Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02082795
  4. Details
NCT02082795 Clinical Trial

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

Presentation; Breech, Complicating Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02082795
Other study ID # breechqualyv1
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 5, 2014
Last updated March 6, 2014
Start date March 2014
Est. completion date August 2014

Study information
Verified date March 2014
Source Chelsea and Westminster NHS Foundation Trust
Contact Angus Rivers, MBBS BSc
Email angusrivers@outlook.com
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Chelsea and Westminster Hospital London

Sponsors (2)
Lead Sponsor Collaborator
Chelsea and Westminster NHS Foundation Trust Chelsea and Westminster Health Charity

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Immediate No
Secondary 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. Immediate No