Contact information
Type
Scientific
Primary contact
Prof Diogo Ayres-de-Campos
ORCID ID
Contact details
Departamento de Ginecologia e Obstetrícia
Faculdade de Medicina do Porto
Porto
4200-319
Portugal
+351 96 670 7112
sisporto@med.up.pt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised clinical trial of intrapartum foetal monitoring with computer analysis and alerts versus previously available monitoring
Acronym
EFM-ALERT
Study hypothesis
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
To be submitted as of 02/12/2008.
Study design
Randomised controlled open multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Incidence of foetal metabolic acidosis, defined as newborn umbilical artery pH <7.05 and BDecf >12 mmol/L.
Secondary outcome measures
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
Overall trial start date
01/04/2009
Overall trial end date
01/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
8,000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2009
Recruitment end date
01/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Departamento de Ginecologia e Obstetrícia
Porto
4200-319
Portugal
Sponsor information
Organisation
University of Porto (Universidade do Porto) (Portugal)
Sponsor details
Faculdade de Medicina do Porto
Alameda Hernani Monteiro
Porto
4200-319
Portugal
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Institute of Biomedical Engineering (Instituto de Engenharia Biomédica) (INEB) (Portugal)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21029466
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27926647
Publication citations
-
Protocol
Ayres-de-Campos D, Ugwumadu A, Banfield P, Lynch P, Amin P, Horwell D, Costa A, Santos C, Bernardes J, Rosen K, A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring., BMC Pregnancy Childbirth, 2010, 10, 71, doi: 10.1186/1471-2393-10-71.