{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T03:40:07Z","timestamp":1793418007555,"version":"4.5.0"},"reference-count":26,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T00:00:00Z","timestamp":1725494400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006388","name":"H\u00f4pitaux Universitaires de Gen\u00e8ve","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006388","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2025,1]]},"abstract":"ABSTRACT<\/jats:title>\n \n Objective<\/jats:title>\n Uncertainty surrounds the risk\u2013benefit of low\u2010molecular\u2010weight 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\u2010term enoxaparin in Europe.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n Pragmatic, open\u2010label pilot randomised controlled trial (RCT).<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Swiss tertiary hospital.<\/jats:p>\n <\/jats:sec>\n \n Population<\/jats:title>\n Postpartum women, within 48\u2009h of delivery, deemed at intermediate risk of VTE with at least one major risk factor (morbid obesity, thrombophilia, emergency caesarean section, pre\u2010eclampsia, preterm delivery, intrauterine growth restriction or systemic peripartum infection) and\/or at least two minor risk factors.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Participants were randomised to enoxaparin 40\u201360\u2009mg once daily for 10\u2009days or no treatment, with a 90\u2010day follow\u2010up.<\/jats:p>\n <\/jats:sec>\n \n Main Outcome Measures<\/jats:title>\n Participation rate and study acceptance (randomised participants among women in whom informed consent was sought).<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Recruitment was open for 25\u2009weeks 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\u2009months, there was no VTE event, but one major, one nonmajor obstetrical bleeding and one surgical site complication, all in the enoxaparin group.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrial.gov<\/jats:ext-link>\n identifier: NCT05878899 and NCT04153760.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/1471-0528.17943","type":"journal-article","created":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T00:14:45Z","timestamp":1725581685000},"page":"35-43","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Preventing Postpartum Venous Thromboembolism With Low\u2010Molecular\u2010Weight Heparin: The PP\u2010HEP Pilot Randomised Controlled Trial"],"prefix":"10.1111","volume":"132","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7032-9491","authenticated-orcid":false,"given":"Marc","family":"Blondon","sequence":"first","affiliation":[{"name":"Division of Angiology and Hemostasis, Faculty of Medicine Geneva University Hospitals Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marine","family":"Claver","sequence":"additional","affiliation":[{"name":"Division of Obstetrics, Department of Paediatrics, Gynecology and Obstetrics, Faculty of Medicine Geneva University Hospitals Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilienne","family":"Celetta","sequence":"additional","affiliation":[{"name":"Division of Obstetrics, Department of Paediatrics, Gynecology and Obstetrics, Faculty of Medicine Geneva University Hospitals Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Righini","sequence":"additional","affiliation":[{"name":"Division of Angiology and Hemostasis, Faculty of Medicine Geneva University Hospitals Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bego\u00f1a Martinez","family":"de Tejada","sequence":"additional","affiliation":[{"name":"Division 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CfD \u201cSurgical Site Infection Event (SSI) \u201d2023: 1\u201340 https:\/\/wwwcdcgov\/nhsn\/pdfs\/pscmanual\/9pscssicurrentpdf."},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0056247"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2105911"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(22)02467-9"},{"issue":"2","key":"e_1_2_10_22_1","article-title":"Understanding Patients' Perspectives and Barriers to Postpartum Clinical Trial Participation: A Qualitative Substudy of the Pilot PARTUM Trial","volume":"7","author":"Andrew L.","year":"2023","journal-title":"Research and Practice in Thrombosis and 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