Investigating Women's Views on the Management of a Breech Pregnancy
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|ClinicalTrials.gov Identifier: NCT02082795|
Recruitment Status : Unknown
Verified March 2014 by Chelsea and Westminster NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
|Condition or disease|
|Presentation; Breech, Complicating Pregnancy|
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.
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 :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Investigating Women's Views on the Management of a Breech Pregnancy|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082795
|Contact: Angus Rivers, MBBS BScemail@example.com|
|Chelsea and Westminster Hospital|
|London, United Kingdom, SW10 9NH|
|Sub-Investigator: Angus Rivers, MBBS BSc|
|Principal Investigator:||Steve Yentis, BSc MBBS MD MA||Chelsea and Westminster Hospital|