Trial document




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  DRKS00004216

Trial Description

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Title

Yolk Sac Screening Trial for Detecting Fetal Aneuploidies at Very Early Pregnancy

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Trial Acronym

YoSST

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URL of the Trial

http://www.yolk-sac.org

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Brief Summary in Lay Language

The yolk sac is the first structure in a pregnancy visible by ultrasound and could serve as a predictor for chromosomal abnormalities. It is the aim of the study to evaluate the yolk sac size for healthy and chromosomal affected fetuses. Derived from the distribution of the frequency of occurrence, it should be examined whether the yolk sac is suitable for using as a screening test parameter. It is expected that the frequency of occurence of healthy fetuses is distributed in a gaussian curve around the normal value, whereas aneuploidies show aswell smaller as larger diameters. The ratio of the frequency of healthy fetueses to the frequency of affected ones could be used for a novel screening method.

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Brief Summary in Scientific Language

This study examines the distribution of the frequency of occurrence of healthy fetuses and those with aneuploidy depending on the ultrasonographically measured yolk sac size at early pregnancy. The hypothesis is, abnormal yolk sac size could serve as a predictor for chromosomal abnormalities.

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Organizational Data

  •   DRKS00004216
  •   2012/09/11
  •   [---]*
  •   yes
  •   Approved
  •   S-240/2010, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   Q99.9 -  Chromosomal abnormality, unspecified
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Interventions/Observational Groups

  •   Sonographical estimation of the yolk sac diameter, the crown-rump-length; aswell as measuring the blood serum concentration of PAPP-A in the maternal blood; karyotyping in case of miscarriage or abortion
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Sonographical estimation of the yolk sac diameter according to the crown-rump-length, aswell as validating the blood serum concentration of PAPP-A in the maternal blood and observing the fetal outcome - in case of miscarriage by karyotyping - in case of abortion by cartyotyping - in case of live birth clinically for unconspicious examination U2

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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 
  • Doctor's Practice 
  • Doctor's Practice 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Planned
  •   2013/01/01
  •   11543
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Pregant woman at age 18 or older after given consent

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Exclusion Criteria

Crown-rump-length > 84mm

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Addresses

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Medizinische Hochschule Hannover, Abteilung für Frauenheilkunde und Geburtshilfe
    • Mr.  PD Dr. med  Peter  Schmidt 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Abteilung für Frauenheilkunde und Geburtshilfe
    • Mr.  PD Dr. med  Peter  Schmidt 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.