ISRCTN17679951进行中（未招募）Unknown
Clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth: the Obstetric Bleeding Study UK (OBS UK) Stepped Wedge Cluster Randomised Trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 189,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Site inclusion criteria:
- •1. Maternity unit with >2000 births per year
- •2. Local NHS maternity leaders support the implementation of the OBS UK intervention and quality improvement time for the local champion team. This must include protected midwifery time (4 hours/week) and non-clinical time for consultant obstetrician, anaesthetist, and haematologist from supporting professional activity during the 9-month implementation period
- •For the psychology sub-study inclusion criteria are (requiring individual consent):
- •1. Women who have experienced a PPH of greater than 1L and their birth partners
- •For the cost-effectiveness sub-study inclusion criteria are (requiring individual consent):
- •1. Women who have experienced a PPH of greater than 1L and their economic partners
- •2. Women who have a blood loss of less than 500mL and their economic partners
- •For the process evaluation inclusion criteria are (interviews require individual consent, observation/ethnography study does not require individual consent):
- •1. Women and, if they would like to be involved, their birth partners who have experienced a PPH of greater than 1 L at one of four maternity units that were included in the pilot study (OBS Cymru) and selected for a site visit
- •2. Women and, if they would like to be involved, their birth partners who have experienced a PPH of greater than 1L at a maternity unit selected for a process evaluation site visit in the OBS UK study
- •3. Members of staff at four maternity units that were included in the pilot study (OBS Cymru) and are selected for a site visit
- •4. Members of the specialist and wider team who work in the maternity service at a maternity unit selected for a process evaluation site visit in the OBS UK study
- •All patients are included in the primary outcome, whilst those opting out will not be included in the datasets/targeted source data. The lower age limit is only for the consenting sub studies.
排除标准
- •Site exclusion criteria:
- •1. Maternity units that have adopted the entire OBS UK obstetric haemorrhage care bundle
- •2. Maternity units that use viscoelastic point-of-care tests of haemostasis on the consultant-led delivery suite or in obstetric theatres
- •3. If a Trust or Health Board has more than one maternity unit then only one can join the study
- •For the psychology sub-study exclusion criteria are (requiring individual consent):
- •1. Age <16 years, prisoners and individuals who lack capacity
- •2. Women and birth partners who have had experienced a stillbirth or neonatal death will be excluded from the psychology study component
- •For the cost-effectiveness sub-study exclusion criteria are (requiring individual consent):
- •1. Age <16 years, prisoners and individuals who lack capacity
- •For the process evaluation exclusion criteria are (interviews require individual consent, observation/ethnography study does not require individual consent):
- •1. Age <16 years, prisoners and individuals who lack capacity
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