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Open Access Study protocol

A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

Diogo Ayres-de-Campos1*, Austin Ugwumadu2, Philip Banfield3, Pauline Lynch4, Pina Amin5, David Horwell6, Antonia Costa7, Cristina Santos8, João Bernardes9 and Karl Rosen10

Author Affiliations

1 Departmento de Ginecologia e Obstetrícia, Faculdade de Medicina do Porto, Alameda Hernani Monteiro 4200-319 Porto, Portugal

2 Department of Obstetrics and Gynaecology, St. George's Hospital, University of London, Blackshaw Rd, London, SW17 0QT, UK

3 Department of Obstetrics and Gynaecology, Glan Clwyd Hospital, Rhyl, Denbighshire, LL18 5UJ, Wales, UK

4 Department of Obstetrics and Gynaecology, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK

5 Department of Obstetrics and Gynaecology, University Hospital of Wales, Heath Park, Cardiff, CF14 4XW, Wales, UK

6 Department of Obstetrics and Gynaecology, Luton and Dunstable Hospital, Lewsey Road, Luton, Bedfordshire LU4 0DZ, UK

7 Departmento de Ginecologia e Obstetrícia, Faculdade de Medicina do Porto, Alameda Hernani Monteiro 4200-319 Porto, Portugal

8 Serviço de Bioestatística e Informática Médica, Faculdade de Medicina do Porto, Alameda Hernani Monteiro 4200-319 Porto, Portugal

9 Departmento de Ginecologia e Obstetrícia, Faculdade de Medicina do Porto, Alameda Hernani Monteiro 4200-319 Porto, Portugal

10 Department of Engineering, University of Borås, Allégat 1, SE-501 90 Borås, Sweden

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BMC Pregnancy and Childbirth 2010, 10:71  doi:10.1186/1471-2393-10-71

Published: 28 October 2010

Abstract

Background

Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG) monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes.

Methods/design

This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm) or continuous CTG monitoring as previously performed (control arm). Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH < 7.05, BDecf > 12 mmol/L). Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score < 7, neonatal intensive care unit admission, moderate and severe neonatal encephalopathy with a marker of hypoxia, perinatal death, rate of internal monitoring, tracing quality, and signal loss. Analysis will follow an intention to treat principle. Incidences of primary and secondary outcomes will be compared between groups. Assuming a reduction in metabolic acidosis from 2.8% to 1.8%, using a two-sided test with alpha = 0.05, power = 0.80, and 10% loss to follow-up, 8133 women need to be randomised.

Discussion

This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real-time alerts on the incidence of adverse perinatal outcomes, intrapartum interventions and signal quality. (Current controlled trials ISRCTN42314164)