The Right Heart During and After Pregnancy - an Echocardiographic Study (EVA)

Gero Bunniger

Status: Enrolling

Conditions: Pregnancy Related

Treatments: Diagnostic Test: echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT03402971

130/17

Details and patient eligibility

About

The main goal is to establish echocardiographic reference values of the right heart for pregnant women, assuming they differ significantly from those of non pregnant women of same age.

Therefore the investigators will use existing reference values published by American society of echocardiography and European Association of Echocardiography. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.

Full description

A lot of lung diseases affect the heart, too - especially the right heart. Well known examples are pulmonary embolism or pulmonary hypertension. But rather unknown is the fact, that right heart function presents as a prognostic parameter in a lot of (left heart) diseases, for example myocardial infarction, atrial fibrillation, left heart failure, but also in chronic obstructive pulmonary disease (COPD) or may be even diabetes mellitus. Since the left part of the heart has been studied by researchers more than fifty years, the right heart has moved into scientific focus not long ago.

The tool of choice to examine the living heart is echocardiography. There are no relevant risks or complications.

During an echocardiographic examination a lot of parameters are collected. To judge data in a clinical way reference values belonging to healthy persons are essential. Those values are highly dependant on sex, body size, age etc.

Since pregnancy changes a lot in the human body, reference values from non pregnant woman of same age (published by American society of echocardiography and European Association of Echocardiography) are presumably not representative. So the investigators want to establish echocardiographic reference values of the right heart for pregnant women. Therefore an echocardiographic examination will be applied within each trimester of pregnancy and after delivery. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pregnant
• 18years or older

Exclusion criteria

• acute illness demanding instant therapy
• poor or none sonographic results

Trial design

1,000 participants in 3 patient groups

healthy pregnant+healthy fetus

Description:

healthy pregnant women with suspected healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery

Treatment:

Diagnostic Test: echocardiography

non healthy pregnant

Description:

non healthy women with suspected healthy or unhealthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery

Treatment:

Diagnostic Test: echocardiography

non healthy fetus

Description:

healthy or non healthy pregnant women with suspected non healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery

Treatment:

Diagnostic Test: echocardiography