Triaging women with pregnancy of unknown location using two‐step protocol including M6 model: clinical implementation study

ABSTRACT Objective The M6 risk‐prediction model was published as part of a two‐step protocol using an initial progesterone level of ≤ 2 nmol/L to identify probable failing pregnancies (Step 1) followed by the M6 model (Step 2). The M6 model has been shown to have good triage performance for stratify...

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Published in:Ultrasound in obstetrics & gynecology 2020-01, Vol.55 (1), p.105-114
Main Authors: Bobdiwala, S., Christodoulou, E., Farren, J., Mitchell‐Jones, N., Kyriacou, C., Al‐Memar, M., Ayim, F., Chohan, B., Kirk, E., Abughazza, O., Guruwadahyarhalli, B., Guha, S., Vathanan, V., Bottomley, C., Gould, D., Stalder, C., Timmerman, D., Calster, B., Bourne, T.
Format: Article
Language:English
Subjects:
adverse event
Chorionic gonadotropin
Clinical medicine
Data analysis
decision support techniques
Deviation
Ectopic pregnancy
Gonadotropins
Guidelines
Hospitals
miscarriage
Patients
Pituitary (anterior)
Prediction models
Pregnancy
pregnancy of unknown location
Progesterone
Risk
Statistical analysis
triage
Ultrasonic imaging
ultrasonography
Ultrasound
Urine
Women
Womens health
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Summary:ABSTRACT Objective The M6 risk‐prediction model was published as part of a two‐step protocol using an initial progesterone level of ≤ 2 nmol/L to identify probable failing pregnancies (Step 1) followed by the M6 model (Step 2). The M6 model has been shown to have good triage performance for stratifying women with a pregnancy of unknown location (PUL) as being at low or high risk of harboring an ectopic pregnancy (EP). This study validated the triage performance of the two‐step protocol in clinical practice by evaluating the number of protocol‐related adverse events and how effectively patients were triaged. Methods This was a prospective multicenter interventional study of 3272 women with a PUL, carried out between January 2015 and January 2017 in four district general hospitals and four university teaching hospitals in the UK. The final pregnancy outcome was defined as: a failed PUL (FPUL), an intrauterine pregnancy (IUP) or an EP (including persistent PUL (PPUL)). FPUL and IUP were grouped as low‐risk and EP/PPUL as high‐risk PUL. Serum progesterone and human chorionic gonadotropin (hCG) levels were measured at presentation in all patients. If the initial progesterone level was ≤ 2 nmol/L, patients were discharged and were asked to have a follow‐up urine pregnancy test in 2 weeks to confirm a negative result. If the progesterone level was > 2 nmol/L or a measurement had not been taken, hCG level was measured again at 48 h and results were entered into the M6 model. Patients were managed according to the outcome predicted by the protocol. Those classified as ‘low risk, probable FPUL’ were advised to perform a urine pregnancy test in 2 weeks and those classified as ‘low risk, probable IUP’ were invited for a scan a week later. When a woman with a PUL was classified as high risk (i.e. risk of EP ≥ 5%) she was reviewed clinically within 48 h. One center used a progesterone cut‐off of ≤ 10 nmol/L and its data were analyzed separately. If the recommended management protocol was not adhered to, this was recorded as a protocol deviation and classified as: unscheduled visit for clinician reason, unscheduled visit for patient reason or incorrect timing of blood test or ultrasound scan. The classifications outlined in the UK Good Clinical Practice (GCP) guidelines were used to evaluate the incidence of adverse events. Data were analyzed using descriptive statistics. Results Of the 3272 women with a PUL, 2625 were included in the final analysis (317 met the exclusio
ISSN:0960-7692
1469-0705
DOI:10.1002/uog.20420