The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Postpartum hemorrhage
研究概览
简要总结
A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Early Preterm birth (< 34+0 weeks) and very low birthweight (< 1,500 g) are the principal risk factors for cerebral palsy. Multiple pregnancy accounts for over 10% of preterm births and has a higher incidence of cerebral palsy than singleton pregnancy (twins have 7 times and triplets 47 times the risk of cerebral palsy compared with singletons).
详细描述
Many of these patients come or get diagnosed as eminent preterm delivery very soon before the real delivery happens and are not able to complete the recommended therapy of loading and maintenance strategy for at least complete 4 hours before delivery.
Till now, there is a gap and lack of knowledge regarding the value of loading dose only as sufficient and effective strategy for neuroprotection compared to full therapy, which needs more health costs, longer monitoring and carries more risk for the patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation.
- •When early preterm birth is planned or expected within 24 h, regardless of:
- •Plurality or parity
- •Reason for the risks of preterm birth
- •Anticipated mode of birth
- •Whether antenatal corticosteroids have been given or not
排除标准
- •Women with known Hypersensitivity to magnesium
- •Caution regarding dosage for patients with renal impairment
- •Preterm delivery after 34 weeks
研究组 & 干预措施
Loading dose only
Those receiving only the loading dose of magnesium sulphate 4 gm infusion over 20 minutes therapy within one hour before delivery without the maintenance dose
干预措施: Magnesium sulfate loading dose only (Drug)
Loading plus maintenance dose
Receiving magnesium sulphate loading 4 gm infusion over 20 minutes, followed by maintenance therapy 1gm per hour infusion until delivery or completion of 24 hours, the sooner.
干预措施: Magnesium sulfate loading with maintenance dose (Drug)
结局指标
主要结局
Postpartum hemorrhage
时间窗: first 24 hours after delivery
Risk of primary postpartum hemorrhage
Neonatal Neurological insult
时间窗: at 18 months age after delivery
The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)
Maternal toxicity
时间窗: from start of therapy, till 12 hours after end of therapy
Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.
次要结局
- Late appearing neurologic insults(at 24 months age after delivery)
- Neonatal death(28 days from birth)
研究者
Hytham Atia
Associate professor
Zagazig University