Timing of Thromboprophylaxis After Postpartum Hemorrhage

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Postpartum Hemorrhage; Pulmonary Embolism
• Intervention / Treatment: Drug: Pharmacologic Thromboprophylaxis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1007
    • Center of Maternity and Neonatology of Tunis (CMNT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with postpartum hemorrhage managed at the Maternity and Neonatology Center of Tunis, who received pharmacologic thromboprophylaxis during the postpartum period and met the study eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early Thromboprophylaxis (≤24 Hours); Women with postpartum hemorrhage who received the first dose of pharmacological thromboprophylaxis within the first 24 hours after delivery.	Drug: Pharmacologic Thromboprophylaxis; 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)
Delayed Thromboprophylaxis (>24 Hours); Women with postpartum hemorrhage who received the first dose of pharmacological thromboprophylaxis more than 24 hours after delivery.	Drug: Pharmacologic Thromboprophylaxis; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of thromboembolic complications	Occurrence of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, according to the timing of initiation of pharmacologic thromboprophylaxis after postpartum hemorrhage.	Up to hospital discharge (maximum 42 days postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hemorrhagic complications	Occurrence of recurrent or worsening postpartum hemorrhage after initiation of pharmacologic thromboprophylaxis.	Up to hospital discharge after initiation of pharmacological thromboprophylaxis (maximum 42 days postpartum)

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis; Postpartum Hemorrhage; Venous Thromboembolism; Thromboprophylaxis; Pulmonary Embolism
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Hemorrhage; Lung Diseases; Embolism and Thrombosis; Embolism; Puerperal Disorders; Uterine Hemorrhage; Thromboembolism; Thrombosis; Pathological Conditions, Signs and Symptoms; Pulmonary Embolism; Venous Thrombosis; Postpartum Hemorrhage; Venous Thromboembolism; Carbohydrates; Glycosaminoglycans; Polysaccharides; Heparin; Heparin, Low-Molecular-Weight
• Other Study ID Numbers: CMNT-HPP-2018-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No