NCT05172076

Brief Summary

Capture of anxiety for anomalies, stillbirth and preterm labor of pregnant women during COVID-19 pandemia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

December 25, 2021

Last Update Submit

November 28, 2023

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (3)

  • anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)

    Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison (cut-off values) with different empiric studies of anxiety for anomalies in pandemics

    6 months

  • anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)

    Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison (cut-off values) with different empiric studies of anxiety for stillbirths in pandemics

    6 months

  • anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)

    Measurement of self-reported anxiety by a questionnaire and State-Trait Anxiety Inventory (STAI) and comparison (cut-off values) with different empiric studies of anxiety for preterm labour in pandemics

    6 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women between 33 until 37 weeks of gestations with planned labor in University Hospital of Halle or St.Elisabeth and St.Barbara Hospital Halle, Germany

You may qualify if:

  • consenting ability

You may not qualify if:

  • language barrier
  • uncompleted questionary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KH St.Elisabeth und St.Barbara

Halle, Saxony-Anhalt, 06110, Germany

Location

University Hospital of Halle

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2021

First Posted

December 29, 2021

Study Start

January 1, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

DE(2)