舒前列素减少胎盘滞留患者手动剥离胎盘的需求：一项随机对照试验。

Sulprostone reduces the need for the manual removal of the placenta in patients with retained placenta: a randomized controlled trial.

作者信息

van Beekhuizen Heleen J, de Groot Akosua N J A, De Boo Theo, Burger David, Jansen Nicoline, Lotgering Fred K

机构信息

Jeroen Bosch Hospital, s-Hertogenbosch, The Netherlands.

出版信息

Am J Obstet Gynecol. 2006 Feb;194(2):446-50. doi: 10.1016/j.ajog.2005.08.029.

DOI:10.1016/j.ajog.2005.08.029

PMID:16458644

Abstract

OBJECTIVE

The purpose of this study was to determine the extent that the administration of sulprostone reduces the need for manual removal of the placenta in patients with retained placenta.

STUDY DESIGN

A double-blinded sequential randomized controlled trial of sulprostone versus placebo was conducted among 103 patients with retained placenta.

RESULTS

In the first phase of this sequential study, sulprostone was compared with placebo. The null hypothesis of equal effectiveness of both treatments was rejected after 50 patients. In patients with retained placenta, the placenta was expelled after sulprostone in 13 of 24 cases (51.8%, bias adjusted), whereas expulsion after placebo was achieved in only 4 of 26 cases (17.6%, bias adjusted). The difference was significant (P = .034). In the second phase of the study, in which the placebo arm was stopped, results were confirmed; in 25 of 53 patients (47%), the placenta was expelled.

CONCLUSION

Sulprostone reduces the need for the manual removal of the placenta by 49%.

摘要

目的

本研究旨在确定使用磺前列酮可减少胎盘滞留患者手动剥离胎盘需求的程度。

研究设计

对103例胎盘滞留患者进行了磺前列酮与安慰剂的双盲序贯随机对照试验。

结果

在该序贯研究的第一阶段，将磺前列酮与安慰剂进行比较。在50例患者后，两种治疗效果相同的无效假设被拒绝。在胎盘滞留患者中，24例中有13例（51.8%，经偏倚调整）在使用磺前列酮后胎盘排出，而安慰剂组26例中仅有4例（17.6%，经偏倚调整）胎盘排出。差异具有统计学意义（P = 0.034）。在研究的第二阶段，安慰剂组停止，结果得到证实；53例中有25例（47%）胎盘排出。