NCT00599898已完成4 期
Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.
Raed Salim1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- delaying labor
研究概览
简要总结
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
- •All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:
- •Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
- •Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
- •Provision of written informed consent
排除标准
- •Chorioamnionitis
- •Preterm rupture of membranes
- •Vaginal bleeding
- •Major fetal malformations
- •Severe hypertensive disorders
- •Intrauterine growth restriction (< 5th percentile).
- •Non-reassuring fetal heart rate
- •Maternal contraindications
- •Chronic hypertension
- •Systolic blood pressure < 90 mmHg
- •Cardiovascular disease
- •Elevated hepatic enzymes
- •Congenital or acquired uterine malformation
研究组 & 干预措施
1
Experimental
干预措施: Atosiban (Drug)
2
Experimental
干预措施: Nifedipine (Drug)
结局指标
主要结局
delaying labor
时间窗: for more than 48 hours after starting treatment
次要结局
- drugs side effects(within the first 48 hours after treatment)
- obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)(within 24 hours after delivery)
- neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)(within 30 days from delivery)
研究者
Raed Salim
MD
HaEmek Medical Center, Israel
研究点 (1)
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