Anxiety StateCAASPNCT04568551
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor
An observational study of Anxiety State, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
Capture of anxiety for anomalies, stillbirth and preterm Labor of pregnant women during COVID-19 pandemia Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety State
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 30 Oct 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- consenting ability
Who cannot join
- language barrier
- uncompleted questionary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Anxiety State
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start30 Oct 2020
- Primary completion31 Mar 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Riemer, MD, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568551
- Sponsor's protocol ID
- UKGEB001
- Acronym
- CAASP
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2020
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor - CAASPtrial
- ClinicalTrials.gov ID
- NCT04568551
- Acronym / sponsor ID
- CAASP / UKGEB001
- Conditions
- Anxiety State
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Capture of anxiety for anomalies, stillbirth and preterm Labor of pregnant women during COVID-19 pandemia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- consenting ability
Key exclusion criteria (2 listed)
- language barrier
- uncompleted questionary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
Time frame: 6 months
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
anxiety for stillbirths during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
Time frame: 6 months
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
anxiety for preterm labour during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire)
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety State, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety for anomalies during COVID-19-pandemic and before (percentage difference in agreement to the items of the questionnaire) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.