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Trial record 3 of 1660 for:    Valve | "Heart Diseases"

Effect of Rheumatic Heart Disease on Maternal and Fetal Outcomes

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ClinicalTrials.gov Identifier: NCT03029117
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Armia Michael, Assiut University

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

Condition or disease Intervention/treatment
Rheumatic; Heart Disease, Maternal, Affecting Fetus Procedure: correction of 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 .

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


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Prospective Cohort Study Compares Effect of Corrected and Uncorrected Rheumatic Heart Valve of Pregnant Women on Maternal and Fetal Outcomes
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016


Group/Cohort Intervention/treatment
corrected and uncorrected rheumatic valve lesions Procedure: correction of rheumatic valve lesions



Primary Outcome Measures :
  1. maternal morbidity [ Time Frame: 40 days after delivery ]
    compare maternal morbidity between corrected and uncorrected valve lesions in pregnant women


Secondary Outcome Measures :
  1. Fetal outcome [ Time Frame: 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
pregnant females with rheumatic heart disease come for antenatal care at out patient clinic at tertiary obstetric center
Criteria

Inclusion Criteria:

  • pregnant females with rheumatic heart disease

Exclusion Criteria:

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

Additional Information:

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Responsible Party: Armia Michael, resident physician, Assiut University
ClinicalTrials.gov Identifier: NCT03029117     History of Changes
Other Study ID Numbers: 12345
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Armia Michael, Assiut University:
rheumatic pregnancy

Additional relevant MeSH terms:
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Heart Diseases
Rheumatic Diseases
Rheumatic Heart Disease
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections