Pregnant WomanCOTEPSNCT04898192
Monitoring of Incidence of Mental Discomfort in Pregnant Women During the Serious COVID-19 Pandemic Conditions
An observational study of Pregnant Woman, run by Comenius University at 1 site in Slovakia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Woman
- What is being tested?
- questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Apr 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant women in her third trimester who attend regular prenatal check-ups
Who may be able to join
- Pregnancy after 34th week
- Vital fetus
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
Bratislava, Slovensko, 83232
Petra Psenkova, MD, +421907629336, petrapsenkova@gmail.com
Jozef Zahumensky, prof. MD, jozef.zahumensky@gmail.com
About this study
Official title: 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
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
- Conditions
- Pregnant Woman
- Being tested
- questionnaire
- Keywords
- mental state, pregnancy, COVID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Musil, Comenius University
- Investigators
- Jozef Zahumensky, prof. MD, Study chair, Comenius University in Bratislava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898192
- Sponsor's protocol ID
- EC/045/2021/UNBRuzinov
- Acronym
- COTEPS
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COTEPS: Monitoring of Incidence of Mental Discomfort in the Population of Pregnant Women in the Third Trimester During the Serious COVID-19 Pandemic Conditions
- ClinicalTrials.gov ID
- NCT04898192
- Acronym / sponsor ID
- COTEPS / EC/045/2021/UNBRuzinov
- Conditions
- Pregnant Woman
- Keywords
- mental state, pregnancy, COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women in her third trimester who attend regular prenatal check-ups
Key inclusion criteria (2 listed)
- Pregnancy after 34th week
- Vital fetus
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaire - 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. | Other | – |
Primary outcome
prevalence and risk factors
Time frame: 9 months
prevalence and risk factors of depression, anxiety and obsessive-compulsive disorder in the population of pregnant women in association with COVID-19 pandemic situation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jozef Zahumensky, prof. MD study chair
Comenius University in Bratislava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Woman, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Musil, PhD. (+421903836788, peter.musil@fmed.uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and risk factors (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.