Condition category
Pregnancy and Childbirth
Date applied
18/12/2017
Date assigned
08/01/2018
Last edited
08/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the UK 1 in 3 women choose an epidural for pain relief during childbirth, as it remains the most effective choice. Pain sensation is conveyed to the brain via nerves that are connected through the spinal cord, which floats in a bag of fluid (dural sac) further protected inside a hollow bony column (vertebral column). The dural sac contains fluid (cerebrospinal fluid or CSF), and its coverings are made of three layers of membranes (dura mater, arachnoid mater and pia mater). The spinal cord is connected directly with the brain, and the dural sac and covering membranes continue upwards in the skull to enclose the brain. Epidural involves placement of a plastic tube by an anaesthetic doctor, through a needle, into a space that lies between the outermost membrane of the sac and the wall of the bony canal (epidural space). In an uncomplicated procedure, this placement of the plastic tube is achieved without puncturing the membranes. However, in 1% cases, the dura may get punctured by the needle leading to the leakage of spinal fluid. It is believed that such a leakage causes traction on the membranes producing headache in 80% of women (called postdural puncture headache or PDPH). If severe this may require an invasive procedure (called an epidural blood patch or EBP) for effective treatment. PDPH can be very incapacitating and debilitating for the new mother; restricting daily activities, impairs looking after her baby, impedes mother-baby bonding and can delay discharge from hospital. In simple terms, PDPH can turn an enjoyable experience into an unpleasant one, with substantial physical, emotional and psychological consequences. Currently, there is no scientific investigative tool that can predict the development, progress and severity of PDPH. Current management relies on a “wait and watch” strategy. This has serious limitations, including unnecessary suffering for the new mother by delayed diagnosis, potentially delayed definitive treatment (EBP), and premature discharge with subsequent readmission. Magnetic resonance imaging (MRI) is a routine investigation tool, frequently used in other fields of medicines (neurology, neurosurgery etc), that can provide high resolution images of spinal cord, its surrounding membranes, spinal fluid and its leakage into the epidural space. This study will be the first attempt to scientifically evaluate the link between features identified on MRI images taken soon after accidental puncture of the dura, and the development, progress and severity of ensuing headache. This may help clinicians to reliably identify the patients at risk of developing more severe headache and offer early institution of effective treatment (EBP), on the basis of scientific evidence instead of the current “wait, watch and intervene” strategy. The aim of this study is to help reduce unnecessary suffering for the new mother and minimise the disruption to family life due to PDPH.

Who can participate?
Adult woman aged 16 and older in labour who received an epidural/CSE for pain relief and sustained an observed ADP with an epidural needle.

What does the study involve?
After recognition of an accidental dural puncture the participant is managed according to the local protocols. Once the baby is delivered and both the mother and the newborn are in reasonably good health, the mother are approached by a member of the direct care team, who explores her potential participation in the study. The local investigator liaises with the local radiology department to arrange an MRI scan as soon as possible, but no later than 24 hours from the detection of ADP. The local investigator accompanies the mother to the MRI scanner. Once the MRI scan is done the mother continues to be managed according to the local protocols. The direct care team are not informed about the MRI scan findings. All the participating women are followed up for the development of PDPH daily for 1 week in person or over the telephone. A follow-up questionnaire is used by the local investigators (LI) for data collection and follow up.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating.

Where is the study run from?
This study is being run by University College London Hospitals NHS Foundation Trust (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
January 2012 to March 2018

Who is funding the study?
National Institute of Academic Anaesthesia (UK)

Who is the main contact?
Dr Amer Majeed

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amer Majeed

ORCID ID

http://orcid.org/0000-0003-2255-6950

Contact details

Consultant Anesthesiologist
King Faisal Specialist Hospital and Research Centre
Riyadh
11211
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14310

Study information

Scientific title

Does Magnetic Resonance Imaging (MRI) correlate with severity of headache following accidental dural puncture (ADP) during epidural catheter placement for labour analgesia?

Acronym

MRiADP

Study hypothesis

There is a positive correlation between the extent of spread of cerebro-spinal fluid measured using Magnetic Resonance Imaging and the severity of headache following accidental dural puncture during epidural catheter placement for labour analgesia.

Ethics approval

National Research and Ethics Service Committee North West - REC, 23/07/2012, ref: 12/NW/0528

Study design

Interventional; Design type: Diagnosis, Imaging

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Complications of labour and delivery

Intervention

Participants receiving epidurals for labour analgesia, who sustain an accidental dural puncture (ADP), would undergo clinical management according to the local departmental protocols as usual. If they agree to participate in this study, they would undergo Magnetic Resonance Imaging (MRI) of their brain and lumbar spine, without contrast, within 48 hours from the occurrence of the ADP. They are also followed up for one week for development of symptoms associated with Post Dural Puncture Headache (PDPH). The images and follow up data are psudoanonymised. These are then reported and analysed by the study neuro-radiologist and the study coordinator respectively.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Presence, or otherwise, of a statistically significant positive correlation between the extent of spread of cerebro-spinal fluid measured using Magnetic Resonance Imaging and the severity of PDPH according to a carefully designed scoring system developed by the study team.

Secondary outcome measures

Incidental findings on the images measured using Magnetic Resonance Imaging.

Overall trial start date

01/01/2012

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

All adult (>16 years of age) women in labour who received an epidural / CSE for pain relief and sustained an observed ADP with an epidural needle.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 31; UK Sample Size: 31

Participant exclusion criteria

1. Patient refusal
2. Unsuitable for MRI (e.g. metal implants, pace maker etc)
3. Pre-existing headaches / migraine, spinal surgery
4. Spine deformity or anomalies

Recruitment start date

01/09/2013

Recruitment end date

08/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals NHSFT
London
NW1 2BU
United Kingdom

Trial participating centre

Stoke Mandeville Hospital
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom

Trial participating centre

St Mary's Hospital
Manchester
M13 9WL
United Kingdom

Trial participating centre

Kings College Hospital NHSFT
London
SE5 9RS
United Kingdom

Trial participating centre

Royal Preston Hospital
Preston
PR2 9HT
United Kingdom

Trial participating centre

Royal Berkshire NHSFT
Reading
RG1 5AN
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHST
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust

Sponsor details

250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute of Academic Anaesthesia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/01/2018: Uploaded protocol Version 8.1 12 June 2016 (not peer-reviewed).