Witlin A G, Friedman S A, Sibai B M
Department of Obstetrics and Gynecology, University of Tennessee, Memphis 38103, USA.
Am J Obstet Gynecol. 1997 Mar;176(3):623-7. doi: 10.1016/s0002-9378(97)70558-1.
The primary outcome was to determine whether magnesium sulfate therapy prolongs the duration of labor in women with mild preeclampsia. Secondary outcomes were to assess the side effects associated with magnesium sulfate therapy: hours and maximum dose of oxytocin, incidence of progression to severe preeclampsia, incidence of cesarean delivery, change in maternal hematocrit, incidence of postpartum hemorrhage, incidence of maternal infection, and Apgar scores.
Women with a diagnosis of mild preeclampsia at term were randomized to receive standard therapy during labor and for 12 hours post partum with either magnesium sulfate (n = 67) or a matching placebo solution (n = 68).
There was no difference between magnesium sulfate and placebo with respect to the primary outcome variables: total length of labor (median 17.8 hours vs 16.5 hours, p = 0.7) and length of the active phase of labor (median 5.4 hours vs 6.0 hours, p = 0.5). In addition, no difference was observed in the secondary outcome variables: hours of oxytocin use, change in hematocrit, frequency of maternal infection, progression to severe preeclampsia, incidence of cesarean delivery, and Apgar scores. Although not statistically significant, the incidence of postpartum hemorrhage was approximately fourfold greater in the magnesium sulfate group (relative risk 4.1, 95% confidence interval 0.5 to 35.4). There was a significant difference in the maximum dose of oxytocin used (13.9 +/- 8.6 mU/min with magnesium sulfate vs 11.0 +/- 7.6 mU/min with placebo, p = 0.036).
The use of magnesium sulfate during labor in women with mild preeclampsia at term does not affect any component of labor but did necessitate a higher dose of oxytocin.
主要结局是确定硫酸镁治疗是否能延长轻度子痫前期女性的产程。次要结局是评估与硫酸镁治疗相关的副作用：缩宫素使用时间和最大剂量、进展为重度子痫前期的发生率、剖宫产发生率、产妇血细胞比容变化、产后出血发生率、产妇感染发生率及阿氏评分。
足月诊断为轻度子痫前期的女性被随机分为两组，一组在分娩期间及产后12小时接受硫酸镁治疗（n = 67），另一组接受匹配的安慰剂溶液治疗（n = 68）。
硫酸镁组和安慰剂组在主要结局变量方面无差异：总产程（中位数17.8小时对16.5小时，p = 0.7）和活跃期产程（中位数5.4小时对6.0小时，p = 0.5）。此外，在次要结局变量方面也未观察到差异：缩宫素使用时间、血细胞比容变化、产妇感染频率、进展为重度子痫前期、剖宫产发生率及阿氏评分。虽然无统计学意义，但硫酸镁组产后出血发生率约为安慰剂组的四倍（相对危险度4.1，95%可信区间0.5至35.4）。两组使用的缩宫素最大剂量有显著差异（硫酸镁组为13.9±8.6 mU/分钟，安慰剂组为11.0±7.6 mU/分钟，p = 0.036）。
足月轻度子痫前期女性分娩期间使用硫酸镁不影响产程的任何组成部分，但确实需要更高剂量的缩宫素。
