NCT02924779

Brief 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 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

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 3, 2016

Last Update Submit

October 3, 2016

Conditions

Labour Analgesia, Epidural Anaesthesia

Outcome Measures

Primary Outcomes (2)

  • Position of epidural catheter

    the structural form of the epidural catheter will be noted

    directly after removal of the epidural

  • Analgesia effectiveness

    All women will be asked about the effectiveness of the epidural catheter during birth

    directly after removal of the epidural

Secondary Outcomes (2)

  • secondary caesarean section

    directly after removal of the epidural

  • Impact on motor function

    directly after removal of the epidural

Study Arms (1)

Women during labour

Women receiving lumbar epidural anaesthesia for pain during birth

Other: No intervention

Interventions

No interventionOTHER

Retrospective observational study

Women during labour

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women who request epidural analgesia during birth are eligible

You may qualify if:

  • any women in labour requesting epidural anaesthesia

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frauenklinik Taxisstrasse

München, Bavaria, 80637, Germany

RECRUITING

Study Officials

  • Ellis Muggleton, MBChB

    Anaesthetist Rotkreuzklinikum München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellis Muggleton, MBChB

CONTACT

015756216128ellis.muggleton@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthetist

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Last Updated

October 5, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)