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Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates (KIPMAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01757028
Recruitment Status : Unknown
Verified December 2014 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : December 28, 2012
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of Oxford

Study Description
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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
Maternal and Newborn Health

Study Design
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Study Type : Observational
Estimated 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 : January 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Maternal mortality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: ongoing ]
    Follow up to 2 years after delivery

  2. Maternal morbidity [ Time Frame: During admission (about 3 days) ]
    Life threatening events and maternal conditions at delivery

  3. Neonatal morbidity [ Time Frame: During admission (approx 2 weeks if admitted) ]
    Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis).


Biospecimen Retention:   Samples With DNA
Cord blood Maternal blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Consent refusal
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757028


Contacts
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Contact: James A Berkley jberkley@kemri-wellcome.org
Contact: Anna C Seale aseale@kemri-wellcome.org

Locations
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Kenya
Kilifi District Hospital Recruiting
Kilifi, Coast, Kenya
Principal Investigator: James A Berkley         
Principal Investigator: Anna C Seale         
Sponsors and Collaborators
University of Oxford
Bill and Melinda Gates Foundation
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01757028    
Other Study ID Numbers: B9RPET0
First Posted: December 28, 2012    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by University of Oxford:
Maternal and newborn health
Africa