Fetal Intrauterine Distress First Noted During Labor and or Delivery in Liveborn Infant, Possible, Team Based on Their Existing Guidelines and the Woman Consents to Have EFM and EFM is
Conditions
Keywords
continuous electronic fetal monitoring, labour, pregnancy, fetal distress
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.
Interventions
DEVICEINFANT software
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.
Sponsors
University of Oxford
University of Birmingham
University of Plymouth
University of Leicester
National Childbirth Trust
K2 Medical Systems
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neuro Development | 2 years | PARCA-R composite score at the age of two years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant outcomes | during admission and at 2 years | * Metabolic acidosis defined as a cord-artery pH \<7.05 (this is 2 standard deviations below the mean) with base deficit ≥ 12 mmol/l (this is a threshold above which the risks of neurological damage increase) * The distribution of cord-blood gas data for cord-artery pH * Apgar score \<4 at 5 minutes * Intrapartum stillbirth * Neonatal death * Seizures * Resuscitation interventions * Admissions to neonatal unit within 48 hours of birth for at least 48 hours * Admissions to neonatal unit within 48 hours of birth for at least 48 hours with evidence of: * Encephalopathy * Feeding difficulties * Respiratory illness * Admission to a higher level of care * In the sub-set of 7,000 surviving children without any degree of encephalopathy and agreed to be followed-up at age 2 years: * PARCA-R composite score * Cerebral palsy - (determined by asking the parents if their child has Cerebral palsy) * Late deaths (after the neonatal period) * General health issues at 2 years |
| Mother | during admission | * Mode of delivery * Any operative intervention (caesarean section and instrumental delivery) for i. fetal distress, or ii. failure to progress, or iii. combination of fetal distress and failure to progress iv. other reason * Any episode of fetal blood sampling * Episiotomy * Grade of caesarean section * Length of first stage, length of second stage, total length of labour from trial entry |
Countries
Ireland, United Kingdom
Outcome results
None listed