Maternal and Newborn HealthKIPMATNCT01757028
Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates
An observational study of Maternal and Newborn Health, run by University of Oxford at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal and Newborn Health
- How many people
- 4,600 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
Who may be able to join
- All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
Who cannot join
- Consent refusal
Trial locations and contacts
1 site in 1 country.
James A Berkley contact
Anna C Seale contact
Kenya1 site, 1 recruiting
- Recruiting
Kilifi District Hospital
Kilifi, Coast
James A Berkley
Anna C Seale
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal mortality
Determine the effects of risk factors and obstetric events on maternal deaths (to 42 days).
Measured: 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
Measured: To 7 days post delivery
Secondary outcomes (3)
Maternal and Newborn long term survival
Follow up to 2 years after delivery
Measured: ongoing
Maternal morbidity
Life threatening events and maternal conditions at delivery
Measured: During admission (about 3 days)
Neonatal morbidity
Neonatal morbidity in terms of admission to the paediatric ward (and diagnosis).
Measured: During admission (approx 2 weeks if admitted)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal and Newborn HealthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757028
- Sponsor's protocol ID
- B9RPET0
- Acronym
- KIPMAT
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2012
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Severe Morbidity and Mortality in Mothers and Neonates
- ClinicalTrials.gov ID
- NCT01757028
- Acronym / sponsor ID
- KIPMAT / B9RPET0
- Conditions
- Maternal and Newborn Health
- Keywords
- Maternal and newborn health, Africa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,600 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
Key inclusion criteria (1 listed)
- All mothers admitted for delivery at Kilifi District Hospital (KDH), Kilifi, Kenya
Key exclusion criteria (1 listed)
- Consent refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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
3 secondary outcomes
Maternal and Newborn long term survival
Time frame: ongoing
Maternal morbidity
Time frame: During admission (about 3 days)
Neonatal morbidity
Time frame: During admission (approx 2 weeks if admitted)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Berkley contact
Anna C Seale contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal and Newborn Health, run by University of Oxford at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Berkley (jberkley@kemri-wellcome.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal mortality (time frame: At delivery and follow up through DHS to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.