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Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01974531
Collaborator
Goethe University (Other)
400
Enrollment
1
Location
83
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    400 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study on Risk and Protective Psychobiological Aspects
    Actual Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2019
    Actual Study Completion Date :
    Dec 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Preterm birth/ Timely birth
    Women/men

    Outcome Measures

    Primary Outcome Measures

    1. stress [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine Frankfurt Hessen Germany 60590

    Sponsors and Collaborators

    • Johann Wolfgang Goethe University Hospital
    • Goethe University

    Investigators

    • Study Director: Frank Louwen, Prof., University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Silvia Oddo, PhD, Johann Wolfgang Goethe University Hospital
    ClinicalTrials.gov Identifier:
    NCT01974531
    Other Study ID Numbers:
    • Louwen/Oddo-Preterm birth
    First Posted:
    Nov 1, 2013
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Mar 2, 2022