Agarwal Nutan, Gupta Anjali, Kriplani Alka, Bhatla Neerja
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.
J Obstet Gynaecol Res. 2003 Jun;29(3):147-51. doi: 10.1046/j.1341-8076.2003.00091.x.
Prospective clinical trials were conducted to assess the safety and efficacy of 6-hourly vaginal misoprostol versus intracervical dinoprostone for induction of labor.
A total of 120 pregnant women requiring induction of labor were recruited. Cases were randomized to receive either 50 microg vaginal misoprostol 6 hourly (group 1, n = 60) or 0.5 mg intracervical dinoprostone 6 hourly (group II, n = 60). Outcome measures, such as change in Bishop's score, need of oxytocin, induction delivery interval; complications like tachysystoly, hyperstimulation, abnormal fetal heart rate, and meconium passage were compared between two groups. Statistical analysis was performed by Wilcoxan's Rank sum and Student's t-test.
Bishop score rise, after 6 h of initiation of therapy was significantly higher in the misoprostol group than dinoprostone, 2.98 +/- 2.57 versus 2.05 +/- 1.83 (P = 0.04). The need of oxytocin augmentation was reduced in misoprostol versus dinoprostone group, 16.6% versus 78.3% (P = <0.001). Induction delivery interval was shorter in misoprostol; 12.8 +/- 6.4 h versus 18.53 +/- 8.5 h in dinoprostone group (P = <0.01). One case (1.6%) in misoprostol group, but none in dinoprostone had tachystole (P = 1.00). Abnormal heart rate pattern was found more in misoprostol than dinoprostone 16.6% versus 4.9% (P = 0.14) and so was the incidence of cesarean section, 26.6 versus 15%, respectively (P = 0.47). Meconium passage was the same in both groups, 10% in each group.
Vaginal misoprostol 50 microg 6-hourly is safe and effective for induction of labor with lesser need of oxytocin augmentation and shorter induction delivery interval.
开展前瞻性临床试验，以评估每6小时阴道使用米索前列醇与宫颈内使用地诺前列酮引产的安全性和有效性。
共招募了120名需要引产的孕妇。将病例随机分为两组，一组每6小时阴道给予50微克米索前列醇（第1组，n = 60），另一组每6小时宫颈内给予0.5毫克地诺前列酮（第II组，n = 60）。比较两组的结局指标，如 Bishop 评分的变化、催产素的使用需求、引产至分娩间隔；以及并发症，如子宫收缩过速、过度刺激、异常胎心和胎粪排出情况。采用 Wilcoxan 秩和检验和学生t检验进行统计分析。
治疗开始6小时后，米索前列醇组的 Bishop 评分升高显著高于地诺前列酮组，分别为2.98±2.57和2.05±1.83（P = 0.04）。与地诺前列酮组相比，米索前列醇组催产素增加的需求减少，分别为16.6%和78.3%（P = <0.001）。米索前列醇组的引产至分娩间隔更短；分别为12.8±6.4小时和地诺前列酮组的18.53±8.5小时（P = <0.01）。米索前列醇组有1例（1.6%）出现子宫收缩过速，而地诺前列酮组无（P = 1.00）。米索前列醇组出现异常心率模式的比例高于地诺前列酮组，分别为16.6%和4.9%（P = 0.14），剖宫产率也是如此，分别为26.6%和15%（P = 0.47）。两组的胎粪排出情况相同，每组均为10%。
每6小时阴道给予50微克米索前列醇引产安全有效，催产素增加需求较少，引产至分娩间隔较短。
