足月单胎初产妇引产：快与慢-比较慢释阴道栓剂与小剂量米索前列醇口服片剂的队列研究。
Induction of labour in nulliparous women- quick or slow: a cohort study comparing slow-release vaginal insert with low-dose misoprostol oral tablets.
机构信息
Department of Obstetrics and Gynaecology, Holbaek Hospital, Holbaek, Denmark.
Department of Obstetrics and Gynaecology, Hvidovre Hospital, Kettegaard Alle 30, 2650, Hvidovre, Denmark.
出版信息
BMC Pregnancy Childbirth. 2020 Feb 7;20(1):79. doi: 10.1186/s12884-020-2770-0.
BACKGROUND
This study was undertaken with the objective of comparing efficacy and safety for two different regimens using misoprostol for induction of labour.
METHODS
The study was set in two different hospitals in the region of Zeeland, Denmark, and designed as a prospective cohort study. Nulliparous women with unripe cervix, eligible for vaginal delivery and medical induction of labour were included. Exclusion criteria were a previous uterine scar, suspicion of growth restriction of the fetus and prelabour rupture of membranes. One department used 25 mcg oral misoprostol tablets and the other department used 200 mcg slow-release misoprostol vaginal insert, for induction of labour. Primary outcomes were predefined as frequency of cesarean section, tachysystole and delivery within 24 h. Secondary outcomes were: time from induction to delivery, use of additional methods for induction, postpartum hemorrhage, anal sphincter rupture, epidural, pyrexia (rectal temperature > 38.5 °C), prolonged rupture of membranes, and use of tocolysis.
RESULTS
No significant differences in women achieving vaginal delivery was found. However, a significantly increased risk of tachysystole for the vaginal administration route was observed; 28.4% compared with 2.3%. There were no events of serious neonatal asphyxia. Half of the women induced with vaginal insert delivered within 24 h, compared with 16.8% of the women induced with oral misoprostol.
CONCLUSIONS
Induction with vaginal slow-release misoprostol leads to quicker delivery with an increased risk of tachysystole but with similar perinatal outcomes and rates of cesarean sections. Low-dose oral misoprostol appears to be safe, however it leads to an increased use of secondary methods and a tendency of more intrapartum pyrexia.
TRIAL REGISTRATION
Clinicaltrials.gov ID: NCT02693587 on February 262,016. EudraCT number 2020-000366-42 on 23 January 2020, retrospectively registered.
背景
本研究旨在比较两种不同方案（米索前列醇诱导分娩）的疗效和安全性。
方法
该研究在丹麦泽兰地区的两家不同医院进行，设计为前瞻性队列研究。纳入初产妇、宫颈未成熟、符合阴道分娩和药物引产条件的患者。排除标准为既往子宫瘢痕、怀疑胎儿生长受限和胎膜早破。一个科室使用 25 mcg 口服米索前列醇片，另一个科室使用 200 mcg 阴道慢释放米索前列醇栓，用于引产。主要结局定义为剖宫产率、心动过速和 24 小时内分娩。次要结局为：引产至分娩的时间、诱导分娩的其他方法的使用、产后出血、肛门括约肌破裂、硬膜外、发热（直肠温度＞38.5°C）、延长的胎膜破裂和使用宫缩抑制剂。
结果
未发现阴道分娩的女性有显著差异。然而，阴道给药途径的心动过速风险显著增加；28.4%比 2.3%。无严重新生儿窒息事件。阴道给药组有一半的产妇在 24 小时内分娩，而口服米索前列醇组有 16.8%。
结论
阴道缓慢释放米索前列醇引产可更快分娩，心动过速风险增加，但围产结局和剖宫产率相似。低剂量口服米索前列醇似乎是安全的，但它会导致更多次的辅助分娩方法的使用，以及更多的产时发热。
试验注册
Clinicaltrials.gov ID：NCT02693587 于 2016 年 2 月 26 日注册，EudraCT 编号 2020-000366-42 于 2020 年 1 月 23 日注册。
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