Using Ongoing Newborn Intervention Trials to Obtain Additional Data Critical to Maternal, Fetal and Newborn Health in a Harmonized Way: The AMANHI* Study *Alliance for Maternal and Newborn Health Improvement (AMANHI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,258
- 试验地点
- 1
- 主要终点
- Burden of maternal and neonatal death and still births
研究概览
简要总结
The goal of this study is to generate unique information to guide improvements on interventions to reduce maternal and newborn mortality as well as prevent stillbirths.
The objective of this study is to determine the burden, timing, and causes of maternal deaths, stillbirths and neonatal deaths.
This will be an observational study where data will be collected retrospectively in the context of the ongoing study in Haryana, India.
Women of reproductive age living in the study area have already been enumerated for the parent studies. Active surveillance is being conducted for identifying pregnancies and deaths among women of reproductive age in the population through 3 monthly home visitations.
Verbal autopsies will be conducted for all deaths of women in the reproductive age, including those who died in pregnancy, childbirth and up to 42-60 days after childbirth. Verbal autopsy interviews will also be conducted for all stillbirths.
详细描述
RATIONAL & BACKGROUND INFORMATION
Among the Millennium Development Goals, those that aim to reach significant reductions in maternal and child mortality have been proving the hardest to achieve.
Most maternal and neonatal deaths are caused by a few conditions, and majority of them are preventable with currently available, effective interventions. About a third of stillbirths occur in the intrapartum period, integrally related to the availability and quality of essential and emergency childbirth services. Effective interventions to reduce maternal deaths, stillbirths and newborn and child deaths reach less than half the pregnant women, mothers, newborns and children who need them. Information on mortality and morbidity as well as health care delivery is largely available only from surveys, which have inherent methodological issues that limit validity. Vital registration information and reliable information from the health system is missing in the same countries where the burden of mortality is the highest and health care is least accessible. This leads to underestimates of the magnitude of the problem with negative implications for the prioritization of interventions to scale-up.
The BMGF and WHO are supporting a set of large intervention trials that will follow cohorts of pregnant women and newborns to document the impact of the interventions. These trials provide a unique opportunity to address additional questions relevant for improving maternal, newborn and child health (MNCH) programs and for addressing the above-mentioned gaps in data.
STUDY GOALS AND OBJECTIVES Goal
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All deaths
排除标准
- •Non consent for verbal autopsy
- •All deaths of women in reproductive age group and all still births in specified window period for whom the respondents have given consent to provide information.
结局指标
主要结局
Burden of maternal and neonatal death and still births
时间窗: 2 years
The parent study is already collecting information on the burden, timing and causes of neonatal deaths and an estimate of maternal deaths and still births. The proposed additional study presents a unique opportunity to estimate population-based burden, timing, and causes of maternal deaths and stillbirths.
Timing of maternal and neonatal death and still births
时间窗: 2 Years
The parent study is already collecting information on the burden, timing and causes of neonatal deaths and an estimate of maternal deaths and still births. The proposed additional study presents a unique opportunity to estimate population-based burden, timing, and causes of maternal deaths and stillbirths.
Causes of maternal and neonatal death and still births
时间窗: 2 Years
The parent study is already collecting information on the burden, timing and causes of neonatal deaths and an estimate of maternal deaths and still births. The proposed additional study presents a unique opportunity to estimate population-based burden, timing, and causes of maternal deaths and stillbirths.
次要结局
未报告次要终点