Global Network for Women's and Children's Health Research Maternal Newborn Health Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 950,000
- 试验地点
- 15
- 主要终点
- Maternal mortality rate
研究概览
简要总结
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.
详细描述
The purpose of the Global Network for Women's and Children's Health Research is to develop and test feasible, sustainable interventions to improve the outcome of women and children and to develop research capacity in resource-poor settings. Because most of the sites have weak health care systems, unacceptably high rates of maternal and neonatal mortality and lack birth and death registries, they lack precise data on outcomes and measures of care. Information from a vital registry system will allow the Global Network to document maternal and neonatal mortality, design trials to address the major causes of poor outcome, assess the outcome of our interventions, and ultimately disseminate the results as the basis of public health policy.
A sub-study to the Maternal Newborn Health Registry will be conducted to understand the prevalence of COVID-19 among pregnant women, the association between COVID-19 and pregnancy outcomes, and the Knowledge, Attitudes, and Practices of pregnant women related to COVID-19 and its prevention during pregnancy. Women who consent to participation in the MNHR COVID sub-study will provide a blood specimen at or near delivery to be tested for COVID-19 antibodies. Four Global Network sites (Guatemala, Bangladesh, Nagpur India and Pakistan) will also collect and analyze blood specimen from participants during antenatal care visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community-level
- •Appropriate for long-term registry data collection and the conduct of ongoing Global Network research
- •At least 300 deliveries per year
- •Participant-level
- •Pregnant women intending to deliver within study cluster
- •Women who deliver within the study cluster
- •Women who reside in the community but are transferred for care at delivery
排除标准
- •Participant-level
- •Opt out of consent to include data in the study
结局指标
主要结局
Maternal mortality rate
时间窗: 42 days post delivery
Maternal mortality rate by site and cluster
Stillbirth rate
时间窗: Delivery
Stillbirth rate by site and cluster
Early neonatal mortality rate
时间窗: 28 days post delivery
ENM by site and by cluster
次要结局
- Peri-partum and postpartum depression(At delivery and 6 weeks post-partum)
- Prevalence of COVID-19 antibody positive results during pregnancy(At 12-14 week antenatal care visit, at delivery or 14 days after)
- Fetal/neonatal outcomes (spontaneous abortion, stillbirth, birth weight (g), and fetal growth restriction, early (7-day) and late (28-day) neonatal death, cause of death, congenital infections, and malformations) associated with COVID-19 positivity(At delivery, 7 days post delivery and 28 days post delivery)
- Cause of maternal death at less than or equal to 42 days(42 days post delivery)
- Cause of neonatal death at less than or equal to 28 days(28 days post delivery)
- Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity(At delivery, 42 days post delivery)
- Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy(At the 12-14 week Antenatal Care visit)