Search PubMed⌕ Search

Biomedical subjects

L Valentin

Publications and source records attributed to L Valentin.

At least 19 recordsLinked to original sources
PubMed2007

By how much does increased nuchal translucency increase the risk of adverse pregnancy outcome in chromosomally normal fetuses? A study of 16,260 fetuses derived from an unselected pregnant population.

OBJECTIVE: In this study we aimed to estimate the magnitude of a possible increase in risk of adverse outcome in fetuses with normal karyotype and increased nuchal translucency (NT), and to determine how well NT measurements can distinguish between fetuses with normal and adverse outcome. METHODS: We studied 16,260 consecutive fetuses with normal karyotype derived from an unselected pregnant population. The following cut-offs for increased risk of adverse outcome were chosen a priori: NT > or = 95th percentile, > or = 3 mm, > or = 3.5 mm, and > or = 4.5 mm. The positive and negative likelihood ratios (+LR, - LR) of the risk cut-offs with regard to fetal malformation, miscarriage, perinatal death, termination of pregnancy and total adverse outcome were calculated, and receiver-operating characteristics (ROC) curves were drawn. RESULTS: The total rate of adverse outcome was 2.7%. + LR and - LR of NT > or = 3.0 mm were: for lethal or severe malformation, + LR 15.0 (95% CI 7.0-28.6), - LR 0.89 (95% CI 0.81-0.95); for malformation of at least intermediate severity, + LR 8.1 (95% CI 4.3-14.0), - LR 0.95 (95% CI 0.92-0.97); for termination of pregnancy, + LR 41.6 (95% CI 17.1-86.6), - LR 0.67 (95% CI 0.41-0.85); for any adverse outcome, + LR 6.4 (95% CI 3.4-11), - LR 0.96 (95% CI 0.94-0.98). The odds for these adverse outcomes increased with increasing NT. NT > or = 3 mm did not significantly increase the risk of miscarriage or perinatal death. Areas under ROC curves for NT were small, with 95% CI below or only slightly above 0.5. CONCLUSION: Our likelihood ratios can be used to calculate the individual risk of unfavorable outcome, but NT screening cannot reliably distinguish between normal and adverse outcome in fetuses with normal karyotype.

Abortion, Spontaneous↗
PubMed2007

Does three-dimensional power Doppler ultrasound help in discrimination between benign and malignant ovarian masses?

OBJECTIVES: To determine if tumor vascularity as assessed by three-dimensional (3D) power Doppler ultrasound can be used to discriminate between benign and malignant ovarian tumors, if adding 3D power Doppler ultrasound to gray-scale imaging improves differentiation between benignity and malignancy, and if 3D power Doppler ultrasound adds more to gray-scale ultrasound than does two-dimensional (2D) power Doppler ultrasound. METHODS: One hundred and six women scheduled for surgery because of an ovarian mass were examined with transvaginal gray-scale ultrasound and 2D and 3D power Doppler ultrasound. The color content of the tumor scan was rated subjectively by the ultrasound examiner on a visual analog scale. Vascularization index (VI), flow index (FI) and vascularization flow index (VFI) were calculated in the whole tumor and in a 5-cm(3) sample taken from the most vascularized area of the tumor. Logistic regression analysis was used to build models to predict malignancy. RESULTS: There were 79 benign tumors, six borderline tumors and 21 invasive malignancies. A logistic regression model including only gray-scale ultrasound variables (the size of the largest solid component, wall irregularity, and lesion size) was built to predict malignancy. It had an area under the receiver-operating characteristics (ROC) curve of 0.98, sensitivity of 100%, false positive rate of 10%, and positive likelihood ratio (LR) of 10 when using the mathematically best cut-off value for risk of malignancy (0.12). The diagnostic performance of the 3D flow index with the best diagnostic performance, i.e. VI in a 5-cm(3) sample, was superior to that of the color content of the tumor scan (area under ROC curve 0.92 vs. 0.80, sensitivity 93% vs. 78%, false positive rate 16% vs. 27% using the mathematically best cut-off value). Adding the color content of the tumor scan or FI in a 5-cm(3) sample to the logistic regression model including the three gray-scale variables described above improved diagnostic performance only marginally, an additional two tumors being correctly classified. CONCLUSIONS: Even though 2D and 3D power Doppler ultrasound can be used to discriminate between benign and malignant ovarian tumors, their use adds little to a correct diagnosis of malignancy in an ordinary population of ovarian tumors. Objective quantitation of the color content of the tumor scan using 3D power Doppler ultrasound does not seem to add more to gray-scale imaging than does subjective quantitation by the ultrasound examiner using 2D power Doppler ultrasound.

Diagnosis, Differential↗
PubMed2006

The extent of endosonographic anal sphincter defects after primary repair of obstetric sphincter tears increases over time and is related to anal incontinence.

OBJECTIVE: To describe and classify endosonographic obstetric sphincter defects at 1 week, 3 months and 1 year after primary repair, and to relate the endosonographic results to anal sphincter pressure and to symptoms of anal incontinence over time. METHODS: Forty-one women who had suffered a third- or fourth-degree perineal tear at delivery underwent anal endosonography and anal manometry 1 week, 3 months and 1 year after primary suture of the tear. The extent of the endosonographic defects was described using defect scores ranging from 0 (no defect) to 16 (maximal defect), the score taking into account the location and the longitudinal and circumferential extent of the defect. The women answered a questionnaire with regard to bowel function 1 and 4 years after delivery, the degree of incontinence being expressed as a Wexner score. RESULTS: Some 90% (37/41) of the women had endosonographic defects at 1 week, 3 months and 1 year. The endosonographic defect scores increased significantly between the first and second examinations and then remained unchanged. At 1 year there was a negative correlation between endosonographic sphincter defect score and sphincter pressure. At 1 and 4 years, 54% (22/41) and 61% (25/41) of the women, respectively, had a Wexner score >/= 1. There was a positive correlation between the endosonographic sphincter defect score at 1 week, 3 months and 1 year and the Wexner incontinence score at 1 and 4 years. The endosonographic sphincter defect score at 1 week was the variable that was most predictive of the Wexner score at 4 years (r = 0.48, P = 0.002). CONCLUSION: The higher the endosonographic sphincter defect score after primary repair of an obstetric sphincter tear the lower the sphincter pressure and the higher the risk of anal incontinence.

Adult↗
PubMed2006

Reference data representative of normal findings at two-dimensional and three-dimensional gray-scale ultrasound examination of the cervix from 17 to 41 weeks' gestation.

OBJECTIVES: To create reference values representative of normal findings on two-dimensional (2D) and three-dimensional (3D) transvaginal ultrasound (TVS) examination of the cervix from 17 to 41 weeks' gestation and to determine the agreement between cervical measurements taken by 2D and 3D TVS. METHODS: Cross-sectional study covering 17 to 41 weeks in 419 nulliparous and 360 parous women who delivered at term and who underwent 2D and 3D TVS examination of the uterine cervix. We examined approximately 25 women in each gestational week. The length, anteroposterior (AP) diameter and width of the cervix (and of any cervical funnel) and AP diameter of the cervical canal were measured. Results were plotted against gestational age. The agreement between 2D and 3D ultrasound results was expressed as the mean (+/- 2 SDs) difference between the results of the two methods and as the interclass correlation coefficient (inter-CC). RESULTS: There was excellent agreement between measurements taken by 2D and 3D ultrasound (inter-CC values, 0.80-0.98) but measurements of cervical length taken using 3D ultrasound were greater than measurements taken by 2D ultrasound (mean difference, -0.04 +/- 0.36 cm). Cervical length did not change substantially between 17 and 32 gestational weeks but decreased progressively thereafter. Cervical length was similar in nulliparous and parous women at 17-32 weeks, but from 33 weeks the cervix tended to be longer in parous women. In nulliparae, cervical length decreased from a median of 3.8 (range, 0.7-6.1) cm at 17-32 weeks to 2.3 (range, 0.4-6.0) cm at 33-40 weeks and to 0.7 (range, 0.2-1.5) cm at 41 weeks. In parous women, the corresponding figures were 3.9 (range, 1.0-6.1) cm, 3.0 (range, 0.4-5.7) cm and 0.8 (range, 0.4-3.4) cm (results obtained by 3D ultrasound). Cervical AP diameter and width did not differ between nulliparous and parous women. Median AP diameter increased from 3.0 (range, 2.0-4.6) cm at 17-30 weeks to 3.5 (range, 1.8-5.5) cm at 31-40 weeks and to 4.0 (range, 2.8-5.9) cm at 41 weeks. Cervical width was 3.7 (range, 2.3-6.0) cm at 17-30 weeks and 4.5 (range, 2.3-6.1) cm at 31-41 weeks. The percentage of women with funneling increased from 4% (3/84) at 17-18 weeks to 63% (12/19) at 41 weeks and the percentage of women with an open cervical canal increased from 19% (15/84) to 72% (13/19). Funneling and opening of the cervical canal were equally common in nulliparous and parous women. CONCLUSIONS: Reference data provide the basis for studies of pathological conditions. Common reference values for nulliparous and parous women can be used for cervical AP diameter and width from 17 to 41 weeks and for cervical length from 17 to 32 weeks. Separate reference values for cervical length for nulliparous and parous women should be used from 33 to 41 weeks.

Adult↗
PubMed2006

Which extrauterine pelvic masses are difficult to correctly classify as benign or malignant on the basis of ultrasound findings and is there a way of making a correct diagnosis?

OBJECTIVES: To determine which extrauterine pelvic masses are difficult to correctly classify as benign or malignant on the basis of ultrasound findings, and to determine if the use of logistic regression models for calculation of individual risk of malignancy would improve the diagnostic accuracy in difficult tumors. METHODS: In a prospective, international, European multicenter study involving nine centers, 1066 women with a pelvic mass judged to be of extrauterine origin underwent transvaginal ultrasound examination by an experienced ultrasound examiner before surgery. A standardized examination technique and predefined definitions of ultrasound characteristics were used. On the basis of subjective evaluation of ultrasound findings, the examiner classified each mass as being certainly benign, probably benign, unclassifiable, probably malignant or certainly malignant. Even when the examiner found the mass unclassifiable (i.e. difficult mass) he or she was obliged to state whether the mass was more likely to be benign or malignant. Borderline tumors were classified as malignant. RESULTS: There were 90 (8%) unclassifiable masses. Multiple logistic regression analysis showed papillary projections, >10 locules in a cyst without solid components, low-level echogenicity of cyst fluid, and moderate vascularization as assessed subjectively at color Doppler examination to be ultrasound variables independently associated with unclassifiable mass. Borderline malignant tumors (n = 55) proved to be most difficult to assess with only 47% being correctly classified (i.e. classified as malignant), 29% being incorrectly classified (i.e. classified as benign) and 24% being unclassifiable vs. 90% of non-borderline tumors being correctly classified, 3% being incorrectly classified and 8% being unclassifiable (P < 0.0001). Papillary cystadeno(fibro)mas, myomas and cases of struma ovarii were also more common among the unclassifiable masses than among the classifiable ones (5.6% vs. 1.1%, P = 0.008; 4.4% vs. 0.9%, P = 0.02; 4.4% vs. 0.2%, P = 0.0006). No ultrasound variable or clinical variable (including CA 125) entered a logistic regression model to predict malignancy in difficult masses. A model could be constructed for difficult masses containing papillary projections but this model performed no better than subjective evaluation of the ultrasound image. Sensitivity and specificity of subjective evaluation with regard to malignancy in the group of unclassifiable masses were 56% (14/25) and 77% (50/65) vs. 91% (220/241) and 97% (712/735) in the classifiable masses. CONCLUSIONS: Borderline tumors cause great diagnostic difficulties, but so do papillary cystadeno(fibro)mas, struma ovarii and some myomas. Logistic regression models do not solve the diagnostic problem in difficult pelvic masses.

Adnexa Uteri↗
PubMed2006

Assessment of changes in endometrial and subendometrial volume and vascularity during the normal menstrual cycle using three-dimensional power Doppler ultrasound.

OBJECTIVES: To describe changes in endometrial and subendometrial volume and vascularity during the normal menstrual cycle using three-dimensional (3D) power Doppler ultrasonography. METHODS: Fourteen healthy volunteers, 24-44 years old with regular menstrual cycles, underwent serial transvaginal 3D power Doppler ultrasound examinations of the uterus on cycle day 2, 3 or 4, then daily from cycle day 9 until follicular rupture and 1, 2, 5, 7 and 12 days after follicular rupture. Endometrial and subendometrial volume (cm3), vascularization index (VI), flow index (FI) and vascularization flow index (VFI) were calculated using the VOCAL (Virtual Organ Computer-aided AnaLysis) software. RESULTS: Endometrial and subendometrial vascularity indices increased throughout the follicular phase, decreased to a nadir 2 days after follicular rupture and then increased again during the luteal phase. Endometrial and subendometrial volume increased rapidly during the follicular phase and then remained almost unchanged during the luteal phase. CONCLUSIONS: Substantial changes occur in endometrial volume and vascularization during the normal menstrual cycle. There is the potential for 3D power Doppler ultrasonography to become a useful tool for assessing pathological changes associated with female subfertility and abnormal uterine bleeding.

Adult↗
PubMed2006

Bishop score and ultrasound assessment of the cervix for prediction of time to onset of labor and time to delivery in prolonged pregnancy.

OBJECTIVES: To determine the ability of Bishop score and sonographic cervical length to predict time to spontaneous onset of labor and time to delivery in prolonged pregnancy. METHODS: Ninety-seven women underwent transvaginal ultrasound examination and palpation of the cervix at 291-296 days' gestation according to ultrasound fetometry at 12-20 weeks' gestation. Sonographic cervical length and Bishop score were recorded. Multivariate logistic regression analysis was used to determine which variables were independent predictors of the onset of labor/delivery < or = 24 h, < or = 48 h, and < or = 96 h. Receiver-operating characteristics (ROC) curves were drawn to assess diagnostic performance. RESULTS: In nulliparous women (n = 45), both Bishop score and sonographic cervical length predicted the onset of labor/delivery < or = 24 h and < or = 48 h (area under ROC curve for the onset of labor < or = 24 h 0.79 vs. 0.80, P = 0.94; for delivery < or = 24 h 0.81 vs. 0.85, P = 0.64; for the onset of labor < or = 48 h 0.73 vs. 0.74, P = 0.90; for delivery < or = 48 h 0.77 vs. 0.71, P = 0.50). Only Bishop score discriminated between nulliparous women who went into labor/delivered < or = 96 h or > 96 h. A logistic regression model including Bishop score and cervical length was superior to Bishop score alone in predicting delivery < or = 24 h (area under ROC curve 0.93 vs. 0.81, P = 0.03) and superior to Bishop score alone and cervical length alone in predicting the onset of labor < or = 24 h (area under ROC curve 0.90 vs. 0.79, P = 0.06; and 0.90 vs. 0.80, P = 0.06). In parous women (n = 52), Bishop score and sonographic cervical length predicted the onset of labor/delivery < or = 24 h (area under ROC curve for the onset of labor 0.75 vs. 0.69, P = 0.49; for delivery 0.74 vs. 0.70, P = 0.62), but only Bishop score discriminated between women who went into labor/delivered < or = 48 h and > 48 h. Three parous women had not gone into labor and six had not given birth at 96 h. In parous women logistic regression models including both Bishop score and cervical length did not substantially improve prediction of the time to onset of labor/delivery. CONCLUSIONS: In prolonged pregnancy Bishop score and sonographic cervical length have a similar ability to predict the time to the onset of labor and delivery. In nulliparous women the use of logistic regression models including Bishop score and cervical length is likely to offer better prediction of the onset of labor/delivery < or = 24 h than the use of the Bishop score alone.

Adolescent↗
PubMed2006

Gray-scale ultrasound morphology in the presence or absence of intrauterine fluid and vascularity as assessed by color Doppler for discrimination between benign and malignant endometrium in women with postmenopausal bleeding.

OBJECTIVE: To determine if gray-scale ultrasound morphology in the presence or absence of intrauterine fluid and endometrial vascular morphology as assessed by color Doppler ultrasonography can discriminate between benign and malignant endometrium in women with postmenopausal bleeding. METHODS: In a prospective study 95 consecutive women with postmenopausal bleeding and endometrial thickness > or = 4.5 mm as measured by transvaginal ultrasound were included. Gray-scale and color Doppler ultrasound examination of the endometrium was performed. The ultrasound examiner characterized the morphology of the endometrium before and during saline infusion and assessed the endometrial vascular tree using a predetermined classification protocol without suggesting a diagnosis. A histopathological diagnosis was obtained by operative hysteroscopy, dilatation and curettage or hysterectomy. RESULTS: There were no statistically significant differences in ultrasound findings between benign and malignant endometria of uterine cavities without fluid. Heterogeneous echogenicity, irregular surface, and both heterogeneous echogenicity and irregular surface of a focal lesion (or of the endometrium in the absence of focal lesions) in a uterine cavity filled with fluid (spontaneous or infused) were significantly more common in malignant than in benign endometrium. The sensitivity, false positive rate, positive and negative likelihood ratios of these findings were as follows: heterogeneous echogenicity, 80%, 29%, 2.74, 0.28, P = 0.003; irregular surface, 89%, 33%, 2.70, 0.17, P = 0.002; and both, 78%, 12%, 6.59, 0.25, P < 0.001. Two or more vessels were found in 67% (8/12) of the malignant endometria vs. 51% (40/79) of the benign endometria (non-significant difference). Vascular branching tended to be more common in malignant endometria (10/11; 91%) than in benign endometria (39/61; 64%), P = 0.09. CONCLUSION: Heterogeneous echogenicity and an irregular surface of a focal lesion or of the endometrium in a fluid-filled uterine cavity are useful ultrasound criteria for predicting endometrial malignancy. Assessment of vascular morphology using color Doppler ultrasound is of limited--if any--value for discrimination between benign and malignant endometrium.

Adult↗
PubMed2006

Is measurement of nuchal translucency thickness a useful screening tool for heart defects? A study of 16,383 fetuses.

OBJECTIVE: To determine the performance of nuchal translucency thickness (NT) measurement as a screening method for congenital heart defects (CHD) among fetuses with normal karyotype. METHODS: An NT measurement was made in 16 383 consecutive euploid fetuses derived from an unselected pregnant population. The cut-offs for increased risk of heart defects, chosen a priori and tested prospectively, were: NT >or= 95th centile for crown-rump length, NT >or= 3 mm, and NT >or= 3.5 mm. The sensitivity and false-positive rate (FPR; 1 minus specificity) of the risk cut-offs and their positive and negative likelihood ratios (+LR and -LR) with regard to CHD were calculated. RESULTS: Among the 16 383 fetuses with an NT measurement there were 127 cases with a diagnosis of heart defect confirmed by cardiac investigations after birth or at autopsy. Of these, 55 defects were defined as major, of which 52 were isolated (no other defects or chromosomal aberrations), corresponding to a prevalence of major heart defects in chromosomally normal fetuses/newborns of 3.3/1000. The sensitivity, FPR, +LR and -LR for NT >or= 95th centile with regard to an isolated major heart defect were: 13.5%, 2.6%, 5.2 and 0.9, respectively. For NT >or= 3.0 mm these values were: 9.6%, 0.8%, 12.0 and 0.9, and for NT >or= 3.5 mm they were: 5.8%, 0.3%, 19.3 and 0.9. CONCLUSIONS: NT measurement is a poor screening method for isolated major CHD. A method with a much higher detection rate and with a reasonably low FPR is needed. However, increased NT indicates increased risk of fetal heart defect, and women carrying fetuses with increased NT should be offered fetal echocardiography in the second trimester.

Epidemiologic Methods↗
PubMed2006

Three-dimensional ultrasound assessment of the cervix for predicting time to spontaneous onset of labor and time to delivery in prolonged pregnancy.

OBJECTIVES: To determine whether three-dimensional (3D) ultrasound including power Doppler examination of the cervix is useful for predicting time to spontaneous onset of labor or time to delivery in prolonged pregnancy. METHODS: A prospective study was conducted in 60 women who went into spontaneous labor. All underwent transvaginal 3D power Doppler ultrasound examination of the cervix immediately before a prolonged-pregnancy check-up at > or = 41 + 5 gestational weeks. Univariate and multivariate logistic regression analysis was used to determine which of the following variables predicted spontaneous onset of labor > 24 h and > 48 h and vaginal delivery > 48 h and > 60 h: length, anteroposterior (AP) diameter and width of the cervix and of any cervical funneling; cervical volume (cm3); vascularization index (VI); flow index (FI); vascularization flow index (VFI); parity; and Bishop score. Multivariate logistic regression analysis was carried out both with and without Bishop score as a predictive variable. Receiver-operating characteristics (ROC) curves were used to describe the diagnostic performance of the tests. RESULTS: The areas under the ROC curves for Bishop score, cervical length, and logistic regression models did not differ significantly (areas ranging from 0.72 to 0.82). If Bishop score was not included in the logistic regression model, cervical length, VI and FI independently predicted delivery > 48 h, the likelihood increasing with increasing cervical length, decreasing VI and increasing FI. CONCLUSIONS: In prolonged pregnancy cervical vascularization as estimated by 3D power Doppler ultrasound is related to time to delivery > 48 h, but the likelihood of delivery > 48 h can be predicted equally well using Bishop score alone or sonographic cervical length alone.

Adult↗
PubMed2006

Reference data representative of normal findings at three-dimensional power Doppler ultrasound examination of the cervix from 17 to 41 gestational weeks.

OBJECTIVES: To develop normal reference ranges for cervical volume and vascular indices using three-dimensional (3D) power Doppler ultrasonography from 17 to 41 gestational weeks. METHODS: This was a cross-sectional study of 352 nulliparous and 291 parous women who delivered at term and underwent transvaginal 3D power Doppler ultrasound examination of the cervix once at 17 to 41 weeks' gestation. We examined approximately 25 women in each gestational week. Cervical volume, vascularization index (VI), flow index (FI) and vascularization flow index (VFI) were calculated. RESULTS: There was no change in cervical volume between 17 and 40 weeks' gestation. At 41 weeks cervical volume was slightly smaller than it was at 17-40 weeks (P=0.03 for nulliparous women and P=0.08 for parous women). The cervical volume was larger in parous than it was in nulliparous women (median 38 cm3 vs. 32 cm3 at 17-40 weeks, P<0.0001; median 31 cm3 vs. 22 cm3 at 41 gestational weeks, P=0.288). FI did not differ between nulliparous and parous women and remained unchanged between 17 and 41 weeks' gestation (median 30.6, range 21.2-55.2). VI and VFI did not change consistently from 17 to 41 weeks, but the values were higher in parous than they were in nulliparous women at 17-30 weeks (median VI 5.3% vs. 3.1%, P<0.0001; median VFI 1.6 vs. 0.9, P<0.0001). At 31-41 gestational weeks the median VI for all women irrespective of parity was 4.9% and the median VFI was 1.4. CONCLUSION: Reference values for cervical volume and blood flow indices as assessed by 3D power Doppler ultrasonography have been established for the second half of pregnancy. These lay the basis for studies of pathological conditions.

Adolescent↗
PubMed2006

Routine ultrasound examination at 12 or 18 gestational weeks for prenatal detection of major congenital heart malformations? A randomised controlled trial comprising 36,299 fetuses.

OBJECTIVE: To compare the rate of prenatal diagnosis of heart malformations between two policies of screening for heart malformations. DESIGN: Randomised controlled trial. SETTING: Six university hospitals, two district general hospitals. SAMPLE: A total of 39 572 unselected pregnancies randomised to either policy. METHODS: The 12-week policy implied one routine scan at 12 weeks including measurement of nuchal translucency (NT), and the 18-week policy implied one routine scan at 18 weeks. Fetal anatomy was scrutinised using the same check-list in both groups, and in both groups, indications for fetal echocardiography were ultrasound findings of any fetal anomaly, including abnormal four-chamber view, or other risk factors for heart malformation. In the 12-week scan group, NT >or=3.5 mm was also an indication for fetal echocardiography. MAIN OUTCOME MEASURE: Prenatal diagnosis of major congenital heart malformation. RESULTS: In the 12-week scan group, 7 (11%) of 61 major heart malformations were prenatally diagnosed versus 9 (15%) of 60 in the 18-week scan group (P= 0.60). In four (6.6%) women in the 12-week scan group, the routine scan was the starting point for investigations resulting in a prenatal diagnosis versus in 9 (15%) women in the 18-week scan group (P=0.15). The diagnosis was made <or=22 weeks in 5% (3/61) of the cases in the 12-week scan group versus in 15% (9/60) in the 18-week scan group (P=0.08). CONCLUSIONS: The prenatal detection rate of major heart malformations was low with both policies. The 18-week scan policy seemed to be superior to the 12-week scan policy, although the differences in prenatal detection rates were not statistically significant.

Female↗
PubMed2006

Detection of malformations in chromosomally normal fetuses by routine ultrasound at 12 or 18 weeks of gestation-a randomised controlled trial in 39,572 pregnancies.

OBJECTIVE: To compare the antenatal detection rate of malformations in chromosomally normal fetuses between a strategy of offering one routine ultrasound examination at 12 gestational weeks (gws) and a strategy of offering one routine examination at 18 gws. DESIGN: Randomised controlled trial. SETTING: Multicentre trial including eight hospitals. POPULATION: A total of 39,572 unselected pregnant women. METHODS: Women were randomised either to one routine ultrasound scan at 12 (12-14) gws including nuchal translucency (NT) measurement or to one routine scan at 18 (15-22) gws. Anomaly screening was performed in both groups following a check-list. A repeat scan was offered in the 12-week scan group if the fetal anatomy could not be adequately seen at 12-14 gws or if NT was >or=3.5 mm in a fetus with normal or unknown chromosomes. MAIN OUTCOME MEASURES: Antenatal detection rate of malformed fetuses. RESULTS: The antenatal detection rate of fetuses with a major malformation was 38% (66/176) in the 12-week scan group and 47% (72/152) in the 18-week scan group (P= 0.06). The corresponding figures for detection at <22 gws were 30% (53/176) and 40% (61/152) (P= 0.07). In the 12-week scan group, 69% of fetuses with a lethal anomaly were detected at a scan at 12-14 gws. CONCLUSIONS: None of the two strategies for prenatal diagnosis is clearly superior to the other. The 12-week strategy has the advantage that most lethal malformations will be detected at <15 gws, enabling earlier pregnancy termination. The 18-week strategy seems to be associated with a slightly higher detection rate of major malformations, although the difference was not statistically significant.

Congenital Abnormalities↗
PubMed2005

Endosonography of the anal sphincter in women of different ages and parity.

OBJECTIVES: To obtain reference data representative of normal findings at anal endosonography in pregnant and non-pregnant women. To determine intraobserver and interobserver agreement in the detection of endosonographic anal sphincter defects in asymptomatic women. METHODS: Twenty-five non-pregnant nulliparous women and 25 non-pregnant parous women (age range, 20-67 years) and 47 pregnant women (age range, 21-39 years) underwent anal manometry and anal endosonography. The endosonographic internal and external sphincter thickness and sphincter length were measured online. Endosonographic sphincter defects were measured and classified offline from videotapes by two independent examiners using an endosonographic defect score ranging from 0 (no defect) to 16 (maximal defect), the score taking into account the location and the longitudinal and circumferential extension of the defect. RESULTS: Endosonographic sphincter thickness and length did not differ between non-pregnant nulliparous and parous women and did not change substantially with age. The anal sphincter was thicker and the anal resting pressure area and manometric sphincter length were greater in pregnant than in non-pregnant women of the same age (20-39 years). There was good intra- and interobserver agreement with regard to detection of endosonographic anal sphincter defects (kappa > or = 0.70). Eighteen (19%) women had endosonographic sphincter defects but in only four (4%; 4/97) cases were they moderate or large (defect score, 7-10). Ten (20%) of the non-pregnant women reported minor gas incontinence and one reported minor incontinence for both gas and liquid stool. The frequency of incontinence did not differ between women with and without sphincter defects. CONCLUSIONS: Reference data representative of normal findings at anal endosonography have been established for non-pregnant women and for nulliparous women in the third trimester of pregnancy. Small endosonographic sphincter defects and minor gas incontinence are common in women without known sphincter trauma. They seem to be unrelated to each other and may be regarded as normal variants.

Adult↗
PubMed2005

Intraobserver and interobserver reproducibility of three-dimensional gray-scale and power Doppler ultrasound examinations of the cervix in pregnant women.

OBJECTIVES: To determine intraobserver and interobserver reproducibility of three-dimensional (3D) gray-scale and power Doppler ultrasound examinations of the cervix in pregnant women. METHODS: Thirty-two pregnant women underwent transvaginal 3D gray-scale and power Doppler ultrasound examination of the cervix by two examiners. Each observer acquired two volumes, and they each analyzed their volumes twice using the commercially available software Virtual Organ Computer-aided AnaLysis (VOCAL). The variables analyzed were cervical volume (cm3), vascularization index (VI), flow index (FI) and vascularization flow index (VFI). Intraobserver repeatability was expressed as the difference between two measurement results (mean difference +/- 2 SD, i.e. limits of agreement) and as intraclass correlation coefficient (intra-CC). Interobserver agreement was expressed as the difference between the results of the two observers (limits of agreement) and as interclass correlation coefficient (inter-CC). The contribution of various factors (examiner, acquisition, analysis of acquired volume) to intrasubject variance was estimated using different analysis of variance models. All statistical analyses were performed using log-transformed data. The results presented are those obtained after antilogarithmic transformation, i.e. the results are presented as ratios between two results of the same observer, or as ratios between the results of Observer 1 and Observer 2. RESULTS: All intraobserver and interobserver log-transformed differences were normally distributed. There was no systematic bias between the two observers. Both intra- and inter-CC values were high (0.93-0.98) for all variables except FI (0.63-0.88), despite the limits of agreement being wide, especially for VI (widest range 0.4-2.4) and VFI (widest range 0.3-2.6). Acquisition explained most of the intrasubject variance of the flow indices, the contribution of examiner and analysis being unimportant. CONCLUSIONS: Given the wide range between the lower and upper limits of agreement, it would probably not be possible to detect anything but large differences or changes in cervical volume or cervical flow indices using current 3D ultrasound techniques. Because acquisition explained most of the intrasubject variance, the average of several repeated acquisitions should be used to enhance reproducibility. However, it is not worth doing more than one analysis of an acquired volume, because the effect of analysis on measurement results is small.

Adult↗
PubMed2005

Screening for Down syndrome based on maternal age or fetal nuchal translucency: a randomized controlled trial in 39,572 pregnancies.

OBJECTIVES: Nuchal translucency (NT) screening increases antenatal detection of Down syndrome (DS) compared to maternal age-based screening. We wanted to determine if a change in policy for prenatal diagnosis would result in fewer babies born with DS. METHODS: A total of 39,572 pregnant women were randomized to a scan at 12-14 gestational weeks including NT screening for DS (12-week group) or to a scan at 15-20 weeks with screening for DS based on maternal age (18-week group). Fetal karyotyping was offered if risk according to NT was > or = 1:250 in the 12-week group and if maternal age was > or = 35 years in the 18-week group. Both policies included the offer of karyotyping in cases of fetal anomaly detected at any scan during pregnancy or when there was a history of fetal chromosomal anomaly. The number of babies born with DS and the number of invasive tests for fetal karyotyping were compared. RESULTS: Ten babies with DS were born alive with the 12-week policy vs. 16 with the 18-week policy (P = 0.25). More fetuses with DS were spontaneously lost or terminated in the 12-week group (45/19,796) than in the 18-week group (27/19 776; P = 0.04). All women except one with an antenatal diagnosis of DS at < 22 weeks terminated the pregnancy. For each case of DS detected at < 22 weeks in a living fetus there were 16 invasive tests in the 12-week group vs. 89 in the 18-week group. NT screening detected 71% of cases of DS for a 3.5% test-positive rate whereas maternal age had the potential of detecting 58% for a test-positive rate of 18%. CONCLUSIONS: The number of newborns with DS differed less than expected between pregnancies that had been screened at 12-14 weeks' gestation by NT compared with those screened at 15-20 weeks by maternal age. One explanation could be that NT screening--because it is performed early in pregnancy--results in the detection and termination of many pregnancies with a fetus with DS that would have resulted in miscarriage without intervention, and also by many cases of DS being detected because of a fetal anomaly seen on an 18-week scan. The major advantage of the 12-week scan policy is that many fewer invasive tests for fetal karyotyping are needed per antenatally detected case of DS.

Adult↗
PubMed2005

Ultrasound dating at 12-14 weeks of gestation. A prospective cross-validation of established dating formulae in in-vitro fertilized pregnancies.

OBJECTIVES: To determine the accuracy of established ultrasound dating formulae when used at 12-14 weeks of gestation. METHODS: One-hundred and sixty-seven singleton pregnancies conceived after in-vitro fertilization (IVF) underwent a dating scan at 12-14 weeks of gestation. Gestational age at the dating scan was calculated by adding 14 days to the number of days between the date of oocyte retrieval and the date of the ultrasound scan. Gestational age according to oocyte retrieval was regarded as the true gestational age. True gestational age was compared to gestational age calculated on the basis of 21 dating formulae based on fetal crown-rump length (CRL) measurements and to three dating formulae based on fetal biparietal diameter (BPD) measurements. In a previous study the three BPD formulae tested here had been shown to be superior to four other BPD formulae when used at 12-14 weeks of gestation. The mean of the differences between estimated and true gestational age and their standard deviation (SD) were calculated for each formula. The SD of the differences was assumed to reflect random measurement error. Systematic measurement error was assumed to exist if zero lay outside the mean difference+/-2SE (SE: standard error of the mean). RESULTS: The three best CRL formulae were associated with mean (non-systematic) measurement errors of -0.0, -0.1 and -0.3 days, and the SD of the measurement errors of these formulae varied from 2.37 to 2.45. All but two of the remaining CRL formulae were associated with systematic over- or under-estimation of gestational age, and the SDs of their measurement error varied between 2.25 and 4.86 days. Dating formulae using BPD systematically underestimated gestational age by -0.4 to -0.7 days, and the SDs of their measurement errors varied from 1.86 to 2.09. CONCLUSIONS: We have identified three BPD formulae that are suitable for dating at 12-14 weeks of gestation. They are superior to all 21 CRL formulae tested here, because their random measurement errors were much smaller than those of the three best CRL formulae. The small systematic negative measurement errors associated with the BPD formulae are likely to be clinically unimportant.

Algorithms↗