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剖宫产术后早期与晚期启动华法林治疗及机械心脏瓣膜患者孕产妇并发症风险增加:一项随机、开放标签的试点研究。

Early Versus Late Post Cesarean Section Warfarin Initiation and Increased Risk of Maternal Complications in Patients With Mechanical Heart Valves: A Randomized, Open-Label Pilot Study.

作者信息

Youssef Ghada, Mohamed Tarek El Husseiny, Abdel Raouf Maged Ahmed, Fouad Tammam Amr Samir, Gabr Amir Araby

机构信息

Department of Cardiovascular Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

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

出版信息

Korean Circ J. 2025 Feb;55(2):151-160. doi: 10.4070/kcj.2024.0002. Epub 2024 Jul 3.

Abstract

BACKGROUND AND OBJECTIVES

The timing of the reinstitution of warfarin after cesarean section (CS) delivery was not adequately addressed in the literature. This study aims to evaluate the risks of early versus late initiation of warfarin post-CS in patients with mechanical heart valves.

METHODS

This randomized, open-label cohort study included 114 pregnant women with mechanical heart valves planned to be delivered by CS at or after 28 weeks of gestation. Patients were randomly divided into two groups: Day-2-group, where warfarin was started on day 2, and Day-5-group, where warfarin was started on day 5 after CS. Maternal postoperative bleeding complications, mechanical valve thrombosis, need for blood transfusion or reoperation, and maternal mortality were identified.

RESULTS

Ten women (8.8%) had 11 bleeding complications, of whom 2 patients (20%) had intraperitoneal hemorrhage (none in Day-2-group and 2 in Day-5-group), 3 patients (30%) had subcutaneous hematoma (none in Day-2-group and 3 in Day-5-group), and 6 patients (60%) had sub-rectus hematoma (3 in Day-2-group and 3 in Day-5-group). No mechanical valve thrombosis, other thromboembolic events, or in-hospital maternal mortality were reported.

CONCLUSION

Despite the small number of events, the bleeding risk was lower in the group with early post-CS warfarin introduction than in the group with late warfarin introduction in patients with prosthetic heart valves.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04855110.

摘要

背景与目的

剖宫产(CS)术后重新使用华法林的时机在文献中未得到充分探讨。本研究旨在评估机械心脏瓣膜患者剖宫产术后早期与晚期开始使用华法林的风险。

方法

这项随机、开放标签的队列研究纳入了114名计划在妊娠28周及以后行剖宫产的机械心脏瓣膜孕妇。患者被随机分为两组:第2天组,术后第2天开始使用华法林;第5天组,术后第5天开始使用华法林。确定产妇术后出血并发症、机械瓣膜血栓形成、输血或再次手术需求以及产妇死亡率。

结果

10名女性(8.8%)出现11例出血并发症,其中2例患者(20%)发生腹腔内出血(第2天组无,第5天组2例),3例患者(30%)出现皮下血肿(第2天组无,第5天组3例),6例患者(60%)出现腹直肌下血肿(第2天组3例,第5天组3例)。未报告机械瓣膜血栓形成、其他血栓栓塞事件或住院期间产妇死亡。

结论

尽管事件数量较少,但在人工心脏瓣膜患者中,剖宫产术后早期引入华法林组的出血风险低于晚期引入华法林组。

试验注册

ClinicalTrials.gov标识符:NCT04855110。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9090/11875978/df0e21485de7/kcj-55-151-g001.jpg

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