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NCT01974531 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01974531
Other study ID # Louwen/Oddo-Preterm birth
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date December 2019

Study information
Verified date February 2022
Source Johann Wolfgang Goethe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date December 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine Frankfurt Hessen

Sponsors (2)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospital Goethe University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary stress two years
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