Use of Decision Support in the Management of Labour (INFANT)

University College London (UCL)

Status: Completed

Conditions: 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

Treatments: Device: INFANT software

Study type: Interventional

Funder types: Other

Identifiers

NCT02010710

06/38/01

Details and patient eligibility

About

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.

Enrollment: 47,062 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47,062 participants in 2 patient groups

Decison support

Experimental group

Description:

"Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time.

Treatment:

Device: INFANT software

No Decision Support

No Intervention group

Description:

"No decision-support" - CTGs with no additional interpretation (UK standard care),