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
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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DOI：
10.1136/bmjopen-2017-016034
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发表时间：
2017-09-01
期刊：
影响因子：
2.9
通讯作者：
Watkinson, Peter J.
中科院分区：
文献类型：
--
作者：
Kumar, Fiona;Kemp, Jude;Watkinson, Peter J.
简介英国对孕产妇死亡的连续秘密调查表明，迫切需要制定专门针对怀孕或新近怀孕的妇女的国家早期预警评分(EWS)，以帮助更及时地识别、转介和治疗在怀孕或产褥期出现危及生命的并发症的妇女。虽然许多地方的EWS在产科使用，但大多数都是启发式开发的。目前还没有产科EWS使用基于证据的正常范围来定义应该触发警报的阈值，它们也没有反映怀孕期间随着怀孕而发生的生理变化。方法和分析一项涉及英国牛津、伦敦和纽卡斯尔三个地点1000名参与者的观察性队列研究。孕妇将在怀孕约14周时被招募，并在怀孕期间每隔4至6周测量一次生命体征(心率、血压、呼吸频率、氧饱和度和体温)。在分娩和分娩期间记录的生命体征将从医院记录中提取。分娩后，参与者将在2周内每天测量和记录自己的生命体征。在产前和产后期间，生命体征将通过定制软件应用程序记录在Android平板电脑上，并通过移动互联网连接传输到安全数据库。收集的数据将被用来定义正常怀孕、分娩和出生后立即的生命体征的参考范围。这将为以循证为基础的产科EWS的设计提供信息。伦理和传播该研究已获得NRES委员会批准(14/LO/1312)，并在ISRCTN注册(10838017)。所有参与者都将提供书面知情同意，并可随时退出研究。所有收集的数据都将以匿名方式进行管理。研究结果将在国际同行评议的期刊和研究会议上传播。
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.