Clinical trial NCT02082795: Investigating Women's Views on the Management of a Breech Pregnancy
Official title: Investigating Women's Views on the Management of a Breech Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Presentation; Breech, Complicating Pregnancy
Keywords: Breech presentation
External cephalic version
Anaesthesia
Qualitative
Pregnancy
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Mothers' opinions on anaesthesia for external cephalic version
timeFrame: Immediate
Secondary outcomes:
measure: Mothers' opinions on management of breech presentation
timeFrame: Immediate
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster Hospital
name: Steve Yentis, BSc MBBS MD MA
role: PRINCIPAL_INVESTIGATOR
References: