CTRI/2020/01/022643已完成不适用
A Prospective, Multicenter, Open-label, Single-arm Study to Assess the Effectiveness andSafety of Isoxsuprine Hydrochloride in Women with Preterm Labor in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- hydrochloride
研究概览
简要总结
This is a post marketing observational study where we intend to find out the effectiveness and safety of Isoxsuprine Hydrochloride patients of preterm labor. This is a multi center PMOS study to be conducted at approx 5 government centers in India.
Participant data collected during the trial afterdeidentification will be made available in the form of publication (text,tables, figures and appendices). Data will be available for anyone who wishesto access the publication.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women ≥18 years old with singleton or twin pregnancy of 24 to 37 weeks of gestation
- •Women with ≥1 contractions per 10 minutes, each lasting for at least 20 seconds with or without cervical dilatation ≤ 4 cm
- •Women willing and able to provide informed consent for participation in the study
- •A woman in whom decision to prescribe isoxsuprine hydrochloride (Duvadilan by Abbott India Limited) (according to the local label) for PTL has been taken by the physician during the routine practice.
排除标准
- •Women with premature rupture of membranes
- •Women with cervical dilatation > 4 cm and /or ≥ 4 contractions per 10 minutes
- •Women with Systolic Blood Pressure <100 and /or Pulse rate >100 Women with heart disease, pre-existing hypotension, and diabetes mellitus
- •Women with short cervix (<25 mm)
- •Women with history of hypersensitivity to tocolysis
- •Women with high-risk pregnancy (history of recent cerebral hemorrhage, antepartum hemorrhage, intrauterine fetal death, lethal fetal anomalies, chorioamnionitis, hydramnios, cervical trauma including surgery like previous cone knife or laser, large loop excision of the transformation zone, radical diathermy).
结局指标
主要结局
hydrochloride
时间窗: At the end of study
Number and percentage of women achieving successful tocolysis (total suppression of
时间窗: At the end of study
labor, i.e., no contractions) at 24 hours and 48 hours of start of therapy with isoxsuprine
时间窗: At the end of study
次要结局
- 1. Safety(a. Number and percentage of women with ADRs, tabulated by system organ class and)
研究者
研究点 (4)
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