Sørbye Ingvil Krarup, Gunnes Nina, Solhoff Aslak Vimme, Haavaldsen Camilla, Kessler Jørg, Kjøllesdal Anne Molne, Jacobsen Anne Flem, Magnussen Elisabeth Balstad, Pettersen Åse Torunn Revholdt, Sande Ragnar Kvie, Sjøborg Katrine Dønvold, Ween-Velken Marte Eline, Leeves Lisa Tangnes, Michelsen Trond Melbye
Department of Obstetrics, Oslo University Hospital, Oslo, Norway
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
BMJ Open. 2025 Mar 3;15(3):e093992. doi: 10.1136/bmjopen-2024-093992.
Presently, more than one in four births in high-income countries undergo labour induction. Induction of labour is an independent risk factor for adverse obstetric outcomes, including high rates of operative delivery. Two drugs, hyoscine butylbromide and sodium bicarbonate, have been used in labour to facilitate cervical dilation and prevent uterine lactate accumulation. However, no previous randomised trial has systematically studied the separate and combined effects of these drugs in women with induction of labour.
The Safe Induction of Labour Trial (SAINT) study will assess the efficacy of oral sodium bicarbonate and intravenous hyoscine butylbromide on facilitating spontaneous (ie, non-operative) delivery in nulliparous participants with induction of labour. We present a 2×2 factorial design where three active treatment arms are compared with double-placebo. Participants are recruited at 10 delivery departments across Norway. Treatment will start on diagnosis of established labour with a maximum of three consecutive doses 4 hours apart. Approximately 5100 women will be screened to achieve 3000 participants randomly assigned to study intervention.
The primary outcome of spontaneous delivery will be analysed using binary logistic regression. Results will be presented as marginal adjusted risk differences between each of the three active treatment groups and the double-placebo group.
The SAINT study is approved by the Regional Committee for Medical and Health Research Ethics, the European Union Clinical Trials Information System, the Norwegian Medical Products Agency and Institutional Review Boards. Results will be disseminated in peer-reviewed journals and communications to congresses.
Clinical Trials: NCT05719467. EudraCT/EUCT: 2021-000392-37/2024-511848-55-00.
目前，高收入国家超过四分之一的分娩采用引产。引产是不良产科结局的独立危险因素，包括较高的手术分娩率。两种药物，丁溴东莨菪碱和碳酸氢钠，已用于分娩过程中以促进宫颈扩张并防止子宫乳酸堆积。然而，之前尚无随机试验系统研究过这些药物在引产女性中的单独及联合作用。
引产安全试验（SAINT）研究将评估口服碳酸氢钠和静脉注射丁溴东莨菪碱对引产初产妇促进自然（即非手术）分娩的疗效。我们采用2×2析因设计，将三个活性治疗组与双安慰剂组进行比较。在挪威的10个分娩科室招募参与者。治疗将在确诊临产时开始，最多连续给药3剂，间隔4小时。大约5100名女性将接受筛查，以获得3000名随机分配到研究干预组的参与者。
自然分娩的主要结局将使用二元逻辑回归进行分析。结果将以三个活性治疗组与双安慰剂组之间的边际调整风险差异呈现。
SAINT研究已获得地区医学与健康研究伦理委员会、欧盟临床试验信息系统、挪威药品管理局和机构审查委员会的批准。研究结果将在同行评审期刊上发表，并在学术会议上进行交流。
临床试验：NCT05719467。欧盟临床试验数据库/欧洲临床试验：2021-000392-37/2024-511848-55-00。
