NCT04568551

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

September 24, 2020

Last Update Submit

December 25, 2021

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 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 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 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 (1)

University Hospital of Halle

Halle, Saxony-Anhalt, 06120, Germany

Location

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
Dr. med. Marcus Riemer

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 29, 2020

Study Start

October 30, 2020

Primary Completion

March 31, 2021

Study Completion

July 31, 2021

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

DE(1)