Serious ConcernsRiskfSBCNCT05216848
Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers
An observational study of Serious Concerns, run by Comenius University at 1 site in Slovakia.
Trial summary
The aim of this study is to determine the prevalence of significant concerns about childbirth and their impact on the course and outcome of childbirth. By identifying a group of mothers who have an excessive fear of childbirth, the occurrence of surgical births can be influenced by the right intervention. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Serious Concerns
- What is being tested?
- Wijma Delivery Expectancy Questionnaire and Clinical data collection
- How many people
- 700 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Sep 2019to 30 Mar 2023
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Total 700 nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years
Who may be able to join
- The investigators involve every nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years
Who cannot join
- unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language, previous Caesarean section (for multipara)
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
Bratislava, Slovak Republic, 83232
About this study
The aim of this study is to determine the prevalence of significant concerns about childbirth and their impact on the course and outcome of childbirth. By identifying a group of mothers who have an excessive fear of childbirth, the occurrence of surgical births can be influenced by the right intervention.
Read the detailed description
The fear of childbirth is one of the most common mental health concerns during pregnancy. Elevated levels of anxiety during childbirth may lead to increased risk of elective caesarean section or prolonged labour. About 80% of pregnant women suffer from certain kind of childbirth fear. The most commonly used tool for assessment and diagnosis of childbirth fear is Wijma Delivery Expectance Questionnaire (WDEQ). This questionnaire has been translated and validated into several languages. In 2020 the Slovak version of the questionnaire was validated. All women who completed antenatal counseling at 36 weeks of gestation were included in the cohort. A slovak version of questionnaire was issued to all women and the results were recorded in the protocol. Subsequently, demographic data, medical facts and childbirth outcome were added from the medical documentation. The results of the birth were compared with the results of the questionnaire.
- Conditions
- Serious Concerns
- Being tested
- Wijma Delivery Expectancy Questionnaire, Clinical data collection
- Keywords
- fear of childbirth, Wijma Delivery Expectancy Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wijma Delivery Expectancy QuestionnaireOther
Simple questionaire identifying the level of fear of childbirth in pregnancy
Clinical data collectionOther
Collection of the standard clinical data during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| nulliparas with no existing complications in the third trimester | The investigators involve every nullipara giving birth in a period of two years.
Exclusion criteria: unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language Receives: Other: Wijma Delivery Expectancy Questionnaire; Other: Clinical data collection | |
| multiparas with no existing complications in the third trimester | The investigators involve every multipara giving birth in a period of two years.
Exclusion criteria: unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language, previous caesarean section Receives: Other: Wijma Delivery Expectancy Questionnaire; Other: Clinical data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant fear of childbirth
Identifying the level of fear of childbirth in pregnancy by using a most widely used tool Wijma Delivery Expectancy Questionnaire
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Sep 2019
- Primary completion1 Dec 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious ConcernsStudies 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216848
- Sponsor's protocol ID
- EC/188/2021/UNBRuzinov
- Acronym
- RiskfSBC
- Status last verified
- Apr 2023
- First submitted
- 19 Jan 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers
- ClinicalTrials.gov ID
- NCT05216848
- Acronym / sponsor ID
- RiskfSBC / EC/188/2021/UNBRuzinov
- Conditions
- Serious Concerns
- Keywords
- fear of childbirth, Wijma Delivery Expectancy Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 1 Feb 2022 (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.
The aim of this study is to determine the prevalence of significant concerns about childbirth and their impact on the course and outcome of childbirth. By identifying a group of mothers who have an excessive fear of childbirth, the occurrence of surgical births can be influenced by the right intervention.
Detailed description
The fear of childbirth is one of the most common mental health concerns during pregnancy. Elevated levels of anxiety during childbirth may lead to increased risk of elective caesarean section or prolonged labour. About 80% of pregnant women suffer from certain kind of childbirth fear. The most commonly used tool for assessment and diagnosis of childbirth fear is Wijma Delivery Expectance Questionnaire (WDEQ). This questionnaire has been translated and validated into several languages. In 2020 the Slovak version of the questionnaire was validated. All women who completed antenatal counseling at 36 weeks of gestation were included in the cohort. A slovak version of questionnaire was issued to all women and the results were recorded in the protocol. Subsequently, demographic data, medical facts and childbirth outcome were added from the medical documentation. The results of the birth were compared with the results of the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nulliparas with no existing complications in the third trimester | – | Other: Wijma Delivery Expectancy Questionnaire, Other: Clinical data collectionThe investigators involve every nullipara giving birth in a period of two years. Exclusion criteria: unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language |
| multiparas with no existing complications in the third trimester | – | Other: Wijma Delivery Expectancy Questionnaire, Other: Clinical data collectionThe investigators involve every multipara giving birth in a period of two years. Exclusion criteria: unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language, previous caesarean section |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Total 700 nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years
Key inclusion criteria (1 listed)
- The investigators involve every nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years
Key exclusion criteria (1 listed)
- unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language, previous Caesarean section (for multipara)
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 |
|---|---|---|
| Wijma Delivery Expectancy QuestionnaireSimple questionaire identifying the level of fear of childbirth in pregnancy | Other | multiparas with no existing complications in the third trimester, nulliparas with no existing complications in the third trimester |
| Clinical data collectionCollection of the standard clinical data during hospitalization | Other | multiparas with no existing complications in the third trimester, nulliparas with no existing complications in the third trimester |
Primary outcome
Significant fear of childbirth
Time frame: 15 minutes
Identifying the level of fear of childbirth in pregnancy by using a most widely used tool Wijma Delivery Expectancy Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Serious Concerns, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant fear of childbirth (time frame: 15 minutes). 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 1 May 2023.