Use of Decision Support in the Management of Labour
- Conditions
- Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn InfantTeam Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM isPossible
- Interventions
- Device: INFANT software
- Registration Number
- NCT02010710
- Lead Sponsor
- University College, London
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 47062
-
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.
-
• triplets or higher order pregnancy
- criteria for EFM not met, including elective caesarean section prior to the onset of labour
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Decison support INFANT software "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time.
- Primary Outcome Measures
Name Time Method Admissions to higher level of care within 48 hours and for longer than 48 hours 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.
- Secondary Outcome Measures
Name Time Method Neuro Development 2 years PARCA-R composite score at the age of two years
Trial Locations
- Locations (21)
University Hospitals Coventry & Warwick
🇬🇧Coventry, United Kingdom
Homerton University Hospital
🇬🇧London, United Kingdom
Northwick Park Hospital
🇬🇧London, United Kingdom
Southern General
🇬🇧Glasgow, United Kingdom
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
Nottingham City/Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Rotunda
🇮🇪Dublin, Ireland
Lancashire Women's and Newborn Centre
🇬🇧Burnley, Lancs, United Kingdom
Birmingham Women's Hospital
🇬🇧Birmingham, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, United Kingdom
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Princess Royal
🇬🇧Glasgow, United Kingdom
Stoke Mandeville Hospital
🇬🇧Stoke Mandeville, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Princess Anne
🇬🇧Southampton, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, United Kingdom
St Mary's Hospital
🇬🇧Manchester, United Kingdom
Queen Alexandra
🇬🇧Portsmouth, United Kingdom
Warrington Hospital
🇬🇧Warrington, United Kingdom
Warwick Hospital
🇬🇧Warwick, United Kingdom
University Hospital North Staffs
🇬🇧Stoke-on-Trent, United Kingdom