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CompletedNCT04568551CAASPUpdated Dec 28, 2021

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

An observational study in Anxiety State, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-28.

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
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

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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 300 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.

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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
300 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 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 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 with different empiric studies of anxiety for preterm labour in pandemics

    Time frame: 6 months

07

Study locations

1 site
  • University Hospital of Halle
    Halle, Saxony Anhalt 06120, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04568551
Lead sponsor
Martin-Luther-Universität Halle-Wittenberg
Responsible party
Marcus Riemer, MD (Dr. med. Marcus Riemer, Martin-Luther-Universität Halle-Wittenberg) — Principal investigator
First posted
Sep 29, 2020
Start date
Oct 30, 2020
Primary completion
Mar 31, 2021
Completion
Jul 31, 2021
Last update
Dec 28, 2021

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 Dec 2021. You cannot join it, but the record below documents what was studied.

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