Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Cardiac Disease
• Intervention / Treatment: Diagnostic test: Focused cardiac echography

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 Type: Observational
• Enrollment (Actual): 612

Contacts and Locations

Study Locations

• Kenya
  • Eldoret, Kenya, 30100
    • Moi Teaching and Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac disease	Point prevalence of cardiac lesions identifiable by cardiac echo	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Moi University
• Collaborators: Duke University; Mount Sinai Hospital, Canada; Mount Sinai Hospital, New York; Moi Teaching and Referral Hospital
• Investigators: Principal Investigator: John Snelgrove, MD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Actual): March 12, 2018
• Study Completion (Actual): March 12, 2018

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Fever; Heart Diseases; Rheumatic Heart Disease
• Other Study ID Numbers: UMoi4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No