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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Tunis, Tunisia, 1007
- Center of Maternity and Neonatology of Tunis (CMNT)
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Early Thromboprophylaxis (≤24 Hours)
Women with postpartum hemorrhage who received the first dose of pharmacological thromboprophylaxis within the first 24 hours after delivery.
|
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.
Altri nomi:
|
|
Delayed Thromboprophylaxis (>24 Hours)
Women with postpartum hemorrhage who received the first dose of pharmacological thromboprophylaxis more than 24 hours after delivery.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Occurrence of thromboembolic complications
Lasso di tempo: 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.
|
Up to hospital discharge (maximum 42 days postpartum)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Occurrence of hemorrhagic complications
Lasso di tempo: 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.
|
Up to hospital discharge after initiation of pharmacological thromboprophylaxis (maximum 42 days postpartum)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie vascolari
- Malattia cardiovascolare
- Processi patologici
- Malattie urogenitali femminili e complicanze della gravidanza
- Complicanze ostetriche del lavoro
- Complicazioni della gravidanza
- Malattie delle vie respiratorie
- Emorragia
- Malattie polmonari
- Embolia e Trombosi
- Embolia
- Disturbi puerperali
- Emorragia uterina
- Tromboembolia
- Trombosi
- Condizioni patologiche, segni e sintomi
- Embolia polmonare
- Trombosi venosa
- Emorragia postpartum
- Tromboembolia venosa
- Carboidrati
- Glicosaminoglicani
- Polisaccaridi
- Eparina
- Eparina, a basso peso molecolare
Altri numeri di identificazione dello studio
- CMNT-HPP-2018-2024-001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Trombosi venosa profonda
-
RenJi HospitalNon ancora reclutamentoDeep Learning, risonanza magnetica lombare
-
Ceren SireNon ancora reclutamentoDeep caries lesione di denti pemanentiTacchino
-
Tishreen UniversityCompletatoValutazione dell'Intervento Deep Plan nella Regione Sottomentoniera per la Gestione del Doppio MentoSiria
-
Misr International UniversityNational Research Centre, EgyptAttivo, non reclutantePazienti con lesioni cariose profonde | Lesione cariosa profonda | Deep caries lesione di denti pemanentiEgitto
-
University of ZurichReclutamentoPrevisione dell'esito dell'ictus supportata dall'algoritmo di deep learningSvizzera
-
Third Affiliated Hospital, Sun Yat-Sen UniversityReclutamentoSviluppare un modello predittivo di germogliamento del tumore basato sulla TC per il cancro alla vescica utilizzando algoritmi di deep learningCina
-
First Affiliated Hospital of Chongqing Medical...CompletatoFocus sullo sviluppo di un modello di deep learning per prevedere il rischio di recidiva dell'adenocarcinoma polmonare invasivo di stadio IA dopo resezione sublobareCina