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剖宫产术中应用米索前列醇预防原发性 PPH 的疗效:一项随机对照试验。

The efficacy of intrauterine misoprostol during cesarean section in prevention of primary PPH, a randomized controlled trial.

机构信息

Reproductive health and family planning department, National Research Centre (Egypt), Giza, Egypt; Aljazeerah Hospital, CAIFM, Egypt.

Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.

出版信息

J Matern Fetal Neonatal Med. 2020 May;33(9):1459-1465. doi: 10.1080/14767058.2018.1519796. Epub 2018 Sep 26.

Abstract

Postpartum hemorrhage is the leading cause of maternal mortality worldwide. To compare the incidence of postpartum hemorrhage in women eligible for elective cesarean section (CS) delivery when using intrauterine misoprostol added to oxytocin versus oxytocin alone. This parallel randomized controlled trial study was conducted in two institutions in Egypt (Kasralainy and Aljazeerah hospital) 0.300 women eligible for elective CS delivery were enrolled in the study. Before randomization, all women received the same preparations. After randomization; in the study group ( = 150), intrauterine misoprostol was used after placental delivery. In the control group ( = 150), the routine oxytocin alone was used. Both groups were comparable (-value >.05) with regard to the age, BMI, and gestational age as well as hemoglobin and hematocrit levels. The incidence of postpartum hemorrhage was significantly lower ( = .018) in the study group (1.33%) than the control group (6.67%). The absolute risk reduction was 5.3% (CI 95%: 0.8-10.6%) with a relative risk of 0.20 (CI 95%: 0.05-0.90) and number needed to treat (NNT) 19 (CI 95%: 125-9). Moreover, the needs for a blood transfusion, extra uterotonics or additional interventions were significantly lower in the study group than in the control group ( < .05). All the three parameters of blood loss ie the mean blood loss, and the mean reductions of hemoglobin and hematocrit levels were significantly (value <.05) lower in the study group (mean and SD) (442.59 and 151.33 mL,0.46 and 0.3 g/dL, and 0.84 and 0.56%), respectively than in the control group (591.01 and 287.97 mL,1.2 and 1.39 g/dL, and 3.47 and 3.52%), respectively. Adverse events were comparable between groups; these were fever, nausea, and vomiting and shivering. Intrauterine misoprostol (400 mg) when added to oxytocin is safe and effective in decreasing the incidence of postpartum hemorrhage (PPH) and reducing the amount of postpartum blood loss in case of elective CS delivery.

摘要

产后出血是全世界产妇死亡的主要原因。比较在有选择性剖宫产(CS)分娩资格的妇女中使用米索前列醇联合催产素与单独使用催产素时产后出血的发生率。本平行随机对照试验在埃及的两个机构(Kasralainy 和 Aljazeerah 医院)进行,共有 300 名有选择性 CS 分娩资格的妇女参加了这项研究。在随机分组之前,所有妇女都接受了相同的准备。随机分组后;在研究组(n=150)中,胎盘娩出后使用宫内米索前列醇。在对照组(n=150)中,常规单独使用催产素。两组在年龄、BMI 和孕龄以及血红蛋白和血细胞比容水平方面均无差异(P 值>.05)。研究组(1.33%)产后出血的发生率明显低于对照组(6.67%)(P 值<.018)。绝对风险降低 5.3%(95%CI:0.8-10.6%),相对风险为 0.20(95%CI:0.05-0.90),需要治疗的人数(NNT)为 19(95%CI:125-9)。此外,研究组需要输血、额外使用子宫收缩剂或其他干预措施的人数明显少于对照组(P<.05)。研究组的出血量平均值、血红蛋白和血细胞比容水平的平均降低值均显著低于对照组(P 值<.05)(研究组:442.59 和 151.33 mL,0.46 和 0.3 g/dL,0.84 和 0.56%,对照组:591.01 和 287.97 mL,1.2 和 1.39 g/dL,3.47 和 3.52%)。两组的不良反应无差异;这些反应包括发热、恶心、呕吐和寒战。米索前列醇(400μg)联合催产素使用可安全有效地降低选择性 CS 分娩产后出血(PPH)的发生率,并减少产后出血量。

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