Evidence map›Paper›PMID 39840550›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2025

Managing Pregnancies of Unknown Location With the M4 Prediction Model or the NICE Algorithm: A Randomised Controlled Trial With Cross-Sectional Diagnostic Accuracy Data.

Johan Fistouris, Helen Garbergs, Katja Bergman, Christina Bergh, Annika Strandell

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03461835 (- a Randomized Control Trial of Two hCG- Based Decision Support Models), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03461835 nacompletednot on this map

- a Randomized Control Trial of Two hCG- Based Decision Support Models

TypeinterventionalSponsorGöteborg UniversityRan2018 to 2024Enrolled609ConditionsPregnancy, Ectopic, Pregnancy, High Risk, Pregnancy EarlyArmsRisk classification of PUL by M4, Risk classification of PUL by NICE
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Johan FistourisDepartment of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID https://orcid.org/0000-0002-6816-5691
Helen GarbergsRegion Västra Götaland, Department of Obstetrics and Gynecology, Skaraborg Hospital Skövde, Skövde, Sweden.
Katja BergmanRegion Västra Götaland, Department of Obstetrics and Gynecology, Södra Älvsborg Hospital, Borås, Sweden.
Christina BerghDepartment of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID https://orcid.org/0000-0001-6049-7731
Annika StrandellDepartment of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID https://orcid.org/0000-0003-1647-5388

Funding

ALFGBG 965130ALFGBG 965526Stiftelsen Handlanden Hjalmar SvenssonsVästra Götalandsregionen
6 · The paper itself

Abstract

objectiveTo determine the diagnostic performance and clinical utility of the M4 prediction model and the NICE algorithm managing women with pregnancy of unknown location (PUL).

designThe 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.

settingEmergency gynaecology units in Sweden. POPULATION: 595 women with PUL.

methodsParticipants 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 measuresThe proportion of EP categorised as high risk (sensitivity) and non-ectopic pregnancies categorised as low risk (specificity). Clinical outcomes were assessed.

resultsThe 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.

conclusionsThe 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 registrationNCT03461835, https://www. CLINICALTRIALS: gov.

Indexed as

AlgorithmsPregnancy, EctopicAdultChorionic GonadotropinCross-Sectional StudiesFemaleHumansPredictive Value of TestsPregnancyRisk AssessmentSensitivity and SpecificitySwedenChorionic Gonadotropinclinical management algorithmectopic pregnancyhuman chorionic gonadotrophinprediction modelpregnancy of unknown location

Identifiers

PMID39840550
PMCPMC11969908

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.