Hofmeyr G J, Nikodem V C, de Jager M, Gelbart B R
Department of Obstetrics and Gynaecology, Coronation Hospital and University of the Witwatersrand, Parktown, Johannesburg, South Africa.
Br J Obstet Gynaecol. 1998 Sep;105(9):971-5. doi: 10.1111/j.1471-0528.1998.tb10259.x.
To compare oral misoprostol 400 microg with placebo in the routine management of the third stage of labour.
A double-blind placebo controlled trial. Setting The labour ward of an academic hospital in Johannesburg, South Africa with 7000 deliveries per annum.
Low-risk women expected to deliver vaginally.
Women in labour were randomly allocated to receive either misoprostol 400 microg orally or placebo after the birth. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan. Side effects were recorded.
Measured blood loss > or = 1000 ml within the first hour after birth. Use of additional oxytocics.
The groups were well matched. Measured blood loss > or = 1000 ml occurred in 15/250 (6%) after misoprostol and 23/250 (9%) after placebo (relative risk 0.65; 95% confidence interval 0.35-1.22). The difference may have been reduced by the greater use of conventional oxytocics in the placebo group, which was statistically significant for intravenous oxytocin infusion (2.8% vs 8.4%, relative risk 0.33, 95% confidence interval 0.14-0.77). Shivering was more common in the misoprostol group (19% vs 5%, relative risk 3.69; 95% confidence interval 2.05-6.64).
Shivering has been shown in this study to be a specific side effect of misoprostol administered orally in the puerperium. No serious side effects were noted. Misoprostol shows promise as a method of preventing postpartum haemorrhage. Because of the potential benefits for childbearing women, particularly those in developing countries, further research to determine its effects with greater certainty should be expedited.
比较口服400微克米索前列醇与安慰剂在第三产程常规管理中的效果。
双盲安慰剂对照试验。地点：南非约翰内斯堡一家学术医院的产房，每年有7000例分娩。
预计经阴道分娩的低风险女性。
分娩后的女性被随机分配接受口服400微克米索前列醇或安慰剂。如果认为失血超过正常量，则立即给予常规催产剂。产后第一小时的失血量通过收集在特殊的扁平塑料便盆中进行测量。记录副作用。
出生后第一小时内测量的失血量≥1000毫升。使用额外的催产剂。
两组匹配良好。米索前列醇组15/250（6%）出现测量失血量≥1000毫升，安慰剂组23/250（9%）出现（相对风险0.65；95%置信区间0.35 - 1.22）。安慰剂组更多地使用常规催产剂可能缩小了差异，静脉注射催产素的使用差异具有统计学意义（2.8%对8.4%，相对风险0.33，95%置信区间0.14 - 0.77）。米索前列醇组寒颤更常见（19%对5%，相对风险3.69；95%置信区间2.05 - 6.64）。
本研究表明寒颤是产后口服米索前列醇的一种特定副作用。未观察到严重副作用。米索前列醇作为预防产后出血方法显示出前景。鉴于对育龄妇女尤其是发展中国家妇女的潜在益处，应加快进一步研究以更确定地确定其效果。
