NCT05744570

Brief Summary

The goal of this retrospective cohort study is to learn about wether the gender of the anesthetist affects time to epidural anesthesia (EDA) for laboring women . The main questions it aims to answer are:

  1. 1.Is there a gender difference in time to applying EDA
  2. 2.What is the mean waiting for EDA in laboring women in Sweden

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

February 10, 2023

Last Update Submit

February 24, 2023

Conditions

Labor Pain

Keywords

labor painepidural anesthesiatime delay

Outcome Measures

Primary Outcomes (1)

  • Time from request of epidural anesthesia to anesthesiologist arrival to labor department

    The waiting time from midwife request of epidural anesthesia to anesthesiologist arrival

    1minute -24 hours

Secondary Outcomes (1)

  • Time from request to application of epidural anesthesia

    1minute-24 hours

Study Arms (2)

Male anesthesiologist

The anesthesiologist gender defined by first name

Procedure: Epidural anesthesia

Female anesthesiologist

The anesthesiologist gender defined by first name

Procedure: Epidural anesthesia

Interventions

Epidural anesthesiaPROCEDURE

Regional anesthesia for labor pain

Female anesthesiologistMale anesthesiologist

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender defined by first name
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All anesthesiologist applying epidurals for labor pain during study time frame

You may qualify if:

  • Registered maternal request of epidural/spinal anesthesia anesthesia

You may not qualify if:

  • Not possible to determine gender by first name or by personal knowledge at participating site
  • Duplicates
  • Misregistered time-points of EDA
  • Not receiving EDA (even if the initial intention was to apply EDA)
  • Uncertain which anesthesiologist that registered the time-point (more than one anesthesiologist involved in documentation or application)
  • None/ambiguous documentation of time-points

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centralsjukhuset Kristianstad

Kristianstad, Sweden

RECRUITING

Related Publications (4)

  • Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

    PMID: 22419342BACKGROUND

  • Barker HM, Simmons SW, Hiscock RJ, Cyna AM, McDonald S. Time to get comfortable with a labour epidural. Anaesth Intensive Care. 2014 Jan;42(1):73-7. doi: 10.1177/0310057X1404200113.

    PMID: 24494256BACKGROUND

  • Yurashevich M, Carvalho B, Butwick AJ, Ando K, Flood PD. Determinants of women's dissatisfaction with anaesthesia care in labour and delivery. Anaesthesia. 2019 Sep;74(9):1112-1120. doi: 10.1111/anae.14756. Epub 2019 Jul 1.

    PMID: 31264207BACKGROUND

  • Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-337. doi: 10.1016/0304-3959(84)90079-4. No abstract available.

    PMID: 6384895RESULT

MeSH Terms

Conditions

Labor Pain

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Karl-Johan Lundström, MD,Ph.D

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl-Johan Lundström, MD, Ph.D

CONTACT

+4663153000karl-johan.lundstrom@umu.se

Karl-Johan Lundström, MD, Ph.D

CONTACT

karl_johan@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 27, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Anonymized data can be obtained where no individual could be identified

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After study completion
Access Criteria
If appropriate authorities approve of data sharing (Ethical Approval Authority and Swedish Authority for Privacy Protection) data can be accessed

Locations

SE(1)