Cardiac DiseaseNCT03411993
Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya
An observational study of Cardiac Disease and Pregnancy Related, run by Moi University at 1 site in Kenya.
Trial summary
There is currently no routine screening for cardiac disease for pregnant women in areas of high prevalence. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Pregnancy Related
- What is being tested?
- Focused cardiac echography
- How many people
- 612 participants
- Where
- 1 siteKenya
- Study dates
- 31 Jan 2018to 12 Mar 2018
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant women attending the antenatal clinic at Moi Teaching and Referral Hospital. This clinic serves approximately 750 women per month. These women draw from urban, peri-urban and rural areas. As this is a public hospital, income and education levels are low.
Who may be able to join
- pregnant women at any gestational age
- capable to give informed consent
Who cannot join
- medically unstable: any condition or complication resulting from or independent of pregnancy that necessitates urgent care or that precludes full and informed consent process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Rheumatic Heart Disease in Pregnancy Among a Population of Antenatal Patients at a Tertiary Care Institution in Western Kenya
There is currently no routine screening for cardiac disease for pregnant women in areas of high prevalence. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.
Read the detailed description
Rheumatic heart disease (RHD) in pregnancy can be associated with severe maternal and neonatal morbidity and mortality. Early identification of these women and referral to specialized, multi-disciplinary care is essential. Overall, studies on RHD prevalence are lacking in sub-Saharan countries and a significant gap in the literature exists for the prospective assessment of disease in the context of pregnancy. At Moi Teaching and Referral Hospital, there are an estimated 3-4 cases per month of women presenting with acute exacerbations of either known or newly diagnosed cardiac disease. These women are often the most challenging clinically and emotionally for the reproductive health team to manage, and contribute to a significant number of the 2-3 maternal deaths per month at MTRH. There is currently no routine screening for cardiac disease in the MTRH antenatal clinics. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to: 1. Use focused echocardiography as a screening tool to evaluate cardiac structure and function; 2. Use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.; 3. Determine the proportion of pregnant women with cardiac disease who endorse clinical symptoms as a potential means to develop a screening tool; 4. Promote a case-finding culture for cardiac disease in pregnancy
- Conditions
- Cardiac Disease, Pregnancy Related
- Being tested
- Focused cardiac echography
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused cardiac echographyDiagnostic test
All pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac disease
Point prevalence of cardiac lesions identifiable by cardiac echo
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start31 Jan 2018
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital, Mount Sinai Hospital, Canada, Duke University, Mount Sinai Hospital, New York
- Responsible party
- Principal investigator, Astrid Christoffersen-Deb, Moi University
- Investigators
- John Snelgrove, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411993
- Sponsor's protocol ID
- UMoi4
- Status last verified
- Jul 2018
- First submitted
- 17 Jan 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Rheumatic Heart Disease in Pregnancy Among a Population of Antenatal Patients at a Tertiary Care Institution in Western Kenya
- ClinicalTrials.gov ID
- NCT03411993
- Acronym / sponsor ID
- UMoi4
- Conditions
- Cardiac Disease, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- Moi Teaching and Referral Hospital, Mount Sinai Hospital, Canada, Duke University, Mount Sinai Hospital, New York
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 26 Jan 2018 (actual)
- 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.
There is currently no routine screening for cardiac disease for pregnant women in areas of high prevalence. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.
Detailed description
Rheumatic heart disease (RHD) in pregnancy can be associated with severe maternal and neonatal morbidity and mortality. Early identification of these women and referral to specialized, multi-disciplinary care is essential. Overall, studies on RHD prevalence are lacking in sub-Saharan countries and a significant gap in the literature exists for the prospective assessment of disease in the context of pregnancy. At Moi Teaching and Referral Hospital, there are an estimated 3-4 cases per month of women presenting with acute exacerbations of either known or newly diagnosed cardiac disease. These women are often the most challenging clinically and emotionally for the reproductive health team to manage, and contribute to a significant number of the 2-3 maternal deaths per month at MTRH. There is currently no routine screening for cardiac disease in the MTRH antenatal clinics. This study will aim to determine the point prevalence of cardiac disease in women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to: 1. Use focused echocardiography as a screening tool to evaluate cardiac structure and function; 2. Use focused echocardiography as a screening tool to determine the prevalence of cardiac disease among pregnant women attending MTRH antenatal clinic.; 3. Determine the proportion of pregnant women with cardiac disease who endorse clinical symptoms as a potential means to develop a screening tool; 4. Promote a case-finding culture for cardiac disease in pregnancy
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant women attending the antenatal clinic at Moi Teaching and Referral Hospital. This clinic serves approximately 750 women per month. These women draw from urban, peri-urban and rural areas. As this is a public hospital, income and education levels are low.
Key inclusion criteria (2 listed)
- pregnant women at any gestational age
- capable to give informed consent
Key exclusion criteria (1 listed)
- medically unstable: any condition or complication resulting from or independent of pregnancy that necessitates urgent care or that precludes full and informed consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused cardiac echographyAll pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease | Diagnostic test | – |
Primary outcome
Cardiac disease
Time frame: through study completion, an average of 3 months
Point prevalence of cardiac lesions identifiable by cardiac echo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Individual participant dataSharing planned: No
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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.
John Snelgrove, MD principal investigator
University of Toronto
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 Cardiac Disease and Pregnancy Related, run by Moi University 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 2 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: finished, as of the sponsor's last update on 27 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac disease (time frame: through study completion, an average of 3 months). 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 27 Jul 2018.