Nat Med:世卫组织分娩护理指南对印度剖宫产的影响:一项实用、阶梯式楔形、集群随机试点试验
本文由小咖机器人翻译整理
期刊来源:Nat Med
原文链接:https://doi.org/10.1038/s41591-023-02751-4
摘要内容如下:
由于医学上不必要的剖宫产使用,世界范围内的剖宫产率正在上升。新的世界卫生组织分娩护理指南(LCG)旨在提高分娩期间妇女的护理质量。使用LCG可能会减少剖宫产的过度使用;然而,其效果尚未在随机试验中进行评估。我们在印度的四家医院进行了一项阶梯式楔形、集群随机试点试验,以评估LCG策略干预的实施情况,并与常规护理进行比较。我们进行了这项试验,以试点干预并获得初步的有效性数据,为未来的研究提供信息。符合条件的聚集地是每年分娩超过4,000例且剖宫产率≥30%的四家医院。符合条件的妇女是那些妊娠≥20周的妇女。根据随机序列,一家医院每2个月过渡到干预。主要转归是Robson 1组妇女的剖宫产率(即未产妇和分娩单胎、足月妊娠、头位和自然分娩的妇女)。共有26331名参与者分娩。观察到主要结果有5.5%的粗略绝对减少(45.2%对39.7%;相对危险度0.85,95%可信区间0.54-1.33)。母亲的护理过程结果没有显著差异,尽管催产素助产比LCG策略低18.0%。在其他健康结果或妇女的分娩经历方面没有观察到差异。这些发现可以指导未来明确的有效性试验,特别是在需要紧急扭转剖宫产率上升的情况下。印度临床试验注册编号:CTRI/2021/01/030695。
英文原文如下:
Abstracts
Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/030695 .
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