Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Conditions
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Maternal and Newborn Health

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya Exclusion Criteria: Consent refusal
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal mortality | Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days). | At delivery and follow up through DHS to 42 days | 
| Perinatal mortality | 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 | To 7 days post delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and Newborn long term survival | Follow up to 2 years after delivery | ongoing | 
| Maternal morbidity | Life threatening events and maternal conditions at delivery | During admission (about 3 days) | 
| Neonatal morbidity | Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis). | During admission (approx 2 weeks if admitted) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal and newborn health, Africa