EFFECT OF ORAL MISOPROSTOL ON INDUCTION OF LABOR: PILOT STUDY

本初步研究的目的是获得不同剂量口服米索前列醇引产效果的初步数据，为口服米索前列醇与阴道米索前列醇引产的随机试验做准备。本研究本质上是观察性的，涉及口服米索前列醇（PGE类似物）给三组10名妊娠35-42周需要引产的妇女。对于每组妇女，药物剂量将从每4小时25微克增加到每4小时50微克，再到每6小时75微克。将测量诱导时间、剖宫产的发生率和原因、子宫过度收缩率、胎儿心动过缓、过度刺激治疗和各种急性新生儿结局。在最初给药后的4至6小时内，将采集母体血清，以确定每种方案的生物利用度曲线。随访研究的方案将根据引产效果和治疗后的子宫过度刺激率来选择。

The purpose of this pilot study is to gain preliminary data on the effectiveness of various doses of oral misoprostol in inducing labor in preparation for a randomized trial of oral versus vaginal misoprostol for labor induction. This study will be observational in nature nad involve administration of oral misoprostol a PGE analogue to three groups of 10 women between 35-42 weeks' gestation requiring induction of labor. With each group of women, the drug dosage will escalate from 25 mcg q 4 hours to 50 mcg q 4 hours to 75 mcg q 6 hours. The length of induction, incidence and reason for cesarean delivery, and rates of uterine hypercontractility, fetal bradycardia, treatment for hyperstimulation and varius acute neonatal outcomes will be measured. During the first four to six hours after the initial drug administration, maternal serum will be sampled to determine the bioavailability curves for each regimen. The regimen for the follow-up study will be chosen based on efficacy of labor induction balanced with rates of treated uterine hyperstimulation.