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  • Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score

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Obstetrics and gynaecology
Protocol
Pregnancy physiology pattern prediction study (4P study): protocol of an observational cohort study collecting vital sign information to inform the development of an accurate centile-based obstetric early warning score
  1. Fiona Kumar1,
  2. Jude Kemp1,
  3. Clare Edwards1,
  4. Rebecca M Pullon2,
  5. Lise Loerup2,
  6. Andreas Triantafyllidis2,
  7. Dario Salvi2,
  8. Oliver Gibson2,
  9. Stephen Gerry3,4,
  10. Lucy H MacKillop1,
  11. Lionel Tarassenko2,
  12. Peter J Watkinson5
  1. 1 Nuffield Department of Obstetrics and Gynaecology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  2. 2 Department of Engineering Science, University of Oxford, Oxford, UK
  3. 3 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, Oxford, UK
  4. 4 Musculoskeletal Sciences, University of Oxford, Oxford, UK
  5. 5 Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
  1. Correspondence to Dr Peter J Watkinson; peter.watkinson{at}ndcn.ox.ac.uk

Abstract

Introduction Successive confidential enquiries into maternal deaths in the UK have identified an urgent need to develop a national early warning score (EWS) specifically for pregnant or recently pregnant women to aid more timely recognition, referral and treatment of women who are developing life-threatening complications in pregnancy or the puerperium. Although many local EWS are in use in obstetrics, most have been developed heuristically. No current obstetric EWS has defined the thresholds at which an alert should be triggered using evidence-based normal ranges, nor do they reflect the changing physiology that occurs with gestation during pregnancy.

Methods and analysis An observational cohort study involving 1000 participants across three UK sites in Oxford, London and Newcastle. Pregnant women will be recruited at approximately 14 weeks’ gestation and have their vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature) measured at 4 to 6-week intervals during pregnancy. Vital signs recorded during labour and delivery will be extracted from hospital records. After delivery, participants will measure and record their own vital signs daily for 2 weeks. During the antenatal and postnatal periods, vital signs will be recorded on an Android tablet computer through a custom software application and transferred via mobile internet connection to a secure database. The data collected will be used to define reference ranges of vital signs across normal pregnancy, labour and the immediate postnatal period. This will inform the design of an evidence-based obstetric EWS.

Ethics and dissemination The study has been approved by the NRES committee South East Coast–Brighton and Sussex (14/LO/1312) and is registered with the ISRCTN (10838017). All participants will provide written informed consent and can withdraw from the study at any point. All data collected will be managed anonymously. The findings will be disseminated in international peer-reviewed journals and through research conferences.

  • Pregnancy
  • Vital Signs
  • Early Warning Score

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-016034

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    Footnotes

    • Contributors PJW is the principal investigator. PJW, LHM, LL, LT, OG, JK and FK made substantial contributions to the conception and design of the project. SG provided advice on statistical methodology. JK, FK and CE are involved in data collection. OG, AT, DS, LL and RMP are involved in software design and data analysis. FK wrote the first draft of the present manuscript. RMP and PJW reviewed and updated the draft. All authors read and approved the final manuscript.

    • Funding The 4P study is supported by the NIHR Biomedical Research Centre, Oxford. RMP and LL acknowledge the support of the RCUK Digital Economy Programme grant number EP/G036861/1 (Oxford Centre for Doctoral Training in Healthcare Innovation). LL is also supported by the Clarendon Fund. University of Oxford. Contact Heather House, Joint Research Office, Block 60, Churchill Hospital, Old Road, Oxford OX3 7LE.

    • Competing interests None declared.

    • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

    • Ethics approval NRES committee South East Coast-Brighton and Sussex (Ref: 14/LO/1312)

    • Provenance and peer review Not commissioned; externally peer reviewed.