- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082795
Investigating Women's Views on the Management of a Breech Pregnancy
Study Overview
Status
Conditions
Detailed Description
Background
Women undergo external cephalic version (ECV) in order to turn a baby in a breech (bottom, or feet down) presentation to a head down position. The procedure traditionally has about a 40% success rate and may be painful, issues that recent literature suggests puts some women off.
Pain relief using a short acting morphine-like painkiller, called remifentanil, can significantly reduce the pain experienced but does not seem to improve ECV success rates. Alternatively, a spinal anaesthetic (similar to that used for a caesarean section) can be used. This increases success rates to around 60% and very effectively reduces pain; however, it is an invasive procedure with potential complications and requires a hospital stay of at least half a day.
Aims and objectives
The investigators aim to perform a qualitative study to explore the views of women with a breech presentation on their management in general, and the use of anaesthesia or analgesia for ECV in particular.
Methods
The investigators will use a semi-structured interview to explore the views of 10-15 expectant mothers recruited from the Breech Clinic at Chelsea and Westminster Hospital. Interviews will be recorded and then transcribed for thematic analysis by two researchers.
Dissemination of output
To our knowledge, this will be the first report on how women view the use of regional anaesthesia and remifentanil analgesia for ECV. In addition, we will add the views of our patient population to the existing literature concerning the management of ECV in general. The investigators anticipate that this information will be used to plan services and to guide future research.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Angus Rivers, MBBS BSc
- Email: angusrivers@outlook.com
Study Locations
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London, United Kingdom, SW10 9NH
- Chelsea and Westminster Hospital
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Sub-Investigator:
- Angus Rivers, MBBS BSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Breech presentation
- eligible for an external cephalic version attempt
Exclusion Criteria:
- Multiple pregnancy
- Previous caesarean section
- English not sufficient to carry out the interview
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mothers' opinions on anaesthesia for external cephalic version
Time Frame: Immediate
|
This is a qualitative study using information gathered during a semi-structured interview.
All information will be gathered at the time of the interview.
There will be no other followup.
|
Immediate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mothers' opinions on management of breech presentation
Time Frame: Immediate
|
This is a qualitative study using information gathered during a semi-structured interview.
All information will be gathered at the time of the interview.
There will be no other followup.
|
Immediate
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steve Yentis, BSc MBBS MD MA, Chelsea and Westminster Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- breechqualyv1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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