Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03029117 |
| Other study ID # |
12345 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 19, 2017 |
| Last updated |
January 25, 2017 |
| Start date |
February 1, 2016 |
| Est. completion date |
December 1, 2016 |
Study information
| Verified date |
January 2017 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females
between corrected and uncorrected rheumatic valve lesions
Description:
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
