Antenatal Magnesium Sulphate in High-Risk Preterm Patients

Phase 3RecruitingNCT07524972

Cairo University138 enrolled

Overview

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.

Preterm birth is strongly associated with adverse neonatal outcomes, including cerebral palsy, which remains one of the most important long-term neurodevelopmental complications among preterm infants. Antenatal magnesium sulphate has been proposed as a fetal neuroprotective therapy because of its potential to reduce neuronal injury through anti-inflammatory, anti-excitotoxic, and membrane-stabilising effects. Although previous trials and systematic reviews support its neuroprotective role, further evaluation is needed in women at high risk of preterm delivery to assess its effectiveness and safety in routine obstetric practice. This study is a randomised, placebo-controlled clinical trial conducted at Suez Canal University Hospital. Eligible pregnant women at high risk of preterm birth between 32 and 35 weeks of gestation, in whom delivery is planned or expected within 24 hours, will be randomised to receive either intravenous magnesium sulphate or placebo. The magnesium sulphate regimen consists of a loading dose followed by a maintenance infusion for up to 24 hours or until delivery. The placebo group will receive an isotonic sodium chloride solution administered in the same volume and schedule. Allocation concealment and blinding procedures are used so that participants and outcome assessors remain unaware of treatment assignment. All participants will receive standard obstetric and neonatal care in addition to the assigned study treatment. Maternal monitoring during infusion will include clinical assessment and observation for adverse effects. Neonatal follow-up will include routine postnatal assessment and cranial ultrasound screening when indicated. Infants will undergo follow-up after discharge, with neurodevelopmental evaluation at corrected age to assess for cerebral palsy. The trial is designed to determine whether antenatal magnesium sulphate provides fetal neuroprotection in women at risk of preterm birth while maintaining acceptable maternal and neonatal safety.

Interventions

Magnesium sulfateDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

Combined incidence of death or cerebral palsy

Composite outcome defined as stillbirth, neonatal mortality, or cerebral palsy diagnosed by corrected age follow-up assessment. Cerebral palsy will be identified by a blinded pediatric and psychological assessment using established diagnostic criteria, including motor dysfunction or tone abnormalities.

Time frame: By 6 months corrected age

Secondary Outcomes

Maternal side effects of magnesium sulphate

Incidence of maternal adverse effects related to study treatment, including flushing, hypotension, and respiratory depression.

Time frame: From the date and time of magnesium sulphate infusion initiation until hospital discharge, assessed up to 48 hours.

Neonatal morbidity

Incidence of neonatal morbidity including intraventricular hemorrhage, periventricular leukomalacia, and respiratory distress syndrome

Time frame: From birth through 4 weeks after birth, cranial ultrasound was assessed within 7 days after birth and repeated at 4 weeks after birth when clinically indicated.