Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial.
low‐molecular‐weight heparin
postpartum
pregnancy
venous thrombosis
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
05 Sep 2024
05 Sep 2024
Historique:
revised:
09
06
2024
received:
18
01
2024
accepted:
15
08
2024
medline:
6
9
2024
pubmed:
6
9
2024
entrez:
6
9
2024
Statut:
aheadofprint
Résumé
Uncertainty surrounds the risk-benefit of low-molecular-weight heparin to prevent postpartum venous thromboembolism (VTE). Data from randomised clinical trials (RCT) are critically needed, but recent feasibility studies in North America yielded low participation rates, with <1 enrolment per month per centre. Our aim was to assess the feasibility of a trial of postpartum short-term enoxaparin in Europe. Pragmatic, open-label pilot randomised controlled trial (RCT). Swiss tertiary hospital. Postpartum women, within 48 h of delivery, deemed at intermediate risk of VTE with at least one major risk factor (morbid obesity, thrombophilia, emergency caesarean section, pre-eclampsia, preterm delivery, intrauterine growth restriction or systemic peripartum infection) and/or at least two minor risk factors. Participants were randomised to enoxaparin 40-60 mg once daily for 10 days or no treatment, with a 90-day follow-up. Participation rate and study acceptance (randomised participants among women in whom informed consent was sought). Recruitment was open for 25 weeks in 2022. Among 1504 postpartum women, 480 were eligible and 77 were randomised. The recruitment rate was 3.1 per week (13.3 per month) and the study acceptance was 23.8%. At 3 months, there was no VTE event, but one major, one nonmajor obstetrical bleeding and one surgical site complication, all in the enoxaparin group. This pilot RCT of postpartum thromboprophylaxis set in Switzerland yielded greater participation rate and acceptance than previous attempts in North America. It calls for a large, international, collaborative trial to guide this important clinical decision. ClinicalTrial.gov identifier: NCT05878899 and NCT04153760.
Identifiants
pubmed: 39238110
doi: 10.1111/1471-0528.17943
doi:
Banques de données
ClinicalTrials.gov
['NCT04153760', 'NCT05878899']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Hôpitaux Universitaires de Genève
Informations de copyright
© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
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