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- Ensayo clínico NCT03029117
Effect of Rheumatic Heart Disease on Maternal and Fetal Outcomes
Prospective Cohort Study Compares Effect of Corrected and Uncorrected Rheumatic Heart Valve of Pregnant Women on Maternal and Fetal Outcomes
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Heart disease is one of the most important medical complications during pregnancy as it is one of the common, indirect obstetric causes of maternal death. Approximately 1% of pregnancies are complicated by cardiac disease .
Rheumatic heart disease (RHD) is the most common acquired heart disease in pregnancy RHD is a chronic acquired heart disorder resulting from acute rheumatic fever. In developing countries, RHD continues to be a major cause of cardiac morbidity and mortality especially among young adult females In pregnancies complicated with cardiac disorders, maternal and perinatal mortality and morbidity depend on the type of disorder, the functional status of the patient and the complications associated with the pregnancy.
Mitral stenosis is the most common valvular lesion in women with rheumatic heart disease, remains the most common acquired valvular lesion in pregnant women and the most common cause of maternal death from cardiac causes .
Although mortality is not high in women, the rate of fetal morbidity rises with the severity of mitral stenosis from 14% in pregnant patients with mild mitral stenosis , to 28% in women with moderate mitral stenosis and 33% in pregnant patients with severe mitral stenosis (area <1.5 CM2).
In the second and third trimesters, when maternal blood volume and cardiac output peak, heart failure may occur in pregnant women with moderate or severe mitral stenosis, even in previously asymptomatic women .
The rates of prematurity in fetus of women with rheumatic heart diseases are 20% to 30%, fetal growth restriction 5% to 20%, and stillbirth (1% to 3%).
The advancement in cardiology and obstetrics has provided major improvements in the management of pregnant patients with cardiac disorders. Now we are facing more women with previous history of surgical correction of rheumatic heart disease.
Vaginal delivery is considered In women with mild mitral stenosis, and in patients with moderate mitral stenosis ,. Even in women with severe MS in whom symptoms are New York Heart Association (NYHA) Class I-II without pulmonary hypertension, vaginal delivery is considered Cesarean section may be preferred in patients with severe mitral stenosis with NYHA Class III-IV symptoms, or who have pulmonary hypertension despite medical therapy.
Therapeutic options for in women with rheumatic heart disease include both medical and surgical alternatives, as well as catheter-based interventions The choice dependent on the degree of valvular affection and patient symptoms. There are few studies that compare the Maternal and fetal outcomes in women with rheumatic heart disease between patient with corrected and uncorrected valve lesions
Tipo de estudio
Inscripción (Anticipado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- pregnant females with rheumatic heart disease
Exclusion Criteria:
- other heart diseases ( cardiomyopathy , myocardial infarction ...etc.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
corrected and uncorrected rheumatic valve lesions
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
maternal morbidity
Periodo de tiempo: 40 days after delivery
|
compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women
|
40 days after delivery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fetal outcome
Periodo de tiempo: first 1 day after delivery
|
compare birth weight and need for admission at neonatal intensive care unit (NICU) between corrected and uncorrected valve lesions in pregnant women
|
first 1 day after delivery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12345 (Danish Center for Healthcare Improvements)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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