Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

• Conditions: Maternal and Newborn Health

• Registration Number: NCT01757028
• Lead Sponsor: University of Oxford

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 4600

Inclusion Criteria

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

Exclusion Criteria

• Consent refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal mortality	At delivery and follow up through DHS to 42 days	Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days).
Perinatal mortality	To 7 days post delivery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kilifi District Hospital; 🇰🇪 Kilifi, Coast, Kenya