Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Maternal and Newborn Health Clinical Trial

— KIPMAT  

Official title:

Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01757028
• Other study ID #: B9RPET0
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2012
• Last updated: December 18, 2014
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Oxford
• Contact: James A Berkley
• Email: jberkley[@]kemri-wellcome.org
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4600
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Consent refusal

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Maternal and Newborn Health

Locations

Country	Name	City	State
Kenya	Kilifi District Hospital	Kilifi	Coast

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal mortality	Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days).	At delivery and follow up through DHS to 42 days	No
Primary	Perinatal mortality	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	To 7 days post delivery	No
Secondary	Maternal and Newborn long term survival	Follow up to 2 years after delivery	ongoing	No
Secondary	Maternal morbidity	Life threatening events and maternal conditions at delivery	During admission (about 3 days)	No
Secondary	Neonatal morbidity	Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis).	During admission (approx 2 weeks if admitted)	No