Labour Analgesia, Epidural AnaesthesiaNCT02924779
An Observational Study Investigating the Positioning of Epidural Catheters and Their Function During Labour Analgesia
An observational study of Labour Analgesia, Epidural Anaesthesia, run by Rotkreuzklinikum München gGmbH at 1 site in Germany.
Trial summary
This is a small observational study investigating the physical changes that occur to epidural catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a correlate for the position of the catheter in the patient we will investigate a connection between the position and e function… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Analgesia, Epidural Anaesthesia
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Oct 2016
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women who request epidural analgesia during birth are eligible
Who may be able to join
- any women in labour requesting epidural anaesthesia
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Frauenklinik Taxisstrasse
München, Bavaria, 80637
Ellis Muggleton, MBChB, 015756216128, ellis.muggleton@gmail.com
Tülin Muggleton, MD
About this study
Official title: An Observational Study Investigating the Influence of Physical Position of Epidural Catheters and Their Function During Labour Analgesia
This is a small observational study investigating the physical changes that occur to epidural catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a correlate for the position of the catheter in the patient we will investigate a connection between the position and e function during labour. This information may be useful in guiding the physicians responses to epidurals that do not provide adequate analgesia to aid in deciding on the most appropriate action
- Conditions
- Labour Analgesia, Epidural Anaesthesia
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Retrospective observational study
| Study group | Role | What they receive |
|---|---|---|
| Women during labour | Women receiving lumbar epidural anaesthesia for pain during birth Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of epidural catheter
the structural form of the epidural catheter will be noted
Measured: directly after removal of the epidural
Analgesia effectiveness
All women will be asked about the effectiveness of the epidural catheter during birth
Measured: directly after removal of the epidural
Secondary outcomes (2)
secondary caesarean section
the proportion of epidurals that were subsequently used for a caesarean section
Measured: directly after removal of the epidural
Impact on motor function
the effect of the epidural catheter on leg strength and the ability of women to ambulate
Measured: directly after removal of the epidural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour Analgesia, Epidural AnaesthesiaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rotkreuzklinikum München gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellis Muggleton, Rotkreuzklinikum München gGmbH
- Investigators
- Ellis Muggleton, MBChB, Principal investigator, Anaesthetist Rotkreuzklinikum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924779
- Sponsor's protocol ID
- RotkreuzklinikumMunchen
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Investigating the Influence of Physical Position of Epidural Catheters and Their Function During Labour Analgesia
- ClinicalTrials.gov ID
- NCT02924779
- Acronym / sponsor ID
- RotkreuzklinikumMunchen
- Conditions
- Labour Analgesia, Epidural Anaesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rotkreuzklinikum München gGmbHUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- 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.
This is a small observational study investigating the physical changes that occur to epidural catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a correlate for the position of the catheter in the patient we will investigate a connection between the position and e function during labour. This information may be useful in guiding the physicians responses to epidurals that do not provide adequate analgesia to aid in deciding on the most appropriate action
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women during labour | – | Other: No interventionWomen receiving lumbar epidural anaesthesia for pain during birth |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women who request epidural analgesia during birth are eligible
Key inclusion criteria (1 listed)
- any women in labour requesting epidural anaesthesia
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| No interventionRetrospective observational study | Other | Women during labour |
Primary outcome
Position of epidural catheter
Time frame: directly after removal of the epidural
the structural form of the epidural catheter will be noted
Analgesia effectiveness
Time frame: directly after removal of the epidural
All women will be asked about the effectiveness of the epidural catheter during birth
2 secondary outcomes
secondary caesarean section
Time frame: directly after removal of the epidural
Impact on motor function
Time frame: directly after removal of the epidural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Ellis Muggleton, MBChB principal investigator
Anaesthetist Rotkreuzklinikum München
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 Labour Analgesia, Epidural Anaesthesia, run by Rotkreuzklinikum München gGmbH at 1 site in Germany.
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 1 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 5 Oct 2016. 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 Germany. 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 Ellis Muggleton, MBChB (015756216128, ellis.muggleton@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Position of epidural catheter (time frame: directly after removal of the epidural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2016.