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

Conditions

Labour management Pregnancy and Childbirth Labour and delivery complicated by fetal stress [distress]

Liz Schroeder, Miaoqing Yang, Peter Brocklehurst, Louise Linsell, Oliver Rivero‐Arias

Archives of Disease in Childhood Fetal & Neonatal2020-08-126 citations

10.1136/archdischild-2020-318806

Computerised interpretation of the fetal heart rate during labour: a randomised controlled trial (INFANT).

Brocklehurst P, Field D, Greene K, Juszczak E, Kenyon S, Linsell L, Mabey C, Newburn M, Plachcinski R, Quigley M, Steer P, Schroeder L, Rivero-Arias O.

2018-02-0116 citations

10.3310/hta22090

A study of an intelligent system to support decision making in the management of labour using the cardiotocograph - the INFANT study protocol.

Brocklehurst P, INFANT Collaborative Group.

2016-01-2020 citations

10.1186/s12884-015-0780-0

Interventions

The specific piece of decision-support software to be evaluated in INFANT has been designed by K2 Medical Systems to run on the K2 data collection system (Guardian™). The data collection system Guardi

Eligibility

Sex/Gender

Female

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
1. Short term: 'Poor neonatal outcome' to include: 1.1. All perinatal deaths, except deaths due to congenital anomalies 1.2. Significant morbidity: neonatal encephalopathy; other admissions to neonatal intensive care unit (NICU) within 48 hours of birth for 48 hours or more, which are associated with adverse intrapartum events including respiratory symptoms and seizures 2. Long term: Developmental Quotient (DQ) at the age of two years	—

Measure

Time frame

1. Short term: 'Poor neonatal outcome' to include: 1.1. All perinatal deaths, except deaths due to congenital anomalies 1.2. Significant morbidity: neonatal encephalopathy; other admissions to neonatal intensive care unit (NICU) within 48 hours of birth for 48 hours or more, which are associated with adverse intrapartum events including respiratory symptoms and seizures 2. Long term: Developmental Quotient (DQ) at the age of two years

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Secondary

Measure	Time frame
1. Cord-artery pH <7.05 with base deficit of 12 mmol/l or more 2. Apgar score <4 at 5 minutes 3. Caesarean section 4. Any operative intervention for (i) foetal distress and (ii) failure to progress 5. Foetal blood sampling 6. Length of labour 7. Episiotomy rates 8. Proportion of babies with an adverse outcome (trial primary outcome plus cord-artery pH <7.05 with base deficit 12 mmol/l or more) judged to have experienced suboptimal care in labour	—

Measure

Time frame

1. Cord-artery pH <7.05 with base deficit of 12 mmol/l or more 2. Apgar score <4 at 5 minutes 3. Caesarean section 4. Any operative intervention for (i) foetal distress and (ii) failure to progress 5. Foetal blood sampling 6. Length of labour 7. Episiotomy rates 8. Proportion of babies with an adverse outcome (trial primary outcome plus cord-artery pH <7.05 with base deficit 12 mmol/l or more) judged to have experienced suboptimal care in labour

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Countries

Ireland, United Kingdom

Outcome results

None listed