CTRI/2020/01/022643已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Women =18 years old with singleton or twin pregnancy of 24 to 37 weeks of gestation
- •2. Women with =1 contractions per 10 minutes, each lasting for at least 20 seconds with or
- •without cervical dilatation = 4 cm
- •3. Women willing and able to provide informed consent for participation in the study
- •4. 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
- •1. Women with premature rupture of membranes
- •2. Women with cervical dilatation > 4 cm and /or = 4 contractions per 10 minutes
- •3. Women with Systolic Blood Pressure <100 and /or Pulse rate >100 Women with heart
- •disease, pre-existing hypotension, and diabetes mellitus
- •4. Women with short cervix ( <25 mm)
- •5. Women with history of hypersensitivity to tocolysis
- •6. 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)
研究者
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