ObjectiveTo assess if off‐label oral solution of misoprostol compared with licensed oral tablet of misoprostol approved for induction of labour (IOL) is as efficient in resulting in vaginal delivery within 24 h, using a non‐inferiority design.DesignProspective, randomised, non‐inferiority, open‐label, blinded endpoint trial.SettingTwo tertiary level hospitals, Stockholm, Sweden, January 2022 to May 2023.PopulationIn all, 874 women, without previous caesarean section, with an unripe cervix and a singleton, cephalic foetus at 37 + 0 to 42 + 0 gestational weeks, with a normal cardiotocography, planned for IOL were included.MethodsWomen were randomised 1:1 to intervention (25 μg oral solution of misoprostol) or control (25 μg oral tablet of misoprostol) two‐hourly for a maximum of eight doses. Subsequent methods of induction followed clinical practice.Main Outcome MeasuresThe primary outcome was vaginal delivery within 24 h tested using non‐inferiority testing procedures at a non‐inferiority margin of 5 percentage points. Secondary efficacy outcomes were tested for superiority of either treatment. Analyses were by intention‐to‐treat.ResultsThere were 207 (47.4%) vaginal deliveries within 24 h for women receiving oral solution and 192 (43.9%) vaginal deliveries within 24 h for women receiving oral tablet, establishing non‐inferiority with an absolute risk difference of 3.4% (95% CI −3.2% to 10.0%). Women receiving oral solution required fewer doses to reach active labour than women receiving oral tablet (5.7 vs. 6.1, p = 0.007). There were no significant differences for other secondary or safety outcomes.ConclusionsOff‐label oral solution of misoprostol was non‐inferior to the licensed oral tablet regarding efficacy of IOL defined as vaginal delivery within 24 h.Trial RegistrationClinicaltrials.gov identifier: NCT05424445

中文翻译：

---

米索前列醇作为口服溶液或用于引产的口服片剂 （MISOBEST）：一项随机对照非劣效性试验


目的使用非劣效性设计，评估米索前列醇超说明书口服溶液与批准用于引产 （IOL） 的许可米索前列醇口服片剂相比，在 24 小时内阴道分娩是否同样有效。Design前瞻性、随机、非劣效性、开放标签、盲法终点试验。地点瑞典斯德哥尔摩的两家三级医院，2022 年 1 月至 2023 年 5 月.人口总共包括 874 名妇女，既往无剖宫产，宫颈未成熟，胎头胎，胎头胎在 37 + 0 至 42 + 0 孕周，胎心宫缩监护正常，计划进行人工晶状体检查。方法女性以 1：1 的比例随机分配到干预组（25 μg 米索前列醇口服溶液）或对照组（25 μg 米索前列醇口服片剂）每两小时一次，最多八剂。随后的诱导方法遵循临床实践。主要结局指标主要结局是使用非劣效性测试程序以 5 个百分点的非劣效性测试程序测试 24 小时内阴道分娩。测试了两种治疗的优效性对次要疗效结局。分析按意向性治疗进行。结果接受口服溶液的妇女在 24 小时内阴道分娩 207 例 （47.4%），接受口服片剂的妇女在 24 小时内阴道分娩 192 例 （43.9%），确立了绝对风险差异 3.4% 的非劣效性 （95% CI -3.2%， 10.0%）。与接受口服片剂的妇女相比，接受口服溶液的妇女需要更少的剂量才能达到积极分娩（5.7 vs. 6.1，p = 0.007）。其他次要或安全结局无显著差异。结论米索前列醇超说明书口服溶液在定义为 24 小时内阴道分娩的 IOL 疗效方面不劣于许可的口服片剂。试验注册临床试验。gov 标识符：NCT05424445