Anxiety State Clinical Trial
— CAASP2Official title:
COVID-19-associated Anxiety of Pregnant Women for Anomalies, Stillbirth and Preterm Labor-2
| NCT number | NCT05172076 |
| Other study ID # | 2021-228 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2022 |
| Est. completion date | July 31, 2023 |
| Verified date | November 2023 |
| Source | Martin-Luther-Universität Halle-Wittenberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Capture of anxiety for anomalies, stillbirth and preterm labor of pregnant women during COVID-19 pandemia
| Status | Completed |
| Enrollment | 276 |
| Est. completion date | July 31, 2023 |
| Est. primary completion date | July 31, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - consenting ability Exclusion Criteria: - language barrier - uncompleted questionary |
| Country | Name | City | State |
|---|---|---|---|
| Germany | KH St.Elisabeth und St.Barbara | Halle | Sachsen Anhalt |
| Germany | University Hospital of Halle | Halle | Saxony Anhalt |
| Lead Sponsor | Collaborator |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 months | |
| Primary | 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 | 6 months | |
| Primary | 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 | 6 months |
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