EPIDURAL- Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia (EPIDURAL)

Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia

The aim of this research project is to anonymously survey pregnant patients before the anaesthesiological consultation about their prior knowledge of planned neuroaxial procedures in the context of childbirth by conducting an online survey and to evaluate the sources of that information.

Study Overview

• Status: Recruiting
• Conditions: Neuroaxial Analgesia Procedures
• Intervention / Treatment: Behavioral: Preliminary information on neuroaxial procedures

Detailed Description

Within labour and delivery, neuroaxial anaesthesia (peridural or spinal anaesthesia) is commonly used in accordance with clinical practice guidelines. However, from a professional perspective, there are still questionable and incorrect statements about possible complications and side effects that cannot be justified medically. In an increasingly technological and networked society, the dissemination of medical information via various sources of information poses a potentially serious problem in terms of disinformation, and the correct classification of information is becoming more and more difficult.

Anaesthesiologists are increasingly confronted with consultations in which, in addition to the actual informed consent for the intervention, extensive clarification of existing contradictory information is required.

The aim of this research project is to survey pregnant patients prior to receiving an anaesthesiological consultation about their previous knowledge of the intended procedure by conducting an anonymous online survey.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Armin N Flinspach, MD.; Phone Number: 00496963015868; Email: armin.flinspach@kgu.de
• Study Contact Backup: Name: Florian J Raimann, MD.; Phone Number: 00496963015868; Email: florian.raimann@kgu.de

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Recruiting
      • University Hospital Frankfurt
      • Contact: Armin N Flinspach, MD; Phone Number: 0049-69-6301-5868; Email: armin.flinspach@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women before delivery for whom a neuroaxiual procedure for pain reduction during childbirth would theoretically be eligible.

Description

Inclusion Criteria:

• Pregnant women prior to delivery

Exclusion Criteria:

• Women under 18 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary information on neuroaxial analgesic procedures for childbirth	Is prior information available.[yes/no]	Between the 25+0 week of pregnancy and delivery
Is the prior information based on internet sources?	Is prior information available based on a internet sources.[yes/no]	Between the 25+0 week of pregnancy and delivery

Collaborators and Investigators

• Sponsor: Goethe University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 2023-1XXX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not possible without major restrictions due to state, national and european data protection legislation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No