Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

NCT01757028 | Unknown

• 1 other identifier: B9RPET0
• Study Type: observational
• Target: 4,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal and Newborn Health

Keywords

Maternal and newborn health; Africa

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Maternal and Newborn long term survival

  ongoing

• Maternal morbidity

  During admission (about 3 days)

• Neonatal morbidity

  During admission (approx 2 weeks if admitted)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Consent refusal

Sponsors & Collaborators

• University of Oxford: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Kilifi District Hospital

Kilifi, Coast, Kenya

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cord blood Maternal blood

Central Study Contacts

James A Berkley

CONTACT

jberkley@kemri-wellcome.org

Anna C Seale

CONTACT

aseale@kemri-wellcome.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 28, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

KE (1)