Safer Births - New Knowledge and Innovations to Decrease Perinatal Mortality and Morbidity Worldwide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20,000
- 试验地点
- 2
- 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
- 否
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
研究组 & 干预措施
Doppler, Fetal heart rate
Eligible women in labour randomized to intermittent fetal heart rate assessments using a wind-up, hand-held Doppler
干预措施: Doppler, Fetal heart rate (Device)
Fetoscope, Fetal heart rate
Eligible women in labour randomized to intermittent fetal heart rate assessments using a Pinard fetoscope, which is the current standard management
干预措施: Fetoscope, Fetal heart rate (Device)
Upright Resuscitator, Resuscitation
Non-breathing newborn infants in need of positive pressure ventilation randomized to an Upright Resuscitator
干预措施: Upright Resuscitator, Resuscitation (Device)
Standard Resuscitator, Resuscitation
Non-breathing newborn infants in need of positive pressure ventilation randomized to a standard horizontal Resuscitator, which is the current standard management
干预措施: Standard Resuscitator, Resuscitation (Device)
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