A multicentre randomised controlled trial of an intelligent system to support decision making in the management of labour using the cardiotocogram

Update Il y a 5 ans
Reference: ISRCTN98680152

Woman Man

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Extract

Background and study aims Babies continue to die in labour or are born with brain injury due to a lack of oxygen during their birth. One way of trying to prevent babies suffering due to a lack of oxygen during birth is to monitor the baby's heart rate. This monitoring is not always easy to interpret. Some patterns are the baby's normal response to the stress of labour whilst others indicate a lack of oxygen. Expertise and experience are essential for accurate interpretation, and mistakes are common. This study will test whether an intelligent computer program can help midwives and doctors improve the care they give in response to abnormalities of the baby's heart rate, and whether this will lead to fewer babies being harmed because of a lack of oxygen. Who can participate? Pregnant women who require electronic foetal monitoring (EFM) What does the study involve? Participants are randomly allocated to one of two groups. One group receives standard care, with the healthcare team looking at the readings from the monitor. In the other group the monitoring is looked at by the ‘intelligent’ computer system as well as the healthcare team. Information is collected during labour on a monitoring machine. We also record details of when the mother and baby are discharged from the hospital, and details of any treatments they receive whilst in hospital. Some of the participants are also contacted with questionnaires at 1 and 2 years after the birth to ask about their general health and how often they have used the NHS since giving birth. What are the possible benefits and risks of participating? We cannot promise that the study will help participants but the information we get from this study may help improve the care provided to women in labour in the future. All information we collect will be kept strictly confidential. Participant will still receive the same level of monitoring from the doctors and midwife whether you participate in the study or not. Where is the study run from? University of Oxford (UK) When is the study starting and how long is it expected to run for? September 2009 to May 2014 Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK) Who is the main contact? Prof. Peter Brocklehurst


Inclusion criteria

  • Labour management

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