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

December 18, 2014 updated by: University of Oxford
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

4600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Coast
      • Kilifi, Coast, Kenya
        • Recruiting
        • Kilifi District Hospital
        • Principal Investigator:
          • James A Berkley
        • Principal Investigator:
          • Anna C Seale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Consent refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At delivery and follow up through DHS to 42 days
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
To 7 days post delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Bill and Melinda Gates Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B9RPET0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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