CTRI/2013/11/004166已完成3 期
An Open-labeled, Non - comparative Clinical trial to evaluate the Efficacy and Tolerability of Atosiban in the Preterm Labour
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Women >18 years of age
- •2. Gestational age between 24 to 34 weeks which has been documented by a definite LMP and sonography up to 20 weeks.
- •3. Women with 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%.
- •4. Provision of written informed consent
排除标准
- •1. Known hypersensitivity to the active substance
- •2. Women with any of the following:
- •a.Chorioamnionitis
- •b.Preterm rupture of membranes
- •c.Vaginal bleeding
- •d.Severe hypertensive disorders
- •e.Intrauterine growth restriction ( < 5th percentile).
- •f.Non-reassuring fetal heart rate
- •g.Maternal contraindications
- •i.Chronic hypertension
- •ii. Systolic blood pressure < 90 mmHg
- •iii.Cardiovascular disease
- •iv. Elevated hepatic enzymes
- •h.Congenital or acquired uterine malformation
- •3. Women who are otherwise judged inappropriate for inclusion in the study by the investigator.
研究者
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