BJOG : an international journal of obstetrics and gynaecology · 2025
Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Fistouris Johan, Garbergs Helen, Bergman Katja, Bergh Christina, Strandell Annika
Аннотация
OBJECTIVE: 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).
DESIGN: The study has a superiority design regarding specificity for non-ectopic pregnancy for M4, given that the primary outcome of sensitivity for ectopic pregnancy (EP) is non-inferior in comparison with the NICE algorithm.
SETTING: Emergency gynaecology units in Sweden.
POPULATION: 595 women with PUL.
METHODS: 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-sectional data and utility by parallel groups.
MAIN OUTCOME MEASURES: The proportion of EP categorised as high risk (sensitivity) and non-ectopic pregnancies categorised as low risk (specificity). Clinical outcomes were assessed.
RESULTS: The sensitivity for EP was 79% (115 of 146) for M4 versus 85% (124 of 146) for the NICE algorithm, p = 0.1496 and the specificity for non-ectopic pregnancies was 67% (300 of 449) for M4 and 74% (334 of 449) for the NICE algorithm, p = 0.0003. Clinical outcomes were similar between groups.
CONCLUSIONS: The sensitivity for EP by M4 was non-inferior to NICE, but specificity was better for the NICE algorithm. No between group differences were observed for clinical outcomes.
TRIAL REGISTRATION: NCT03461835, https://www.
CLINICALTRIALS: gov.
DESIGN: The study has a superiority design regarding specificity for non-ectopic pregnancy for M4, given that the primary outcome of sensitivity for ectopic pregnancy (EP) is non-inferior in comparison with the NICE algorithm.
SETTING: Emergency gynaecology units in Sweden.
POPULATION: 595 women with PUL.
METHODS: 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-sectional data and utility by parallel groups.
MAIN OUTCOME MEASURES: The proportion of EP categorised as high risk (sensitivity) and non-ectopic pregnancies categorised as low risk (specificity). Clinical outcomes were assessed.
RESULTS: The sensitivity for EP was 79% (115 of 146) for M4 versus 85% (124 of 146) for the NICE algorithm, p = 0.1496 and the specificity for non-ectopic pregnancies was 67% (300 of 449) for M4 and 74% (334 of 449) for the NICE algorithm, p = 0.0003. Clinical outcomes were similar between groups.
CONCLUSIONS: The sensitivity for EP by M4 was non-inferior to NICE, but specificity was better for the NICE algorithm. No between group differences were observed for clinical outcomes.
TRIAL REGISTRATION: NCT03461835, https://www.
CLINICALTRIALS: gov.