Clinical trial NCT01757028: Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates
Official title: Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maternal and Newborn Health
Keywords: Maternal and newborn health
Africa
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2012-12-28
Enrollment: 4600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya

Exclusion Criteria:

* Consent refusal

Primary outcomes:
measure: Maternal mortality
timeFrame: At delivery and follow up through DHS to 42 days
measure: Perinatal mortality
timeFrame: To 7 days post delivery
Secondary outcomes:
measure: Maternal and Newborn long term survival
timeFrame: ongoing
measure: Maternal morbidity
timeFrame: During admission (about 3 days)
measure: Neonatal morbidity
timeFrame: During admission (approx 2 weeks if admitted)
Other outcomes:
Locations:
city: Kilifi
country: Kenya
facility: Kilifi District Hospital
state: Coast
Study officials:
References: