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

ABSTRACT:

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 out

SUBMITTER: Fistouris J 

PROVIDER: S-EPMC11969908 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature