CTRI/2017/03/008065已完成4 期
An Open-Label, Non - Comparative Phase-IV Study to Evaluate the Efficacy and Safety of Atosiban 7.5 mg/ml in Preterm Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 440
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 from 24 until 33 completed weeks which has been documented by a definite LMP or sonography in the first trimester
- •3.Women with preterm labor. The diagnosis of preterm labor requires the presence of >= 4 uterine contractions over 30 minutes, each lasting at least 30 seconds, and documented cervical change. Criteria for cervical changes are defined as follows:
- •a.Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 3 cm and effacement of at least 50%
- •b.Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 3 cm and effacement of at least 50%.
排除标准
- •1.Women with any of the following:
- •a.Chorioamnionitis
- •b.Preterm rupture of membranes
- •c.Vaginal bleeding
- •d.Eclampsia and severe pre-eclampsia requiring delivery
- •e.Intrauterine growth restriction
- •f.Intrauterine fetal death
- •g.Congenital or acquired uterine malformation
- •h.Severe placental insufficiency
- •i.Placenta previa and abruptio placentae
- •2.Fetal distress
- •3.Women who are otherwise judged inappropriate for inclusion in the study by the investigator.
研究者
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