Centre for Trials Research, Cardiff University, Cardiff, UK
School of Healthcare Sciences, Cardiff University, Cardiff, UK.
BMJ Open. 2021 Jan 8;11(1):e040684. doi: 10.1136/bmjopen-2020-040684.
Approximately 60 000 (9/100) infants are born into water annually in the UK and this is likely to increase. Case reports identified infants with water inhalation or sepsis following birth in water and there is a concern that women giving birth in water may sustain more complex perineal trauma. There have not been studies large enough to show whether waterbirth increases these poor outcomes. The POOL Study (ISRCTN13315580) plans to answer the question about the safety of waterbirths among women who are classified appropriate for midwifery-led intrapartum care.
A cohort study with a nested qualitative component. Objectives will be answered using retrospective and prospective data captured in electronic National Health Service (NHS) maternity and neonatal systems. The qualitative component aims to explore factors influencing pool use and waterbirth; data will be gathered via discussion groups, interviews and case studies of maternity units.
The protocol has been approved by NHS Wales Research Ethics Committee (18/WA/0291) the transfer of identifiable data has been approved by Health Research Authority Confidentiality Advisory Group (18CAG0153).Study findings and innovative methodology will be disseminated through peer-reviewed journals, conferences and events. Results will be of interest to the general public, clinical and policy stakeholders in the UK and will be disseminated accordingly.
在英国,每年大约有 60000(9/100)名婴儿在水中出生,这一数字可能还会增加。有病例报告称,婴儿在水中出生后会吸入水或发生败血症,人们担心在水中分娩的女性会遭受更复杂的会阴创伤。目前还没有足够大的研究表明水中分娩是否会增加这些不良结局。POOL 研究(ISRCTN13315580)旨在回答关于适合助产士主导的产时护理的女性水中分娩安全性的问题。
这是一项队列研究,包含一个嵌套的定性部分。将使用电子国民保健服务(NHS)产妇和新生儿系统中捕获的回顾性和前瞻性数据来回答目标。定性部分旨在探讨影响泳池使用和水中分娩的因素;数据将通过小组讨论、访谈和产妇单位的案例研究收集。
该方案已获得威尔士国民保健服务伦理委员会(18/WA/0291)的批准,可识别数据的转移已获得健康研究管理局保密咨询小组(18CAG0153)的批准。研究结果和创新方法将通过同行评议的期刊、会议和活动进行传播。结果将引起英国公众、临床和政策利益相关者的兴趣,并将相应地进行传播。