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

NCT ID: NCT01974531

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Birth Pregnancy Stress Psychological Distress

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm birth/ Timely birth

No interventions assigned to this group

Women/men

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goethe University

OTHER

Sponsor Role collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Silvia Oddo

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Louwen, Prof.

Role: STUDY_DIRECTOR

University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine

Locations

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University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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Sommerlad S, Schermelleh-Engel K, La Rosa VL, Louwen F, Oddo-Sommerfeld S. Trait anxiety and unplanned delivery mode enhance the risk for childbirth-related post-traumatic stress disorder symptoms in women with and without risk of preterm birth: A multi sample path analysis. PLoS One. 2021 Aug 31;16(8):e0256681. doi: 10.1371/journal.pone.0256681. eCollection 2021.

Reference Type DERIVED
PMID: 34464408 (View on PubMed)

Other Identifiers

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Louwen/Oddo-Preterm birth

Identifier Type: -

Identifier Source: org_study_id

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