KIPMAT: Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Sponsor
University of Oxford (Other)
Overall Status
Unknown status
CT.gov ID
NCT01757028
Collaborator
Bill and Melinda Gates Foundation (Other)
4,600
1
71
64.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4600 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates
    Study Start Date :
    Jan 1, 2010
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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

    1. Maternal and Newborn long term survival [ongoing]

      Follow up to 2 years after delivery

    2. Maternal morbidity [During admission (about 3 days)]

      Life threatening events and maternal conditions at delivery

    3. Neonatal morbidity [During admission (approx 2 weeks if admitted)]

      Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
    Exclusion Criteria:
    • Consent refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kilifi District Hospital Kilifi Coast Kenya

    Sponsors and Collaborators

    • University of Oxford
    • Bill and Melinda Gates Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT01757028
    Other Study ID Numbers:
    • B9RPET0
    First Posted:
    Dec 28, 2012
    Last Update Posted:
    Dec 19, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by University of Oxford

    Study Results

    No Results Posted as of Dec 19, 2014