Investigating Women's Views on the Management of a Breech Pregnancy
NCT ID: NCT02082795
Last Updated: 2014-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
15 participants
OBSERVATIONAL
2014-03-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Induction of Labor in Breech Presentation
NCT07071662
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position
NCT00565383
IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.
NCT04417296
Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)
NCT01948115
Nitrous Oxide for External Cephalic Version
NCT03502915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* eligible for an external cephalic version attempt
Exclusion Criteria
* Previous caesarean section
* English not sufficient to carry out the interview
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chelsea and Westminster NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steve Yentis, BSc MBBS MD MA
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chelsea and Westminster Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
breechqualyv1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.