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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Oxford
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01757028
First received: November 28, 2012
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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
Maternal and Newborn Health

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Maternal mortality [ Time Frame: At delivery and follow up through DHS to 42 days ] [ Designated as safety issue: No ]
    Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days).

  • Perinatal mortality [ Time Frame: To 7 days post delivery ] [ Designated as safety issue: No ]
    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:
  • Maternal and Newborn long term survival [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    Follow up to 2 years after delivery

  • Maternal morbidity [ Time Frame: During admission (about 3 days) ] [ Designated as safety issue: No ]
    Life threatening events and maternal conditions at delivery

  • Neonatal morbidity [ Time Frame: During admission (approx 2 weeks if admitted) ] [ Designated as safety issue: No ]
    Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis).


Biospecimen Retention:   Samples With DNA

Cord blood Maternal blood


Estimated Enrollment: 4600
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757028

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

Locations
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

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01757028     History of Changes
Other Study ID Numbers: B9RPET0
Study First Received: November 28, 2012
Last Updated: December 20, 2012
Health Authority: Kenya: Ethical Review Committee

Keywords provided by University of Oxford:
Maternal and newborn health
Africa

ClinicalTrials.gov processed this record on November 27, 2014