Timing of Thromboprophylaxis After Postpartum Hemorrhage

NCT07689136 | Completed

• 1 other identifier: CMNT-HPP-2018-2024-001
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism; Pulmonary Embolism; Deep Vein Thrombosis; Postpartum Hemorrhage

Keywords

Postpartum Hemorrhage; Thromboprophylaxis; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occurrence of hemorrhagic complications

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

Study Arms (2)

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

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

Interventions

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.

Also known as: Low Molecular Weight Heparin (LMWH), Unfractionated Heparin (UFH)

Delayed Thromboprophylaxis (>24 Hours); Early Thromboprophylaxis (≤24 Hours)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Center of Maternity and Neonatology of Tunis (CMNT)

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Venous Thromboembolism; Pulmonary Embolism; Venous Thrombosis

Interventions

Heparin, Low-Molecular-Weight; Heparin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thrombosis

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 8, 2026
• Study Start: March 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: March 30, 2025
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)