Use of Decision Support in the Management of Labour

Study Overview
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Brief Summary
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In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: No decision-support - CTGs with no additional interpretation (UK standard care), compared with: Decision-support - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.

Official Title
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A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram

Conditions
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Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is, Possible

Intervention / Treatment
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* Device: INFANT software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Require continuous electronical fetal monitoring during labour they have a singleton or twin pregnancy they are ≥ 35 weeks' gestation (≥ 245 days) there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block they are 16 years of age or older they are able to give consent to participate in the trial as judged by the attending clinicians. Exclusion Criteria: • triplets or higher order pregnancy criteria for EFM not met, including elective caesarean section prior to the onset of labour

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decison support<br>Decision-support - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. | Device: INFANT software<br>* The decision-support software to be evaluated in INFANT has been designed to run on the K2 data collection system (Guardian®). The data collection system (Guardian®) is a system for managing information from labour monitoring. It displays the CTG on a computer screen alongside other clinical data which are collected as part of routine clinical care. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour.<br>|
| No Intervention: No Decision Support<br>No decision-support - CTGs with no additional interpretation (UK standard care), | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admissions to higher level of care | A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for ≥ 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy. | within 48 hours and for longer than 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro Development | PARCA-R composite score at the age of two years | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous electronic fetal monitoring, labour, pregnancy, fetal distress