Diagnostic accuracy of point-of-care testing (POCT) devices for postpartum haemorrhage: A protocol of a systematic review and meta-analysis

Introduction In postpartum haemorrhage (PPH), coagulation factors, mainly fibrinogen, are exhausted early during the course of the disease, which can easily lead to disseminated intravascular coagulation (DIC) and cause maternal mortality. Although some studies have reported the efficacy of point-of-care testing (POCT) devices in detecting hypofibrinogenaemia, little research has been conducted on their usefulness in the diagnosis of PPH. We plan to perform a systematic review of the diagnostic accuracy of existing POCT devices for the diagnosis of hypofibrinogenaemia in PPH. Methods and analysis We plan to identify studies using POCT devices for PPH and perform a systematic review and meta-analysis of their accuracy of diagnosing hypofibrinogenaemia. The results of fibrinogen measurements using the conventional Clauss method are used as reference standards. Literature searches will be conducted using electronic databases (MEDLINE, Embase, Cochrane Database, and Web of Science), and two reviewers will screen independently from the search results. The eligible literature will be used to synthesise true positive, false positive, true negative, and false negative results for the diagnosis of hypofibrinogenaemia. We will estimate the diagnostic accuracy of POCT devices for diagnosing hypofibrinogenaemia in patients with PPH using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve. Ethics and dissemination This systematic review will be conducted through the secondary use of literature extracted from electronic databases. There are no ethical issues associated with this research. The final integrated results will be submitted to a peer-reviewed journal. Protocol registration The study protocol was registered with University Hospital Medical Information Network Clinical Trials (UMIN000048272) and PROSPERO (CRD42023394785). Strengths and limitations of the study ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present work are contained in the manuscript