neurodevelopmental assessment and recording of maternal and neonatal adverse events. The trial is conducted at Suez Canal University Hospital with allocation concealment and specified loading and maintenance infusion protocols.
Why it matters
Potential benefit: If successful, the treatment could reduce the rate of cerebral palsy and improve long-term neurodevelopment for infants born preterm without adding major maternal or neonatal risks.
How similar studies have gone: Previous randomized trials and meta-analyses have generally supported antenatal magnesium sulphate for neuroprotection in preterm infants, though targeted data for the 32–35 week window in routine practice remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
* 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
Where it's running
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Suez Canal University
Ismailia, Ismailia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: mohamed shaaban, MD
- Email: mshaaban@hotmail.com
- Phone: +2010 05153911
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.