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Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

NCT01757028 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4600

Last updated 2014-12-19

No results posted yet for this study

Summary

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.

Conditions

  • Maternal and Newborn Health

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of Oxford

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757028 on ClinicalTrials.gov