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

  • Slovakia
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 83232
        • 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic

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
Other: Wijma Delivery Expectancy Questionnaire
Simple questionaire identifying the level of fear of childbirth in pregnancy
Other: Clinical data collection
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
Other: Wijma Delivery Expectancy Questionnaire
Simple questionaire identifying the level of fear of childbirth in pregnancy
Other: Clinical data collection
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

Comenius University

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

Keywords

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.

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