Psychological Distress & Stress in Parents With Preterm i... | NCT01974531

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

NCT01974531

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Preterm Birth
Pregnancy
Stress
Psychological Distress

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Jan 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Oct 28, 2013

First Submission Date that Met QC Criteria

Oct 28, 2013

First Posted Date

Nov 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 2, 2022Actual

Name	Class
Goethe University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Measure	Description	Time Frame
stress		two years

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Louwen, Prof.	University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine		Frankfurt am Main	Hesse	60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34464408	Derived	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.

Label	Type	Description	Intervention Names
Preterm birth/ Timely birth
Women/men

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications