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Published on: October 24, 2017
Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled
Johan Fistouris1,2, Helen Garbergs3, Katja Bergman4
1Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
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.
