Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013622

Trial Description

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Title


The right heart during and after pregnancy - an echocardiographic study

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Trial Acronym

EVA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A lot of lung diseases affect the heart, too - especially the right heart (right atrium and chamber), because this part is pumping blood through the lungs. Well known examples are pulmonary embolism or pulmonary hypertension. Since the left part of the heart has been studied by researchers more than fifty years, the right heart moved into scientifical focus not long ago.
The tool of choice to examine the living heart is echocardiography. There are no relevant risks or complications.
During an echographic examination alot 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, etc.
Since pregnancy changes a lot in the human body, reference values from non pregnant woman of same age are presumably not representative. So we want to establish echocardiographic reference values of the right heart for pregnant women. Therefor an echocardiographic examination will be applied within each Trimenon and after delivery.

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Brief Summary in Scientific Language

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

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Organizational Data

  •   DRKS00013622
  •   2017/12/28
  •   [---]*
  •   yes
  •   Approved
  •   130/17, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   O00-O99 -  Pregnancy, childbirth and the puerperium
  •   Standard values for cardiac ultrasound in pregnancy
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Interventions/Observational Groups

  •   healthy pregnant women with suspected healthy fetus will get one echokardiography examination each trimenon and one after delivery
  •   non healthy women with suspected healthy or unhealthy fetus will get one echokardiography examination each trimenon and one after delivery
  •   healthy or non healthy pregnant women with suspected non healthy fetus will get one echokardiography examination each trimenon and one after delivery
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Historical, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

significant change of echocardiographic parameters of the right heart during pregnancy (enddiastolic size of ventricle (basal, mid-cavity, longitudinal, RV wall thickness), atrium endsystolic area, RV outflow distal and profile: Acceleration time AccT and AccT/RVET, RIMP, tricuspidal Flow: E/A & E/E', TAPSE, S', sPAP, VCI + sniff test to estimate CVP) in each Trimenon and after delivery.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/11/02
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

pregnant, older than 18 years

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Exclusion Criteria

too poor quality of echocardiographic results, acute illness, requiring instant treatment

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Addresses

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    • Universität Giessen und Marburg Standort Giessen
    • Klinikstrasse 33
    • 35392  Giessen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universität Giessen und Marburg Standort Giessen Abteilung für Gynäkologie und Geburtshilfe
    • Mr.  Dr. med.  Frank  Oehmke 
    • Klinikstrasse 33
    • 35392  Giessen
    • Germany
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    • Universität Giessen und Marburg Standort Giessen
    • Mr.  PD Dr. med. Dr.   Henning  Gall 
    • Klinikstrasse 33
    • 35392  Giessen
    • Germany
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    • Universität Giessen und Marburg Standort Giessen
    • Mr.  Gero  Bunniger 
    • Klinikstrasse 33
    • 35392  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Gießen und Marburg, Standort Gießen
    • Mr.  Prof. Dr. med.  Werner  Seeger 
    • Klinikstraße 33
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
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* This entry means the parameter is not applicable or has not been set.