Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates (KIPMAT)
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.
Maternal and Newborn Health
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates|
- Maternal mortality [ Time Frame: At delivery and follow up through DHS to 42 days ] [ Designated as safety issue: No ]Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days).
- Perinatal mortality [ Time Frame: To 7 days post delivery ] [ Designated as safety issue: No ]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
- Maternal and Newborn long term survival [ Time Frame: ongoing ] [ Designated as safety issue: No ]Follow up to 2 years after delivery
- Maternal morbidity [ Time Frame: During admission (about 3 days) ] [ Designated as safety issue: No ]Life threatening events and maternal conditions at delivery
- Neonatal morbidity [ Time Frame: During admission (approx 2 weeks if admitted) ] [ Designated as safety issue: No ]Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis).
Biospecimen Retention: Samples With DNA
Cord blood Maternal blood
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757028
|Contact: James A Berkleyemail@example.com|
|Contact: Anna C Sealefirstname.lastname@example.org|
|Kilifi District Hospital||Recruiting|
|Kilifi, Coast, Kenya|
|Principal Investigator: James A Berkley|
|Principal Investigator: Anna C Seale|