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
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolytic
研究概览
简要总结
An Open-labeled,Non-Comparative Clinical trial to Evaluate the Efficacy and Tolerability of Atosibanin the Preterm Labour.
Phase III
Atosibanis used in the clinical setting for the treatment of preterm labour (PTL) since1981. Atosiban is recommended by the Royal College of Obstetricians andGynecologists as a first line agent in the management of preterm labor. Therationale for Atosiban’s development was based on producing a novel compoundthat mimicked normal physiological processes with high uterine specificity, butwith limited or no systemic effects. The efficacy and safety of Atosiban inclinical trials conducted globally on over 2000 women suggest that Atosiban hasproven benefit in the treatment of PTL and fares better than the availabletocolytics with its distinctive advantage of the least incidence of maternaland fetal side effects.
Considering the importanceof evaluation of treatment success in real-life clinical practice in Indiansetting, the current study was conducted to establish the efficacy and safetyof Atosiban (7.5 mg/ml) in the Indian patient population. A follow-up of allpatients till the time of discharge was conducted wherein the delivery statusand adverse events (if any) after treatment completion were assessed.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women >18 years of age
- •Gestational age between 24 to 34 weeks which has been documented by a definite LMP and sonography up to 20 weeks.
- •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%.
- •Provision of written informed consent.
排除标准
- •Known hypersensitivity to the active substance
- •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
- •Women who are otherwise judged inappropriate for inclusion in the study by the investigator.
结局指标
主要结局
The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolytic
时间窗: The primary outcome in the study is the proportion of women remaining undelivered and not requiring an alternative tocolytic
次要结局
- 1. Proportion of women remaining undelivered at 24 48 and 72 hrs of treatment(2. Proportion of women who did not receive an alternative tocolytic within 48 and 72 hrs)