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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Departamento de Ginecologia e Obstetrícia
Faculdade de Medicina do Porto
Porto
4200-319
Portugal
| Phone | +351 96 670 7112 |
|---|---|
| sisporto@med.up.pt |
Study information
| Study design | Randomised controlled open multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2009 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 8,000 |
| 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
- Portugal
- United Kingdom
Study participating centre
Departamento de Ginecologia e Obstetrícia
Porto
4200-319
Portugal
4200-319
Portugal
Sponsor information
University of Porto (Universidade do Porto) (Portugal)
University/education
University/education
Faculdade de Medicina do Porto
Alameda Hernani Monteiro
Porto
4200-319
Portugal
| Website | http://sigarra.up.pt/fmup |
|---|---|
"ROR" |
https://ror.org/043pwc612 |
Funders
Funder type
Research organisation
Institute of Biomedical Engineering (Instituto de Engenharia Biomédica) (INEB) (Portugal)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/10/2010 | Yes | No | |
| Results article | results | 01/01/2017 | Yes | No |
Editorial Notes
08/12/2016: Publication reference added.
