PDF(Pubmed)
Abstract：
Objective Misoprostol has attracted low-income low-resource countries for the active management of the third stage of labor. The objective of this study was to compare the efficacy of sublingual misoprostol and intramuscular oxytocin in the active management of the third stage of labor. Study design This was a prospective randomized controlled trial in which a total of 407 healthy pregnant women having singleton pregnancy, cephalic presentation, and normal vaginal delivery were divided into two groups. In the first group (n=203), women received 600 µg misoprostol tablet sublingually, and in the second group (n=204), women received 10 IU of intramuscular oxytocin, within 1 minute of the delivery of the baby during the third stage of labor. Three patients from the first group and four patients from the second group were excluded from the analysis due to traumatic postpartum hemorrhage (PPH). The primary outcome was an incidence of PPH. Secondary outcomes were the duration of the third stage of labor, amount of blood loss, fall in hemoglobin concentration after 48 hours of delivery, need for additional uterotonics, and side effects of the drugs. Data were compared using the chi-square and independent samples t-test. Results The incidence of PPH was 6.5% in the misoprostol group as compared to 2% in the oxytocin group (p=0.026). The misoprostol group also had significantly higher blood loss (293.75±125.8 mL) and a greater fall in hemoglobin level (0.58±0.25 g/dL) as compared to that in the oxytocin group (226.13±98.44 mL and 0.45±0.20 g/dL) (p<0.001). The mean duration of the third stage of labor was significantly higher in the misoprostol group (5.31±2.1 min) as compared to that in the oxytocin group (3.65±1.75 min) (p<0.001). The additional need for uterotonics was recorded in 15% of the study participants in the misoprostol group as compared to 8% in the oxytocin group (p=0.028). The incidence of side effects such as shivering and fever was significantly higher in the misoprostol group as compared to the oxytocin group. No significant difference between the two groups was observed concerning the incidence of nausea, vomiting, diarrhea, and headache. Conclusion Intramuscular oxytocin is a safe and useful alternative to sublingual misoprostol in facilitating the third stage of labor with minimal blood loss, fewer incidences of hemorrhage, and fewer adverse effects.
摘要：
目的米索前列醇吸引低收入低资源国家积极管理第三产程。这项研究的目的是比较舌下米索前列醇和肌内催产素在第三产程积极管理中的疗效。研究设计这是一项前瞻性随机对照试验，共有407名健康孕妇单胎妊娠，头颅表现，正常阴道分娩分为两组。在第一组（n=203）中，女性舌下接受600微克米索前列醇片，在第二组(n=204)中，女性接受了10IU的肌内催产素，在分娩第三阶段的婴儿分娩后1分钟内。由于创伤性产后出血（PPH），第一组的3例患者和第二组的4例患者被排除在分析之外。主要结果是PPH的发生率。次要结局是第三产程的持续时间，失血量,分娩48小时后血红蛋白浓度下降，需要额外的子宫收缩，和药物的副作用。数据比较采用卡方检验和独立样本t检验。结果米索前列醇组的PPH发生率为6.5%，而催产素组为2%（p=0.026）。与催产素组（226.13±98.44mL和0.45±0.20g/dL）相比，米索前列醇组的失血量（293.75±125.8mL）和血红蛋白水平下降幅度更大（0.58±0.25g/dL）（p<0.001）。与催产素组（3.65±1.75min）相比，米索前列醇组第三产程的平均持续时间（5.31±2.1min）明显更高（p<0.001）。米索前列醇组15％的研究参与者记录了对子宫收缩的额外需求，而催产素组为8％（p=0.028）。与催产素组相比，米索前列醇组的发抖和发热等副作用的发生率明显更高。两组间恶心发生率无显著差异,呕吐,腹泻,和头痛。结论肌内催产素是舌下米索前列醇的一种安全有效的替代方案，可促进第三产程的发生，出血最少。出血发生率较低，更少的不利影响。
