Assessment of the Role of Antenatal Magnesium Sulphate in High-Risk Preterm Patients With Cerebral Palsy: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Combined incidence of death or cerebral palsy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is designed as a double-blind randomized clinical trial. Allocation will be concealed using sequentially numbered opaque sealed envelopes. Study drugs will be coded by a pharmacist, labels will be replaced with plain covers, and the code key will be kept until the end of the study. Participants, investigators, care providers administering the coded infusion, and outcome assessors will remain unaware of treatment assignment. Pediatricians and psychologists performing follow-up neurodevelopmental assessments will also be blinded to allocation.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
Combined incidence of death or cerebral palsy
时间窗: By 6 months corrected age
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.
次要结局
- Maternal side effects of magnesium sulphate(From the date and time of magnesium sulphate infusion initiation until hospital discharge, assessed up to 48 hours.)
- Neonatal morbidity(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.)
研究者
ahmed nagy shaker ramadan
Lecturer of obstetrics and gynecology
Cairo University