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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04898192
Other study ID # EC/045/2021/UNBRuzinov
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date August 1, 2022

Study information

Verified date May 2021
Source Comenius University
Contact Peter Musil, PhD.
Phone +421903836788
Email peter.musil@fmed.uniba.sk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is aimed to detect severe fear of delivery and its association with the incidence of obsessive-compulsive disorder and symptoms of depression and anxiety in the population of pregnant women in the third trimester during the serious COVID-19 pandemic situation in Slovakia. Data will be acquired from three departments of gynaecology and obstetrics of University Hospital Bratislava. The majority of pregnancies from the region are managed in this hospital; the total number of deliveries in 2020 achieved 7,835


Description:

The pregnancy is a risk factor for the first manifestation of several mental disorders. Current serious pandemic situation and a constant risk of COVID-19 infection negatively affects the mental state of the population, risk groups of pregnant women in particular. The aim of this project is to discover the incidence of symptoms of depression, anxiety and obsessive-compulsive disorder in association with the fear of delivery in current COVID-19 pandemic conditions in Slovakia. We also decided to add a short tool for detection of domestic violence among other scales to detect the incidence among Slovak pregnant population. All pregnant women in their third trimester who visit the prenatal clinic for their routine weekly check-up will be asked to participate in the study. The questionnaire which comprises of validated mental scales will be handed out to the patients waiting for their examination. After collection of filled questionnaires, those will be later paired with patients' medical documentation and statistically evaluated. The questionnaires will be collected during the period of 1.4.2021-31.3.2022 and statistical analysis will be conducted in the period of 1.4.2022-1.8.2022. It is expected that approximately 1,500 women will be included into the study. All three departments of gynaecology and obstetrics of the University Hospital Bratislava will participate at the study. In total, approximately 7,800 deliveries a year are managed in the University Hospital Bratislava. Following questionnaires are planned to be used in the study: - Wijma Delivery Expectancy/Experience Questionnaire - aimed at fear of delivery - PASS (Perinatal Anxiety Screening Scale) - aimed at anxiety in women before and after delivery - PHQ-9-SK (Patient Health Questionnaire) - aimed at depressive disorder - HITS Domestic Violence Screening Tool - aimed at domestic violence - DOK (The Obsessive-Compulsive Inventory) - aimed at obsessive and compulsive symptoms - GAD-7 (General Anxiety Disorder-7) - aimed at general anxiety disorder - EPDS (Edinburgh Postnatal Depression Scale) - aimed at symptoms of postpartal depression


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date August 1, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnancy after 34th week - Vital fetus Exclusion Criteria: - Unwilling to participate - Age less than 18 years - Foetus mortus or perinatal death of the newborn - Low knowledge of Slovak language - Serious pathology in the pregnancy (e.g. placenta praevia, known congenital disorders)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
questionnaire - the complex of 6 questionnaires aimed to recognize the fear of delivery, perinatal anxiety, depressive disorder, obsessive-compulsive disorder, general anxiety disorder, postpartal depression and domestic violence.

Locations

Country Name City State
Slovakia 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic Bratislava Slovensko

Sponsors (1)

Lead Sponsor Collaborator
Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence and risk factors prevalence and risk factors of depression, anxiety and obsessive-compulsive disorder in the population of pregnant women in association with COVID-19 pandemic situation. 9 months
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