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临床试验/NCT01869582
NCT01869582已完成不适用

Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide

Helse Stavanger HF4 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20,000
试验地点
4
主要终点
Perinatal Mortality

研究概览

简要总结

Safer Births is a research and development collaboration to establish new knowledge and new innovative products to better equip and increase competence of health workers for safer births and increased newborn survival worldwide.

The main objectives are:

To randomize different devices for fetal heart rate assessments. To assess if a novel Newborn Resuscitation Monitor will facilitate newborn resuscitation in a low-resource setting. To determine bag mask ventilation treatment and devices beneficial for neonatal outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Randomizing fetal heart rate assessment: Singleton delivery, Term gestation age, Cephalic presentation, Fetal heart rate normal, Cervical dilatation ≤7cm, Consent to participate
  • Randomizing bag mask ventilation: infants in need of positive pressure ventilation, Consent to participate

排除标准

  • Randomizing fetal heart rate assessment: Placenta abruption/praevia, Ruptured uterus, Morbid Obesity

结局指标

主要结局

Perinatal Mortality

时间窗: From start of labour to 7 days postpartum

Death during or shortly following birth

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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