Objectives
A prediction model (M4) can successfully classify PUL into low and high risk groups. We aim to externally validate the M4 model in classifying women in a non-UK population, into low and high risk pregnancies of unknown location (PULs).
Introduction
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Methods
A retrospective analysis of women classified with PUL attending a Sydney-based teaching hospital between June 2006 and March 2016. PUL was defined as nil signs of intra- or extra-uterine pregnancy on transvaginal ultrasound (TVS). The reference standard was the final characterization of PUL as failed PULs or intra-uterine pregnancies (IUPs) (low risk), or as ectopic pregnancies (EPs) (high risk). M4 is a multinomial logistic regression model based on the serum human chorionic gonadotrophin (hCG) levels at presentation and 48 h later. This model was applied to each PUL and the estimated risks of failed PULs, IUPs or EPs were recorded. In the event that M4 classified women to have an EP risk >= 5%, then these women were classified high risk.
Results
8360 consecutive women underwent TVS and 7.94% (664/8360) women were classified with a PUL. 57 women were excluded due to incomplete data. The final diagnoses were 64.4% (391/607) failed PULs, 23.5% (143/607) IUPs and 12% (73/607) EPs; includes EPs and persisting PULs.
Final diagnosis (n = 607)Failed PUL
|
IUP |
EP; includes EPs and persisting PULs
|
64.4% (391)
|
23.5% (143)
|
12% (73)
|
454 were considered low risk of which 397 (87.4%) were failed PULs or IUPs and 22 were EPs.
67% (49/73) of the EPs were considered high risk.
Prediction of PULs as low or high risk based on the M4 prediction model.Final diagnosis |
Low risk |
High risk |
Low risk (IUP/failed PUL) |
397 (87.4%) |
|
High risk (EP) |
22
|
49 (67.1%) |
The M4-based protocol classified 17.6% of failed PUL, 31% of IUP and 69% of EP as high risk. For all PUL this protocol classified 73% of PUL as at low risk, and amongst these 95% were indeed failed PUL or IUP. Thus, of PUL classified as at low risk using M4, about 1 in 19 would be an EP.
Discussion
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Conclusion
We have externally validated prediction model M4 which classified around 73% of PULS at low risk, of which around 95% were later characterized as failed PULs or IUPs, while still classifying only 69% of EPs as high risk.