Extract

Background and study aims The two most recent Confidential Enquiries into Maternal Deaths reports in the UK have highlighted an urgent need to develop a national Modified Obstetric Early Warning System (known as MEOWS) to make sure that women who are developing life threatening complications of pregnancy are identified quickly, and referred and treated accordingly. Modified Early Obstetric Warning Charts (MEOWS) assign increasing scores (or colours) to each individual physiological measurement (blood pressure, heart rate, temperature, breathing rate and amount of oxygen in the blood) as they become more abnormal. If either the sum of scores for several physiological measurements, or a score for a single physiological measurement exceed set thresholds, an alert is triggered. We want to develop a database of physiology of pregnancy and the postpartum period (period from just after birth to around 6 weeks after birth) from which an evidence-based, robust early warning score can be developed. Who can participate? Pregnant women aged at least 16 without any underlying medical condition known to affect vital signs, that is blood pressure, heart rate, temperature, oxygen saturation levels (amount of oxygen in the blood) and respiratory (breathing) rate. What does the study involve? Participants have their vital signs measured by a research midwife at selected points throughout their pregnancy. After pregnancy they are required to carry out home monitoring of their own vital signs using a set of home monitoring equipment for approximately 2 weeks. Each participant is likely to be involved in the study from around 14 weeks of pregnancy to around 14 days postnatal (maximum 30 weeks to allow for women who deliver at 42 weeks). Vital signs data are collected from patients on a monthly basis from their recruitment to the study (at the first routine antenatal appointment or the nuchal scan) to two weeks postpartum. This is a combination of data recorded at regular antenatal visits, any in-hospital stay during pregnancy, delivery and immediately after birth, and data recorded by home monitors in the two weeks immediately after birth. Resting observations for the standard physiological variables used in the current MEOWS charts are recorded from each mother. Demographic, laboratory and medication data which may be related to vital signs is also collected. As a result, a large database of maternal and postpartum physiology will be assembled, from which an evidence-based, national MEOWS will be developed for all stages of pregnancy, the intrapartum (during childbirth) and postpartum periods. A pregnancy stage specific alerting system will be created for use in monitored areas and hospital environments. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? The 4P study has been set up by the University of Oxford and runs from The Oxford University Hospitals NHS Trust. Guys and St. Thomas Hospital London and The Newcastle Upon Tyne Hospitals NHS Foundation Trust are in the process of being set up as recruiting sites. When is the study starting and how long is it expected to run for? November 2014 to August 2017 Who is funding the study? Biomedical Research Centre (BRC) (UK) Who is the main contact? Dr Peter Watkinson [email protected]

Inclusion criteria

• Vital signs during pregnancy, intrapartum and two weeks post partum

Links

• isrctn
• ictrp