Muhamad Normaliza, Abu Muhammad Azrai, Kalok Aida Hani, Shafiee Mohd Nasir, Shah Shamsul Azhar, Ismail Nor Azlin Mohamed
Department of Obstetrics and Gynecology, UKM Medical Centre, Kuala Lumpur, Malaysia.
Department of Public Health, UKM Medical Centre, Kuala Lumpur, Malaysia.
Front Pharmacol. 2022 Sep 23;13:887020. doi: 10.3389/fphar.2022.887020. eCollection 2022.
Venous thromboembolism (VTE) remains one of the leading causes of maternal morbidity and mortality, with postpartum period carrying the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in the obstetrics population, however, its porcine-derived content may lead to reduced uptake amongst certain religious groups. We aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis. We conducted a prospective, single arm, open label study from September 2017 until March 2018. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient received subcutaneous injection of Fondaparinux, 2.5 mg daily for 10 days. A telephone interview was conducted on day 10 post delivery. Each woman was subsequently reviewed in the outpatient clinic 6 weeks postpartum. The primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. Secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. Allergic reaction and bleeding tendency in neonates were also recorded. Sixty women were included in the analysis. There were no VTE cases amongst our cohort. No major bleeding was recorded. Two patients (3.3%) had wound haematoma, one of which occurred 3 weeks post delivery. No adverse effect in neonates was noted. Fondaparinux is a safe alternative thromboprophylaxis for postpartum women.
静脉血栓栓塞症（VTE）仍然是孕产妇发病和死亡的主要原因之一，产后阶段风险最大。围产期血栓预防通常基于风险因素评估进行。低分子量肝素在产科人群中已被证明具有安全特性，然而，其猪源性成分可能导致某些宗教群体的接受度降低。我们旨在评估磺达肝癸钠作为产后血栓预防替代药物的安全性。我们于2017年9月至2018年3月进行了一项前瞻性、单臂、开放标签研究。招募了符合2015年英国皇家妇产科医师学院（RCOG）指南中产后血栓预防标准的女性。每位患者皮下注射磺达肝癸钠，每日2.5毫克，共10天。在分娩后第10天进行电话访谈。随后，每位女性在产后6周于门诊接受复查。主要结局指标是由临床症状和评估提示的肺栓塞或深静脉血栓形成的发生情况。次要结局指标是过敏反应和出血倾向，如继发性产后出血、脊柱部位出血和伤口血肿。还记录了新生儿的过敏反应和出血倾向。60名女性纳入分析。我们的队列中未出现VTE病例。未记录到严重出血情况。两名患者（3.3%）出现伤口血肿，其中一例发生在分娩后3周。未观察到新生儿有不良反应。磺达肝癸钠是产后女性安全的血栓预防替代药物。
