NCT00641784终止3 期
A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin
MemorialCare1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
研究概览
简要总结
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (>4 uterine contractions in 20 minutes):
- •Cervix > 2 cm in dilation or 80% effaced
- •Positive fetal fibronectin (if performed).
- •Demonstrated cervical change between two exams within 90 minutes.
排除标准
- •Negative fetal fibronectin
- •> 5cm dilatation
- •Multiple gestations
- •Known fetal anomalies or chromosomal abnormalities
- •Ruptured membranes
- •Significant vaginal bleeding
- •Suspected chorioamnionitis
- •Preeclampsia or uncontrolled hypertension
- •Non-reassuring fetal heart tracing
- •Placenta previa and/or accreta
- •Placenta abruption
- •Intrauterine growth restriction
- •Maternal renal disease
- •Underlying maternal cardiac condition
- •Symptomatic hyperthyroidism
- •Significant maternal disease
- •Contraindication to nifedipine or magnesium
- •Cerclage presence
- •Tocolytic use within the last 12 hours
- •Hypotension (defined as average blood pressure of <70/40's unresponsive to 1000 cc fluid bolus
研究组 & 干预措施
1
Experimental
Oral Nifedine
干预措施: Nifedlipine (Drug)
2
Active Comparator
Intravenous Magnesium
干预措施: Magnesium (Drug)
结局指标
主要结局
In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures
时间窗: At delivery
次要结局
- To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.(At Delivery)
- To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.(At delivery)
- To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis(At discharge)
研究者
研究点 (1)
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