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Ultrasonography [MESH] AND prenatal [ALL] OR perinatal [ALL] OR pregnancy [MESH] AND randomized controlled trial [PTYP]
Ultrasonography [MESH] AND pregnancy [MESH] AND randomized controlled trial [PTYP]
Related Articles search conducted for:
Crane JP, et al. (1994). A randomized trial of prenatal ultrasonographic
screening: impact on the detection, management, and outcome of anomalous
fetuses. The RADIUS Study Group. Am J Obstet Gynecol., 171(2), 392-399.
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Ref ID : 6
Anonymous A randomised controlled trial of Doppler ultrasound velocimetry of the umbilical artery in low risk pregnancies. Doppler French Study Group. Br.J.Obstet.Gynaecol. 104(4):419-424, 1997.
Notes : 97286410 CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To evaluate the effect on management and outcome of pregnancy of routine umbilical Doppler examination in low risk populations. DESIGN: Pragmatic randomised controlled trial. SETTING: Twenty centres caring for low risk pregnant women. PARTICIPANTS: 4187 women were randomly assigned to umbilical Doppler between 28 and 34 weeks of gestation or no routine umbilical Doppler. The women included were at low risk at 28 weeks of gestation defined by a normal ultrasonographic examination at the time of randomisation and no obstetric or medical complications during the first two trimesters of the pregnancy. RESULTS: The general characteristics at inclusion were comparable for the two groups. Performance of umbilical Doppler led to a significant increase in the number of ultrasonographic and Doppler examinations subsequently conducted; there were no other effects on the management of the pregnancy. There was no significant difference in fetal distress during labour (odds ratio [OR] 0.96; 95% confidence interval [CI] 0.70-1.33). There were three times fewer perinatal deaths in the Doppler group (three versus nine), but this difference was not significant (OR 0.33; 95% CI 0.06-1.33). CONCLUSION: Based on this trial routine use of umbilical doppler for low risk pregnancy cannot be recommended. More data are needed to reach a definite conclusion of the value of routine Doppler.
Ref ID : 12
Ben-Ami, M., Battino, S., Geslevich, Y., and Shalev, E. A random single Doppler study of the umbilical artery in the evaluation of pregnancies complicated by diabetes. Am.J.Perinatol. 12(6):437-438, 1995.
Notes : 96159209 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL To evaluate a random single Doppler study of the systolic to diastolic ratio of the umbilical artery as a predictor of perinatal outcome in diabetic pregnancies, a prospective double-blind study was performed in 92 diabetic pregnant women between 28 and 40 weeks of gestation. Main outcome measures were perinatal outcome: group A, normal outcome; group B, poor outcome. The sensitivity and specificity of the Doppler studies as a predictor of poor perinatal outcome were 39% and 92%, respectively. The positive and negative predictive values were 54% and 86%, respectively. Our results suggest that the systolic to diastolic ratio of the umbilical artery offers no advantage over other well-established tests in the management of diabetic pregnancies.
Ref ID : 1
Carlan, S.J., Richmond, L.B., and O'Brien, W.F. Randomized trial of endovaginal ultrasound in preterm premature rupture of membranes. Obstet.Gynecol. 89(3):458-461, 1997.
Notes : 97205098 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To assess the effect of weekly endovaginal ultrasound on the incidence of maternal infection and the time from rupture to delivery in women with preterm premature rupture of membranes (PROM). METHODS: Women with singleton pregnancies complicated by preterm PROM at 24-34 weeks' gestation were assigned randomly to groups having endovaginal ultrasound or no vaginal sonography. Along with the standard expectant management, the endovaginal-ultrasound group had weekly vaginal probe ultrasound scans. Power analysis based upon expected maternal infection required a sample size of 45 patients in each group. RESULTS: Forty-seven and 45 subjects were assigned to the no-probe and probe groups, respectively. The latency period, defined as days from rupture to delivery, was 9.8 and 11.7 days for the no-probe and probe groups, respectively (95% confidence interval -5.9, 2.1). There were no significant differences in the incidence of chorioamnionitis (28% and 20%), endometritis (6% and 9%), or neonatal infection (17% and 20%). The mean latency period in women who went into spontaneous labor and whose initial cervical length was 3.0 cm or less was 9.4 days, compared with 11.0 days if the cervix exceeded 3.0 cm, a nonsignificant difference. There were three neonatal deaths, all in the probe group and none directly related to infection. CONCLUSIONS: Endovaginal ultrasound in patients whose pregnancies are complicated by preterm PROM does not appear to increase the incidence of maternal infection.
Ref ID : 20
Crane, J.P., LeFevre, M.L., Winborn, R.C., Evans, J.K., Ewigman, B.G., Bain, R.P., Frigoletto, F.D., and McNellis, D. A randomized trial of prenatal ultrasonographic screening: impact on the detection, management, and outcome of anomalous fetuses. The RADIUS Study Group [see comments]. Am.J.Obstet.Gynecol. 171(2):392-399, 1994.
Notes : 94337820 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL 0002-9378 A M X 3NI 199411 OBJECTIVE: The objective of this randomized clinical trial was to test the hypothesis that ultrasonographic screening would significantly alter perinatal outcome as a result of the antenatal detection of fetal congenital malformations. STUDY DESIGN: Pregnant women without a specific indication for ultrasonography were randomly assigned to have either two screening sonograms (15 to 22 weeks and 31 to 35 weeks) or conventional obstetric care with ultrasonography used only as determined by the clinical judgment of the patient's physician. The frequency of birth defect detection in the screened and control populations was compared, as was the impact of discovery on pregnancy outcome. RESULTS: Major congenital malformations occurred in 2.3% of the 15,281 fetuses and infants in this study. Antenatal ultrasonography detected 35% of the anomalous fetuses in the screened group versus only 11% in the control population (relative detection rate 3.1; 95% confidence interval 2.0 to 5.1). Ultrasonography screening did not, however, significantly influence the management or outcome of pregnancies complicated by congenital malformations. Specifically, only 9 abortions were performed for anomalies among 7685 fetuses in the screened group whereas 4 pregnancies were terminated for fetal anomalies detected among 7596 control subjects. Ultrasonography screening also had no significant impact on survival rates among infants with potentially treatable, life-threatening anomalies despite the opportunity to take precautionary measures such as delivery in a tertiary center. CONCLUSIONS: Ultrasonography screening in a low-risk pregnant population had no significant impact on the frequency of abortion for fetal anomalies. Survival rates for anomalous fetuses were also unaffected by screening.
Ref ID : 43
Duff, G.B. A randomized controlled trial in a hospital population of ultrasound measurement screening for the small for dates baby. Aust.N.Z.J.Obstet.Gynaecol. 33(4):374-378, 1993.
Notes : CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL 0004-8666 M 9I0 199408 Poor fetal growth is an important cause of perinatal mortality and morbidity. Based on the hypothesis that early diagnosis of fetal growth problems leads to more appropriate management and therefore, improved outcome, a randomized controlled trial of ultrasound measurement was performed on 1,528 women booked through a hospital antenatal clinic. This compared a number of perinatal outcomes between the group who had a routine 2-stage examination (early dating and 34-week scan) and a group who had only a dating scan and then additional scans as generated by their clinical situations. No significant differences could be found between the groups when these perinatal outcomes were considered. These results mirror previously published randomized controlled trials. Selection of women for third trimester ultrasound examination for suspected fetal growth problems should be based on careful clinical assessment and should not be routine.
Ref ID : 9
Evans, S., Newnham, J., MacDonald, W., and Hall, C. Characterisation of the possible effect on birthweight following frequent prenatal ultrasound examinations. Early Hum.Dev. 45(3):203-214, 1996.
Notes : 97008239 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL The objective of this study was to evaluate and characterise by study of newborn biometry a possible effect on birthweight which we observed previously in a randomised controlled trial of multiple prenatal ultrasound examinations. A total of 2743 women with single pregnancies had been allocated at random to either a protocol of ultrasound imaging and continuous wave Doppler studies at 18, 24, 28, 34 and 38 weeks gestation (intensive group), or to a protocol of a single imaging examination at 18 weeks and further imaging scans only as clinically indicated (regular group). When compared with those in the regular group, and adjusted for other confounding variables, normally formed babies of term gestational age in the intensive group tended to be shorter when measured at birth (P = 0.123) and on day 2-3 of age (P = 0.068). There were statistically insignificant reductions in the circumferences of the chest, abdomen and mid-arm; and in the skinfold thicknesses of the triceps, parascapular and subscapular regions. Principal component analysis showed a trend for a reduction for the skeletal component (P = 0.085) but not for the soft tissue component (P = 0.332). Comparison of the neonatal biometry in the two groups is not conclusive, but the differential effects on the various growth parameters suggest that if multiple scans do indeed restrict fetal growth, the mechanism is more likely to be an effect on bone growth rather than a reduction in nutrient supply from the placenta.
Ref ID : 25
Ewigman, B.G., Crane, J.P., Frigoletto, F.D., LeFevre, M.L., Bain, R.P., and McNellis, D. Effect of prenatal ultrasound screening on perinatal outcome. RADIUS Study Group [see comments]. N.Engl.J.Med. 329(12):821-827, 1993.
Notes : 93361063 CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL 0028-4793 A M X NOW 199311 BACKGROUND. Many clinicians advocate routine ultrasound screening during pregnancy to detect congenital anomalies, multiple-gestation pregnancies, fetal growth disorders, placental abnormalities, and errors in the estimation of gestational age. However, it is not known whether the detection of these conditions through screening leads to interventions that improve perinatal outcome. METHODS. We conducted a randomized trial involving 15,151 pregnant women at low risk for perinatal problems to determine whether ultrasound screening decreased the frequency of adverse perinatal outcomes. The women randomly assigned to the ultrasound-screening group underwent one sonographic examination at 15 to 22 weeks of gestation and another at 31 to 35 weeks. The women in the control group underwent ultrasonography only for medical indications, as identified by their physicians. Adverse perinatal outcome was defined as fetal death, neonatal death, or neonatal morbidity such as intraventricular hemorrhage. RESULTS. The mean numbers of sonograms obtained per woman in the ultrasound- screening and control groups were 2.2 and 0.6, respectively. The rate of adverse perinatal outcome was 5.0 percent among the infants of the women in the ultrasound-screening group and 4.9 percent among the infants of the women in the control group (relative risk, 1.0; 95 percent confidence interval, 0.9 to 1.2; P = 0.85). The rates of preterm delivery and the distribution of birth weights were nearly identical in the two groups. The ultrasonographic detection of congenital anomalies had no effect on perinatal outcome. There were no significant differences between the groups in perinatal outcome in the subgroups of women with post-date pregnancies, multiple-gestation pregnancies, or infants who were small for gestational age. CONCLUSIONS. Screening ultrasonography did not improve perinatal outcome as compared with the selective use of ultrasonography on the basis of clinician judgment.
Ref ID : 11
Geerts, L.T., Brand, E.J., and Theron, G.B. Routine obstetric ultrasound examinations in South Africa: cost and effect on perinatal outcome--a prospective randomised controlled trial. Br.J.Obstet.Gynaecol. 103(6):501-507, 1996.
Notes : 96245147 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To compare routine midtrimester with selective obstetric ultrasonography concerning the Health Service cost and the effect on perinatal outcome. DESIGN: A randomised controlled trial. SETTING: Urban area served by Tygerberg Hospital, a tertiary referral centre in South Africa. PARTICIPANTS: Pregnant patients without risk factors for congenital anomalies referred for ultrasonography between 18 and 24 weeks of gestation. INTERVENTION: Between 18 and 24 weeks, a level one ultrasound examination was performed on study patients only. Except for the routine scan, both groups received the same antenatal care and could be referred later for additional scans as judged by their clinicians. MAIN OUTCOME MEASURES: Overall adverse perinatal outcome and use of antenatal and neonatal services. RESULTS: The groups did not differ significantly in their use of antenatal and neonatal services except for a greater number of ultrasound scans in the study group. More suspected postdate pregnancies occurred in control patients, as well as more amniocenteses for confirmation of lung maturity. More babies of low birthweight were born in the study group. The incidence of overall or major adverse perinatal outcome was comparable. Routine ultrasonography was accompanied by a considerable increase in costs. CONCLUSION: Selective use of obstetric ultrasonography did not increase the use of antenatal and neonatal services. Not routinely performing ultrasonography has led to considerable Health Service savings without increasing the risk for adverse perinatal outcome. It saved 75% of selected patients a referral to an ultrasound unit. Specific problems related to inaccurate gestational age determination need to be addressed.
Ref ID : 8
14. Goffinet, F., Paris, J., Heim, N., Nisand, I., and Breart, G. Predictive value of Doppler umbilical artery velocimetry in a low risk population with normal fetal biometry. A prospective study of 2016 women. Eur.J.Obstet.Gynecol.Reprod.Biol. 71(1):11-19, 1997.
Notes : 97183994 CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To assess the predictive value of Doppler umbilical artery velocimetry in a low-risk population with normal fetal biometry. STUDY DESIGN: Multicenter prospective study in 17 hospitals with prenatal clinics in France. Two thousand sixteen women who, before 28 weeks gestation were defined as at low risk after routine consultation and after ultrasound. Doppler umbilical artery velocimetry was performed between 28 and 34 weeks gestation. Confounding factors were used to perform multivariate regression. RESULTS: 1903 cases were analysed and 192 (10.1%) had an abnormal Doppler Resistance Index (RI). The abnormal Doppler group contained a significantly higher frequency of severe and moderate small for gestational age infants (SGA), both severe and moderate with a sensitivity of 25.5 and 18.8% respectively. There was no difference in hypertensive disorders or criteria of fetal distress. Mean birth weight was very significantly lower in the abnormal group (162 g). Birth weight was very significantly linked to RI after taking into account confounding variables in the multiple linear regression model (continuous relationship). After multiple logistic regression, the odds ratio associated with an abnormal Doppler result, adjusted for all the confounding factors, was 2.3 (95% CI 1.5-3.7) for moderate SGA and 3.5 (95% CI of 1.8-7.1) for severe SGA. CONCLUSION: Low umbilical Doppler RI is predictive with moderate or severe SGA in a low-risk population with normal fetal biometry, even when the information generally available in clinical practice and ultrasound parameters are taken into account. There is a continuous relationship between RI and birthweight. This predictive value cannot, however, lead to an improvement in neonatal health unless effective measures to prevent SGA exist and umbilical Doppler should not be used in low-risk population on a routine basis.
Ref ID : 14
Harding, K., Evans, S., and Newnham, J. Screening for the small fetus: a study of the relative efficacies of ultrasound biometry and symphysiofundal height. Aust.N.Z.J.Obstet.Gynaecol. 35(2):160-164, 1995.
Notes : 95408193 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL In this study 3 different methods of screening for birth-weight < 10th percentile in pregnancy were evaluated both individually and in combination; 1,135 women with singleton pregnancies were studied. Measurements of symphysiofundal height by tape measure, and amniotic fluid index and fetal abdominal circumference by ultrasound imaging, were made at 18, 24, 28, 34 and 38 weeks. At none of these gestational ages did amniotic fluid index perform well as a screening test for birth-weight < 10th percentile. Combining the tests, using symphysiofundal height to select a group at high risk who then had a fetal abdominal circumference measurement, reduced the false positive rate but significantly decreased the percentage of infants diagnosed. The results of this study confirm that the most appropriate antenatal diagnostic test for birth-weight <10th percentile is ultrasound measurement of fetal abdominal circumference. Selecting pregnancies at risk by clinical measurement of symphysiofundal height will provide a lower false positive rate than a policy of performing ultrasound on all pregnancies during the third trimester, but will also reduce the sensitivity.
Ref ID : 3
Kieler, H., Ahlsten, G., Haglund, B., Salvesen, K., and Axelsson, O. Routine ultrasound screening in pregnancy and the children's subsequent neurologic development. Obstet.Gynecol. 91(5:Pt 1):Pt 1):750-6, 1998.
Notes : 98231935 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To test the null hypothesis of no association between ultrasound exposure in early fetal life and impaired neurologic development in childhood. METHODS: Study of children age 8-9 years whose mothers participated in a randomized controlled trial of ultrasound screening during pregnancy in Sweden during 1985-1987. Of 4637 eligible singletons, 3265 (70%) were studied through a questionnaire to their mothers. Assessment of neurologic development was based on parents' report of their child's speech and motor development. Behavioral disorders were assessed by a ten-item parent scale. Analyses were performed according to both assignment and ultrasound exposure. With a sample size of 1600 children in each group, a two-sided alpha of .05 and beta of .10, a risk ratio of less than 1.4 for the studied variables could not be detected. RESULTS: Delayed speech development was reported by 2.9% in the screening group compared with 2.4% in the nonscreening group (odds ratio [OR] 1.21; 95% confidence interval [CI] 0.79, 1.88). Similar prevalences were found when analysis was according to ultrasound exposure (OR 1.19, 95% CI 0.78, 1.83). Delayed motor development was reported by 7.6% in the screening group compared with 7.2% in the nonscreening group (OR 1.05; 95% CI 0.81, 1.37). Corresponding figures for ultrasound-exposed and -unexposed were 7.7% and 7.2%, respectively (OR 1.08; 95% CI 0.83, 1.40). There also were no significant differences in behavioral disorders between screened and unscreened children or between exposed and unexposed children, respectively, according to parents' ratings. CONCLUSION: No significant difference in impaired neurologic development between ultrasound-exposed and -unexposed children was found in this study.
Ref ID : 5
Kieler, H., Haglund, B., Waldenstrom, U., and Axelsson, O. Routine ultrasound screening in pregnancy and the children's subsequent growth, vision and hearing. Br.J.Obstet.Gynaecol. 104(11):1267-1272, 1997.
Notes : 98045794 CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To test a hypothesis of no association between ultrasound exposure in early fetal life and growth or impaired vision or hearing during childhood. DESIGN: Follow up of eight to nine year old children born to women who participated in a randomised controlled trial on ultrasound screening during pregnancy. SETTING: Nineteen antenatal care clinics run by three central hospitals in Sweden from 1985 to 1987. POPULATION AND METHODS: Of 4637 eligible singleton pregnancies, 3265 (71%) were followed up through a questionnaire sent to their mothers. Analyses were performed both according to randomised groups and to ultrasound exposure. MAIN OUTCOME MEASURES: Parents' report of vision and hearing tests as recorded on child's record card. Parents' report of their child's weight and height at 1, 4 and 7 years of age. RESULTS: Reduced hearing was reported by 3.4% in the screening group compared with 3.5% in the nonscreening group (odds ratio [OR] 1.0; 95% confidence interval [CI] 0.67-1.41). The same prevalences were found when analysed according to ultrasound exposure (OR 1.0; 95% CI 0.67-1.42). Reduced vision was reported by 6.3% in the screening group compared with 7.8% in the nonscreening group (OR 0.8; 95% CI 0.60-1.03). Corresponding figures for ultrasound exposed and unexposed were 6.2% and 8.0%, respectively (OR 0.8; 95% CI 0.58-1.00). No statistically significant differences in body weight or height at 1, 4 or 7 years of age between screened and not screened children or between exposed and unexposed were found. CONCLUSION: This study found no association between ultrasound exposure in early fetal life and growth or impaired vision or hearing during childhood.
Ref ID : 16
Larsen, T., Greisen, G., and Petersen, S. Prediction of birth weight by ultrasound-estimated fetal weight: a comparison between single and repeated estimates. Eur.J.Obstet.Gynecol.Reprod.Biol. 60(1):37-40, 1995.
Notes : 95361956 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL OBJECTIVES: Ultrasound estimation of fetal weight is used for diagnosing intrauterine growth retardation. The aim of the present study was to assess the accuracy of birth weight prediction by use of a single or repeated estimations of fetal weight in the third trimester. STUDY DESIGN: 1000 pregnant women considered at risk were scheduled to ultrasound estimation of fetal weight, using Warsof's formula, at 28, 31, 34 and 37 weeks of gestation. The 421 pregnancies with term delivery and complete set of ultrasound examinations and 57 pregnancies with preterm delivery with ultrasound examination at 16 and 28 weeks and once more before delivery were included in the present analysis. RESULTS: The accuracy of birth weight prediction improved significantly for every three weeks from 28 to 37 weeks of gestation in the term infants. Prediction based on the average of repeated weight estimates or linear extrapolation from two estimates or extrapolation by a second order polynomium fitted to four estimates did not improve accuracy compared to prediction based on the last estimate before delivery. CONCLUSION: When more than one ultrasound estimation of fetal weight are available, prediction of birth weight in relation to gestational age should be based on the last ultrasound examination only.
Ref ID : 4
Lee, W., Comstock, C.H., Kirk, J.S., Smith, R.S., Monck, J.W., Deenadayalu, R., and Bendick, P.J. Birthweight prediction by three-dimensional ultrasonographic volumes of the fetal thigh and abdomen. J.Ultrasound.Med. 16(12):799-805, 1997.
Notes : 98065555 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL Our validation study examined a three-dimensional ultrasonographic phantom that contained irregularly shaped volume targets ranging from 0.5 to 76.1 milliliters. Four different examiners made blinded measurements from volume datasets that were acquired by 4 and 7 MHz transducers. Birthweight predictions using abdominal and thigh volumes from 18 term fetuses also were compared with two-dimensional ultrasonographic methods. In vitro volume measurements were accurate, precise, and repeatable despite a small systematic overestimation with increasing object size. Mean systematic error and precision for birthweight predictions by three-dimensional ultrasonography (-0.03% +/-6.1%) were not significantly different from those by two-dimensional ultrasonography (-0.60% +/- 8.8%). Conventional prediction methods yielded three birthweights with greater than 15% error. By comparison, except for one infant whose birthweight indicated an 11% error, all predictions based on fetal volume parameters were within 10% of true values. Accurate birthweight predictions by fetal volume parameters appear to be technically feasible at term gestation although their practical clinical application requires further investigation. Birthweight predictions in this manner may allow remote consultants to evaluate the fetus over wide-area computer networks despite the physical absence of the patient.
Ref ID : 24
LeFevre, M.L., Bain, R.P., Ewigman, B.G., Frigoletto, F.D., Crane, J.P., and McNellis, D. A randomized trial of prenatal ultrasonographic screening: impact on maternal management and outcome. RADIUS (Routine Antenatal Diagnostic Imaging with Ultrasound) Study Group [see comments]. Am.J.Obstet.Gynecol. 169(3):483-489, 1993.
Notes : CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL 0002-9378 A M X 3NI 199312 OBJECTIVES: This randomized clinical trial of 15,530 women was designed to test the hypothesis that screening ultrasonography in low-risk pregnancies would improve perinatal outcome. A secondary hypothesis addressed in this article was that screening ultrasonography would have a favorable impact on maternal management or outcome. STUDY DESIGN: Pregnant women without a specific indication for ultrasonographic examination in early pregnancy were randomly assigned to have either two screening sonograms or conventional obstetric care. Pregnancy interventions and maternal outcomes were compared in the two groups. RESULTS: No significant differences were found in maternal outcomes. Use of ultrasonography was markedly higher in the screened group. The rates of induced abortion, amniocentesis, tests of fetal well-being, external version, induction, and cesarean section and the distribution of total hospital days were similar in the two groups. Use of tocolytics and the rate of postdate pregnancy were both slightly lower in the screened group. CONCLUSION: Screening ultrasonography resulted in no clinically significant benefit.
Ref ID : 17
LeFevre, M.L., Evans, J.K., and Ewigman, B. Is smoking an indication for prenatal ultrasonography? RADIUS Study Group. Arch.Fam.Med. 4(2):120-123, 1995.
Notes : 95144355 CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL OBJECTIVE: To evaluate whether ultrasound screening during pregnancy decreases the frequency of smoking in women who present with a history of smoking. DESIGN: The Routine Antenatal Diagnostic Imaging with Ultrasound Study was a multicenter, randomized clinical trial of ultrasound screening during pregnancy. We obtained information on smoking habits during pregnancy from birth certificate records for the subset of women who were delivered of a neonate in Missouri hospitals, and determined the effect of ultrasound screening on smoking habits during pregnancy. SETTING: The study was conducted in multiple practices in six states. PARTICIPANTS: Women who registered for prenatal care at participating practices. INTERVENTION: Women in the screened group were routinely scheduled for ultrasound screening at 16 to 22 weeks' gestation and at 31 to 35 weeks' gestation. Those in the control group received ultrasound screening only for medical indications, as determined by their physicians. MAIN OUTCOME MEASURE: Smoking habits were measured by the number of cigarettes smoked per day. RESULTS: There was no difference in the rates of smoking cessation between the screened group and the control group. For those who continued smoking, the mean number of cigarettes smoked per day, as reported at the time of delivery, was slightly higher in the screened group. CONCLUSION: Ultrasound screening does not reduce the frequency of smoking during pregnancy.
Ref ID : 2
20. Leivo, T., Tuominen, R., Saari-Kemppainen, A., Ylostalo, P., Karjalainen, O., and Heinonen, O.P. Cost-effectiveness of one-stage ultrasound screening in pregnancy: a report from the Helsinki ultrasound trial [see comments]. Ultrasound.Obstet.Gynecol. 7(5):309-314, 1996.
Notes : 96370155 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL The objective of this study was to evaluate, in a controlled clinical trial, the costs of standardized one-stage ultrasound screening in pregnancy in relation to the reduction in perinatal mortality. A trial population of 9310 pregnant women was randomly allocated to ultrasound screening or a control group. Two obstetric hospitals and 64 recruiting antenatal health centers were involved. The costs included actually realized costs, i.e. positive costs, and gains, i.e. negative costs, resulting from lower health-care use. Cost-accounting data were obtained by a questionnaire to all attenders and measurements at the screening, and later complemented by a questionnaire to a random sample of 534 screened women. Internal accounting and other hospital data, national statistics and health-market sources were also used. The actually realized cost of each avoided perinatal death was FIM 84 378 ($21,938), while the net overall estimate combining all positive and negative costs showed a cost saving of FIM 65 680 ($17,077). The total positive unit cost of ultrasound screening was FIM 393 ($102). Longer ultrasound examination time and more numerous advanced examinations were rewarded by clearly fewer perinatal deaths and a better cost-effectiveness ratio. One-stage second-trimester ultrasound screening is cost-effective when all significant costs and effects are taken into account.
Ref ID : 7
Nienhuis, S.J., Vles, J.S., Gerver, W.J., and Hoogland, H.J. Doppler ultrasonography in suspected intrauterine growth retardation: a randomized clinical trial. Ultrasound.Obstet.Gynecol. 9(1):6-13, 1997.
Notes : 97213357 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL A randomized clinical trial was performed to test the hypothesis that if suspected intrauterine growth retardation (IUGR) is associated with normal umbilical artery Doppler ultrasound findings, hospitalization can safely be avoided. One hundred and fifty women with singleton pregnancies and suspected IUGR were randomized between an intervention (n = 74) and a control group (n = 76). In the intervention group, clinicians were strongly requested not to hospitalize for suspected IUGR if the Doppler findings were normal. In the control group, the Doppler results were not revealed and the participants received the standard management for suspected IUGR. Endpoints of the trial were: costs in terms of hospitalization, perinatal outcome, neurological development, and postnatal growth. Duration of hospitalization was significantly shorter in the intervention group than in the control group. Contrary to expectations, the hospitalization rate during pregnancy in the intervention group was not below that of the control group. This negative finding was partly due to the admission of patients in the intervention group despite their normal Doppler results. Moreover, the trial might have induced a more critical attitude towards hospitalization in suspected IUGR, decreasing admission in the control group. No clear differences were found in perinatal outcome, neurological development, or postnatal growth. The results suggest that normal umbilical artery Doppler findings in suspected cases of IUGR justify outpatient management.
Ref ID : 23
Omtzigt, A.M., Reuwer, P.J., and Bruinse, H.W. A randomized controlled trial on the clinical value of umbilical Doppler velocimetry in antenatal care. Am.J.Obstet.Gynecol. 170(2):625-634, 1994.
Notes : 94161111 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL 0002-9378 A M X 3NI 199406 OBJECTIVE: Our aim was to assess the clinical value of umbilical Doppler velocimetry with regard to maternal hospitalization policy, obstetric management, and perinatal outcome. STUDY DESIGN: We conducted a randomized controlled trial in a university hospital population. A total of 1598 women participated, of whom 809 were allocated to the Doppler group and 789 to the control group. In the Doppler group umbilical Doppler studies were performed only when indicated. Abnormal pulsatility index values prompted intensified (clinical) fetal monitoring. In the control group Doppler velocimetry was not available. RESULTS: The use of umbilical Doppler velocimetry did not show any clinical or economical benefit with regard to maternal admission rate and duration or neonatal admission policy and requirements of ventilatory support. Neither did the use of Doppler have any beneficial effect on obstetric management during labor and the occurrence of fetal distress during labor. In the control group a higher perinatal mortality rate was observed. In the Doppler group the risk ratio of perinatal mortality of fetuses and infants weighing > or = 500 gm was 0.45 (95% confidence interval 0.21 to 0.94), as compared with the control group. Neonatal mortality was equal in both groups; therefore the reduction in perinatal mortality was not the result of a delay in timing of fetal death. CONCLUSION: Selective use of umbilical Doppler velocimetry in pregnancies "at fetal risk" may be of benefit in antenatal care by a reduction of perinatal mortality and especially late fetal mortality.
Ref ID : 13
Skupski, D.W., Chervenak, F.A., and McCullough, L.B. Routine obstetric ultrasound. Int.J.Gynaecol.Obstet. 50(3):233-242, 1995.
Notes : 96100143 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL REVIEW REVIEW, TUTORIAL A detailed review of the literature reveals that routine obstetric ultrasound has value in providing more accurate gestational dating and in the diagnosis of fetal anomalies. The recent RADIUS study, which has concluded that routine obstetric ultrasound is of no clinical benefit, is critically analyzed, focusing on four areas: the applicability of the results to the general population, the appropriateness of the outcome parameters, the quality of the ultrasound provided, and the issue of excessive cost. Finally, an ethical analysis of the role of routine obstetric ultrasonography is provided, focusing on the principles of beneficence and respect for autonomy. The offering obstetric ultrasound is necessary in both beneficence-based and autonomy-based ethical analyses, and the use of routine ultrasound is supported from an analysis of the scientific data.
Ref ID : 32
Whittle, M.J., Hanretty, K.P., Primrose, M.H., and Neilson, J.P. Screening for the compromised fetus: a randomized trial of umbilical artery velocimetry in unselected pregnancies. Am.J.Obstet.Gynecol. 170(2):555-559, 1994.
Notes : 94161097 CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL 0002-9378 A M X 3NI 199406 OBJECTIVE: Meta-analysis of randomized trials of Doppler ultrasonography in high-risk pregnancies has showed reduced mortality rates among normally formed fetuses. This trial addressed the impact on outcome of umbilical artery velocimetry in a nonselected population (i.e., as a screening test in low-risk and high-risk pregnancies). STUDY DESIGN: A randomized, controlled trial with Doppler ultrasonographic investigation was performed at two gestational age windows: 26 to 30 weeks and 34 to 36 weeks. The 2986 women were randomly allocated to revealed or concealed groups in which the Doppler results were either made available or not made available to clinicians; 1056 women were studied at only the first window, 544 at only the second, and 1386 at both. RESULTS: There were no significant differences between groups in antenatal admissions to hospital, preterm deliveries, rates of cesarean section, admission to the neonatal unit, and need for assisted ventilation. There was, however, a trend toward fewer stillbirths in the "revealed" group (three vs eight, odds ratio 0.34, confidence interval 0.10 to 1.07). CONCLUSIONS: The incidence of stillbirths was reduced by more than half in the Doppler-revealed group, but the confidence intervals were wide and these findings could be compatible with chance.
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Albert, T.J., Landon, M.B., Wheller, J.J., Samuels, P., Cheng, R.F., and Gabbe, S. Prenatal detection of fetal anomalies in pregnancies complicated by insulin-dependent diabetes mellitus. Am.J.Obstet.Gynecol. 174(5):1424-1428, 1996.
Notes : 96240068 0 (alpha-Fetoproteins) 0 (Hemoglobin A, Glycosylated) JOURNAL ARTICLE 0002-9378 A M X 3NI 199705 OBJECTIVES: We evaluated the clinical utility of a comprehensive program of prenatal diagnostic testing for congenital anomalies in pregnancies complicated by insulin-dependent diabetes mellitus. STUDY DESIGN: Data were retrospectively analyzed from 289 diabetic women and their newborns from August 1987 to July 1993. Our protocol included initial hemoglobin A1 and maternal serum alpha-fetoprotein determinations and comprehensive fetal ultrasonography inclusive of a standard four-chamber view of the heart and detailed multiimage fetal echocardiography. RESULTS: Anomalies were identified in 29 of 289 (10%) fetuses and neonates: 12 cardiac only, 14 noncardiac, and 3 combined. In 21 of the 29 (72%) neonates the anomalies were detected prenatally. Twelve of 15 (80%) cardiac and 10 of 17 (59%) noncardiac lesions were identified prenatally. Cardiac lesions, especially of the cardiac septum and great vessels, accounted for 50% of all fetal defects. Malformations of the neuroaxis, skeleton, and genitourinary system were also detected. There were six neonatal deaths and four therapeutic pregnancy terminations associated with congenital anomalies. Although the hemoglobin A1 level was statistically significantly increased in 22 mothers of anomalous fetuses (p = 0.017), the actual difference between affected and nonaffected pregnancies was not clinically meaningful and much overlap occurred. Although 96% of women with a normal hemoglobin A1 level were delivered of normal infants, only 14% of those with an elevated value had a malformed fetus. Similarly, although 89% of gravid women with a normal maternal serum alpha-fetoprotein level were delivered of nonaffected fetuses, only 7.3% of patients with an elevated value had a malformed fetus. For the detection of cardiac defects, the sensitivity of the four-chamber view compared with detailed multiimage fetal echocardiography was 33% and 92%, respectively. CONCLUSIONS: This study demonstrates the utility of a comprehensive program to detect fetal anomalies in pregnancies complicated by diabetes mellitus.
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Ashe, R.G., Dornan, J.C., Patterson, C.C., and Thompson, W. Evaluation of routine ultrasound in the prenatal diagnosis of structural anomalies of the fetus. Ir.Med.J. 89(5):180-182, 1996.
Notes : 97091105 JOURNAL ARTICLE 0332-3102 GXD 199703 The objective of this study was to evaluate routine obstetric ultrasound in detecting fetal structural anomalies and the impact of changing clinical practice on success rates. A retrospective study of routine ultrasound in a population of 6,869 pregnancies was performed during 1985-86 (phase 1) to establish efficacy of ultrasound in the detection of fetal anomalies. Changes in ultrasound practice comprised timing, personnel and technique of fetal examination. After alterations in practice, a prospective study of 6,969 pregnancies during 1987-89 (phase 2) was performed. All abnormal fetuses (cases) were assessed in both studies. Random samples of normal infants (controls) were chosen from both populations to establish specificity. In 83 cases in phase 1,116 anomalies were diagnosed postnatally of which 11 were suspected by routine prenatal ultrasound at < 24 weeks (sensitivity 9%, 95% C.I. 4-15). In 72 cases in phase 2, 89 anomalies were identified postnatally of which 27 were suspected by routine prenatal ultrasound at < 24 weeks (sensitivity 30%, 95% C.I. 21-41). The change in sensitivity was statistically significant (p = 0.0003). Of the 382 control infants randomly selected in phase 1, false abnormal scans were not identified (specificity 100%, 95% C.I. 99-100). Of the 367 control infants in phase 2, 12 false abnormal scans were identified (specificity 96.7%, 95% C.I. 95-99). The decrease in specificity was statistically significant (p = 0.0013). The detection of urorenal and to a lesser degree central nervous system anomalies showed most improvement between the two phases. The alterations to routine ultrasound practice in timing, personnel and technique have significantly improved the detection of all fetal structural anomalies but at the cost of a small but significant loss of specificity.
Ref ID : 52
Bernaschek, G., Kolankaya, A., Stuempflen, I., and Deutinger, J. Chromosomal abnormalities: how much can we predict by ultrasound examination in low-risk pregnancies? Am.J.Perinatol. 13(5):259-263, 1996.
Notes : 97017342 JOURNAL ARTICLE 0735-1631 M AA3 199703 We examined the rates of chromosomal anomalies detected by ultrasound investigations for the whole region of Vienna. We evaluated the data of 250 private offices, 10 clinics for Obstetrics and Gynecology, and one university Department of Prenatal Diagnosis and Therapy during the period from January, 1990, to July, 1991. The study group consisted of low-risk patients, since cases where prenatal karyotyping has been performed for other reasons than sonographic findings (for example, maternal age) were excluded from the study. An overall detection rate of 53.7% was found for the region. Structural malformations of fetuses (41.5%) were the most prominent factors leading to the diagnosis of chromosomal abnormalities. In addition, detection rate of trisomy 21 (17.6%) by prenatal ultrasonography was found to be significantly lower compared to all other chromosomal abnormalities in our study (50 to 100%).
Ref ID : 50
Bonilla-Musoles, F.M., Raga, F., Ballester, M.J., and Serra, V. Early detection of embryonic malformations by transvaginal and color Doppler sonography. J.Ultrasound.Med. 13(5):347-355, 1994.
Notes : JOURNAL ARTICLE 0278-4297 M KBU 199409 A total of 834 women with uneventful pregnancies were followed prospectively until the 15th week of gestation by TVS to screen for early embryonic malformations. Twenty-eight embryonic anomalies were detected in this series (3.3%). The median gestational age at diagnosis was 11 (range, 8 to 15) weeks. Two neural tube defects were missed by early TVS screening. Two suspected abdominal wall defects were not confirmed by repeat mid-second trimester abdominal sonography representing 6.7% of all fetal malformations evident by 24 weeks of gestation. The sensitivity and specificity of TVS screening for fetal malformations in this series were 93.3 and 99.7%, respectively. In addition, the role of TCDU also was investigated in these 28 abnormal embryos. TCDU proved to be of limited value as it was useful only for evaluating those embryonic malformations with vascular involvement. In such cases, the diagnosis was greatly enhanced with this technique. Two previously undetected single umbilical arteries were also diagnosed by TCDU as well. This series included 11 aneuploid embryos (44%), most of them among the embryos with focal or generalized edema. This study demonstrates that screening for early embryonic malformations is feasible using TVS techniques, but a repeat mid-second trimester abdominal sonogram still is recommended.
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Brand, I.R., Kaminopetros, P., Cave, M., Irving, H.C., and Lilford, R.J. Specificity of antenatal ultrasound in the Yorkshire Region: a prospective study of 2261 ultrasound detected anomalies. Br.J.Obstet.Gynaecol. 101(5):392-397, 1994.
Notes : 94289355 JOURNAL ARTICLE 0306-5456 A M AZC 199410 OBJECTIVE: To evaluate the specificity of the ultrasound diagnosis of fetal anomalies. Pregnancies which proceeded to termination and ultrasound-diagnosed fetal anomalies which were not offered termination were considered. DESIGN: Prospective, region-wide study over three and a half years. SETTING: Cases were identified through 25 ultrasound departments representing the 15 districts in the Yorkshire Region. SUBJECTS: Pregnant women with an ultrasound-diagnosed fetal anomaly. MAIN OUTCOME MEASURES: Information obtained from the ultrasound report was compared with the outcomes determined by cytogenetics, postmortem or paediatric examination. RESULTS: Of 2261 pregnancies with an ultrasound-diagnosed fetal anomaly 369, (16%) were terminated and 357 (97%) were followed by postmortem examination. Ultrasound findings exactly matched those of the postmortem or were accompanied by additional anomalies in 325 cases (91%). In 32 cases ultrasound findings were not confirmed by postmortem, but in 30 of these the decision to offer termination remained justified because the correct diagnosis was judged equally or more serious. Two (0.5%) were terminated for an anomaly which subsequently proved less severe than predicted on ultrasound. Ultrasound significantly over- or under- diagnosed a major fetal anomaly in 27 of the 1139 (2.4%) cases in which an anomaly was detected, but the pregnancy was not terminated. CONCLUSION: Termination of pregnancy was based on the correct prognosis in over 99.5% of cases. This does not obviate the need for pathological examination of the fetus which changed or refined the diagnosis in 35% of cases.
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Chescheir, N.C. and Reitnauer, P.J. A comparative study of prenatal diagnosis and perinatal autopsy. J.Ultrasound.Med. 13(6):451-456, 1994.
Notes : 94365906 JOURNAL ARTICLE 0278-4297 M KBU 199412 The objective of this study was to assess the accuracy of prenatal ultrasonography and to identify patterns of fetal malformations. All fetal and neonatal autopsies over a 3 year period were compared to prenatal sonographic findings and comparisons were made between the results of the two examinations. We identified 133 fetuses and neonates who had both a complete autopsy and a perinatal autopsy. Approximately 87% of autopsy-demonstrated major abnormalities had been detected by prenatal ultrasonography, with 61% of all malformations detected. Some limitations in accuracy of prenatal diagnosis are unavoidable, but strict attention to a thorough fetal examination should improve accuracy. Autopsy examination remains an important component of the evaluation of perinatal losses, especially if dysmorphology is known or suspected.
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D'Ottavio, G., Mandruzzato, G., Meir, Y.J., Rustico, M.A., Fischer-Tamaro, L., Conoscenti, G., and Natale, R. Comparisons of first and second trimester screening for fetal anomalies. Ann.N.Y.Acad.Sci. 847:200-209, 1998.
Notes : 98333310 JOURNAL ARTICLE 0077-8923 M X 5NM 199810 Four thousand fifty unselected pregnant women bearing a total of 4,078 fetuses were examined by transvaginal sonography (TVS) at 14 weeks of gestational age and rescreened via transabdominal sonography (TAS) at 21 weeks. Fifty-four of 88 anomalies were correctly identified at first scan whereas 34 were not; of these, 24 were discovered at second trimester rescreening, and the remaining 10 were observed later in pregnancy or after birth. The sensitivity of TVS screening with respect to final outcome was 61.4% (54 of 88 malformations in total) and 69.2% in comparison to TAS screening results (54 malformations detected among 78 recognized within 21 weeks). The association between fetal malformation and chromosomal aberrations was also investigated: in our study population there were 21 aneuploidies, 14 of which were recognized because of abnormal findings at the 14 weeks' TVS, 5 at the TAS rescreening, and 2 after birth in neonates free of structural abnormalities.
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Economides, D.L. and Braithwaite, J.M. First trimester ultrasonographic diagnosis of fetal structural abnormalities in a low risk population. Br.J.Obstet.Gynaecol. 105(1):53-57, 1998.
Notes : 98104191 JOURNAL ARTICLE 0306-5456 A M AZC 199804 OBJECTIVES: Ultrasonographic screening between 12(+0) and 13(+6) weeks for fetal structural abnormalities using transabdominal sonography and, where necessary, transvaginal sonography in a low risk population. DESIGN: A prospective observational study. SETTING: London teaching hospital. METHODS: Pregnant women with a total of 1632 low risk viable fetuses between 12(+0) and 13(+6) weeks of gestation were scanned using transabdominal and, where necessary, transvaginal sonography (40%). If the anatomical survey was normal, the women underwent routine 18-20 week anomaly scans. Pregnancy outcomes were obtained from radiological and neonatal computerised databases, and postal or telephone patient enquiry. RESULTS: Seventeen (1.0%) major structural abnormalities were diagnosed in the study group. Of these, 11 (64.7%) were diagnosed at the 12-13 week scan, three diagnosed in the mid-trimester and three postnatally. Of the fetal abnormalities diagnosed antenatally, 78.6% were diagnosed in the first trimester. The sensitivity of abnormality detection by the combination of both first and second trimester scans was 82.3%. In addition, a significant number of missed abortions (n = 36) were also diagnosed by the first trimester scan. CONCLUSION: This study has demonstrated the potential of screening a low risk population for fetal abnormalities at 12-13 weeks of gestation using transabdominal sonography and, where necessary, transvaginal sonography. Larger studies are required to establish the clinical value of the first trimester scan.
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Eurenius, K., Axelsson, O., and Eriksson, L. Second trimester routine ultrasound and abnormal findings. Acta Obstet.Gynecol.Scand. 75(3):235-240, 1996.
Notes : 96200072 JOURNAL ARTICLE 0001-6349 M 1E8 199607 OBJECTIVE: To estimate the detection rate of abnormal findings, especially fetal anomalies, at second trimester ultrasound screening performed in a way representative of Swedish antenatal clinics. DESIGN: A prospective study carried out over two years in Uppsala county, Sweden, including 8,228 unselected pregnant women (8,345 fetuses). The ultrasound scans were performed by specially trained midwives. MAIN OUTCOME MEASURES: The number of abnormalities suspected by the midwives and the number of abnormalities confirmed by the obstetricians were registered, as was pregnancy outcome for these cases. RESULTS: Midwives reported suspected abnormalities at the screening procedure in 59 cases (0.7%), abnormalities were confirmed by obstetricians in 42 cases (0.5%, of which 0.36% were fetal malformations). Seventeen of these 42 pregnancies were terminated and 11 ended with miscarriages or intrauterine fetal deaths. Fourteen of the 42 pregnancies ended with a live born infant, of which two died postnatally. CONCLUSIONS: The described ultrasound screening procedure led to suspected abnormalities in 0.7% of the scanned cases and to confirmed abnormalities in 0.5% of the cases. The outcome for the confirmed abnormalities was poor, as 71% were either terminated or ended with miscarriage or perinatal death.
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Hernadi, L. and Torocsik, M. Screening for fetal anomalies in the 12th week of pregnancy by transvaginal sonography in an unselected population. Prenat.Diagn. 17(8):753-759, 1997.
Notes : 97413256 JOURNAL ARTICLE 0197-3851 M PJ7 199712 The advantages and limitations of transvaginal (TV) sonography in detecting fetal anomalies in the 12th week of pregnancy were examined in a prospective screening study of an unselected population. During a 3-year period, 3991 examinations were performed and 35 fetuses were identified as having 43 anomalies (0.9 per cent). Most of these malformations were either severe structural disorders or isolated nuchal changes when karyotyping revealed chromosomal aberration in six cases. Twenty-one pregnancies were terminated and three fetuses died. Routine transabdominal (TA) ultrasonographic examinations were performed at 18 and 30 weeks in all those pregnancies where the TV scan had not found fetal anomalies. TA sonography identified 19 abnormal fetuses and ten cases remained undetected. TV sonography detected 51 per cent of malformed fetuses which were diagnosed prenatally (not including cases with nuchal oedema) and 41 per cent of the total were found in this study. Besides offering the possibility of early termination, first trimester screening has the advantage of identifying a transient sonographic sign, nuchal oedema, which can be used as a marker in screening for fetal chromosomal abnormalities. However, standard mid-second-trimester TA scanning is still recommended, since a significant number of malformations cannot be detected so early in pregnancy.
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Hori, E., Koyanagi, T., Yoshizato, T., Maeda, H., Satoh, S., Suita, S., Ueda, K., and Nakano, H. How antenatal ultrasound diagnosis of congenital malformations has contributed to fetal outcome: a 22-year review. Fetal Diagn.Ther. 8(6):388-401, 1993.
Notes : 94114078 JOURNAL ARTICLE 1015-3837 M AF5 199404 We herein reviewed 630 malformed fetuses delivered from 24 weeks of gestation onwards in our institute over the past 22 years. These fetuses were divided into 2 groups: 210 from 1970 to 1982 (group 1) and 420 from 1983 to 1991 (group 2). Twenty-two varieties of congenital malformations were diagnosed antenatally in group 1, whereas 55 additional malformations became diagnosable in group 2. Thirty-four varieties of congenital malformations still remained undiagnosed throughout the 22-year study period. Cases receiving 'fetal therapy' and 'close obstetric care' increased, with statistical significance, from 1.8 to 15.7%, and from 22.9 to 55.7% in groups 1 and 2, respectively. A significant increase was also noted in the survival rate from group 1 (63.3%: 105/166) to group 2 (75.5%: 259/343). This study has revealed that the steady advancement in antenatal diagnosis of congenital malformations, along with great efforts in terms of intensive care, has contributed to improved fetal outcome.
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Levi, S. and Montenegro, N.A. Eurofetus: an evaluation of routine ultrasound screening for the detection of fetal defects. Aims and method. Ann.N.Y.Acad.Sci. 847:103-117, 1998.
Notes : JOURNAL ARTICLE 0077-8923 M X 5NM 199810 The aims of this study are (1) to evaluate the efficiency of ultrasound in detecting CA in low-risk populations of pregnant women by routine screening performed in hospital ultrasound labs (level II); (2) to highlight the areas where improvement could be obtained; (3) to determine efficient timing and number of examinations; (4) to evaluate the psychological returns of detection and nondetection of CA; and (5) to evaluate the cost-effectiveness ratio of antenatal screening of CA. A European collaboration was supposed to help in meeting these objectives because results concerning the analysis of individual CAs or groups of CAs can only be statistically significant when their number is sufficiently large. It was estimated that it was necessary to collect nearly 5,000 CA; this corresponds to about 200,000 pregnant women, the prevalence of malformations at birth being estimated at 2.5%. These conditions yield worthy conclusions, given the following circumstances: a large variety of CA, the extremely low incidence of each CA, the multiple approaches for diagnosis and management, the manifold classes of defects, the differences in gestational age when anomalies are detectable and detected. We study prospectively (1) the reliability of ultrasound in detecting antenatal malformations by recording all CA, ultrasonically suspected and not; (2) the gestational age of anomaly recognition; (3) the response to antenatal diagnosis of CA; (4) the individual outcome of pregnancies; (5) the financial cost of the screening program; and (6) the psychological consequences for the parents.
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Muller, R.J., Asseryanis, E., Wieser, F., and Schurz, B. [Reliability of ultrasound pregnancy screening]. Ultraschall.Med. 17(4):163-166, 1996.
Notes : JOURNAL ARTICLE 0172-4614 M UIM 199703 This study investigates the reliability of ultrasonographic screenings for detecting fetal malformations in pregnancy. The data from 1505 screening examinations of pregnant women who underwent routine checks at the Department of Obstetrics of the University of Vienna, were compared with the anomalies diagnosed in the newborn of the same collective. Fetal malformations were diagnosed in 28 screening cases. The statistical distribution of these anomalies is shown for the different organ systems. In 5 newborn malformations were found, which had not been diagnosed sonographically. Another 23 newborn had minor malformations in regions that are not included in the routine screening ultrasound. The results show a high accuracy of the sonographic screening examination, with the exception of the median facial region and the large vessels of the base of the heart. The fact that not all of the cardiac malformations were diagnosed prompts the performance of an extended sonographic inspection of the fetal heart within the framework of routine screening.
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37. Pagnotta, G., Torcia, F., Giancotti, A., and Aureli, S. High resolution real time ultrasonography in antenatal diagnosis of skeletal anomalies. Bull.Hosp.Jt.Dis. 54(4):226-229, 1996.
Notes : 96301343 JOURNAL ARTICLE 0018-5647 M BML 199701 Two protocols were used for the ultrasonographic antenatal diagnosis of skeletal anomalies. The first was less selective and was used in pregnancies with a low risk of skeletal malformations. The second was applied to higher risk pregnancies. Both involved several ultrasound examinations, according to the patient's past medical history. In the period 1988 to 1993, 740 pregnant women in whom fetal malformations were suspected underwent serial ultrasound scanning. In 56 (7.5%), a skeletal anomaly was identified. The use of two protocols offers wide applicability and acceptable reliability in screening congenital skeletal problems in the fetus.
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Queisser-Luft, A., Stopfkuchen, H., Stolz, G., Schlaefer, K., and Merz, E. Prenatal diagnosis of major malformations: quality control of routine ultrasound examinations based on a five-year study of 20, 248 newborn fetuses and infants [In Process Citation]. Prenat.Diagn. 18(6):567-576, 1998.
Notes : 98329303 0197-3851 M PJ7 Antenatal ultrasound screening for birth defects is increasingly becoming a routine procedure of prenatal care. Prenatal detection of malformations and subsequent adjustment of obstetric management are essential for secondary prevention. It is unknown whether ultrasound screening is effective in all pregnant women, or should only be performed in high risk populations. From 1990-1994, 20,248 livebirths, stillbirths and abortions underwent physical and sonographic examinations and anamnestic data were collected. To identify the high risk group, case control analyses of births with one of the 23 selected major malformations (controls) were performed with respect to anamnestic risk factors. All women had at least three routine ultrasound scans. The selected malformations were diagnosed in 298 children; 95 (30.3 per cent) were diagnosed antenatally. Detection rates were: CNS (68.6 per cent), gastro-intestinal tract (42.3 per cent), urinary system (24.1) per cent), heart (5.9 per cent). Complications during pregnancy were calculated as indicators of congenital anomalies: premature labour (< 28 week) OR 4.7 (3.8-5.9), placental insufficiency OR 1.9 (1.1-2.7) and vaginal bleeding OR 1.5 (1.2-1.8), etc. Antenatal routine ultrasound screening is not effective risk populations. Anamnestic risk factors risk factors during pregnancy may be essential indicators for identifying high risk populations. We propose screening of the described high risk pregnancies (about 22 per cent of all pregnancies) to be performed by specially trained and highly experienced ultrasonographers to increase sensitivity rates and benefit cost effectiveness.
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Rustico, M.A., Benettoni, A., D'Ottavio, G., Maieron, A., Fischer-Tamaro, I., Conoscenti, G., Meir, Y., Montesano, M., Cattaneo, A., and Mandruzzato, G. Fetal heart screening in low-risk pregnancies. Ultrasound.Obstet.Gynecol. 6(5):313-319, 1995.
Notes : 96160085 JOURNAL ARTICLE 0960-7692 M CAH 199605 The aim of this study was to assess whether a screening program for fetal cardiac malformations is justified in a low-risk population, and which factors influence its accuracy. The fetal heart was evaluated in 7024 pregnant women at 20-22 weeks, and evaluation was repeated at a more advanced gestational age in 9% of cases. Cardiological follow-up was continued postnatally until 2 years of age. The overall prevalence of cardiac anomaly was 0.93%. The incidences of major and minor defects were 0.44% and 0.48%, respectively. There were 23 true positives (0.33%): in 20 cases, the diagnosis was made in the second trimester, and 13 women (65%) chose termination of pregnancy. Seventeen of the 20 cases identified in the second trimester were serious malformations. There were 42 false negatives (0.60%). Of these, 12 had signs of cardiac dysfunction at birth or within the 1st month of life, and three of them died as a result of their cardiac anomaly. There were eight false positives (0.11%), all of a minor type. Six abnormal karyotypes, out of a total of 21 performed in the true-positive group (28.5%), were found. In addition, five of the 42 newborns in the false-negative group had trisomy 21. The overall sensitivity was 35.4%, and 61.3% for major defects. The accuracy in two distinct periods was estimated because the level of experience of the operators was different: sensitivity was 45.2% in period 1 (1986-88) (77.8% for major defects) and 26.5% in period 2 (1989-92) (52.9% for major defects). We conclude that a fetal heart screening program in the obstetric population is justified. It defines a high-risk group for karyotyping, allows planning of delivery in a tertiary center or the choice of terminating the pregnancy for the parents and appears to have a positive cost-benefit ratio. A crucial factor is the level of training and experience of the operators, who need specific teaching support.
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Skupski, D.W., Newman, S., Edersheim, T., Hutson, J.M., Udom-Rice, I., Chervenak, F.A., and McCullough, L.B. The impact of routine obstetric ultrasonographic screening in a low- risk population. Am.J.Obstet.Gynecol. 175(5):1142-1145, 1996.
Notes : 97097938 JOURNAL ARTICLE 0002-9378 A M X 3NI 199703 OBJECTIVES: Our goal was to develop a framework for evaluating the current controversy regarding routine obstetric ultrasonography in a population of low-risk pregnancies. STUDY DESIGN: A retrospective chart review was performed for all low-risk pregnancies from a single obstetric practice during 1990 to 1994, to determine the accuracy of screening ultrasonography for fetal anomalies. All patients received a routine ultrasonographic examination at 18 to 20 weeks' gestation. Neonatal records for all patients were evaluated for the presence of both major and minor anomalies. The data were analyzed with attention to the classification of anomalies (all anomalies vs major anomalies, detectable vs nondetectable). RESULTS: A total of 860 fetuses in 854 pregnancies were evaluated. Anomalies were present in 5.35% (46/860); these were major anomalies in 1.16% (10/860) and minor anomalies in 4.19% (36/860). The sensitivity, specificity, and positive and negative predictive values for the diagnosis of all anomalies were 8.7%, 99.9%, 80%, and 95.7%, respectively. However, if only major anomalies detectable by ultrasonography are included, these values become 75%, 100%, 100%, and 99.9%, respectively. There was one false-positive diagnosis not affecting outcome, a small ventriculoseptal cardiac defect. Postnatal ascertainment of anomalies was excellent, as determined by an incidence of ventriculoseptal defects of 1 in 120. CONCLUSION: Distinguishing between major and minor anomalies and between ultrasonographically detectable versus nondetectable anomalies is essential in the evaluation of the diagnostic accuracy of screening ultrasonography. Any comparisons of studies examining the effectiveness of prenatal screening for congenital anomalies with ultrasonography should use the same outcome: major anomalies identifiable by ultrasonography.
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Sprigg, A. Fetal malformations diagnosed antenatally. 2: Ultrasound diagnosis of fetal structural anomalies. Br.J.Hosp.Med. 54(9):447-450, 1995.
Notes : 96154525 0 (Biological Markers) JOURNAL ARTICLE 0007-1064 M BZ5 199605 Paediatricians should be consulted about the significance of abnormalities seen on antenatal ultrasound scans. Good teamwork and communication is necessary between the obstetrician, paediatrician and ultrasonographer to explain the significance of any abnormality to a pregnant woman. Follow-up is important both for the parents and for audit purposes.
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Stoll, C., Alembik, Y., and Dott, B. Impact of routine fetal ultrasonographic screening on the prevalence of Down syndrome in non aged mothers. Ann.Genet. 41(1):27-30, 1998.
Notes : 98262382 JOURNAL ARTICLE 0003-3995 M 56I 199808 In many countries the introduction of screening programs based on maternal serum has reduced the number of Down syndrome. In France routine maternal serum screening was not available whereas ultrasound scanning during pregnancy is routine practice in private offices and in hospitals using high-resolution real-time scanners and there are no legal upper limits on gestational age at termination of pregnancy for fetal abnormality. The objective of this study was to determine the impact of routine fetal ultrasonographic screening on birth prevalence of Down syndrome in non aged mothers. Total prevalence of Down syndrome during 1989 to 1996 was stable 1.43 per 1,000 with no upward or downward trend. The total number of liveborn Down syndrome during this period was higher than previously due to a changing pattern of risk in relation to maternal age. All women who delivered an infant with Down syndrome had had routine ultrasonography, including 88% in the second trimester. Out of the 154 Down syndrome fetuses examined, 38 had been found to have an anomaly. This low sensitivity (24.7%) is not the result of the quality of the ultrasound equipment. It may be explained by the inadequate routine, first level ultrasonographic examination. This study demonstrated that other screening methods than routine fetal ultrasonographic examination are needed in our region.
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Stoll, C., Dott, B., Alembik, Y., and Roth, M.P. Evaluation of routine prenatal ultrasound examination in detecting fetal chromosomal abnormalities in a low risk population. Hum.Genet. 91(1):37-41, 1993.
Notes : 93202649 JOURNAL ARTICLE 0340-6717 M X GED 199306 Prenatal diagnosis performed by fetal ultrasound scan is now a routine part of antenatal care in many countries. We have used our registry of congenital malformations to determine how many fetal anomalies and consequently how many chromosomal abnormalities are detected by this procedure. In our region, evaluation of prenatal diagnosis of chromosomal abnormalities in women of 38 years and younger (chromosomal prenatal diagnosis is offered to women > or = 38 years) with no personal or familial history of chromosomal anomaly was performed in 119,099 consecutive pregnancies of known outcome from 1980 to 1987. At least one ultrasonographic examination seeking congenital malformations was performed in more than 95% of the pregnant women studied. The total number of chromosomal anomalies during the study period was 199, 123 of these being Down syndrome. Only 41 (34.5%) of the 119 fetuses with chromosomal abnormalities and congenital malformation examined had been found to have a malformation at ultrasound examination. This low sensitivity was different for the diverse chromosomal abnormalities. Only 10 out of the 54 fetuses with Down syndrome and malformations (18.5%) were detected and only 3 out of 24 (12.5%) atrioventricular canal defects in those trisomic 21 patients were detected. Only 5 out of 11 (45.4%) fetuses with trisomy 13, 13 out of 26 (50.0%) fetuses with trisomy 18, 7 out of 12 patients with monosomy X (58.3%) and 6 out of 27 (22.2%) fetuses with other chromosomal abnormalities were diagnosed. Moreover, the time of detection of these anomalies was early enough to allow amniocentesis and termination of pregnancy in the case of a chromosomal abnormality in only 15 out of these 41 patients, including 7 cases of cystic hygroma in fetuses with monosomy X. This low sensitivity is not the result of the quality of the ultrasound equipment. It may be explained by the inadequate qualification of some operators and by the insufficient duration of the routine examination. In conclusion, our study has shown that the sensitivity of the detection of chromosomal abnormalities by routine prenatal ultrasound screening is low. Other screening methods are needed.
Ref ID : 60
Todros, T., Faggiano, F., Chiappa, E., Gaglioti, P., Mitola, B., and Sciarrone, A. Accuracy of routine ultrasonography in screening heart disease prenatally. Gruppo Piemontese for Prenatal Screening of Congenital Heart Disease. Prenat.Diagn. 17(10):901-906, 1997.
Notes : JOURNAL ARTICLE MULTICENTER STUDY 0197-3851 M PJ7 199804 The aim of the present study was to assess the accuracy of the four- chamber view as a screening test for detection of congenital heart disease (CHD) prenatally in a low-risk population. A prospective observational study was conducted in 17 ultrasound units of the Piemonte Region, Italy, in pregnancies with no risk factors for CHD. At each routine scan, from 18 weeks of gestational age, the four-chamber view of the heart was looked for. When an anomaly was suspected, the patients were referred to a specialized unit. Follow-up of the babies until discharge from the hospital was obtained. 11,232 sonograms were performed on 8299 pregnancies. Cardiac malformations were diagnosed in 40 newborns (4.8/1000). Six of them (15 per cent) had been recognized in utero. The sensitivity, specificity, and positive and negative predictive values were 15, 99.9, 50, and 99.6 per cent, respectively. When malformations that are not associated with an abnormal four- chamber view were excluded from the analysis, the sensitivity increased to 35.3 per cent. The sensitivity found in this study is low, but it is probably realistic since it is comparable to that reported in other multicentric studies. This type of study should reflect the state of the art of the method applied in the field. Although the sensitivity is low, it would be nil if the test were not performed. Moreover, it will probably increase with better training of the operators and by extending the examination to the ventriculo-arterial connections.
Ref ID : 27
VanDorsten, J.P., Hulsey, T.C., Newman, R.B., and Menard, M.K. Fetal anomaly detection by second-trimester ultrasonography in a tertiary center. Am.J.Obstet.Gynecol. 178(4):742-749, 1998.
Notes : 98239039 JOURNAL ARTICLE 0002-9378 A M X 3NI 199807 OBJECTIVE: Our purpose was to determine the relative accuracy of indicated versus screening second-trimester ultrasonography for detection of fetal anomalies and to assess the cost effectiveness of anomaly screening. STUDY DESIGN: The study population consisted of 2031 pregnant women with singleton gestations who prospectively underwent ultrasonographic scanning between 15 and 22 weeks and received complete obstetric care at the Medical University of South Carolina between July 1, 1993, and June 30, 1996. Patients were divided into two groups: (1) indicated and (2) screening. The cost of screening ultrasonography was compared with the cost of newborn care for selected anomalous fetuses. RESULTS: Forty-seven fetuses (2.3%) were diagnosed by ultrasonography as having a major anomaly: 8.6% in the indicated group and 0.68% in the screening group (p=0.001). The sensitivity for detecting the anomalous fetus was 75.0% overall: 89.7% in the indicated group and 47.6% in the screening group (p=0.001). Of the 47 patients diagnosed with fetal anomalies, 11 (23.4%) chose pregnancy termination; of the 35 (74.5%) live-born anomalous infants, 29 (82.9%) were discharged alive. Projected newborn cost savings offset the cost of routine midtrimester screening. CONCLUSIONS: Detection of anomalous fetuses was significantly better in the indicated compared with the screening group. Nevertheless, routine ultrasonographic screening appeared cost-effective in our population.
Ref ID : 57
Waitzman, N.J. and Romano, P.S. Reduced costs of congenital anomalies from fetal ultrasound: are they sufficient to justify routine screening in the United States? Ann.N.Y.Acad.Sci. 847:141-153, 1998.
Notes : 98333304 JOURNAL ARTICLE 0077-8923 M X 5NM 199810 No comprehensive benefit-to-cost analysis has been performed to date on a policy of routine ultrasound screening for fetal anomalies in the United States. We performed a preliminary benefit-to-cost analysis drawing upon our previous research on the cost or birth defects in the United States and upon the literature regarding (1) the sensitivity of ultrasound in detecting congenital anomalies, (2) the rate at which pregnancies are terminated upon detection of fetal anomalies, (3) the number of ultrasounds performed per pregnancy under a routine screening policy, and (4) the average cost of an ultrasound. We assumed a 100% subsequent replacement rate of terminated pregnancies with a normal child, an assumption most favorable to routine screening. The benefit- to-cost ratio ranged from .33 to 3, suggesting that a routine screening policy for fetal anomalies is of uncertain net societal benefit. Routine screening may be justified, however, based on standards that elude the methods for establishing societal benefits adopted in this analysis.
Ref ID : 35
Zimmer, E.Z., Avraham, Z., Sujoy, P., Goldstein, I., and Bronshtein, M. The influence of prenatal ultrasound on the prevalence of congenital anomalies at birth. Prenat.Diagn. 17(7):623-628, 1997.
Notes : 97393345 JOURNAL ARTICLE 0197-3851 M PJ7 199711 The objectives of the study were (1) to assess whether prenatal ultrasound examinations affected the prevalence of congenital anomalies at birth and the incidence of terminations of pregnancy for fetal anomalies and (2) to examine the detection rate of the main fetal anomalies. We studied all births and stillbirths with congenital defects, and all terminations of pregnancy for fetal anomalies in the Rambam Medical Center during a 5-year period (1989-1993) and correlated them to ultrasound findings. There were 23439 births during the study period. The incidence of newborns with anomalies decreased from 1.95 to 1.34 per cent (P < 0.01). The incidence of termination of pregnancy because of fetal anomalies increased from 0.35 to 0.83 per cent (P < 0.003) and the detection rate of malformations increased from 53.94 to 79.60 per cent (P < 0.001). It is concluded that terminations of pregnancy after ultrasound detection of fetal anomalies had an impact on the prevalence of anomalies in newborns. There was also continuing significant improvement in the detection rate of ultrasound examinations.
Ref ID : 36
Chitty, L.S. Ultrasound screening for fetal abnormalities [see comments]. Prenat.Diagn. 15(13):1241-1257, 1995.
Notes : 96221062 JOURNAL ARTICLE REVIEW REVIEW, TUTORIAL 0197-3851 M PJ7 199611 Ultrasound screening for fetal abnormalities is increasingly becoming part of routine antenatal care in Europe and the UK. However, there has been very little formal evaluation of this practice. In this article reports of routine ultrasound screening are reviewed and the advantages and disadvantages discussed. The majority of routine anomaly scanning is done in the second trimester but there may be a case for screening at other times in pregnancy and alternative anomaly screening policies are discussed.
Ref ID : 41
Garmel, S.H. and D'Alton, M.E. Fetal ultrasonography. West.J.Med. 159(3):273-285, 1993.
Notes : 94055240 JOURNAL ARTICLE REVIEW REVIEW, TUTORIAL 0093-0415 A M XN5 199402 Since its introduction in the 1950s, ultrasonography in pregnancy has been helpful in determining gestational age, detecting multiple pregnancies, locating placentas, diagnosing fetal anomalies, evaluating fetal well-being, and guiding obstetricians with in utero treatment. We review current standards and controversies regarding the indications, safety, accuracy, and limitations of ultrasonography in pregnancy.
Ref ID : 51
Levi, S. Routine ultrasound screening of congenital anomalies. An overview of the European experience. Ann.N.Y.Acad.Sci. 847:86-98, 1998.
Notes : 98333298 JOURNAL ARTICLE REVIEW REVIEW, TUTORIAL 0077-8923 M X 5NM 199810 Results from ultrasound in low-risk pregnant women are significant when routine screening is performed on a large population because the anomalies are rare. Professionals expect from routine ultrasound objective information that cannot usually be obtained by clinical procedures. Parents seek reassurance about the absence of fetal congenital anomalies and overall fetal health. Therefore, Europeans view routine ultrasound as a part of obstetrical care, capable of filling important gaps by delivering much key information for improving obstetrical practice. Fetal anomalies screening (FAS) requires higher education and qualifications than obstetrical ultrasound. The health insurance systems support ultrasound screening and allow its spread in most European countries; approximately 98% of pregnant women are examined by ultrasound and, frequently, two to three times (usually once per trimester). Detection rate of congenital anomalies is about 28% in geographical areas (private practice and hospitals), 60 to 80% in Ob/Gyn's ultrasound labs. Routine ultrasound screening policy has not proved to result in an immoderate use of ultrasound; on the contrary, chaotic use of routine ultrasound can lead to an unproductive and excessive number of scans. New trends in FAS, such as the early detection of fetal defects and chromosomal anomalies, bring more arguments for routine screening. Effectiveness should increase by enhancing education and training and the systematic referral for FAS to accredited laboratories.
Ref ID : 58
Bucher, H.C. and Schmidt, J.G. Does routine ultrasound scanning improve outcome in pregnancy? Meta- analysis of various outcome measures [see comments]. BMJ. 307(6895):13-17, 1993.
Notes : JOURNAL ARTICLE META-ANALYSIS
0959-8138 A M X BMJ 199311 OBJECTIVE--To evaluate the effectiveness of
routine ultrasound scanning in pregnancy by a meta-analysis of various
outcome measures. DESIGN-- Meta-analysis of randomised controlled trials
evaluating the effect of routine ultrasound scanning on perinatal mortality
and morbidity. Live birth rate (that is, live births per pregnancy) is
included as a measure of pregnancy outcome in addition to the conventional
perinatal mortality. SUBJECTS--15, 935 pregnancies (7992 in which routine
ultrasound scanning was used and 7943 controls with selective scanning)
from four randomised controlled trials. MAIN OUTCOME MEASURES-- Perinatal
mortality, live birth rate, rate of miscarriage, Apgar score < 7 at
1 minute, and number of induced labours. RESULTS--The live birth rate was
identical in both screening and control groups (odds ratio = 0.99; 95%
confidence interval 0.88 to 1.12) although the perinatal mortality was
significantly lower in the group who had routine ultrasonography (0.64,
0.43 to 0.97). Differences in perinatal morbidity between the two groups
as measured by the proportion of newborn babies with Apgar score < 7
at 1 minute were not significant (1.05; 0.93 to 1.19). CONCLUSION--Routine
ultrasound scanning does not improve the outcome of pregnancy in terms
of an increased number of live births or of reduced perinatal morbidity.
Routine ultrasound scanning may be effective and useful as a screening
for malformation. Its use for this purpose, however, should be made explicit
and take into account the risk of false positive diagnosis in addition
to ethical issues.
