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Completed

NCT Number: NCT07689136

Timing of Thromboprophylaxis After Postpartum Hemorrhage

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Pharmacologic Thromboprophylaxis

Drug

Pharmacologic thromboprophylaxis administered as part of routine postpartum clinical care after postpartum hemorrhage. Patients received either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) according to the treating physician's clinical judgment and institutional practice. The study did not assign the intervention; it retrospectively evaluated the association between the timing of thromboprophylaxis initiation (≤24 hours versus >24 hours after delivery) and the occurrence of thromboembolic and hemorrhagic complications.

Other names: Low Molecular Weight Heparin (LMWH), Unfractionated Heparin (UFH)

Primary outcomes

  1. Occurrence of thromboembolic complications

    Time frame: 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.

Secondary outcomes

  1. Occurrence of hemorrhagic complications

    Time frame: Up to hospital discharge after initiation of pharmacological thromboprophylaxis (maximum 42 days postpartum)

    Occurrence of recurrent or worsening postpartum hemorrhage after initiation of pharmacologic thromboprophylaxis.

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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