The Right Heart During and After Pregnancy - an Echocardiographic Study
NCT ID: NCT03402971
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2017-11-02
2024-11-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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healthy pregnant+healthy fetus
healthy pregnant women with suspected healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery
echocardiography
echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.
non healthy pregnant
non healthy women with suspected healthy or unhealthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery
echocardiography
echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.
non healthy fetus
healthy or non healthy pregnant women with suspected non healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery
echocardiography
echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.
Interventions
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echocardiography
echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18years or older
Exclusion Criteria
* poor or none sonographic results
18 Years
FEMALE
No
Sponsors
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Gero Bunniger
OTHER
Responsible Party
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Gero Bunniger
MD
Principal Investigators
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Henning Gall, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Pulmology, Department of pulmonal Hypertension
Locations
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University of Gießen
Giessen, Hesse, Germany
Countries
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Central Contacts
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Other Identifiers
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130/17
Identifier Type: -
Identifier Source: org_study_id
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