{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T20:29:46Z","timestamp":1777926586816,"version":"3.51.4"},"reference-count":38,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,1,22]],"date-time":"2025-01-22T00:00:00Z","timestamp":1737504000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003744","name":"Stiftelsen Handlanden Hjalmar Svenssons","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003744","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007212","name":"V\u00e4stra G\u00f6talandsregionen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007212","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine the diagnostic performance and clinical utility of the M4 prediction model and the NICE algorithm managing women with pregnancy of unknown location (PUL).<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>The study has a superiority design regarding specificity for non\u2010ectopic pregnancy for M4, given that the primary outcome of sensitivity for ectopic pregnancy (EP) is non\u2010inferior in comparison with the NICE algorithm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Emergency gynaecology units in Sweden.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population<\/jats:title><jats:p>595 women with PUL.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Participants were randomised (1:1) to M4 or the NICE algorithm after two serum human chorionic (hCG) levels and were categorised as high or low risk of having an EP. The diagnostic performance was evaluated on cross\u2010sectional data and utility by parallel groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcome Measures<\/jats:title><jats:p>The proportion of EP categorised as high risk (sensitivity) and non\u2010ectopic pregnancies categorised as low risk (specificity). Clinical outcomes were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The sensitivity for EP was 79% (115 of 146) for M4 versus 85% (124 of 146) for the NICE algorithm, <jats:italic>p<\/jats:italic>\u2009=\u20090.1496 and the specificity for non\u2010ectopic pregnancies was 67% (300 of 449) for M4 and 74% (334 of 449) for the NICE algorithm, <jats:italic>p<\/jats:italic>\u2009=\u20090.0003. Clinical outcomes were similar between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The sensitivity for EP by M4 was non\u2010inferior to NICE, but specificity was better for the NICE algorithm. No between group differences were observed for clinical outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>NCT 03461835, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.18079","type":"journal-article","created":{"date-parts":[[2025,1,22]],"date-time":"2025-01-22T05:45:10Z","timestamp":1737524710000},"page":"742-751","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Managing Pregnancies of Unknown Location With the <scp>M4<\/scp> Prediction Model or the <scp>NICE<\/scp> Algorithm: A Randomised Controlled Trial With Cross\u2010Sectional Diagnostic Accuracy Data"],"prefix":"10.1111","volume":"132","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6816-5691","authenticated-orcid":false,"given":"Johan","family":"Fistouris","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg  Gothenburg Sweden"},{"name":"Region V\u00e4stra G\u00f6taland, Department of Gynecology and Reproductive Medicine Sahlgrenska University Hospital  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Garbergs","sequence":"additional","affiliation":[{"name":"Region V\u00e4stra G\u00f6taland, Department of Obstetrics and Gynecology Skaraborg Hospital Sk\u00f6vde  Sk\u00f6vde Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katja","family":"Bergman","sequence":"additional","affiliation":[{"name":"Region V\u00e4stra G\u00f6taland, Department of Obstetrics and Gynecology S\u00f6dra \u00c4lvsborg Hospital  Bor\u00e5s Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6049-7731","authenticated-orcid":false,"given":"Christina","family":"Bergh","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg  Gothenburg Sweden"},{"name":"Region V\u00e4stra G\u00f6taland, Department of Gynecology and Reproductive Medicine Sahlgrenska University Hospital  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1647-5388","authenticated-orcid":false,"given":"Annika","family":"Strandell","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg  Gothenburg Sweden"},{"name":"Region V\u00e4stra G\u00f6taland, Department of Gynecology and Reproductive Medicine Sahlgrenska University Hospital  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/hropen\/hoaa055"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dew105"},{"key":"e_1_2_10_4_1","unstructured":"MM\u2010ARG \u201cKvinnol\u00e4karen \u201d (2021) (5):8 https:\/\/www.sfog.se\/start\/kvinnolaekaren\/kvinnolaekaren\/."},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2005.12.056"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dem073"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000002560"},{"key":"e_1_2_10_8_1","unstructured":"\u201cNICE guideline [NG126] \u201d (2019) https:\/\/wwwniceorguk\/guidance\/ng126."},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.6061\/clinics\/2019\/e1111"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2016.02.015"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jogc.2021.01.002"},{"key":"e_1_2_10_12_1","unstructured":"\u201cTubaire Extra Uteriene Graviditeit (EUG) en Zwangerschap met Onbekende Locatie (ZOL) \u201d (2016) https:\/\/richtlijnendatabasenl\/richtlijn\/tubaire_extra_uteriene_graviditeit_eug_en_zwangerschap_met_onbekende_locatie_zol\/tubaire_eug_en_zol_\u2010_startpaginahtml."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/humupd\/dms035"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/1471-0528.15442"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2014.09.007"},{"key":"e_1_2_10_16_1","doi-asserted-by":"crossref","DOI":"10.1136\/bmj-2023-074819","article-title":"Evaluation of Clinical Prediction Models (Part 1): From Development to External Validation","volume":"384","author":"Collins G. 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