Department of Gynecology and Obstetrics, Farhat Hached University Hospital, Sousse, Tunisia.
Faculty of Medicine, Sousse, Tunisia.
Pan Afr Med J. 2020 Jul 15;36:186. doi: 10.11604/pamj.2020.36.186.22538. eCollection 2020.
obstetric hemorrhage is estimated to cause 25% of all maternal deaths and is the leading direct cause of maternal mortality worldwide. The World Health Organization recommended the use of uterotonics that should be offered for all women who will give birth but in some countries or in special situations oxytocin is not available. The goal of this study is to determine whether the 400μg dose of Misoprostol decreases the incidence of postpartum hemorrhage (PPH) of women who did not show signs of hemorrhage.
a prospective randomized double blind controlled trial was conducted between February 2012 and June 2012, among women in the active stage of labor attending the Obstetric Gynecology Department, University Hospital Farhat Hached of Sousse, Tunisia. Women with term singleton pregnancies greater than 32 weeks of amenorrhea with anticipated vaginal delivery were eligible for the study. Participants were randomly assigned to receive 400 μg sublingual Misoprostol or 2 ets of placebo immediately after cord clamping. The primary outcome measures were an estimation of blood loss including the subjective finding of vaginal hemorrhage > 500 ml, the decrease of hemoglobin and hematocrit, a change in hemodynamic parameters, and the need for additional dose of oxytocin. Secondary outcomes were occurrence of possible side effects such as: headache, nausea, vomiting, pyrexia, diarrhea and abdominal pain.
a total of 211 patients were randomized: 111 in the Misoprostol group (Cytotec*) and 100 patients in the placebo group. The two groups were similar in terms of sociodemographic characteristics. Significant difference between the 400-μg of Misoprostol and placebo group were recorded in mean postpartum blood and PPH occurrence. The difference in pre- and postpartum hemoglobin loss (expressed in grams per 100 ml) was 1.21 ± 1.05 for the Misoprostol group and 1.51 ± 0.74 for the placebo group with significant difference (p = 0.02). No differences were observed in the occurrence of headache, dizziness, vomiting, diarrhea and metallic taste but the incidence of shivering was more than twice as great among women receiving Misoprostol than among those treated with placebo with a significant difference (p = 0.01). Similarly, women who received Misoprostol had a significantly higher mean temperature after delivery in comparison with those receiving placebo.
misoprostol, administered as 400 μg after delivery, appears to be effective for the prevention of post-partum hemorrhage, but its side effects appears to be significant.
据估计，产科出血导致了 25%的孕产妇死亡，是全世界孕产妇死亡的主要直接原因。世界卫生组织建议对所有分娩的妇女使用宫缩剂，但在一些国家或特殊情况下，催产素无法获得。本研究的目的是确定米索前列醇 400μg 剂量是否会降低未出现出血迹象的产妇产后出血（PPH）的发生率。
这是一项在 2012 年 2 月至 6 月间进行的前瞻性随机双盲对照试验，在突尼斯苏塞法哈特哈切大学医院妇产科分娩活跃期的妇女中进行。符合条件的妇女为预期经阴道分娩、单胎足月妊娠大于 32 周的妇女。参与者随机分配接受舌下含服米索前列醇 400μg 或安慰剂 2 剂，在脐带夹闭后立即使用。主要结局指标是估计出血量，包括阴道出血量>500ml 的主观发现、血红蛋白和血细胞比容下降、血流动力学参数变化以及需要额外剂量的催产素。次要结局是观察可能的副作用，如头痛、恶心、呕吐、发热、腹泻和腹痛。
共有 211 名患者被随机分配：米索前列醇组（Cytotec*）111 例，安慰剂组 100 例。两组在社会人口统计学特征方面相似。米索前列醇 400μg 组与安慰剂组相比，产后平均出血量和 PPH 发生率有显著差异。米索前列醇组产后血红蛋白丢失量（每 100ml 克数表示）为 1.21±1.05，安慰剂组为 1.51±0.74，差异有统计学意义（p=0.02）。头痛、头晕、呕吐、腹泻和金属味的发生率无差异，但米索前列醇组的寒战发生率是安慰剂组的两倍以上，差异有统计学意义（p=0.01）。同样，与接受安慰剂的妇女相比，接受米索前列醇的妇女产后平均体温明显升高。
米索前列醇 400μg 用于产后，似乎能有效预防产后出血，但副作用明显。
