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OpenTrials
Completed

NCT Number: NCT03411993

Prevalence of Rheumatic Heart Disease Among Pregnant Women in 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Moi Teaching and Referral Hospital

Eldoret, 30100, Kenya

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focused cardiac echography

Diagnostic Test

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

Primary outcomes

  1. Cardiac disease

    Time frame: through study completion, an average of 3 months

    Point prevalence of cardiac lesions identifiable by cardiac echo

Sponsors and collaborators

Lead sponsor

Moi University

Other

Collaborators

  • Duke University
  • Moi Teaching and Referral Hospital
  • Mount Sinai Hospital, Canada
  • Mount Sinai Hospital, New York

Registry information

Official study title

Prevalence of Rheumatic Heart Disease in Pregnancy Among a Population of Antenatal Patients at a Tertiary Care Institution in Western Kenya

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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