Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya

NCT ID: NCT03411993

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 612 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2018-03-12

Brief 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. 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

Conditions

Cardiac Disease; Pregnancy Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Focused cardiac echography

All pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• pregnant women at any gestational age
• capable to give informed consent

Exclusion Criteria

• medically unstable: any condition or complication resulting from or independent of pregnancy that necessitates urgent care or that precludes full and informed consent process

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Moi Teaching and Referral Hospital

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, New York

OTHER

Sponsor Role: collaborator

Moi University

OTHER

Sponsor Role: lead

Responsible Party

Astrid Christoffersen-Deb

Visiting Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Snelgrove, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Moi Teaching and Referral Hospital

Eldoret, , Kenya

Countries

Kenya

Other Identifiers

UMoi4

Identifier Type: -

Identifier Source: org_study_id