Evaluation of a computer system that alerts heathcare professionals to changes in foetal monitoring signals acquired during labour

ISRCTN	ISRCTN42314164
DOI	https://doi.org/10.1186/ISRCTN42314164
Protocol serial number	N/A
Sponsor	University of Porto (Universidade do Porto) (Portugal)
Funder	Institute of Biomedical Engineering (Instituto de Engenharia Biomédica) (INEB) (Portugal)

Submission date: 02/12/2008
Registration date: 26/01/2009
Last edited: 08/12/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Diogo Ayres-de-Campos
Scientific

Departamento de Ginecologia e Obstetrícia
Faculdade de Medicina do Porto
Porto
4200-319
Portugal

Phone	+351 96 670 7112
Email	sisporto@med.up.pt

Study information

Primary study design	Interventional
Study design	Randomised controlled open multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised clinical trial of intrapartum foetal monitoring with computer analysis and alerts versus previously available monitoring
Study acronym	EFM-ALERT
Study objectives	Use of a system for computer analysis of intrapartum foetal monitoring signals, with real-time alerts for healthcare professionals, will reduce the number of foetuses born with metabolic acidosis, when compared with conventional monitoring.
Ethics approval(s)	To be submitted as of 02/12/2008.
Health condition(s) or problem(s) studied	Intrapartum foetal hypoxia
Intervention	Continuous foetal monitoring during labour with computer analysis by the Omniview-SisPorto 3.5 system vs continuous intrapartum monitoring as previously performed.
Intervention type	Other
Primary outcome measure(s)	Incidence of foetal metabolic acidosis, defined as newborn umbilical artery pH <7.05 and BDecf >12 mmol/L.
Key secondary outcome measure(s)	1. Overall rates of caesarean section and caesarean section for non-reassuring foetal state 2. Overall rates of instrumental vaginal delivery and instrumental vaginal delivery for non-reassuring foetal state 3. Foetal blood sampling rates 4. Incidence of 5-minute Apgar score <7 5. Need for neonatal intensive care unit admission 6. Incidence of moderate and severe neonatal encephalopathy with a hypoxic marker 7. Perinatal death 8. Rate of delayed interventions (interval between red alerts [intervention arm]/offline analysis [control arm] and delivery in metabolic acidosis cases) 8. Tracing quality and signal loss
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	8000
Key inclusion criteria	1. Pregnant women, aged more than 16 years 2. Able to provide written informed consent 3. Singleton pregnancy 4. Gestation of 36 or more completed weeks 5. Cephalic presentation 6. No known major foetal malformations 7. In active labour but not in active second stage 8. No known contraindication to vaginal delivery 9. Clinical decision made to perform continuous cardiotocography (CTG) monitoring
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2009
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

United Kingdom
Portugal

Study participating centre

Departamento de Ginecologia e Obstetrícia

Porto
4200-319
Portugal

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2017		Yes	No
Protocol article	protocol	28/10/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/12/2016: Publication reference added.