Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers (RiskfSBC)
April 28, 2023 updated by: Comenius University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Slovak Republic
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Bratislava, Slovak Republic, Slovakia, 83232
- 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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
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 (for multipara)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 |
Simple questionaire identifying the level of fear of childbirth in pregnancy
Collection of the standard clinical data during hospitalization
|
|
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 |
Simple questionaire identifying the level of fear of childbirth in pregnancy
Collection of the standard clinical data during hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
March 30, 2023
Study Registration Dates
First Submitted
January 19, 2022
First Submitted That Met QC Criteria
January 19, 2022
First Posted (Actual)
February 1, 2022
Study Record Updates
Last Update Posted (Actual)
May 1, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EC/188/2021/UNBRuzinov
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.