A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram

Not Applicable

Completed

• Conditions: abour management; Pregnancy and Childbirth; Labour and delivery complicated by fetal stress [distress]

• Registration Number: ISRCTN98680152
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26791569 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28341515 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29437032 2020 economic evaluation in https://pubmed.ncbi.nlm.nih.gov/32796054/ (added 18/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-30
• Study Completion: 2014-05-31
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 46000

Inclusion Criteria

Women admitted to a participating labour ward who fulfil all of the following criteria will be eligible to be randomised in the trial (no age limits):
1. They are judged to require continuous electronic foetal monitoring (EFM) by the local clinical team based on their existing guidelines, and the woman consents to have EFM, and EFM is possible
2. They have a singleton or twin pregnancy
3. They are above or equal to 35 weeks' gestation
4. There is no known gross foetal abnormality
5. They are able to give consent to participate in the trial as judged by the attending clinicians

Exclusion Criteria

1. Triplets or higher order pregnancy
2. Criteria for EFM not met

Study & Design

• Study Type: Interventional
• Study Design: Not specified