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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05744570
Other study ID # TALW
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date September 1, 2023

Study information

Verified date February 2023
Source Umeå University
Contact Karl-Johan Lundström, MD, Ph.D
Phone +4663153000
Email karl-johan.lundstrom@umu.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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. Is there a gender difference in time to applying EDA 2. What is the mean waiting for EDA in laboring women in Sweden Participants (anesthesiologists) will be reviewed according to the time from when the midwife asks for EDA to anesthesiologist register that it was in place


Description:

In certain hospital in Sweden, a module on the most contemporary Obstetric chart system in Sweden allows for registration of time from request of EDA to applied EDA.Time of request is made by the midwife and the Tim of application is registered by the anesthesiologist. Not all hospitals makes these registrations, thus only (i)hospitals having this module and (ii) hospitals willing to participate will be included.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date September 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Registered maternal request of epidural/spinal anesthesia anesthesia Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Epidural anesthesia
Regional anesthesia for labor pain

Locations

Country Name City State
Sweden Centralsjukhuset Kristianstad Kristianstad

Sponsors (1)

Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Time from request to application of epidural anesthesia The waiting time from midwife request of epidural anesthesia to anesthesiologist application of epidural anesthesia 1minute-24 hours
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