{
  "abstract": "Introduction 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.Methods and analysis 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 >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.Ethics and dissemination 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.Trial registration number NCT05312658.",
  "authors": [
    {
      "affiliations": [
        "Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden",
        "Department of Women’s Health, Danderyd Hospital, Stockholm, Sweden"
      ],
      "name": "Helena Grobecker"
    },
    {
      "affiliations": [
        "Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden",
        "Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Gothenburg, Sweden"
      ],
      "name": "Mårten Alkmark"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences, Pediatrics/Neonatology, Lund University Faculty of Medicine, Lund, Sweden",
        "Department of Neonatology, Skåne University Hospital Lund, Lund, Sweden"
      ],
      "name": "Ola Andersson"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden",
        "BB Sankt Göran, Capio Sankt Göran Hospital, Stockholm, Sweden"
      ],
      "name": "Sandra Bergendahl"
    },
    {
      "affiliations": [
        "Department of Women's and Children’s Health, Karolinska Institutet, Stockholm, Sweden",
        "Department of Women’s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Annika Carlson"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Vrinnevi Hospital, Norrköping, Sweden"
      ],
      "name": "Amanda Fagerkrantz"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden",
        "Department of Anesthesia and Intensive Care, Danderyd Hospital, Stockholm, Sweden"
      ],
      "name": "Anette Hein"
    },
    {
      "affiliations": [
        "Centre for Clinical Research Dalarna, Uppsala University, Falun, Sweden",
        "Department of Obstetrics and Gynaecology, Falu Hospital, Falun, Sweden"
      ],
      "name": "Susanne Hesselman"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden",
        "Department of Women’s Health, Danderyd Hospital, Stockholm, Sweden"
      ],
      "name": "Ulrika Johannesson"
    },
    {
      "affiliations": [
        "Sahlgrenska Academy, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden",
        "Department of Anesthesiology and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden"
      ],
      "name": "Ove Karlsson"
    },
    {
      "affiliations": [
        "Department of Women’s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Isabel Löhr"
    },
    {
      "affiliations": [
        "Department of Women's and Children’s Health, Akademiska University Hospital, Uppsala, Sweden"
      ],
      "name": "Maria Nelander"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden",
        "Department of Anesthesia and Intensive Care, Danderyd Hospital, Stockholm, Sweden"
      ],
      "name": "Daniel Törnberg"
    },
    {
      "affiliations": [
        "Department of Clinical Research and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden",
        "Department of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden"
      ],
      "name": "Hanna Åmark"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Södertälje Hospital, Stockholm, Sweden"
      ],
      "name": "Malin Öndemark"
    },
    {
      "affiliations": [
        "Department of Women's and Children’s Health, Karolinska Institutet, Stockholm, Sweden",
        "Department of Women’s Health, Division of Obstetrics, Karolinska University Hospital, Stockholm, Sweden"
      ],
      "name": "Sophia Brismar Wendel"
    }
  ],
  "title": "Routine external aortic compression versus no aortic compression in elective caesarean delivery to reduce blood loss: study protocol of a randomised controlled trial",
  "uid": "bd6270f4-4510-5860-ba2c-7c697c7d9e9e"
}