Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 1:32 PM
Ignite Modification Date: 2025-12-24 @ 1:32 PM
NCT ID: NCT02082795
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.
Study: NCT02082795
Study Brief:
Protocol Section: NCT02082795