A randomized controlled trial of dinoprostone vaginal suppository versus double-balloon catheter for labor induction in term pregnancies with hypertension
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摘要:
目的 比较地诺前列酮阴道栓剂与双球囊导管在足月妊娠期高血压疾病患者引产中的安全性和有效性，为临床引产方法选择提供依据。 方法 选取2022年8月—2024年6月郑州大学第三附属医院收治的确诊妊娠期高血压或非重度子痫前期140例足月妊娠孕妇为研究对象，采用随机数字表法将患者分为地诺前列酮栓组（70例）与双球囊导管组（70例）。 结果 地诺前列酮栓组的24 h内阴道分娩率显著高于双球囊导管组[37例（52.86%) vs. 16例（22.86%)，P＜0.001]，且48 h内阴道分娩率也更高[54例（77.14%) vs. 31例（44.29%)，P＜0.001]。地诺前列酮栓组的引产至产程开始的间隔时间[9.00(3.59, 14.25)h vs. 17.67(15.67, 19.50)h，P＜0.001]和分娩间隔时间[21.85(13.02, 31.92)h vs. 27.65(24.99, 32.18)h，P=0.020]均显著短于导管组。2组总体不良反应发生率比较差异无统计学意义[16例（22.86%) vs. 11例（15.71%），P=0.284]，但地诺前列酮栓组的子宫过度刺激发生率更高[6例（8.57%）vs. 0例，P=0.028]。 结论 在合并高血压疾病的足月妊娠患者引产中，地诺前列酮阴道栓剂可显著提高阴道分娩率、缩短引产所需时间，且未增加总体不良反应发生率，表明地诺前列酮阴道栓剂可作为足月妊娠期高血压疾病孕妇的优选引产方案。 Abstract:Objective This study aimed to compare the safety and efficacy of dinoprostone vaginal suppositories and a double-balloon catheter for labor induction in women at term with hypertensive disorders of pregnancy, such as gestational hypertension and non-severe preeclampsia, to inform clinical decision-making. Methods This single-center, open-label, randomized controlled trial was conducted at the Third Affiliated Hospital of Zhengzhou University between August 2022 and June 2024. A total of 140 pregnant women diagnosed with gestational hypertension or non-severe preeclampsia at ≥ 37 weeks of gestation were enrolled and randomly assigned to the Dinoprostone group (n=70) or the catheter group (n=70) using a computer-generated randomization sequence. Results Successful labor induction was defined as vaginal delivery within 48 hours. The Dinoprostone group demonstrated a significantly higher rate of vaginal delivery within 24 hours compared to the double-balloon catheter group [37 (52.86%) vs. 16 (22.86%), P < 0.001], as well as a higher 48-hour delivery rate [54 (77.14%) vs. 31 (44.29%), P < 0.001]. Among nulliparous women, the dinoprostone group demonstrated significantly shorter time to labor onset [9.00 (3.59, 14.25) h vs. 17.67 (15.67, 19.50) h] and shorter time to vaginal delivery [21.85 (13.02, 31.92) h vs. 27.65 (24.99, 32.18) h] compared to controls (P < 0.05). While overall incidence of adverse events showed no significant differences between groups [16 (22.86%) vs. 11 (15.71%), P=0.284]. However, uterine hyperstimulation occurred more frequently in the dinoprostone group [6 (8.57%) vs. 0, P=0.028]. Conclusion Dinoprostone vaginal suppositories are more effective than the double-balloon catheter for labor induction in term pregnancies complicated by hypertension, achieving higher delivery rates and shorter induction times with comparable safety. These findings support dinoprostone as a preferable option in this patient population. -
表 1 2组患者基线特征比较
Table 1. Comparison of baseline characteristics between the two groups of patients
项目 双球囊导管组
(n=70)地诺前列酮栓组
(n=70)统计量 P值 年龄(x±s，岁) 30.51±4.12 30.87±3.73 0.538a 0.592 孕周[M(P25，P75), 周] 39.28(38.54，40.29) 40.00(38.64，40.33) -1.339b 0.180 产次类型[例(%)] 0.560c 0.454 初产妇 48(68.57) 52(74.29) 经产妇 22(31.43) 18(25.71) Bishop评分[例(%)] 0.099c 0.753 0~2分 5(7.14) 6(8.57) 3~5分 65(92.86) 64(91.43) 引产前血压(x±s，mmHg) 收缩压 135.77±14.04 135.77±12.34 ＜0.001a 0.999 舒张压 86.56±10.30 86.11±9.76 0.261a 0.794 尿蛋白[例(%)] 1.458c 0.227 阴性 51(72.86) 57(81.43) 阳性 19(27.14) 13(18.57) 降压治疗[例(%)] 41(58.57) 34(48.57) 1.407c 0.236 BMI(x±s) 25.57±4.62 25.18±4.41 0.522a 0.602 注：a为t值，b为Z值，c为χ2值。1 mmHg=0.133 kPa。 
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表 2 2组患者引产成功率、时间及不良反应比较
Table 2. Comparison of the success rate of induced abortion, time and adverse reactions between the two groups of patients
项目 双球囊导管组
(n=70)地诺前列酮栓组
(n=70)统计量 P值 24 h阴道分娩[例(%)] 16(22.86) 37(52.86) 13.390a ＜0.001 48 h阴道分娩[例(%)] 31(44.29) 54(77.14) 15.842a ＜0.001 引产至分娩间隔时间[M(P25, P75)，h] 27.65(24.99, 32.18) 21.85(13.02, 31.92) -2.319b 0.020 引产至产程发动间隔时间[M(P25, P75)，h] 17.67(15.67, 19.50) 9.00(3.59, 14.25) -3.549b ＜0.001 母婴不良反应[例(%)] 11(15.71) 16(22.86) 0.201a 0.284 子宫过度刺激[例(%)] 0 6(8.57) 0.028c 胎心异常[例(%)] 3(4.29) 1(1.43) 0.620c 严重高血压[例(%)] 3(4.29) 1(1.43) 0.620c 产后出血[例(%)] 1(1.43) 3(4.29) 0.620c 羊水污染[例(%)] 4(5.71) 2(2.86) 0.681c 胎盘早剥[例(%)] 0 2(2.86) 0.496c 新生儿窒息[例(%)] 0 1(1.43) 0.999c 中转剖宫产[例(%)] 1(1.43) 0 0.999c 器械助产[例(%)] 1(1.43) 2(2.86) 0.999c 产时出血[M(P25, P75)，mL] 210.00(170.00，260.00) 200.00(167.50，232.50) -0.818b 0.414 注：a为χ2值，b为Z值，c为采用Fisher精确检验。
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