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临床试验/NCT05134688
NCT05134688尚未招募不适用

Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes

Assiut University0 个研究点目标入组 124 人开始时间: 2024年7月30日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Fathi Abdelraouf

Ahmed Fathi Abdelraouf

Assiut University

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