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米索前列醇经宫内给药与舌下含服用于预防择期剖宫产产后出血的效果比较:一项随机对照试验。

Comparative study between the roles of intrauterine misoprostol versus the sublingual route for prevention of postpartum blood loss in elective cesarean sections: a randomized controlled trial.

机构信息

Ob/gyn Department, Faculty of Medicine, Cairo University, Cairo University, Cairo, Egypt.

Resident of obstetrics and gynecology, Helwan General Hospital, Cairo, Egypt.

出版信息

BMC Pregnancy Childbirth. 2024 Oct 29;24(1):710. doi: 10.1186/s12884-024-06889-y.

DOI:10.1186/s12884-024-06889-y
PMID:39472831
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11523850/
Abstract

BACKGROUND

The prostaglandin E1 analog "misoprostol" is a drug that has powerful ecbolic effects and can be beneficial in the prevention and treatment of postpartum hemorrhage, which is the leading cause of maternal mortality worldwide.

OBJECTIVES

To assess the value of adding intrauterine misoprostol together with intravenous oxytocin injection compared with sublingual misoprostol together with intravenous oxytocin injection during elective cesarean section to reduce blood loss intraoperatively and prevent postpartum hemorrhage.

METHODS

A total of 192 pregnant women were counseled and recruited from the labor and delivery unit at Kasr Al Aini Hospital, Cairo University, and equally randomized into two groups. Group (A) included 96 women who received intrauterine misoprostol (400 mg) + oxytocin. Group (B) included 96 women who received sublingual misoprostol (400 mg) + oxytocin. The primary outcome of our study was estimation of the amount of blood loss during and after cesarean delivery. The secondary outcomes were the incidence of PPH within the first 6 h after labor, the need for blood transfusion, the need for any supplementary ecbolic drugs, the need for additional surgical intervention for PPH, changes in hematocrit and hemoglobin in both groups after delivery, and the incidence of side effects of the study medications.

RESULTS

We observed a significant discrepancy between the two groups in terms of postoperative Hb and Hct, postoperative differences (pre- and post-Hb and post-Hct) and EBL favoring the intrauterine group. However, no significant difference was observed between the groups with respect to excessive blood loss > 1000 ml in the 1st six hours, the need for supplementary ecbolics, the necessity for blood or blood prod, the need for additional surgical intervention (for PPH) or side effects.

CONCLUSION

Intrauterine misoprostol combined with oxytocin intravenous infusion is more effective than sublingual misoprostol combined with oxytocin intravenous infusion in lowering intraoperative blood loss and preventing postpartum hemorrhage in elective cesarean section.

TRIAL REGISTRATION

This trial was retrospectively registered with the ClinicalTrials.gov Registry on 12-April-2024 (registration number: NCT06364098).

摘要

背景

前列腺素 E1 类似物“米索前列醇”是一种具有强大引产作用的药物,可用于预防和治疗产后出血,产后出血是全世界产妇死亡的主要原因。

目的

评估在选择性剖宫产术中,与舌下含服米索前列醇联合静脉滴注催产素相比,宫腔内放置米索前列醇联合静脉滴注催产素对减少术中出血量和预防产后出血的价值。

方法

在开罗大学卡西尔阿尼医院的产房对 192 名孕妇进行了咨询和招募,并将她们平均随机分为两组。组(A)包括 96 名接受宫腔内米索前列醇(400mg)+催产素的妇女。组(B)包括 96 名接受舌下含服米索前列醇(400mg)+催产素的妇女。本研究的主要结局是估计剖宫产术中及术后的出血量。次要结局包括产后 6 小时内 PPH 的发生率、输血需求、任何补充性引产药物的需求、因 PPH 而需要额外手术干预的情况、两组产后血细胞比容和血红蛋白的变化,以及研究药物的副作用发生率。

结果

我们观察到两组在术后 Hb 和 Hct、术后差异(Hb 和 Hct 的术前和术后值)和 EBL 方面存在显著差异,宫腔内组更有利。然而,两组在 1 小时内出血量超过 1000ml、需要补充引产药物、需要输血或血制品、需要额外手术干预(用于 PPH)或副作用方面无显著差异。

结论

与舌下含服米索前列醇联合静脉滴注催产素相比,宫腔内放置米索前列醇联合静脉滴注催产素在选择性剖宫产术中降低术中出血量和预防产后出血更有效。

试验注册

本试验于 2024 年 4 月 12 日在 ClinicalTrials.gov 注册(注册号:NCT06364098)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/11523850/a5e1bfa8f405/12884_2024_6889_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/11523850/a5e1bfa8f405/12884_2024_6889_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/11523850/a5e1bfa8f405/12884_2024_6889_Fig1_HTML.jpg

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本文引用的文献

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