ISRCTN98680152
Completed
N/A
A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram (INFANT)
niversity of Oxford (UK)0 sites46,000 target enrollmentSeptember 30, 2008
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford (UK)
- Enrollment
- 46000
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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