Condition category
Pregnancy and Childbirth
Date applied
02/12/2008
Date assigned
26/01/2009
Last edited
27/01/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://sigarra.up.pt/fmup

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

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21029466

Publication citations

  1. 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.

Additional files

Editorial Notes