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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
Sponsor:
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

Brief Summary:
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.

Condition or disease
Presentation; Breech, Complicating Pregnancy

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.

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women found to have a fetus in a breech presentation at >34 weeks gestation following a presentation scan in Chelsea and Westminster Hospital.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Angus Rivers, MBBS BSc angusrivers@outlook.com

Locations
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United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Sub-Investigator: Angus Rivers, MBBS BSc         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
Investigators
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Principal Investigator: Steve Yentis, BSc MBBS MD MA Chelsea and Westminster Hospital
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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02082795    
Other Study ID Numbers: breechqualyv1
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Keywords provided by Chelsea and Westminster NHS Foundation Trust:
Breech presentation
External cephalic version
Anaesthesia
Qualitative
Pregnancy
Additional relevant MeSH terms:
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Pregnancy Complications
Breech Presentation
Obstetric Labor Complications