Labor PainNCT05744570
Gender of Anesthesiologist and Time to Labor Epidural
An observational study of Labor Pain, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Labor Pain
- What is being tested?
- Epidural anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to 1 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All anesthesiologist applying epidurals for labor pain during study time frame
Who may be able to join
- Registered maternal request of epidural/spinal anesthesia anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Karl-Johan Lundström, MD, Ph.D contact
Sweden1 site, 1 recruiting
- Recruiting
Centralsjukhuset Kristianstad
Kristianstad
Evija Austruma, M.D, Evija.Austruma@skane.se
About this study
Official title: The Influence of the Anesthesiologists' Gender on Time Delay for Labor Epidural Anesthesia
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:
- Is there a gender difference in time to applying EDA
- 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
Read the detailed 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.
- Conditions
- Labor Pain
- Being tested
- Epidural anesthesia
- Keywords
- labor pain, epidural anesthesia, time delay
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Regional anesthesia for labor pain
| Study group | Role | What they receive |
|---|---|---|
| Male anesthesiologist | The anesthesiologist gender defined by first name Receives: Procedure: Epidural anesthesia | |
| Female anesthesiologist | The anesthesiologist gender defined by first name Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from request of epidural anesthesia to anesthesiologist arrival to labor department
The waiting time from midwife request of epidural anesthesia to anesthesiologist arrival
Measured: 1minute -24 hours
Secondary outcomes (1)
Time from request to application of epidural anesthesia
The waiting time from midwife request of epidural anesthesia to anesthesiologist application of epidural anesthesia
Measured: 1minute-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl-Johan Lundström, MD,Ph.D, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744570
- Sponsor's protocol ID
- TALW
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data can be obtained where no individual could be identified
Publications
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.
PubMed 22419342Barker 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.
PubMed 24494256Yurashevich 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.
PubMed 31264207Melzack 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.
PubMed 6384895
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Anesthesiologists' Gender on Time Delay for Labor Epidural Anesthesia
- ClinicalTrials.gov ID
- NCT05744570
- Acronym / sponsor ID
- TALW
- Conditions
- Labor Pain
- Keywords
- labor pain, epidural anesthesia, time delay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a gender difference in time to applying EDA
- 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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male anesthesiologist | – | Procedure: Epidural anesthesiaThe anesthesiologist gender defined by first name |
| Female anesthesiologist | – | Procedure: Epidural anesthesiaThe anesthesiologist gender defined by first name |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All anesthesiologist applying epidurals for labor pain during study time frame
Key inclusion criteria (1 listed)
- Registered maternal request of epidural/spinal anesthesia anesthesia
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaRegional anesthesia for labor pain | Procedure or surgery | Female anesthesiologist, Male anesthesiologist |
Primary outcome
Time from request of epidural anesthesia to anesthesiologist arrival to labor department
Time frame: 1minute -24 hours
The waiting time from midwife request of epidural anesthesia to anesthesiologist arrival
1 secondary outcome
Time from request to application of epidural anesthesia
Time frame: 1minute-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 22419342Jones 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.
- Background: PubMed 24494256Barker 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.
- Background: PubMed 31264207Yurashevich 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.
- Results publication: PubMed 6384895Melzack 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.
- Individual participant dataSharing planned: Yes. Anonymized data can be obtained where no individual could be identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Johan Lundström, MD, Ph.D contact
Karl-Johan Lundström, MD,Ph.D principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl-Johan Lundström, MD, Ph.D (+4663153000, karl-johan.lundstrom@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from request of epidural anesthesia to anesthesiologist arrival to labor department (time frame: 1minute -24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744570, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.