Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 主要终点
- Latency period after rupture of membranes
研究概览
简要总结
To assess the outcome of using magnesium sulphate on fetus and women with preterm premature rupture of membranes
详细描述
Preterm premature rupture of membranes (PPROM) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. Approximately 1% to 5% of pregnancies are complicated by PPROM . PPROM contributes to perinatal morbidity and mortality, secondary to premature birth, and maternal morbidity. Overall, PPROM accounts for about one-third of all preterm births . In order to reduce the effects of prematurity, early PPROM (24 to 33 weeks) is best served with conservative management in the absence of labor, infection, or fetal distress . The conservative management of PPROM consists of the use of antibiotic treatment and antenatal steroid to enhance fetal lung maturity . With or without the presence of labor, it is unclear whether tocolysis of women with PPROM would be efficacious in reducing the consequences of prematurity .The use of tocolytics in women with PPROM is still controversial. Many physicians use tocolytic therapy as a prophylactic measure and others initiate tocolysis only with the onset of contractions. There is also a variety of options for tocolysis: betamimetics, calcium channel blockers, cyclo-oxygenase (COX) inhibitors, oxytocin receptor antagonists and magnesium sulphate . As betamimetis is not available and isn't used in our country and magnesium sulphate is available magnesium sulphate is used widly. The loading dose of magnesium sulphate is IV 4 gm over 20 minutes followed by 1gm/hour for 6 hours The potential benefit from increased latency due to tocolysis must be weighed against the potential harm in increased maternal and perinatal infection, the latter of which can possibly lead to long-term sequelae for the child, including cerebral palsy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with gastational age between 28 weeks and 36 weeks and 6 days who are diagnosed with preterm prelabour rupture of membranes
排除标准
- •clinical suspicion of chorioamnionitis
- •Patients refusal to participate in clinical research.
- •significant vaginal bleeding
- •previous tocolysis use after rupture of membranes
- •nonreassuring fetal heart tracing
- •fetal anomalies
- •significant maternal medical complications, and maternal or fetal indication for delivery
研究组 & 干预措施
Grup 1
Group receive magnesium sulphate IV(4gm loading dose over 20 minutes followed by 1gm /hour for 6 hours
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
Latency period after rupture of membranes
时间窗: Baseline
Measure letancy period between prelabour rupture of membranes and delivery during using magnesium sulphate as a tocolytic and without using magnesium sulphate
次要结局
未报告次要终点
研究者
Ahmed Fathi Abdelraouf
Ahmed Fathi Abdelraouf
Assiut University
