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临床试验/NCT07689136
NCT07689136已完成不适用

Impact of the Timing of Pharmacological Thromboprophylaxis on Thromboembolic and Hemorrhagic Complications Following Postpartum Hemorrhage: A Retrospective Cohort Study

University Tunis El Manar1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2025年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
1
主要终点
Occurrence of thromboembolic complications

研究概览

简要总结

Postpartum hemorrhage is a leading cause of maternal morbidity and mortality worldwide. Women who experience severe postpartum hemorrhage are at increased risk of both recurrent bleeding and venous thromboembolism. The optimal timing for starting pharmacological thromboprophylaxis after postpartum hemorrhage remains uncertain.

This retrospective observational cohort study was conducted at the Center of Maternity and Neonatology of Tunis, Tunisia. The study included women who experienced postpartum hemorrhage between 2018 and 2024 and received pharmacological thromboprophylaxis during the postpartum period. The objective was to evaluate the association between the timing of thromboprophylaxis initiation and the occurrence of thromboembolic and hemorrhagic complications.

The findings are expected to contribute to the optimization of thromboprophylaxis timing after postpartum hemorrhage and to improve the balance between the prevention of venous thromboembolism and the risk of recurrent bleeding.

详细描述

Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide. Women with severe PPH are at increased risk of venous thromboembolism during the postpartum period because of pregnancy-related hypercoagulability, prolonged immobilization, surgical interventions, and blood transfusion. At the same time, the early initiation of pharmacological thromboprophylaxis may increase the risk of recurrent hemorrhage. Consequently, determining the optimal timing for thromboprophylaxis after PPH remains a major clinical challenge.

This retrospective observational cohort study was conducted at the Center of Maternity and Neonatology of Tunis, Tunisia. The study included women who experienced postpartum hemorrhage and received pharmacological thromboprophylaxis during the postpartum period. Clinical, biological, obstetric, therapeutic, and outcome data were collected from medical records.

The primary objective was to evaluate the association between the timing of initiation of pharmacological thromboprophylaxis and the occurrence of thromboembolic complications following postpartum hemorrhage. Secondary objectives included the assessment of hemorrhagic complications after thromboprophylaxis, identification of factors associated with adverse outcomes, and evaluation of the safety of different initiation times in routine clinical practice.

The results of this study are expected to provide evidence supporting clinical decision-making regarding the optimal timing of thromboprophylaxis after postpartum hemorrhage and to contribute to improving maternal outcomes while balancing the risks of thrombosis and recurrent bleeding.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women who delivered vaginally or by cesarean section in the obstetrics and gynecology departments of Maternity and Neonatology Center of Tunis.
  • Diagnosed with postpartum hemorrhage.
  • subsequently admitted to the intensive care unit (ICU).

排除标准

  • Women with recurrent hemorrhage related to a surgical complication (e.g., splenic decapsulation during dry mopping, suture dehiscence, vascular injury).
  • Women who underwent radiological arterial embolization.
  • Medical records with incomplete or non-exploitable data.

结局指标

主要结局

Occurrence of thromboembolic complications

时间窗: Up to hospital discharge (maximum 42 days postpartum)

Occurrence of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, according to the timing of initiation of pharmacologic thromboprophylaxis after postpartum hemorrhage.

次要结局

  • Occurrence of hemorrhagic complications(Up to hospital discharge after initiation of pharmacological thromboprophylaxis (maximum 42 days postpartum))

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben marzouk Sofiene

Principal Investigator

University Tunis El Manar

研究点 (1)

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