Monitoring of Incidence of Mental Discomfort in Pregnant Women During the Serious COVID-19 Pandemic Conditions

NCT04898192 | Unknown

• 1 other identifier: EC/045/2021/UNBRuzinov
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pregnant Woman

Keywords

mental state; pregnancy; COVID

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women in her third trimester who attend regular prenatal check-ups

You may qualify if:

• Pregnancy after 34th week
• Vital fetus

You may not qualify if:

• 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)

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic

Bratislava, Slovensko, 83232, Slovakia

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jozef Zahumensky, prof. MD

  Comenius University in Bratislava

  STUDY CHAIR

Central Study Contacts

Peter Musil, PhD.

CONTACT

+421903836788; peter.musil@fmed.uniba.sk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of project centre Faculty of Medicine

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 24, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: August 1, 2022
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

SL (1)