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Clinical Trials/NCT01974531
NCT01974531
Completed
Not Applicable

Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study on Risk and Protective Psychobiological Aspects

Johann Wolfgang Goethe University Hospital1 site in 1 country400 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Johann Wolfgang Goethe University Hospital
Enrollment
400
Locations
1
Primary Endpoint
stress
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Silvia Oddo

PhD

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

Inclusion Criteria

  • pregnant women and their partners from the 24th week of gestation on
  • 18 years of age

Exclusion Criteria

  • psychiatric, mainly psychotic diseases
  • drug abuse
  • severe neurological disorders
  • stillbirth

Outcomes

Primary Outcomes

stress

Time Frame: two years

Study Sites (1)

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