Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,020
- 试验地点
- 4
- 主要终点
- Number of cases of maternal death or severe morbidity
研究概览
简要总结
The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of adverse outcomes is high. The Investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. The resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.
详细描述
This is a prospective multi-country cohort study of up to 15,000 women admitted to the hospital for delivery or for management of respiratory infection. Women will be recruited and screened for study participation at the time of presentation to the hospital. Participants will be assessed through hospitalization, labor, delivery, and discharge and at 1- and 6-week postpartum contacts. Liveborn infants will be enrolled at birth and followed through 42 days of life. The pilot phase of this protocol will enroll up to 500 women in labor and their newborns and follow them through labor, delivery, and 42 days postpartum.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of cases of maternal death or severe morbidity
时间窗: enrollment - 42 days postpartum
Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection
Number of cases of neonatal death or severe morbidity
时间窗: enrollment - 42 days postpartum
Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis
次要结局
未报告次要终点