title: Embedding surveillance into clinical care to detect serious adverse events in pregnancy.
abstract: Severe maternal complications in pregnancy in sub-Saharan Africa contribute to high maternal mortality and morbidity. Incidence data on severe maternal complications, life-threatening conditions, maternal deaths and birth outcomes are essential for clinical audit and to inform trial design of the types and frequency of expected severe adverse events (SAEs). However, such data are very limited, especially in sub-Saharan Africa. We set up standardized, systematic clinical surveillance embedded into routine clinical care in a rural county hospital in Kenya. Pregnant women and newborns are systematically assessed and investigated. Data are reported using a standardized Maternal Admission Record that forms both the hospital's clinical record and the data collection tool. Integrating clinical surveillance with routine clinical care is feasible and should be expanded in sub-Saharan Africa, both for improving clinical practice and as a basis for intervention studies to reduce maternal and newborn mortality and morbidity where rates are highest.
authors.affiliation: KEMRI-Wellcome Trust Programme, Kilifi, Kenya; Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom. Electronic address: aseale@nhs.net.
authors.forename: Anna C
authors.initials: AC
authors.lastname: Seale
authors.affiliation: KEMRI-Wellcome Trust Programme, Kilifi, Kenya.
authors.forename: Hellen C
authors.initials: HC
authors.lastname: Barsosio
authors.affiliation: KEMRI-Wellcome Trust Programme, Kilifi, Kenya.
authors.forename: Angela C
authors.initials: AC
authors.lastname: Koech
authors.affiliation: KEMRI-Wellcome Trust Programme, Kilifi, Kenya; Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom.
authors.forename: James A
authors.initials: JA
authors.lastname: Berkley
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007231:Infant, Newborn; D007630:Kenya; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology* / Q000473:pathology; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: Surveillance maternal pregnancy vaccine