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CompletedNCT05172076CAASP2Updated Nov 29, 2023

COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2

An observational study in Anxiety State, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 2 sites in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Martin-Luther-Universität Halle-Wittenberg · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
276
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

03

In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

This study's enrollment of 276 is above the median of 125 across 85 observational studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Inclusion criteria

  • consenting ability

Exclusion criteria

Exclusion Criteria:

  • language barrier
  • uncompleted questionary
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
276 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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

    Time frame: 6 months

07

Study locations

2 sites
  • KH St.Elisabeth und St.Barbara
    Halle, Sachsen Anhalt 06110, Germany
  • University Hospital of Halle
    Halle, Saxony Anhalt 06120, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05172076
Lead sponsor
Martin-Luther-Universität Halle-Wittenberg
Responsible party
Marcus Riemer, MD (Principal Investigator, Martin-Luther-Universität Halle-Wittenberg) — Principal investigator
First posted
Dec 29, 2021
Start date
Jan 1, 2022
Primary completion
Jul 31, 2022
Completion
Jul 31, 2023
Last update
Nov 29, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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