Trial document





This trial has been registered retrospectively.
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  DRKS00005741

Trial Description

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Title

STrain and support in Early Pregnancy: Onward Neonatal Epigenetic effects (STEP ONE)

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Trial Acronym

STEP ONE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We will study pregnant women that decide for amniocentesis. At the time of amniocentesis, we assess strain and support of the participants. When the human genetic investigations are finished, we will study epigenetic features using cultivated cells that are no longer needed for diagnostic purposes. Also, we will measure stress hormones and trophic hormones in the amniotic fluid. At birth, we will re-assess the epigenetic features in cord blood. In extreme groups, we will assess the influence of strain and support on epigenetic features of the child.

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Brief Summary in Scientific Language

We will investigate in amniotic fluid of women undergoing amniocentesis for medical reasons DNA methylation in cultivated amniotic cells, steroid hormones, BDNF, IGF-I. Also, we assess with questionnaires and interview: support, stress, psychological features, social situation. At birth, we will sample cord blood for the investigation of epigenetic features.

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Organizational Data

  •   DRKS00005741
  •   2014/02/21
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  •   yes
  •   Approved
  •   2013-621N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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

  •   Pregnant women undergoing amniocentesis due to medical reasons
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Interventions/Observational Groups

  •   There will be no intervention. We will compare extreme groups with regard to perceived stress, psychopathology and social stressors. The dependent variable is the methylation of the infant's DNA in amniotic cells as well as cells of the cord blood.
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Characteristics

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

Relationship between strain, psychological features and social support of the pregnant women (measured with questionnaires and interview) and epigenetic features of the infant (DNA methylation in cells of amniotic fluid and cord blood).

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/12/19
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

pregnant women, amniocentesis for medical reasons

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Exclusion Criteria

severe genetic findings, severe disability of the child, insufficient german language, impaired ability to consent, multiples

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. (apl) Dr. med.  Michael  Deuschle 
    • J5
    • 68159  Mannheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/30
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Trial Publications, Results and other Documents

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