Paisarntantiwong Rita, Getgan Mayuri
Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration (BMA) Medical College and Vajira Hospital, Bangkok 10300, Thailand.
J Med Assoc Thai. 2005 Oct;88 Suppl 2:S56-62.
To compare the efficacy and safety of a single dose of 50 microg oral misoprostol with 25 microg vaginal misoprostol for labor induction.
This study was a randomized, double-blind controlled trial conducting in pregnant women admitted at delivery room, Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital between March 2002 and January 2005. All 146 pregnancies at > or = 37 weeks' gestation who had indication for labor induction with unfavorable cervix were randomly divided into a group of single dose of 50 microg misoprostol orally or 25 microg misoprostol vaginally. Initial and six hours after misoprostol administration, Bishop scores were evaluated. Requirement of oxytocin augmentation, complication due to uterine hypertonus, incidence of vaginal delivery, Apgar score at 1 and 5 minutes, and number of neonate admitted at neonatal intensive care unit (NICU) were recorded.
The baseline characteristics and median initial Bishop scores were comparable in both groups. At 6 hours after misoprostol administration the median cervical changes of women who received oral or vaginal misoprostol were statistically significant different, 3 and 4, respectively. The median time interval to vaginal delivery of women who received oral misoprostol was significantly longer than of those who had vaginal drug, 16.9 and 11.8 hours respectively. Comparable neonatal outcomes were found in both groups in terms of assigned Apgar score at 1 and 5 minutes.
A single dose of 25 microg vaginal misoprostol appears to be more effective than 50 microg oral dose in improving Bishop scores and decreasing the time to vaginal delivery in women with unfavorable cervix without severe adverse effects.
比较单剂量50微克口服米索前列醇与25微克阴道米索前列醇用于引产的有效性和安全性。
本研究为随机、双盲对照试验,于2002年3月至2005年1月在曼谷都市管理医学院妇产科及瓦吉拉医院产房收治的孕妇中进行。所有146例妊娠≥37周、宫颈条件不利于引产且有引产指征的孕妇被随机分为单剂量50微克口服米索前列醇组或25微克阴道米索前列醇组。在给予米索前列醇初始及6小时后评估Bishop评分。记录催产素加强的需求、子宫过度收缩引起的并发症、阴道分娩发生率、1分钟和5分钟时的阿氏评分以及入住新生儿重症监护病房(NICU)的新生儿数量。
两组的基线特征和初始Bishop评分中位数具有可比性。在给予米索前列醇6小时后,口服或阴道米索前列醇的女性宫颈变化中位数在统计学上有显著差异,分别为3和4。口服米索前列醇的女性至阴道分娩的中位时间间隔显著长于阴道用药的女性,分别为16.9小时和11.8小时。在1分钟和5分钟时的阿氏评分方面,两组的新生儿结局相当。
单剂量25微克阴道米索前列醇在改善宫颈条件不利的女性的Bishop评分和缩短至阴道分娩时间方面似乎比50微克口服剂量更有效,且无严重不良反应。