COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor (CAASP)

COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor - CAASPtrial

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

Study Overview

• Status: Completed
• Conditions: Anxiety State

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Germany
  • Saxony Anhalt
    • Halle, Saxony Anhalt, Germany, 06120
      • University Hospital of Halle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability 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

Description

Inclusion Criteria:

• consenting ability

Exclusion Criteria:

• language barrier
• uncompleted questionary

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2020
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): July 31, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (ACTUAL): September 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 25, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Death; Fetal Death; Anxiety Disorders; Obstetric Labor, Premature; Stillbirth
• Other Study ID Numbers: UKGEB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No