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临床试验/NCT01757028
NCT01757028Unknown不适用

Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

University of Oxford1 个研究点 分布在 1 个国家目标入组 4,600 人开始时间: 2010年1月最近更新:
适应症

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

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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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