ClinicalTrials.gg
Status unknownNCT02082795Updated Mar 10, 2014

Investigating Women's Views on the Management of a Breech Pregnancy

An observational study in Presentation; Breech, Complicating Pregnancy, sponsored by Chelsea and Westminster NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-10.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
Female
01

Study 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.

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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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Conditions studied

  • Presentation; Breech, Complicating Pregnancy

Keywords

  • Breech presentation
  • External cephalic version
  • Anaesthesia
  • Qualitative
  • Pregnancy
03

In context

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

This study's planned enrollment of 15 is below the median of 400 across 198 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Breech presentation
  • eligible for an external cephalic version attempt

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancy
  • Previous caesarean section
  • English not sufficient to carry out the interview
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mothers' opinions on anaesthesia for external cephalic version

    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.

    Time frame: Immediate

Secondary outcomes

  1. Mothers' opinions on management of breech presentation

    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.

    Time frame: Immediate

07

Study locations

1 site
  • Chelsea and Westminster Hospital
    London, SW10 9NH, United Kingdom
    • Angus Rivers, MBBS BSc · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02082795
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible party
Sponsor
First posted
Mar 10, 2014
Start date
Mar 2014
Primary completion
Aug 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Mar 10, 2014

Study contacts

Angus Rivers, MBBS BSc
Contact
angusrivers@outlook.com
Steve Yentis, BSc MBBS MD MA
principal investigator · Chelsea and Westminster Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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