Parazzini F, Benedetto C, Danti L, Zanini A, Facchinetti F, Ettore G, Franchi M, Bertulessi C, Caruso A
Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
Eur J Obstet Gynecol Reprod Biol. 1998 Oct;81(1):15-20. doi: 10.1016/s0301-2115(98)00148-1.
To compare the effects of oxytocin and amniotomy or vaginal prostaglandin E2 (PGE2) for induction of labour.
We conducted a randomized clinical trial. Eligible for the trial were women with normal pregnancy, parity 0-3, with intact membranes, >40 weeks of gestation documented by ultrasound examination before 20 weeks gestation, observed in a network of 13 general and teaching hospitals in Italy. Inclusion criteria were cervical Bishop's score 5-7, less than six uterine contractions per hour, single pregnancy, cephalic presentation, no history of cesarean section and uterine surgery. Eligible women were randomly assigned by phone to oxytocin plus amniotomy (163 women) or vaginal PGE2 2 mg, two doses at 6-h intervals (157 women).
Overall, 50 women (15.6%) delivered by cesarean section, 22 (13.5%) randomized to oxytocin, and 28 (17.8%) randomized to PGE2 (not significant). Twelve hours after randomization, induction had failed in 26 women of the 163 randomized to oxytocin plus amniotomy (21.6%) and 34 out of the 157 randomized to PGE2 (15.9%): the difference was not significant. Neonatal outcome was similar in the two groups.
This study did not find marked differences in labour and neonatal outcome between women randomized to oxytocin plus amniotomy or vaginal PGE2. A shorter induction delivery interval in the group receiving amniotomy and oxytocin after PGE2 priming was observed.
比较缩宫素与人工破膜或阴道用前列腺素E2（PGE2）引产的效果。
我们进行了一项随机临床试验。试验对象为妊娠正常、0-3胎次、胎膜完整、妊娠20周前超声检查记录孕周>40周的女性，这些女性来自意大利13家综合医院和教学医院组成的网络。纳入标准为宫颈Bishop评分5-7分、每小时宫缩少于6次、单胎妊娠、头先露、无剖宫产和子宫手术史。符合条件的女性通过电话随机分为缩宫素加人工破膜组（163例）或阴道用PGE2 2mg组，每6小时给药2次（157例）。
总体而言，50例（15.6%）通过剖宫产分娩，缩宫素组22例（13.5%），PGE2组28例（17.8%）（差异无统计学意义）。随机分组12小时后，缩宫素加人工破膜组的163例中有26例（21.6%）引产失败，PGE2组的157例中有34例（15.9%）引产失败：差异无统计学意义。两组新生儿结局相似。
本研究未发现随机接受缩宫素加人工破膜或阴道用PGE2的女性在分娩和新生儿结局方面有显著差异。观察到在PGE2预处理后接受人工破膜和缩宫素的组引产至分娩间隔较短。
