Combination of Foley Bulb and Vaginal Misoprostol Compared With Vaginal Misoprostol Alone for Cervical Ripening and Labor Induction A Randomized Controlled Trial

Combination of Foley Bulb and Vaginal Misoprostol Compared With Vaginal Misoprostol Alone for Cervical Ripening and Labor Induction A Randomized Controlled Trial
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DOI:
10.1097/aog.0b013e31827e5dca
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发表时间:
2013-02-01
影响因子:
7.2
通讯作者:
Macones, George A.
Macones, George A.
中科院分区:
医学2区
文献类型:
--
作者:
Carbone, Jeanine F.;Tuuli, Methodius G.;Macones, George A.

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目的:验证Foley球联合阴道米索前列醇比单独阴道米索前列醇诱导至分娩时间更短的假设。方法:我们将123名妊娠24周或更大且宫颈不良(Bishop评分6分或更低)的单胎妊娠妇女随机分为Foley球加阴道米索前列醇组(n=56)或阴道米索前列醇组(n=61)。排除胎姿不良、多胎妊娠、自然分娩、前列腺素禁忌症、胎心描记不可靠、宫内生长受限、胎儿异常、胎儿死亡、既往剖宫产或其他重大子宫手术的妇女。主要结局指标为诱导至分娩时间。次要结局为分娩方式、心动过速伴胎儿减速、特布他林的使用、产后出血、绒毛膜羊膜炎、新生儿Apgar评分和新生儿重症监护病房入住情况。分析遵循意向治疗原则。结果:与单独阴道米索前列醇相比,Foley球联合阴道米索前列醇的平均诱导至分娩时间更短(15.3 +/- 6.5小时比18.3 +/- 8.7小时,差值为-3.1小时,95%可信区间[CI] -5.9 ~ -0.30)。联合用药还可缩短引产至宫颈完全扩张的时间(13.7 +/- 5.9小时比17.1 +/- 8.7小时,差异23.5小时,95% CI -6.7 ~ -0.4)。分娩并发症或新生儿和产妇的不良结局没有差异。结论:与单独使用阴道米索前列醇相比,Foley球联合阴道米索前列醇可缩短引产时间,且不会增加分娩并发症。
OBJECTIVE: To test the hypothesis that use of the Foley bulb plus vaginal misoprostol will result in shorter induction-to-delivery time compared with vaginal misoprostol alone.METHODS: We randomized 123 women undergoing induction of labor with singleton pregnancies at 24 weeks of gestation or greater with an unfavorable cervix (Bishop score 6 or lower) to Foley bulb plus vaginal misoprostol (n=56) or vaginal misoprostol alone (n=61). Women with fetal malpresentation, multifetal gestation, spontaneous labor, contraindication to prostaglandins, nonreassuring fetal heart rate tracing, intrauterine growth restriction, anomalous fetus, fetal demise, or previous cesarean delivery or other significant uterine surgery were excluded. The primary outcome measure was induction-to-delivery time. Secondary outcomes were mode of delivery, tachysystole with fetal decelerations, terbutaline use, postpartum hemorrhage, chorioamnionitis, neonatal Apgar scores, and neonatal intensive care unit admission. Analysis followed the intention-to-treat principle.RESULTS: The mean induction-to-delivery time was shorter with the combination of the Foley bulb and vaginal misoprostol when compared with vaginal misoprostol alone (15.3 +/- 6.5 compared with 18.3 +/- 8.7 hours, difference -3.1 hours, 95% confidence interval [CI] -5.9 to -0.30). The combination also resulted in shorter induction to complete cervical dilation time (13.7 +/- 5.9 compared with 17.1 +/- 8.7 hours, difference 23.5 hours, 95% CI -6.7 to -0.4). There were no differences in labor complications or adverse neonatal and maternal outcomes.CONCLUSION: A combination of the Foley bulb and vaginal misoprostol resulted in a shorter induction- todelivery time when compared with vaginal misoprostol alone without increasing labor complications.