Denison Fiona C, Norrie John, Lawton Julia, Norman Jane E, Scotland Graham, McPherson Gladys C, McDonald Alison, Forrest Mark, Hudson Jemma, Brewin Jane, Peace Mathilde, Clarkson Cynthia, Brook-Smith Sheonagh, Morrow Susan, Hallowell Nina, Hodges Laura, Carruthers Kathryn F
Tommy's Centre for Maternal and Fetal Health Research, Medical Research Council Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
The Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
BMJ Open. 2017 Sep 18;7(9):e017134. doi: 10.1136/bmjopen-2017-017134.
A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP).
The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice.
Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals.
ISCRTN88609453; Pre-results.
胎儿娩出后胎盘未娩出即诊断为胎盘滞留。胎盘滞留是产后出血的主要原因，需通过人工剥离胎盘术（MROP）这一手术操作进行治疗。
这项在英国范围内开展的实用、随机、安慰剂对照、双盲试验，设有内部预试验和嵌套定性研究以调整策略来完善主要试验的实施，其目的是确定舌下含服硝酸甘油（GTN）对于胎盘滞留的（药物）治疗在临床和成本效益方面是否具有优势。主要临床结局是是否需要进行人工剥离胎盘术，定义为研究治疗后15分钟胎盘仍未娩出和/或因安全问题在治疗后15分钟内需要进行该操作。主要安全结局是测量从治疗给药至转至产后病房或其他临床区域期间的失血量。主要患者层面结局是对治疗的满意度和副作用情况。主要经济结局是与标准治疗相比，使用GTN给英国国家医疗服务体系带来的净增量成本（或成本节省）。次要结局将在一系列临床和经济领域进行测量。主要结局将使用适合各结局分布的线性模型进行分析。在GTN与标准治疗的成本 - 后果分析中，将把卫生服务成本与多个试验结局进行比较。
已获得东北纽卡斯尔和北泰恩赛德2研究伦理委员会的伦理批准（13/NE/0339）。该试验的传播计划包括卫生技术评估专著、在国际科学会议上的报告以及在高影响力、同行评审期刊上发表。
ISCRTN88609453；预结果。
