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Clinical Trials/NCT03029117
NCT03029117CompletedNot Applicable

Prospective Cohort Study Compares Effect of Corrected and Uncorrected Rheumatic Heart Valve of Pregnant Women on Maternal and Fetal Outcomes

Assiut University0 sites125 target enrollmentStarted: February 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
125
Primary Endpoint
maternal morbidity

Study Overview

Brief Summary

It's prospective Cohort study to compare maternal and fetal outcomes in pregnant females between corrected and uncorrected rheumatic valve lesions

Detailed 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 .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • pregnant females with rheumatic heart disease

Exclusion Criteria

  • other heart diseases ( cardiomyopathy , myocardial infarction ...etc.

Outcomes

Primary Outcomes

maternal morbidity

Time Frame: 40 days after delivery

compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women

Secondary Outcomes

  • Fetal outcome(first 1 day after delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Armia Michael

resident physician

Assiut University

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