Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 4,600
- 试验地点
- 1
- 主要终点
- Maternal mortality
研究概览
简要总结
Improving maternal and infant mortality are key priorities in Kenya and internationally. This study aims to establish a hospital-based surveillance system for pregnant women so that the contribution of risk factors (HIV and other infections, maternal nutrition, sepsis, malaria and anaemia) to maternal and infant morbidity and mortality can be accurately assessed. All mothers who are admitted to Kilifi District Hospital will be invited to enrol in the study. Routine clinical data from maternal admissions for delivery will be systematically collected using a standardised admissions procedure. Analysis will be carried out for the risk factor effects of HIV, maternal nutrition, malaria infection, bacterial infection, and anaemia on maternal and infant outcomes after adjusting for other factors (mode of delivery, age, and parity etc). Subsequent morbidity and survival of mothers and infants, and the later consequences to children's health will be monitored through the Kilifi epi-DSS. Samples for research purposes will be collected for detailed future studies of particular pathogens and risk factors, such as malaria parasite strain, bacterial species and HIV-induced immunological impairment. This will be the first prospective study in sub-Saharan Africa (sSA) to assess the effect of these risk factors on both maternal and infant health together, and that considers both short and long term outcomes. Information generated by the study will be used by the maternity department in a rolling audit that will help improve care. The study will therefore improve care of new mothers and infants attending the Kilifi District Hospital as well as informing health planning so that future interventions for maternal and child health are targeted more effectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
排除标准
- •Consent refusal
结局指标
主要结局
Maternal mortality
时间窗: At delivery and follow up through DHS to 42 days
Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days).
Perinatal mortality
时间窗: To 7 days post delivery
Determine the effects of risk factors and obstetric events on perinatal mortality (stillbirth and deaths to 7 days of life); infant mortality to 60 days
次要结局
- Maternal morbidity(During admission (about 3 days))
- Maternal and Newborn long term survival(ongoing)
- Neonatal morbidity(During admission (approx 2 weeks if admitted))
