Performance of Serum Quad Test in Screening for Fetal Down Syndrome in a Large-Scale Unselected Population in a Developing Country.

Objective: To assess the effectiveness of Quad test in the detection of Down syndrome (DS) in routine practice among a large-scale population and to compare the effectiveness of Quad test based on the Western reference model (WM) and that based on Thai reference model (TM). Methods: Quad test was performed on 42,769 pregnancies at 14-21 weeks. The fetal risk of DS derived from Quad test was automatically computed based on WM and used in evaluating the effectiveness. Also, the fetal risk was calculated based on the TM. Results: Of 39,740 women with complete follow-ups including 74 fetuses with DS, with WM, the detection and false positive rates were 81.1% and 7.2%, respectively, whereas the detection and false positive rates with TM were 87.8%, and 6.8%, respectively. According to ROC curves, the performance of Quad test based on TM was slightly but significantly better than that based on WM (AUC of 0.959 vs. 0.940, p = 0.001). Conclusion: Quad test is highly effective in service settings and suitable for developing countries and the effectiveness is even higher when based on ethnicity-specific reference model.

Effectiveness of Nitrous Oxide versus Pethidine/Midazolam for Pain Relief in Minor Gynecological Operative Procedures: A Randomized Controlled Trial.

Aim and Objective: To compare the analgesic effectiveness of the patient-controlled inhaled nitrous oxide (Entonox®) with intravenous opioids (pethidine/midazolam) in reducing pain during minor gynecological operative procedures, including manual vacuum aspiration (MVA), fractional curettage and dilatation and curettage. Materials and Methods: Patients undergoing minor gynecological procedures from August 2021 to December 2022 were randomized to receive nitrous oxide or intravenous pethidine (50-75 micrograms) plus midazolam (2 mg). Pain scores during and post-procedure, satisfaction level, and side effects were assessed and compared. Results: A total of 106 patients met the inclusion criteria, including 53 in the pethidine/midazolam group and 53 in the nitrous oxide group. Baseline characteristics were comparable (p-value > 0.05). Pain scores during, immediately and 30 min after procedures were not significantly different in two groups (4.94 ± 3.15, 2.74 ± 2.57, 1.58 ± 2.13 vs. 5.47 ± 2.80, 2.98 ± 2.70, 1.64 ± 2.70; p-value: 0.174, 0.634, 0.889, for pethidine/midazolam vs. nitrous oxide group, respectively. Satisfaction scores were comparable in both groups (p-value > 0.05). However, the rate of side effects was significantly lower in the nitrous oxide group (3.8% vs. 28.3%; p-value 0.001). Additionally, the discharge scores showed a significantly faster recovery time in the nitrous oxide group at 60 and 90 min after the procedure; median (IQR): 10 (9-10) vs. 9 (8-10) and 10 (10-10) vs. 10 (8.5-10); p-value 0.002 and 0.029, respectively). Conclusions: Nitrous oxide is as effective as pethidine/midazolam for pain relief in minor gynecological operative procedures but associated with significantly lower side effects and significantly faster recovery time.

Effectiveness of ultrasound algorithm in prenatal diagnosis of hemoglobin Bart's disease among pregnancies at risk.

OBJECTIVE: To evaluate the effectiveness of ultrasound algorithm in diagnosis of fetal Hb Bart's disease among pregnancies at risk. METHODS: Pregnancies at risk underwent ultrasound for the first time at 12-14 weeks of gestation and serial ultrasound every 2-4 weeks until 24 weeks to identify pre-hydropic signs. The invasive procedure was omitted in case of no pre-hydropic signs. RESULTS: A total of 237 fetuses were recruited, including 53 affected and 184 unaffected fetuses. The algorithm has a sensitivity of 100% in the detection of fetal Hb Bart's disease with a false positive rate of 10.9%. Of the affected group, the mean gestational age at the time of diagnosis was 15.5 ± 2.6 week. 30.8% of all pregnancies at risk underwent invasive procedures. The algorithm had a 70% reduction in the rate of invasive procedures among pregnancies at risk without missing the affected cases. CONCLUSIONS: The algorithm is highly effective in the early detection of fetal Hb Bart's disease with a detection rate of 100%, and invasive diagnosis can be avoided in about 70% of cases. Thus, this algorithm should be used as a guideline for prenatal diagnosis of fetal Hb Bart's disease, especially in geographical areas of high prevalence.

Entonox® versus Pethidine in Labor Pain Relief: A Randomized Controlled Trial.

BACKGROUND: Pain relief during labor is a part of standard care in modern obstetrics. Several modalities used for pain relief have their own disadvantages and benefits in terms of side effects, effectiveness, availability, and satisfaction. The objectives of this study are primarily to compare the effectiveness and patients' satisfaction for pain relief during labor between pethidine and inhaled 50% nitrous oxide (Entonox®). METHODS: Laboring women at 37-41 + 6 weeks of gestation were randomly allocated to receive pethidine (50 mg intravenously) or Entonox® for reducing labor pain. Pain scores were evaluated at 0, (baseline), 30, 60, 90, and 120 min after initiation, using the visual analog scale (VAS) and also satisfaction score after delivery using the verbal rating scale (VRS). The secondary outcomes were also assessed, including APGAR scores, labor course, side effects, and cesarean section rate. RESULTS: A total of 136 laboring women underwent randomization into two groups, but only 58 and 65 in the pethidine group and the Entonox® group were available for analysis. The median pain scores at baseline, 30, 60, and 90 min were comparable between both groups (p-value > 0.05); however, pain score at 120 min in the pethidine group was significantly higher (p-value: 0.038). The median of satisfaction score was significantly higher in the Entonox® group (4 vs. 3; p-value 0.043). All of the secondary outcomes were comparable between the two groups. CONCLUSIONS: Both have comparable effectiveness, but Entonox® has a higher satisfaction score. Entonox® could be an alternative to pethidine for reducing labor pain, because of its efficacy, ease for self-adjustment for satisfaction, and no serious effects on the labor course and newborns.

Ethnicity-Specific Normative Models of Quadruple Test as a Screening Test for Down Syndrome.

Background and Objectives: To establish normative models for median levels of serum biomarkers of the second trimester quad test (alpha-fetoprotein: AFP; free beta-human gonadotropins: hCG; inhibin-A; and unconjugated estriol: uE3) specific to Thai women and to compare multiples of the median (MoMs) derived from ethnicity-specific models and those derived from Caucasian models with ethnic correction. Materials and Methods: A cross-sectional study was undertaken in a tertiary, medical teaching center among low-risk pregnant Thai women between 14 and 21 weeks of gestation to measure the levels of the four serum biomarkers. The measured values of each biomarker were analyzed using the multivariable factorial polynomial technique for quantile regression as a function of gestational age and maternal weight. Results: The Thai-specific normative models for the four biomarkers were generated and available for use. The MoMs of all individuals generated from our models were significantly different from conventional (Caucasian) models with ethnic correction (Wilcoxon signed-rank test; p < 0.0001 for all biomarkers). The MoMs of AFP and hCG from both methods were in agreement, but those from Thai-specific models were significantly higher. However, those of inhibin-A and uE3 were markedly different and ethnic correction was unlikely to be useful. Conclusions: The Thai-specific normative models of the quad test as a function of gestational age and maternal weight were constructed using multivariable factorial polynomial models, better than simple quantile regression or log-linear regression used in earlier decades. The analysis of MoMs supports the use of ethnicity-specific models instead of Caucasian models with ethnic correction.

A comparison of pregnancy outcomes after second-trimester amniocentesis between cases with penetration of the placenta and nonpenetration.

OBJECTIVE: To compare the fetal loss rate associated with second-trimester amniocentesis between the procedures with penetration and nonpenetration of the placenta, as a primary outcome and to compare the rates of adverse pregnancy outcomes including preterm birth, fetal growth restriction and low birth weight, as secondary outcomes. METHOD: A retrospective cohort study was conducted on women undergoing second-trimester amniocentesis. Our prospective database of amniocentesis, from January 1989 to December 2018, was accessed to retrieve the records meeting the inclusion criteria consisting of singleton pregnancies, gestational age of 16-22 weeks, and known obstetric outcomes. The patients were categorized into two groups: placental penetration and nonpenetration. The rates of fetal loss, including abortion (<24 weeks of gestation) and fetal death in utero (>24 weeks of gestation), and other adverse pregnancy outcomes were compared between the two groups. RESULTS: A total of 21,566 procedures were performed during the study period. Of them, 8601 were excluded due to chromosomal/structural abnormalities, various underlying medical diseases and incomplete data or unavailability of final outcomes. Finally, 12,965 cases were available for analysis including 4692 (36.2%) in the group of placental penetration and 8273 (63.8%) in the group of nonpenetration. The abortion rate after amniocentesis trended to be increased in the placental penetration group (0.6 versus 0.4%, p = .064; RR: 1.60, 95%CI 0.97-2.64). Likewise, the fetal loss rate trended to be increased in the placental penetration group (1.0 versus 0.7%, p = .121; RR: 1.35 95%CI 0.92-1.98). Interestingly, preterm birth rate was significantly increased in the placental penetration group (13.8 versus 12.6%, p = .043; RR: 1.10 95%CI 1.00-1.20). CONCLUSION: Fetal loss rate was slightly increased, but not statistically significant, among the procedures with placental penetration. However, penetration of the placenta was slightly but significantly associated with an increase in rates of preterm birth.

Ultrasound Features of Fetal Anemia Lessons From Hemoglobin Bart Disease.

Insights gained from this review are as follows: (1) Ultrasound is highly effective in early detection of fetal hemoglobin (Hb) Bart disease. (2) The most sensitive parameters in predicting Hb Bart anemia appear to be the cardiac diameter-to-thoracic diameter ratio, middle cerebral artery peak systolic velocity, and placental thickness. (3) Several other ultrasound markers are helpful in increasing specificity, such as hepatosplenomegaly. (4) Hydrops fetalis is not a consequence of heart failure but rather of hypervolemia and high vascular permeability of fetuses, whereas heart failure is a very late consequence of a long-standing overworked heart. (5) Management guidelines for fetuses at risk of Hb Bart disease are proposed.

Quad test for fetal aneuploidy screening as a predictor of small-for-gestational age fetuses: a population-based study.

BACKGROUND: To identify the relationship between quadruple test for aneuploidy screening (alpha-fetoprotein: AFP; free beta-human chorionic gonadotropin: b-hCG; unconjugated estriol: uE3 and inhibin-A: IHA) and fetal growth restriction and to construct predictive models for small-for-gestational-age (SGA) fetuses. METHODS: Women who underwent quadruple test for aneuploidy were followed-up for final outcomes. The multiples of the median (MoMs) of the four biochemical markers for the SGA group and those of normal fetuses were compared. The models for predicting SGA by the individual biomarkers and their combination were constructed using binary logistic regression analysis, and their diagnostic performances in predicting SGA were determined. RESULTS: Of 10,155 eligible pregnant women, 578 (5.7%) and 9577 (94.3%) had SGA and normal growth, respectively. High levels of AFP, b-hCG and IHA but low levels of uE3 significantly increased the risk of SGA. The constructed predictive equations had predictive performance for SGA, with areas under the receiver-operated characteristic curve of 0.724, 0.655, 0.597, 0.664 and 0.754 for AFP, b-hCG, uE3, IHA, and the combination, respectively. CONCLUSION: The quad test for aneuploidy screening could also be used as a predictor of SGA, without extra-effort and extra-cost.

Comparisons of pregnancy outcomes between twin pregnancies with and without second-trimester amniocentesis.

OBJECTIVE: To assess the amniocentesis-related pregnancy loss rate and preterm birth rate among twin pregnancies undergoing amniocentesis. METHODS: A retrospective cohort study was conducted at a tertiary center. The study group included twin pregnancies undergoing amniocentesis during 16 to 22 weeks of gestation. The control group was those not undergoing amniocentesis. All amniocenteses were performed by the MFM specialists. The main outcomes were the rate of pregnancy loss (before 24 weeks) and preterm birth. RESULTS: A total of 332 cases in the study group and 1188 controls were analyzed. The percentages of maternal age ≥35 years, high parity, and cases complicated with medical diseases were significantly higher in the study group. The pregnancy loss rate after the procedure tended to be higher, but not significant, in the study group (3.0% vs 2.2% P = .383). Likewise, the rate of preterm birth in the study group was higher, but not significant (70.5% vs 66.0% P = .130). Logistic regression analysis to adjust confounding factors showed no significance of amniocentesis on pregnancy loss and preterm birth. CONCLUSION: Though amniocentesis in twin pregnancies has theoretical risk of pregnancy loss, it is relatively safe when performed by maternal-fetal medicine specialists. This information is useful for counseling, especially when performed by experienced hands.

First-trimester serum biomarker screening for fetal Down syndrome as a predictor of preterm delivery: a population-based study.

Objective: To examine the relationship between the first-trimester serum biomarker levels (pregnancy-associated plasma protein A:PAPP-A; and free beta-human chorionic gonadotropin: b-hCG) and preterm birth; and to create the predictive models for preterm birth in case of strong correlation.Methods: Secondary analysis on a large prospective database of singleton pregnancies undergoing first-trimester serum screening with complete follow-up for pregnancy outcomes. The multiples of medians (MoM) of the biomarkers were compared between the group of term and preterm/early preterm birth. Predictive models were developed based on adjusted MoMs and logistic regression analysis, and then diagnostic performances in predicting preterm birth were assessed.Results: Of 24,611 pregnancies eligible for analysis, 1908 (7.8%) and 500 (2.0%) had preterm and early preterm birth, respectively. Medians MoMs of both biomarkers were significantly lower in preterm and early preterm birth group. The predictive models were constructed. Performance in predicting preterm birth of these models yielded the area-under-ROC-curve of 0.560, 0.652, and 0.653 for b-hCG, PAPP-A, and combined biomarkers, respectively. In predicting early preterm birth, the areas-under-the-curve were found to be 0.551, 0.675, and 0.674 for b-hCG, PAPP-A, and combined biomarkers, respectively.Conclusion: The routine first-trimester serum screening of fetal Down syndrome could also be used as a tool of risk identification of preterm birth. We could take advantage of the screening by incorporating the predictive models into the Down syndrome screening software to report the preterm risk in the same test without extra effort and extra cost.

Fetal Down syndrome screening models for developing countries; Part II: Cost-benefit analysis.

BACKGROUND: To identify the most cost-beneficial model as a national policy of screening and diagnosis of fetal Down syndrome (DS) in developing countries. METHODS: Cost-benefit analysis (CBA) was performed based on the effectiveness and probabilities derived from a large prospective study on MSS (maternal serum screening) among Thai population. Various models including maternal age alone, STS (second trimester screen), I-S (independent screen: first or second trimester screen depending on the time of first visit), C-S (contingent serum screen) plus STS, maternal age with NIPS (non-invasive prenatal test), STS alone with NIPS, I-S with NIPS, C-S plus STS with NIPS, and Universal NIPS were compared. RESULTS: I-S with NIPS as a secondary screening was most cost-beneficial (Benefit/Cost ratio 4.28). Cost-benefit is directly related to the costs of NIPS. CONCLUSION: In addition to simplicity and feasibility, I-S with expensive NIPS as a secondary screening is the most cost-beneficial method for low resource settings and should be included in universal healthcare coverage as a national policy. This study could be a model for developing countries or a guideline for international health organizations to help low resource countries, probably leading to a paradigm shift in prenatal diagnosis of fetal DS in the developing world.

Fetal Down syndrome screening models for developing countries; Part I: Performance of Maternal Serum Screening.

BACKGROUND: To identify the performance of fetal Down syndrome (DS) screening for developing countries. METHODS: A prospective study on MSS (maternal serum screening) with complete follow-ups (n = 41,924) was conducted in 32 network hospitals in the northern part of Thailand. Various models of MSS were tested for performance. RESULTS: MSS based on Caucasian reference range resulted in very high false positive rate (FPR; 13%) in our country, compared to the rate of 7.8% with our own (Thai) reference range, whereas the detection rate was comparable. As individual screening, C-S (contingent first trimester screening including PAPP-A, and free beta-hCG, classified as a) high risk [> 1:30], indicated for invasive diagnosis; b) intermediate risk [1:30-1500], indicated for STS; and c) low risk [< 1:1500], need no further tests.) was the most effective model (sensitivity 84.9%, FPR 7.7%) but nearly one-third needed the second trimester test (STS) because of intermediate results. Additionally, about one-third had their first visits in the second trimester and had no chance of FTS (first trimester screening). C-S plus STS had a sensitivity of 82.4% and FPR 8.1% whereas independent first and second trimester screening model (I-S) gave the sensitivity of 78.4% and FPR of 7.5% but was much more convenient and practical. CONCLUSION: C-S plus STS was the most effective models while I-S model was also effective and may be better for developing countries because of its simplicity and feasibility.

Comparison of the diagnostic accuracy of International Ovarian Tumor Analysis simple rules and the risk of malignancy index to discriminate between benign and malignant adnexal masses.

OBJECTIVE: To compare the diagnostic accuracy of International Ovarian Tumor Analysis (IOTA) simple rules and risk of malignancy index (RMI 1/RMI 2) scoring to discriminate between benign and malignant adnexal masses. METHODS: Secondary analysis of a cohort of patients scheduled for surgery for adnexal masses in a tertiary center between April 2010 and March 2018. Ultrasound examinations were performed by general gynecologists within 24 hours prior to surgery to evaluate sonographic features. Demographic data and preoperative CA 125 levels were recorded. IOTA rules and RMI scoring were applied to predict malignancy and prospectively recorded. Final diagnosis was based on pathological or intraoperative diagnosis. RESULTS: A total of 479 masses met the inclusion criteria and were retrieved from the database: 334 (69.7%) benign and 145 (30.3%) malignant. IOTA rules could be applied to 392 (81.8%) masses and were inconclusive in 87 (18.2%). Sensitivity and specificity of IOTA rules (83.8% and 92.0%, respectively) were significantly higher than RMI 1 (77.2% and 86.8%, respectively) and RMI 2 (82.1% and 82.6%, respectively). CONCLUSION: IOTA simple rules had higher diagnostic accuracy compared with RMI to discriminate between benign and malignant adnexal masses; however, nearly 20% of IOTA results were inconclusive and needed expert consultation.

A cohort study of the association between maternal serum Inhibin-A and adverse pregnancy outcomes: a population-based study.

BACKGROUND: To compare the rates of adverse pregnancy outcomes between women with normal and abnormal inhibin-A levels. METHODS: Based on a prospective database of Down syndrome screening program, the consecutive records were comprehensively reviewed. Pregnancies were classified into three groups: normal, high (> 2 MoM) and low (< 0.5 MoM) inhibin-A levels. The pregnancies with medical diseases, chromosome abnormalities and fetal anomalies were excluded. The primary outcomes were the rates of preterm birth, preeclampsia, and fetal growth restriction (FGR). RESULTS: Of 6679 recruited pregnancies, 5080 met the inclusion criteria, including 4600, 205 and 275 pregnancies in the group of normal, high, and low inhibin-A levels respectively. The rates of preterm birth, preeclampsia and FGR were significantly higher in the group of high levels; (RR, 1.51, 95%CI: 1.01-2.26; 3.47, 95% CI: 2.13-5.65; 3.04, 95% CI: 1.99-4.65 respectively), whereas the rates of other adverse outcomes were comparable. However, the rate of spontaneous preterm birth among women with high inhibin-A was not significantly increased. Based on multivariate analysis, the preterm birth rate was not significantly associated with inhibin-A levels, but it was rather a consequence of preeclampsia and FGR. Low levels of serum inhibin-A were not significantly associated with any adverse outcomes. CONCLUSIONS: High levels of maternal serum inhibin-A in the second trimester are significantly associated with abnormal placentation, which increases the risk of preeclampsia and FGR with a consequence of indicated preterm birth but not a risk of spontaneous preterm birth. In contrast, low inhibin-A levels were not associated with any common adverse pregnancy outcomes.

Second Trimester Serum Biomarker Screen for Fetal Aneuploidies as a Predictor of Preterm Delivery: A Population-Based Study.

OBJECTIVE: To determine the association between second-trimester serum Down syndrome screening (alpha-fetoprotein [AFP] free beta-human chorionic gonadotropin [b-hCG] unconjugated estriol [uE3]) and preterm birth and to create predictive models for preterm birth. METHODS: Secondary analysis on a prospective database of pregnancies undergoing second-trimester screen with complete follow-up. The multiples of medians (MoM) of the biomarkers were compared between the group of term, preterm (< 37 weeks), early preterm (< 34 weeks), and very early preterm (< 32 weeks) delivery. Predictive models were developed based on adjusted MoMs and logistic regression and diagnostic performances in predicting preterm birth were determined. RESULTS: Of 20,780 pregnancies, 1,554 (7.5), 363 (1.7), and 158 (0.8%) had preterm, early preterm, and very early preterm birth respectively. High levels of AFP and b-hCG but low levels of uE3 were significantly associated with higher rates of preterm, early preterm and very early preterm delivery. The predictive models had diagnostic performance in predicting preterm birth with the areas under the ROC curve of 0.688, 0.534, 0.599, and 0.718 for AFP, b-hCG, uE3, and combined biomarkers respectively. CONCLUSION: The second trimester Down syndrome screening could also be used as a tool of risk identification of preterm birth in the same test, without extra-effort and extra-cost.

How to correct the impact of ethnicity on effectiveness of the second trimester maternal serum screen of fetal Down syndrome?

Objectives: To compare the performance of second trimester maternal serum screen (MSS) for fetal Down syndrome in Thai population between the conventional method using Caucasian reference ranges with ethnic factor correction (CRR-EC) and the method using specific Thai reference ranges (TRRs). Methods: A prospective database of the MSS project was accessed. The concentrations of alpha fetoprotein (AFP), beta-hCG, and uE3 were converted to their multiple of medians (MoMs) by two methods; CRR-EC for Asian women and TRR. The detection rate and false positive rate derived from the two methods were compared. Results: Of 20,229 cases, 35 women had fetal Down syndrome. The detection rates of both methods were comparable, whereas the false-positive rate of TRR was significantly lower (8.8 versus 11.7%; p < .001). The improvement was mainly caused by more accuracy of the MoMs of beta-hCG, not AFP/uE3, based on TRR. Conclusions: The effectiveness of MSS could be improved by using our own reference ranges instead of using ethnic factor correction. With TRR, the false-positive rate or the number of invasive diagnoses could be significantly decreased without compromise of the detection rate. To improve MSS performance, each population should use its own reference ranges.

Second-trimester maternal serum screening for fetal Down syndrome: As a screening test for hemoglobin Bart's disease: A prospective population-based study.

PURPOSE: The purpose of this study is to determine the effectiveness of second-trimester maternal serum screening for Down syndrome as a screening test for fetal hemoglobin (Hb) Bart's disease among an unselected population. METHODS: A secondary analysis of a large prospective database (20 254 pregnancies) was conducted to compare the levels of maternal serum screening, alpha-fetoprotein (AFP), free beta-human chorionic gonadotropin, and unconjugated estriol between pregnancies with Hb Bart's disease and unaffected pregnancies. RESULTS: The median AFP levels were much higher among affected fetuses (1.96 vs 1.12 multiple of the median; P < .001), yielding a sensitivity of 81.6% and specificity of 86.4%. Thus, AFP measurement is effective in predicting fetal Hb Bart's disease among an unselected population when using a cutoff value of 1.5 multiple of the median. The serum free beta-human chorionic gonadotropin levels were slightly, but significantly, higher in the affected pregnancies, while the serum unconjugated estriol levels were minimally, but significantly, lower among the affected pregnancies. CONCLUSION: Second-trimester maternal serum AFP levels were significantly elevated in cases of fetal Hb Bart's disease. Pregnancies with unexplained elevated serum AFP levels in areas of high prevalence of Hb Bart's disease should always undergo a detailed ultrasound examination to detect any early signs of fetal anemia before development of hydrops fetalis.

Optimal risk cut-offs for Down syndrome contingent maternal serum screening.

OBJECTIVES: The objective of this study is to identify the optimal cut-off points of contingent serum screening excluding nuchal translucency (NT) measurement, to categorize the risk level in the first trimester. METHODS: A prospective database of women undergoing contingent serum screening, without NT measurement, was reviewed. In conventional categorization, the results of first-trimester screening were categorized into high risk (>1:30) (invasive diagnosis was offered); intermediate risk (1:30-1:1500) (second-trimester screening was needed); and low risk (<1:1500) (no further test). We recategorized the risk levels using various upper and lower cut-offs and compared detection rates, false-positive rates, and rates of intermediate risk. RESULTS: Among 24,874 women, the prevalence of Down syndrome was 1:691. The previously agreed cut-offs had a detection rate of 88.9% and a false-positive rate of 8.5% with high rate of intermediate risk (38.2%). Re-categorization provided the optimal lower and upper cut-offs 1/900 and 1/50, respectively, giving a detection rate of 86.1%, a false-positive rate of 8.1%, and a rate of intermediate risk of 24.8%. CONCLUSIONS: This is the first study on contingent serum screening without NT measurement which shows a high detection rate with an acceptable false-positive rate. The optimal cut-offs to categorize the risk levels of the upper and the lower cut-off was 1:30-1:50 and 1:900, respectively.

Strong impact of ethnicity on effectiveness of the first trimester maternal serum screen of fetal Down syndrome.

OBJECTIVES: The objective of this study is to compare the effectiveness of first-trimester maternal serum screening (MSS) for fetal Down syndrome among Thai women between the method using Caucasian reference ranges with racial factor correction (CRR-RC) and that using Thai reference ranges (TRR). METHODS: A prospective database of MSS was accessed. The levels of PAPP-A and beta-hCG were calculated to determine their MoMs (multiple of medians) by two methods: (1) CRR-RC for Asian women and (2) TRR. The MoMs from both methods were used to determine the fetal risk. RESULTS: Of 24,885 women including 36 fetuses with Down syndrome, the detection rates were significantly higher with TRR when compared with CRR-RC, 77.8 and 63.9%, respectively, p < .001. Additionally, the false-positive rates were significantly lower with TRR when compared to CRR-RC (7.5 versus 12.5%, respectively, p < .001) Conclusions: The effectiveness of MSS was much better by using our own reference ranges rather than the method of racial factor correction. The important insight is that ethnicity strongly impacts on the effectiveness that cannot be completely corrected by ethnic factor. MSS derived by the CRR-RC in other regions should be interpreted with high precaution, especially where the biophysical characteristics of the women are much different from Caucasian population.

Sonographic Diagnosis of Tubal Cancer with IOTA Simple Rules Plus Pattern Recognition

Objective: To evaluate diagnostic performance of IOTA simple rules plus pattern recognition in predicting tubal cancer. Methods: Secondary analysis was performed on prospective database of our IOTA project. The patients recruited in the project were those who were scheduled for pelvic surgery due to adnexal masses. The patients underwent ultrasound examinations within 24 hours before surgery. On ultrasound examination, the masses were evaluated using the well-established IOTA simple rules plus pattern recognition (sausage-shaped appearance, incomplete septum, visible ipsilateral ovaries) to predict tubal cancer. The gold standard diagnosis was based on histological findings or operative findings. Results: A total of 482 patients, including 15 cases of tubal cancer, were evaluated by ultrasound preoperatively. The IOTA simple rules plus pattern recognition gave a sensitivity of 86.7% (13 in 15) and specificity of 97.4%. Sausage-shaped appearance was identified in nearly all cases (14 in 15). Incomplete septa and normal ovaries could be identified in 33.3% and 40%, respectively. Conclusion: IOTA simple rules plus pattern recognition is relatively effective in predicting tubal cancer. Thus, we propose the simple scheme in diagnosis of tubal cancer as follows. First of all, the adnexal masses are evaluated with IOTA simple rules. If the B-rules could be applied, tubal cancer is reliably excluded. If the M-rules could be applied or the result is inconclusive, careful delineation of the mass with pattern recognition should be performed.