CClinicalTrials.gg
Status unknownNCT04898192COTEPSUpdated May 26, 2021

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

An observational study in Pregnant Woman, sponsored by Comenius University. Status unknown at 1 site in Slovakia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Comenius University · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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
02

Conditions studied

  • Pregnant Woman

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Keywords

  • mental state
  • pregnancy
  • COVID
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Comenius University is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Pregnancy after 34th week
  • Vital fetus

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • Otherquestionnaire

    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.

06

What researchers measure

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.

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
    Bratislava, Slovensko 83232, Slovakia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04898192
Lead sponsor
Comenius University
Responsible party
Peter Musil (head of project centre Faculty of Medicine, Comenius University) — Principal investigator
First posted
May 24, 2021
Start date
Apr 1, 2021
Primary completion
Mar 31, 2022 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
May 26, 2021

Study contacts

Peter Musil, PhD.
Contact
peter.musil@fmed.uniba.sk
+421903836788
Jozef Zahumensky, prof. MD
study chair · Comenius University in Bratislava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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