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

first trimester miscarriage miscarriage risk prediction primary transvaginal scan viable intrauterine pregnancy viable pregnancy

Journal

The Australian & New Zealand journal of obstetrics & gynaecology
ISSN: 1479-828X
Titre abrégé: Aust N Z J Obstet Gynaecol
Pays: Australia
ID NLM: 0001027

Informations de publication

Date de publication:
17 Jul 2024
Historique:
received: 23 04 2023
accepted: 10 06 2024
medline: 18 7 2024
pubmed: 18 7 2024
entrez: 18 7 2024
Statut: aheadofprint

Résumé

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. To validate the miscarriage risk prediction model (MRP) in women who present with a viable intrauterine pregnancy (IUP) at the primary ultrasound. 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. 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). The MRP model is not able to be used in real time for counselling, and management should be individualised.

Sections du résumé

BACKGROUND 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 OBJECTIVE
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 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 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 CONCLUSIONS
The MRP model is not able to be used in real time for counselling, and management should be individualised.

Identifiants

pubmed: 39021061
doi: 10.1111/ajo.13855
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : RANZCOG Women's Health Foundation

Informations de copyright

© 2024 Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Références

Abuelghar WM, Fathi HM, Ellaithy MI, Anwar MA. Can a smaller than expected crown‐rump length reliably predict the occurrence of subsequent miscarriage in a viable first trimester pregnancy? J Obstet Gynaecol Res 2013; 39: 1449–1455.
Doubilet PM, Benson CB. Outcome of first‐trimester pregnancies with slow embryonic heart rate at 6–7 weeks gestation and Normal heart rate by 8 weeks at US. Radiology 2005; 236(2): 643–646.
Bromley B, Harlow BL, Laboda LA, Benacerraf BR. Small sac size in the first trimester: A predictor of poor fetal outcome. Radiology 1991; 178(2): 375–377.
Figueras F, Torrents M, Muñoz A et al. Three‐dimensional yolk and gestational sac volume. A prospective study of prognostic value. J Reprod Med 2003; 48: 252–256.
Frates MC, Benson CB, Doubilet PM. Pregnancy outcome after a first trimester sonogram demonstrating fetal cardiac activity. J Ultrasound Med 1993; 12(7): 383–386.
Küçük T, Duru NK, Yenen MC et al. Yolk sac size and shape as predictors of poor pregnancy outcome. J Perinat Med 1999; 27(4): 316–320.
Tadmor OP, Achiron R, Rabinowiz R et al. Predicting first‐trimester spontaneous abortion: Ratio of mean sac diameter to crown‐rump length compared to embryonic heart rate. J Reprod Med Obstet Gynecol 1994; 39(6): 459–462.
Oates J, Casikar I, Campain A et al. A prediction model for viability at the end of the first trimester after a single early pregnancy evaluation. Aust NZ J Obstet Gynaecol 2013; 53(1): 51–57.
Stamatopoulos N, Condous G. Ultrasound follow‐up in the first trimester when pregnancy viability is uncertain. Aust J Ultrasound Med 2017; 20(3): 95–96.
van Calster B, Abdallah Y, Guha S et al. Rationalizing the management of pregnancies of unknown location: Temporal and external validation of a risk prediction model on 1962 pregnancies. Hum Reprod 2013; 28(3): 609–616.
Condous G, Okaro E, Khalid A et al. The use of a new logistic regression model for predicting the outcome of pregnancies of unknown location. Hum Reprod 2004; 19(8): 1900–1910.
Bottomley C, van Belle V, Pexsters A et al. A model and scoring system to predict outcome of intrauterine pregnancies of uncertain viability. Ultrasound Obstet Gynecol 2011; 37(5): 588–595.
Cohen JF, Korevaar DA, Altman DG et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: Explanation and elaboration. BMJ Open 2016; 6(11): e012799.
Stamatopoulos N, Lu C, Casikar I et al. Prediction of subsequent miscarriage risk in women who present with a viable pregnancy at the first early pregnancy scan. Aust NZ J Obstet Gynaecol 2015; 55(5): 464–472.
Choong S, Rombauts L, Ugoni A, Meagher S. Ultrasound prediction of risk of spontaneous miscarriage in live embryos from assisted conceptions. Ultrasound Obstet Gynecol 2003; 22(6): 571–577.
Falco P, Milano V, Pilu G et al. Sonography of pregnancies with first‐trimester bleeding and a viable embryo: A study of prognostic indicators by logistic regression analysis. Ultrasound Obstet Gynecol 1996; 7(3): 165–169.
Hill LM, Guzick D, Fries J, Hixson J. Fetal loss rate after ultrasonically documented cardiac activity between 6 and 14 weeks, menstrual age. J Clin Ultrasound 1991; 19(4): 221–223.

Auteurs

Nicole Stamatopoulos (N)

Acute Gynaecology, Early Pregnancy and Advanced Endoscopy Surgery Unit, Sydney Medical School Nepean, University of Sydney, Penrith, New South Wales, Australia.
Women and Children's Health Services, Nepean Hospital, Kingswood, New South Wales, Australia.

Donna Ngo (D)

Women and Children's Health Services, Nepean Hospital, Kingswood, New South Wales, Australia.

Chuan Lu (C)

Department of Computer Sciences, Aberystwyth University, Aberystwyth, Wales, UK.

Mercedes Espada Vaquero (M)

Acute Gynaecology, Early Pregnancy and Advanced Endoscopy Surgery Unit, Sydney Medical School Nepean, University of Sydney, Penrith, New South Wales, Australia.

Mathew Leonardi (M)

Acute Gynaecology, Early Pregnancy and Advanced Endoscopy Surgery Unit, Sydney Medical School Nepean, University of Sydney, Penrith, New South Wales, Australia.
Department of Obstetrics and Gynecology, McMaster University, Hamilton, Ontario, Canada.

George Condous (G)

Acute Gynaecology, Early Pregnancy and Advanced Endoscopy Surgery Unit, Sydney Medical School Nepean, University of Sydney, Penrith, New South Wales, Australia.

Classifications MeSH