Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers

NCT05216848 | Completed

• 1 other identifier: EC/188/2021/UNBRuzinov
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Serious Concerns

Keywords

fear of childbirth; Wijma Delivery Expectancy Questionnaire

Outcome Measures

Primary Outcomes (1)

• Significant fear of childbirth

  Identifying the level of fear of childbirth in pregnancy by using a most widely used tool Wijma Delivery Expectancy Questionnaire

  15 minutes

Study Arms (2)

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; 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

Other: Wijma Delivery Expectancy Questionnaire; Other: Clinical data collection

Interventions

Wijma Delivery Expectancy Questionnaire OTHER

Simple questionaire identifying the level of fear of childbirth in pregnancy

multiparas with no existing complications in the third trimester; nulliparas with no existing complications in the third trimester

Clinical data collection OTHER

Collection of the standard clinical data during hospitalization

multiparas with no existing complications in the third trimester; nulliparas with no existing complications in the third trimester

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: primipara giving birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Comenius University: lead

Study Sites (1)

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

Bratislava, Slovak Republic, 83232, Slovakia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: September 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: March 30, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)