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

COTEPS: Monitoring of Incidence of Mental Discomfort in the Population of Pregnant Women in the Third Trimester During the Serious COVID-19 Pandemic Conditions

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

Study Overview

• Status: Recruiting
• Conditions: Pregnant Woman
• Intervention / Treatment: Other: questionnaire

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Peter Musil, PhD.; Phone Number: +421903836788; Email: peter.musil@fmed.uniba.sk

Study Locations

• Slovakia
  • Slovensko
    • Bratislava, Slovensko, Slovakia, 83232
      • Recruiting
      • 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
      • Contact: Petra Psenkova, MD; Phone Number: +421907629336; Email: petrapsenkova@gmail.com
      • Contact: Jozef Zahumensky, prof. MD; Email: jozef.zahumensky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Comenius University
• Investigators: Study Chair: Jozef Zahumensky, prof. MD, Comenius University in Bratislava

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; COVID; mental state
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EC/045/2021/UNBRuzinov

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No