{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T13:48:54Z","timestamp":1782827334487,"version":"3.54.5"},"reference-count":31,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"unspecified","delay-in-days":29,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001862","name":"The Swedish Research Council","doi-asserted-by":"crossref","award":["2021-06579 and 2024-00265"],"award-info":[{"award-number":["2021-06579 and 2024-00265"]}],"id":[{"id":"10.13039\/501100001862","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,6,16]]},"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>External aortic compression is used to reduce excessive blood loss in childbirth. However, it has never been evaluated for the prevention of postpartum haemorrhage. This study aims to investigate whether routine external aortic compression, in patients undergoing elective caesarean delivery, is an effective and acceptable preventive method to reduce severe postpartum haemorrhage.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This multicentre, randomised, controlled, open-label trial aims to enrol 2246 patients across 10 maternity hospitals in Sweden. Patients with a live single or multiple pregnancy after 34 complete gestational weeks undergoing elective caesarean delivery will be randomised to either routine manual external aortic compression or no aortic compression (standard care). The primary objective is to investigate whether external aortic compression in caesarean delivery is an effective preventive method to reduce severe postpartum haemorrhage, defined as a calculated blood loss &gt;1000 mL or blood transfusion within 48 hours. The secondary objectives are to investigate whether it reduces overall maternal morbidity, shortens time in surgery or hospital, affects patient-reported outcomes and is safe and acceptable to patients. Analyses will follow the intention-to-treat (ITT) principle, using generalised linear mixed-effects models for the primary and secondary outcomes with adjustment for study centre. Multiplicity for confirmatory outcomes will be controlled using a hierarchical testing procedure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was obtained on 20 September 2022 from the Swedish Ethical Review Authority (2022-04327-01), and amendments were approved on 28 November 2022 (2022-06377-02), 17 February 2025 (2025-00700-02) and 9 June 2026 (2026-03503-02). Results of the study will be published in peer-reviewed medical journals, presented at scientific meetings and communicated to the public through mass media.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05312658\">NCT05312658<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-123793","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T13:28:03Z","timestamp":1782826083000},"page":"e123793","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Routine external aortic compression versus no aortic compression in elective caesarean delivery to reduce blood loss: study protocol of a randomised controlled trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct05312658","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05312658","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-3164-154X","authenticated-orcid":false,"given":"Helena","family":"Grobecker","sequence":"first","affiliation":[{"name":"Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden"},{"name":"Department of Women\u2019s Health, Danderyd Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00e5rten","family":"Alkmark","sequence":"additional","affiliation":[{"name":"Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden"},{"name":"Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Gothenburg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3972-0457","authenticated-orcid":false,"given":"Ola","family":"Andersson","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Pediatrics\/Neonatology, Lund University Faculty of Medicine, Lund, Sweden"},{"name":"Department of Neonatology, Sk\u00e5ne University Hospital Lund, Lund, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Bergendahl","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden"},{"name":"BB Sankt G\u00f6ran, Capio Sankt G\u00f6ran Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annika","family":"Carlson","sequence":"additional","affiliation":[{"name":"Department of Women's and Children\u2019s Health, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Women\u2019s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Fagerkrantz","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Vrinnevi Hospital, Norrk\u00f6ping, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anette","family":"Hein","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden"},{"name":"Department of Anesthesia and Intensive Care, Danderyd Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Hesselman","sequence":"additional","affiliation":[{"name":"Centre for Clinical Research Dalarna, Uppsala University, Falun, Sweden"},{"name":"Department of Obstetrics and Gynaecology, Falu Hospital, Falun, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrika","family":"Johannesson","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden"},{"name":"Department of Women\u2019s Health, Danderyd Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ove","family":"Karlsson","sequence":"additional","affiliation":[{"name":"Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden"},{"name":"Department of Anesthesiology and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabel","family":"L\u00f6hr","sequence":"additional","affiliation":[{"name":"Department of Women\u2019s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Nelander","sequence":"additional","affiliation":[{"name":"Department of Women's and Children\u2019s Health, Akademiska University Hospital, Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"T\u00f6rnberg","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden"},{"name":"Department of Anesthesia and Intensive Care, Danderyd Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7599-567X","authenticated-orcid":false,"given":"Hanna","family":"\u00c5mark","sequence":"additional","affiliation":[{"name":"Department of Clinical Research and Education, S\u00f6dersjukhuset, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Obstetrics and Gynecology, S\u00f6dersjukhuset, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malin","family":"\u00d6ndemark","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, S\u00f6dert\u00e4lje Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9401-8062","authenticated-orcid":false,"given":"Sophia","family":"Brismar Wendel","sequence":"additional","affiliation":[{"name":"Department of Women's and Children\u2019s Health, Karolinska Institutet, Stockholm, Sweden"},{"name":"Department of Women\u2019s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,6,30]]},"reference":[{"key":"2026063005552992000_16.6.e123793.1","unstructured":"WHO Guidelines Approved by the Guidelines Review Committee . WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: World Health Organization Copyright \u00a9, 2012."},{"key":"2026063005552992000_16.6.e123793.2","article-title":"Mechanical and surgical interventions for treating primary postpartum haemorrhage","volume":"7","author":"Kellie","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"key":"2026063005552992000_16.6.e123793.3","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0144274","article-title":"Delineating the Association between Heavy Postpartum Haemorrhage and Postpartum Depression","volume":"11","author":"Eckerdal","year":"2016","journal-title":"PLoS One"},{"key":"2026063005552992000_16.6.e123793.4","doi-asserted-by":"crossref","first-page":"e582","DOI":"10.1016\/j.wombi.2023.05.001","article-title":"Primary postpartum haemorrhage adversely impacts breastfeeding initiation in Victoria, Australia","volume":"36","author":"Flood","year":"2023","journal-title":"Women Birth"},{"key":"2026063005552992000_16.6.e123793.5","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0041114","article-title":"Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis","volume":"7","author":"Calvert","year":"2012","journal-title":"PLoS One"},{"key":"2026063005552992000_16.6.e123793.6","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1016\/j.ejogrb.2024.08.011","article-title":"Trends, causes and factors associated with primary Postpartum Haemorrhage (PPH) in Ireland: A review of one million hospital childbirths","volume":"301","author":"Fitzgerald","year":"2024","journal-title":"Eur J Obstet Gynecol Reprod Biol"},{"key":"2026063005552992000_16.6.e123793.7","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2393-9-55","article-title":"Trends in postpartum hemorrhage in high resource countries: a review and recommendations from the International Postpartum Hemorrhage Collaborative Group","volume":"9","author":"Knight","year":"2009","journal-title":"BMC Pregnancy Childbirth"},{"key":"2026063005552992000_16.6.e123793.8","doi-asserted-by":"crossref","first-page":"152","DOI":"10.1097\/AOG.0000000000004972","article-title":"Postpartum Hemorrhage Trends and Outcomes in the United States, 2000-2019","volume":"141","author":"Corbetta-Rastelli","year":"2023","journal-title":"Obstet Gynecol"},{"key":"2026063005552992000_16.6.e123793.9","unstructured":"Graviditetsregistret . Annual report 2021 of the Swedish pregnancy register. Stockholm, Sweden Swedish Pregnancy Register, MedSciNet; 2022. Available: https:\/\/www.medscinet.com\/GR\/uploads\/hemsida\/dokumentarkiv\/GR%20\u00c5rsrapport%202021_3.0.pdf"},{"key":"2026063005552992000_16.6.e123793.10","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2028788"},{"key":"2026063005552992000_16.6.e123793.11","doi-asserted-by":"crossref","first-page":"101049","DOI":"10.1016\/j.ajogmf.2023.101049","article-title":"Tranexamic acid for the prevention of blood loss after cesarean section: an updated systematic review and meta-analysis of randomized controlled trials","volume":"5","author":"Cheema","year":"2023","journal-title":"Am J Obstet Gynecol MFM"},{"key":"2026063005552992000_16.6.e123793.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2021.09.025"},{"key":"2026063005552992000_16.6.e123793.13","unstructured":"SBU . Behov av kunskap och utveckling inom omr\u00e5det kejsarsnitt. Prioritering baserad p\u00e5 James Lind Alliance metod. Prioritering av vetenskapliga kunskapsluckor. Stockholm Statens beredning f\u00f6r medicinsk och social utv\u00e4rdering (SBU. Available: https:\/\/www.sbu.se\/357"},{"key":"2026063005552992000_16.6.e123793.14","unstructured":"L\u00d6F . Postpartumbl\u00f6dning vid vaginal f\u00f6rlossning. Sweden S\u00e4ker f\u00f6rlossningsv\u00e5rd, Landstingens \u00d6msesidiga F\u00f6rs\u00e4kring; 2023. Available: https:\/\/lof.se\/filer\/Postpartumblodning.pdf"},{"key":"2026063005552992000_16.6.e123793.15","doi-asserted-by":"crossref","first-page":"110","DOI":"10.55460\/7HOX-2JW6","article-title":"Temporizing Life-Threatening Abdominal-Pelvic Hemorrhage Using Proprietary Devices, Manual Pressure, or a Single Knee: An Integrative Review of Proximal External Aortic Compression and Even \u201cKnee BOA\u201d","volume":"20","author":"O\u2019Dochartaigh","year":"2020","journal-title":"J Spec Oper Med"},{"key":"2026063005552992000_16.6.e123793.16","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1177\/0310057X9402200512","article-title":"External abdominal aortic compression: a study of a resuscitation manoeuvre for postpartum haemorrhage","volume":"22","author":"Riley","year":"1994","journal-title":"Anaesth Intensive Care"},{"key":"2026063005552992000_16.6.e123793.17","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1111\/j.1447-0756.2008.00975.x","article-title":"External aortic compression device: the first aid for postpartum hemorrhage control","volume":"35","author":"Soltan","year":"2009","journal-title":"J Obstet Gynaecol Res"},{"key":"2026063005552992000_16.6.e123793.18","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/j.ijgo.2010.03.034","article-title":"Assessing changes in flow velocimetry and clinical outcome following use of an external aortic compression device in women with postpartum hemorrhage","volume":"110","author":"Soltan","year":"2010","journal-title":"Int J Gynaecol Obstet"},{"key":"2026063005552992000_16.6.e123793.19","unstructured":"Nationella riktlinjer Rekommendationer om avnavling av det nyf\u00f6dda barnet (National guideline recommendations on umbilical cord clamping in the newborn). 2022. Available: https:\/\/www.sfog.se\/media\/338294\/rekommendationer_avnavling_2022.pdf"},{"key":"2026063005552992000_16.6.e123793.20","doi-asserted-by":"crossref","first-page":"728","DOI":"10.1111\/aogs.14560","article-title":"Key outcomes in childbirth: Development of a perinatal core outcome set for management of labor and delivery at or near term","volume":"102","author":"Savchenko","year":"2023","journal-title":"Acta Obstet Gynecol Scand"},{"key":"2026063005552992000_16.6.e123793.21","doi-asserted-by":"publisher","DOI":"10.3109\/08039488.2011.590606"},{"key":"2026063005552992000_16.6.e123793.22","doi-asserted-by":"publisher","DOI":"10.1177\/0890334414523836"},{"key":"2026063005552992000_16.6.e123793.23","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1111\/1471-0528.15335","article-title":"Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study","volume":"126","author":"Meher","year":"2019","journal-title":"BJOG"},{"key":"2026063005552992000_16.6.e123793.24","unstructured":"Graviditetsregistret . Annual report 2022 of the Swedish pregnancy register. Stockholm, Sweden Swedish Pregnancy Register, MedSciNet; 2023. Available: https:\/\/www.medscinet.com\/GR\/uploads\/hemsida\/Graviditetsregistrets%20\u00c5rsrapport%202022.pdf"},{"key":"2026063005552992000_16.6.e123793.25","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2026063005552992000_16.6.e123793.26","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2024-081477","article-title":"SPIRIT 2025 statement: updated guideline for protocols of randomised trials","volume":"389","author":"Chan","year":"2025","journal-title":"BMJ"},{"key":"2026063005552992000_16.6.e123793.27","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1016\/j.ajog.2024.09.017","article-title":"External aortic compression: buying time to save lives in obstetric hemorrhage","volume":"232","author":"Nieto-Calvache","year":"2025","journal-title":"Am J Obstet Gynecol"},{"key":"2026063005552992000_16.6.e123793.28","doi-asserted-by":"crossref","first-page":"e9","DOI":"10.1016\/j.annfar.2013.11.014","article-title":"Lower limb peripheral NIRS parameters during a vascular occlusion test: an experimental study in healthy volunteers","volume":"33","author":"Fellahi","year":"2014","journal-title":"Ann Fr Anesth Reanim"},{"key":"2026063005552992000_16.6.e123793.29","doi-asserted-by":"publisher","DOI":"10.1177\/1538574411406746"},{"key":"2026063005552992000_16.6.e123793.30","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1113\/EP090540","article-title":"Metabolic and microvascular function assessed using near-infrared spectroscopy with vascular occlusion in women: age differences and reliability","volume":"108","author":"Rogers","year":"2023","journal-title":"Exp Physiol"},{"key":"2026063005552992000_16.6.e123793.31","doi-asserted-by":"crossref","DOI":"10.3390\/medicina59061146","article-title":"rSO2 Measurement Using NIRS for Lower-Limb Blood Flow Monitoring and Estimation of Safe Balloon Occlusion\/Deflation Time in Patients with PAS Who Underwent PBOA during CS","volume":"59","author":"Tokue","year":"2023","journal-title":"Medicina (Kaunas)"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-123793","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T13:28:21Z","timestamp":1782826101000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-123793"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6]]},"references-count":31,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2026,6,30]]},"published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1136\/bmjopen-2026-123793"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-123793","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6]]}}}