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
- 试验地点
- 14
- 主要终点
- 1. Proportion of women remaining undelivered at 72hrs after start of atosiban treatment
研究概览
简要总结
Aim & Objectives
The aim of this study is to establish efficacy, safety and tolerability of atosiban in treatment of preterm labor.
Primary Objective
- The primary objective is to evaluate the efficacy of atosiban in delaying impending preterm birth
Secondary Objective
- To evaluate the safety and tolerability of atosiban in Indian women
Study Design:
Prospective, Open-label, Multicentric, Non-comparative study
Study Outcomes:
Primary outcome:
**1.**Proportion of women remaining undelivered at 72 hrs after start of atosiban treatment
-
Evaluation of time gained in utero after initiation of treatment
-
Percentage reduction in uterine contractions from baseline
-
Proportion of women re-treated with atosiban
-
Proportion of women re-treated with alternative tocolytic agent
Secondary outcomes:
**1.**Proportion of maternal and fetal adverse events reported during the study period
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
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.
结局指标
主要结局
1. Proportion of women remaining undelivered at 72hrs after start of atosiban treatment
时间窗: till the time of delivery
2. Evaluation of time gained in utero after initiation of treatment
时间窗: till the time of delivery
3. Percentage reduction in uterine contractions from baseline
时间窗: till the time of delivery
4. Proportion of women re-treated with atosiban
时间窗: till the time of delivery
5. Proportion of women re-treated with alternative tocolytic agent
时间窗: till the time of delivery
次要结局
- 1. Proportion of maternal and fetal adverse events reported during the study period(till the time of delivery)