背景:所有孕妇中约有20-30%使用机械方法或药理药物进行引产。我们专门比较地诺前列酮与经宫颈Foley导管在足月妊娠妇女中引产的有效性和安全性,子宫颈不利,样本充足。
目的:比较地诺前列酮与经宫颈Foley导管在足月孕妇宫颈不良引产中的有效性和安全性。
方法:这是并行的,上海两个孕产妇中心的开放标签随机对照试验,2019年10月至2022年7月之间的中国。足月头部单胎妊娠和计划引产的子宫颈不良(Bishop评分<6)的妇女符合资格。1,860名妇女被随机分配到使用地诺前列酮阴道插入物(10mg)或60ccFoley导管长达24小时的宫颈成熟。主要结果是阴道分娩率和阴道分娩时间。次要结局包括分娩时间和孕产妇和新生儿发病率。分析是从意向治疗的角度进行的。该试验在中国试验注册中心(CTR2000038435)注册。
结果:阴道分娩率为72.8%(677/930)阴道地诺前列酮和Foley导管中69.9%(650/930),分别(ARR1.04,95%CI0.98至1.10,风险差异:0.03)。两组之间至阴道分娩的时间没有显着差异(子分布风险比1.11,95%CI0.99-1.24)。阴道地诺前列酮更可能伴有胎儿心率变化的过度刺激(5.8%vs.2.8%,aRR2.09,95%CI1.32-3.31)和胎盘早剥(0.9%与0.1%,RR:8.04,95%CI1.01-64.15),而Foley导管更有可能并发可疑的产时感染(5.1%vs.8.2%,aRR:0.62,95%CI0.44-0.88)和产后感染(1.4%与3.7%,RR:0.38,95%CI0.20-0.72)。两组新生儿不良结局的复合差异无统计学意义(4.5%vs.3.8%,RR1.21,95%CI0.78至1.88),而地诺前列酮组发生更多的新生儿窒息(1.2%vs.0.2%,RR5.39,95%CI1.22至23.92)。在亚组分析中,阴道地诺前列酮可略微降低经产妇女的阴道出生率(90.6%与97.0%,RR0.93,95%CI0.88至0.99)。
结论:子宫颈不良的足月孕妇,使用阴道地诺前列酮或Foley导管引产的效果相似。Foley导管为新生儿带来更好的安全性,虽然它可能导致更高的产妇感染的风险。此外,Foley导尿管应优先用于经产妇女。
BACKGROUND: Induction of labor with mechanical methods or pharmacological agents is used in about 20-30% of all pregnant women. We specialized in comparing the effectiveness and safety of dinoprostone versus transcervical Foley catheter for induction of labor in term pregnant women with an unfavorable cervix with adequate samples.
OBJECTIVE: To compare the effectiveness and safety of dinoprostone versus transcervical Foley catheter for induction of labor in term pregnant women with an unfavorable cervix.
METHODS: This is a parallel, open-label randomized controlled
trial in two maternal centers in Shanghai, China between October 2019 and July 2022. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score < 6) scheduled for induction of labor were eligible. 1,860 women were randomly allocated to cervical ripening with either a dinoprostone vaginal insert (10mg) or a 60cc Foley catheter for up to 24 hours. The primary outcomes were vaginal delivery rate and time to vaginal delivery. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was done from an intention-to-treat perspective. The
trial was registered with the China
trial registry (CTR2000038435).
RESULTS: The vaginal birth rates were 72.8% (677/930) vs. 69.9% (650/930) in vaginal dinoprostone and Foley catheter, respectively (aRR 1.04, 95% CI 0.98 to 1.10, risk difference: 0.03). Time to vaginal delivery was not significantly different between the two groups (sub-distribution hazard ratio 1.11, 95% CI 0.99-1.24). Vaginal dinoprostone was more likely complicated with hyperstimulation with fetal heart rate changes (5.8% vs. 2.8%, aRR 2.09, 95% CI 1.32-3.31) and placenta abruption (0.9% vs. 0.1%, aRR: 8.04, 95% CI 1.01-64.15), while Foley catheter was more likely complicated with suspected intrapartum infection (5.1% vs. 8.2 %, aRR: 0.62, 95% CI 0.44-0.88) and postpartum infection (1.4% vs. 3.7%, aRR: 0.38, 95% CI 0.20-0.72). The composite of poor neonatal outcomes was not significantly different between the two groups (4.5% vs. 3.8%, aRR 1.21, 95% CI 0.78 to 1.88), while more neonatal asphyxia occurred in the dinoprostone group (1.2% vs. 0.2%, aRR 5.39, 95% CI 1.22 to 23.92). In a subgroup analysis, vaginal dinoprostone decreased vaginal birth rate slightly in multiparous women (90.6% vs. 97.0%, aRR 0.93, 95% CI 0.88 to 0.99).
CONCLUSIONS: In term pregnant women with an unfavorable cervix, induction of labor with vaginal dinoprostone or Foley catheter has similar effectiveness. Foley catheter leads to better safety for neonates, while it may result in a higher risk of maternal infection. Furthermore, Foley catheter should be preferred in multiparous women.