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

February 28, 2022 updated by: Dr. Silvia Oddo, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pregnant women either with risk of with no risk of preterm birth from the obstetric ward or from the antenatal class of the obstetric department and their partners

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preterm birth/ Timely birth
Women/men

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stress
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

Goethe University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Louwen/Oddo-Preterm birth

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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