Table G.6What is the diagnostic value of ultrasound for determining a viable intrauterine pregnancy?

Bibliographic informationReason for exclusion
Abdallah,Y., Daemen,A., Guha,S., Syed,S., Naji,O., Pexsters,A., Kirk,E., Stalder,C., Gould,D., Ahmed,S., Bottomley,C., Timmerman,D., Bourne,T., Gestational sac and embryonic growth are not useful as criteria to define miscarriage: a multicenter observational study, Ultrasound in Obstetrics and Gynecology, 38, 503-509, 2011No outcomes of interest reported - evaluates growth of fetus, not threshold for diagnosis of miscarriage
Bae,S., Karnitis,J., Triple ultrasound markers including fetal cardiac activity are related to miscarriage risk, Fertility and Sterility, 96, 1145-1148, 2011Presence of fetal cardiac activity is not reported in a stratified manner; therefore it is not possible to determine the point of 100% visualisation
Barnhart,K.T., Fay,C.A., Suescum,M., Sammel,M.D., Appleby,D., Shaunik,A., Dean,A.J., Clinical factors affecting the accuracy of ultrasonography in symptomatic first-trimester pregnancy, Obstetrics and Gynecology, 117, 299-306, 2011No reported outcomes of interest - does not report accuracy of ultrasound stratified by CRL, sac diameter or gestational age
Barnhart,K.T., Fay,C., Suescum,M., Sammel,M.D., Appleby,D., Shaunik,A., Dean,A.J., Clinical Factors Affecting the Accuracy of Ultrasonography in Symptomatic First-Trimester Pregnancy, Obstetrics & Gynecology, 117, -, 2011No outcomes of interest reported - does not report diagnostic accuracy stratified by any parameter.
Bottomley,C., Daemen,A., Mukri,F., Papageorghiou,A.T., Kirk,E., Pexsters,A., De Moor,B., Timmerman,D., Bourne,T., Assessing first trimester growth: the influence of ethnic background and maternal age, Human Reproduction, 24, 284-290, 2009No outcomes of interest reported - evaluates growth of fetus, not visualisation of cardiac activity
Bottomley,C., Van,Belle,V, Mukri,F., Kirk,E., Van,Huffel S., Timmerman,D., Bourne,T., The optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy, Human Reproduction, 24, 1811-1817, 2009No outcomes of interest - this study does not report visualisation of a heart beart stratified by gestational age, crown rump length or mean gestational sac diameter. In addition, it is not reported whether those women who were diagnosed with a miscarriage on one scan were followed up and given a repeat scan to definitively confirm this diagnosis
Bottomley,C., Van Belle,V., Pexsters,A., Papageorghiou,A.T., Mukri,F., Kirk,E., Van Huffel,S., Timmerman,D., Bourne,T., A model and scoring system to predict outcome of intrauterine pregnancies of uncertain viability, Ultrasound in Obstetrics and Gynecology, 37, 588-595, 2011Study evaluates the use of a model with multiple variables, not the use of CRL or gestation sac diameter thresholds on ultrasound
Brigham,S.A., Conlon,C., Farquharson,R.G., A longitudinal study of pregnancy outcome following idiopathic recurrent miscarriage, Human Reproduction, 14, 2868-2871, 1999No outcomes of interest reported - visualisation of cardiac activity is not reported with sufficient accuracy to be able to determine the point of 100% visualisation in later viable fetuses
Bromley,B., Harlow,B.L., Laboda,L.A., Benacerraf,B.R., Small sac size in the first trimester: a predictor of poor fetal outcome, Radiology, 178, 375-377, 1991No outcomes of interest reported - this study is assessing prognosis not diagnosis - all foetuses have cardiac activity at point of ultrasound
Burger,I.M., Filly,R.A., Value of “minimum menstrual age” in determining early pregnancy failure, Journal of Ultrasound in Medicine, 30, 1553-1559, 2011Insufficient detail is to provided to report the point of 100% accuracy in visualisation
Clifford,K., Rai,R., Regan,L., Future pregnancy outcome in unexplained recurrent first trimester miscarriage, Human Reproduction, 12, 387-389, 1997No outcomes of interest reported - does not report point of visualisation of fetal heartbeat
Enk,L., Wikland,M., Hammarberg,K., Lindblom,B., The value of endovaginal sonography and urinary human chorionic gonadotropin tests for differentiation between intrauterine and ectopic pregnancy, Journal of Clinical Ultrasound, 18, 73-78, 1990No outcomes of interest reported - stratifies by hCG level only and does not report ultrasound accuracy at different crown-rump lengths or gestation sac sizes
Eriksen,P.S., Philipsen,T., Prognosis in threatened abortion evaluated by hormone assays and ultrasound scanning, Obstetrics and Gynecology, 55, 435-438, 1980Wrong population - includes women with 6-20 weeks gestation and does not stratify visualisation of cardiac activity by any parameter
Ismail,A.A., Kishk,S.M., Empty gestational sacs diagnosed by abdominal real-time ultrasonography, European Journal of Obstetrics, Gynecology, and Reproductive Biology, 42, 205-209, 1991Study is not conducted in a developed country; visualisation of cardiac activity is not reported
Jain,K.A., Hamper,U.M., Sanders,R.C., Comparison of transvaginal and transabdominal sonography in the detection of early pregnancy and its complications, AJR, American Journal of Roentgenology. 151, 1139-1143, 1988No outcomes of interest reported - does not report visualisation of cardiac activity stratified by crown-rump length or gestation sac size
Jeve,Y., Rana,R., Bhide,A., Thangaratinam,S., Accuracy of first-trimester ultrasound in the diagnosis of early embryonic demise: a systematic review, Ultrasound in Obstetrics and Gynecology, 38, 489-496, 2011All included studies have been appraised for inclusion separately
Kaur,A., Transvaginal ultrasonography in first trimester of pregnancy and its comparison with transabdominal ultrasonography, Journal of Pharmacy and Bioallied Sciences, 3, 329-338, 2011This study is a comparison of the features of an embryo that can be visualised on TVU and TAU - it does not evaluate any outcomes of interest
Lautmann,K., Cordina,M., Elson,J., Johns,J., Schramm-Gajraj,K., Ross,J.A., Clinical use of a model to predict the viability of early intrauterine pregnancies when no embryo is visible on ultrasound, Human Reproduction, 26, 2957-2963, 2011Study evaluates a model with multiple variables and not thresholds of CRL or sac diameter; women with an initially diagnosis of miscarriage at first scan were excluded from the study population, and therefore not followed up to confirm diagnosis (reruns)
Madazli,R., Tunali,S., Idil,M., Aksu,M.F., Benefits of transvaginal sonographic assessment of early pregnancy, Marmara Medical Journal, 14, 223-226, 2001Women in whom fetal cardiac activity was not visualised on the initial scan were not followed up any further; also does not report visualisation stratified by any measure of age or size
Nyberg,D.A., Laing,F.C., Filly,R.A., Threatened abortion: sonographic distinction of normal and abnormal gestation sacs, Radiology, 158, 397-400, 1986No outcomes of interest - study does not report the point of 100% accuracy stratified by CRL or sac diameter, it merely dichotomises into above and below 25 mm. Some miscarriages were also diagnosed on the basis of curettage findings
Nyberg,D.A., Mack,L.A., Harvey,D., Wang,K., Value of the yolk sac in evaluating early pregnancies, Journal of Ultrasound in Medicine, 7, 129-135, 1988No outcomes of interest reported - reports visualisation of a yolk sac, not detection of cardiac activity
Nyberg,D.A., Mack,L.A., Laing,F.C., Patten,R.M., Distinguishing normal from abnormal gestational sac growth in early pregnancy, Journal of Ultrasound in Medicine, 6, 23-27, 1987No outcomes of interest - does not report visualisation of cardiac activity; therefore point at which all viable pregnancies should have a visible heartbeat cannot be determined
Papaioannou,G.I., Syngelaki,A., Maiz,N., Ross,J.A., Nicolaides,K.H., Ultrasonographic prediction of early miscarriage, Human Reproduction, 26, 1685-1692, 2011No outcomes of interest reported - study is evaluating factors that predict miscarriage in a fetus previously shown to be viable.
Papaioannou,G.I., Syngelaki,A., Poon,L.C., Ross,J.A., Nicolaides,K.H., Normal ranges of embryonic length, embryonic heart rate, gestational sac diameter and yolk sac diameter at 6-10 weeks, Fetal Diagnosis and Therapy, 28, 207-219, 2010No reported outcomes of interest - study does not evaluate assessment of viability stratified by any parameter
Pexsters,A., Luts,J., Van Schoubroeck, D., Bottomley,C., Van Calster, B., Van Huffel, S., Abdallah,Y., D'Hooghe,T., Lees,C., Timmerman,D., Bourne,T., Clinical implications of intra- and interobserver reproducibility of transvaginal sonographic measurement of gestational sac and crown-rump length at 6-9 weeks' gestation, Ultrasound in Obstetrics and Gynecology, 38, 510-515, 2011Wrong comparison - evaluating variability in ultrasound measurements, not the point at which miscarriage can be reliably diagnosed
Rowland,J., Heazell,A., Melvin,C., Hill,S., Auscultation of the fetal heart in early pregnancy, Archives of Gynecology and Obstetrics, 283 Suppl 1, 9-11, 2011Women with a ‘diagnosed’ miscarriage were excluded from the study population, not followed up to ensure that they were not a viable pregnancy
Scott,R.F., Featherstone,T., Hussey,J.K., Ultrasound of the empty gestation sac in threatened abortion, Clinical Radiology, 38, 127-130, 1987Determination of viability is not reported with sufficient stratification to be able to determine the point of 100% accuracy - the study simply reports that all viable gestations were less than 26 mm. Also, does not report whether transvaginal or transabdominal ultrasound was used.
Tan,S., Ipek,A., Pektas,M.K., Arifoglu,M., Teber,M.A., Karaoglanoglu,M., Irregular yolk sac shape: is it really associated with an increased risk of spontaneous abortion?, Journal of Ultrasound in Medicine, 30, 31-36, 2011Only included women in whom fetal cardiac activity was already visible
Tannirandorn,Y., Sangsawang,S., Manotaya,S., Uerpairojkit,B., Samritpradit,P., Charoenvidhya,D., Fetal loss in threatened abortion after embryonic/fetal heart activity, International Journal of Gynaecology and Obstetrics, 81, 263-266, 2003Wrong population - developing country setting; all participants had visible cardiac activity, so the study reports prognosis by heart rate;
Tongsong,T., Wanapirak,C., Srisomboon,J., Sirichotiyakul,S., Polsrisuthikul,T., Pongsatha,S., Transvaginal ultrasound in threatened abortions with empty gestational sacs, International Journal of Gynaecology and Obstetrics, 46, 297-301, 1994Wrong population - developing country setting; no relevant outcomes - does not report presence of cardiac activity
Varelas,F.K., Prapas,N.M., Liang,R.I., Prapas,I.M., Makedos,G.A., Yolk sac size and embryonic heart rate as prognostic factors of first trimester pregnancy outcome, European Journal of Obstetrics, Gynecology, and Reproductive Biology, 138, 10-13, 2008No outcomes of interest reported - all participants had visible cardiac activity, therefore reports prognosis by heart rate
Yegul,N.T., Filly,R.A., Further observations on the empty “amnion sign”, Journal of Clinical Ultrasound, 38, 113-117, 2010No outcomes of interest reported - does not report presence or absence of cardiac activity
Yegul,N.T., Filly,R.A., The expanded amnion sign: evidence of early embryonic death, Journal of Ultrasound in Medicine, 28, 1331-1335, 2009No outcomes of interest reported - cardiac activity was never visualised in the embryos

From: Appendix G, Excluded studies

Cover of Ectopic Pregnancy and Miscarriage
Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage.
NICE Clinical Guidelines, No. 154.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG; 2012 Dec.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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