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NCT04238741
Audio-recording of Consent for Anaesthesia for Elective Caesarean Section
NA trial testing Audio-recording of consent for anaesthesia for elective caesarean section in Caesarean Section in 29 participants. Completed in 29 January 2019.
29 January 2019
Quick facts
| Lead sponsor | Chelsea and Westminster NHS Foundation Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 29 |
| Start date | 25 September 2018 |
| Primary completion | 29 January 2019 |
| Estimated completion | 29 January 2019 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Audio-recording of consent for anaesthesia for elective caesarean section
Conditions studied
- Caesarean Section — all drugs for Caesarean Section →
- Anesthesia — all drugs for Anesthesia →
Sponsor
Chelsea and Westminster NHS Foundation Trust
Who can join
18 and older, female only, with Caesarean Section or Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Informed consent should be obtained from patients (with capacity) before treatment - including anaesthesia - is administered. If the consent process is inadequate, it may lead to poor decision-making and dissatisfaction, sometimes leading to complaints or legal claims. Obstetric practice is a high-risk area for medicolegal claims and accurate, reliable documentation of consent is therefore vital in this group. The hypothesis is that audio-recording of consent discussions would provide a record of the discussion for the patient and healthcare staff to refer to later, to assist in understanding and potentially prevent dissatisfaction, complaints and claims; and may improve the consent process itself if both parties know that the discussion will be audio-recorded. This project aims to establish the acceptability and feasibility of audio-recording of consent for elective caesarean section. The investigators will trial the concept by establishing audio-recording of consent for anaesthesia for elective caesarean section, and aim to investigate the views of patients at Chelsea and Westminster Hospital taking part. The investigators aim to address the following research questions: * what are the views of patients (and to a lesser extent, doctors) involved in audio-recording of consent discussions for anaesthesia for elective caesarean section regarding its acceptability and utility? * what were the perceived concerns and/or practical obstacles to overcome in the trial of concept?
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04238741
- Europe PMC full search
- ASCO Meeting Library
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Other Chelsea and Westminster NHS Foundation Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04238741 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chelsea and Westminster NHS Foundation Trust
- Last refreshed: 23 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04238741.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing