Clinical trial NCT03411993: Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya
Official title: Prevalence of Rheumatic Heart Disease in Pregnancy Among a Population of Antenatal Patients at a Tertiary Care Institution in Western Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Pregnancy Related
Lead sponsor: Moi University
Sponsor class: OTHER
Collaborators: name: Moi Teaching and Referral Hospital
name: Mount Sinai Hospital, Canada
name: Duke University
name: Mount Sinai Hospital, New York
First posted: 2018-01-26
Enrollment: 612
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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

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

Primary outcomes:
measure: Cardiac disease
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
Study officials:
affiliation: University of Toronto
name: John Snelgrove, MD
role: PRINCIPAL_INVESTIGATOR
References: