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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Tunis, Túnez, 1007
- Center of Maternity and Neonatology of Tunis (CMNT)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Early Thromboprophylaxis (≤24 Hours)
Women with postpartum hemorrhage who received the first dose of pharmacological thromboprophylaxis within the first 24 hours after delivery.
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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.
Otros nombres:
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Delayed Thromboprophylaxis (>24 Hours)
Women with postpartum hemorrhage who received the first dose of pharmacological thromboprophylaxis more than 24 hours after delivery.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Occurrence of thromboembolic complications
Periodo de tiempo: Up to hospital discharge (maximum 42 days postpartum)
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Occurrence of venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, according to the timing of initiation of pharmacologic thromboprophylaxis after postpartum hemorrhage.
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Up to hospital discharge (maximum 42 days postpartum)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Occurrence of hemorrhagic complications
Periodo de tiempo: Up to hospital discharge after initiation of pharmacological thromboprophylaxis (maximum 42 days postpartum)
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Occurrence of recurrent or worsening postpartum hemorrhage after initiation of pharmacologic thromboprophylaxis.
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Up to hospital discharge after initiation of pharmacological thromboprophylaxis (maximum 42 days postpartum)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones obstétricas del parto
- Complicaciones del embarazo
- Enfermedades de las vías respiratorias
- Hemorragia
- Enfermedades pulmonares
- Embolia y Trombosis
- Embolia
- Trastornos Puerperales
- Hemorragia uterina
- Tromboembolismo
- Trombosis
- Condiciones Patológicas, Signos y Síntomas
- Embolia pulmonar
- Trombosis venosa
- Hemorragia post parto
- Tromboembolismo venoso
- Carbohidratos
- Glicosaminoglicanos
- Polisacáridos
- Heparina
- Heparina de bajo peso molecular
Otros números de identificación del estudio
- CMNT-HPP-2018-2024-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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