Temporal and external validation of the algorithm predicting first trimester outcome of a viable pregnancy

BACKGROUND: Symptoms like vaginal bleeding or abdominal pain in early pregnancy can create anxiety about potential miscarriage. Previous studies have demonstrated ultrasonographic variables at the first trimester transvaginal scan (TVS) which can assist in predicting outcomes by 12 weeks gestation. AIM: To validate the miscarriage risk prediction model (MRP) in women who present with a viable intrauterine pregnancy (IUP) at the primary ultrasound. MATERIALS AND METHODS: A multi-centre diagnostic study of 1490 patients was performed between 2011 and 2019 for retrospective external and 2017-2019 for prospective temporal validation. The reference standard was a viable pregnancy at 12 + 6 weeks. The MRP model is a multinomial logistic regression model based on maternal age, embryonic heart rate, logarithm (gestational sac volume/crown-rump length (CRL)) ratio, CRL and presence or absence of clots. RESULTS: Temporal validation data from 290 viable IUPs were collected: 225 were viable at the end of the first trimester, 31 had miscarried and 34 were lost to follow-up. External validation data from 1203 viable IUPs were collected at two other ultrasound units: 1062 were viable, 69 had miscarried and 72 were lost to follow-up. Temporal validation with a cut-off of 0.1 demonstrated: area under the curve (AUC) of 0.8 (0.7-0.9), sensitivity 66.7%, specificity 83.9%, positive predictive value (PPV) 35.7%, negative predictive value (NPV) 94.9%, positive likelihood ration (LR+) 4.1 and negative LR (LR-) 0.4. External validation demonstrated: AUC 0.7 (0.7-0.8), sensitivity 44.9%, specificity 90.4%, PPV 23.3%, NPV 96.2%, LR+ 4.6 and LR- 0.6 (0.4-0.7). CONCLUSION: The MRP model is not able to be used in real time for counselling, and management should be individualised.