Nomograms of Iranian fetal middle cerebral artery Doppler waveforms and uniformity of their pattern with other populations' nomograms

<p>Abstract</p> <p>Background</p> <p>Doppler flow velocity waveform analysis of fetal vessels is one of the main methods for evaluating fetus health before labor. Doppler waves of middle cerebral artery (MCA) can predict most of the at risk fetuses in high risk pregnancies. In this study, we tried to obtain normal values and their nomograms during pregnancy for Doppler flow velocity indices of MCA in 20 – 40 weeks of normal pregnancies in Iranian population and compare their pattern with other countries' nomograms.</p> <p>Methods</p> <p>During present descriptive cross-sectional study, 1037 normal pregnant women with 20^th–40^thweek gestational age were underwent MCA Doppler study. All cases were studied by gray scale ultrasonography initially and Doppler of MCA afterward. Resistive Index (RI), Pulsative Index (PI), Systolic/Diastolic ratio (S/D ratio), and Peak Systolic Velocity (PSV) values of MCA were determined for all of the subjects.</p> <p>Results</p> <p>Results of present study showed that RI, PI, S/D ratio values of MCA decreased with parabolic pattern and PSV value increased with simple pattern, as gestational age progressed. These changes were statistically significant (P = 0.000 for all of indices) and more characteristic during late weeks of pregnancy.</p> <p>Conclusion</p> <p>Values of RI, PI and S/D ratio indices reduced toward the end of pregnancy, but PSV increased. Despite the trivial difference, nomograms of various Doppler indices in present study have similar pattern with other studies.</p

Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial

Background: Oral semaglutide is the first oral formulation of a glucagon-like peptide-1 (GLP-1) receptor agonist developed for the treatment of type 2 diabetes. We aimed to compare the efficacy and safety of flexible dose adjustments of oral semaglutide with sitagliptin 100 mg. Methods: In this 52-week, multicentre, randomised, open-label, phase 3a trial, we recruited patients with type 2 diabetes from 81 sites in ten countries. Patients were eligible if they were aged 18 years or older (19 years or older in South Korea), had type 2 diabetes (diagnosed ≥90 days before screening), HbA1c of 7·5–9·5% (58–80 mmol/mol), and were inadequately controlled on stable daily doses of one or two oral glucose-lowering drugs (for 90 days or more before screening). Participants were randomly assigned (1:1) by use of an interactive web-response system, stratified by background glucose-lowering medication at screening, to oral semaglutide with flexible dose adjustments to 3, 7, or 14 mg once daily or sitagliptin 100 mg once daily. To approximate treatment individualisation in clinical practice, oral semaglutide dose could be adjusted on the basis of prespecified HbA1c and tolerability criteria. Two efficacy-related estimands were prespecified: treatment policy (regardless of treatment discontinuation or use of rescue medication) and trial product (on treatment and without use of rescue medication) for participants randomly assigned to treatment. The primary endpoint was achievement of HbA1c of less than 7% (53 mmol/mol) at week 52 and the confirmatory secondary efficacy endpoint was change in bodyweight from baseline to week 52. Safety was assessed in all participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02849080, and European Clinical Trials Database, EudraCT number 2015-005593-38, and an open-label extension is ongoing. Findings: Between Sept 20, 2016, and Feb 7, 2017, of 804 patients assessed for eligibility, 504 were eligible and randomly assigned to oral semaglutide (n=253) or sitagliptin (n=251). Most participants were male (285 [57%] of 504) with a mean age of 57·4 years (SD 9·9). All participants were given at least one dose of their allocated study drug except for one participant in the sitagliptin group. From a mean baseline HbA1c of 8·3% (SD 0·6%; 67 mmol/mol [SD 6·4]), a greater proportion of participants achieved an HbA1c of less than 7% with oral semaglutide than did with sitagliptin (treatment policy estimand: 58% [134 of 230] vs 25% [60 of 238]; and trial product estimand: 63% [123 of 196] vs 28% [52 of 184]). The odds of achieving an HbA1c of less than 7% was significantly better with oral semaglutide than sitagliptin (treatment policy estimand: odds ratio [OR] 4·40, 95% CI 2·89–6·70, p&lt;0·0001; and trial product estimand: 5·54, 3·54–8·68, p&lt;0·0001). The odds of decreasing mean bodyweight from baseline to week 52 were higher with oral semaglutide than with sitagliptin (estimated mean change in bodyweight, treatment policy estimand: −2·6 kg [SE 0·3] vs −0·7 kg [SE 0·2], estimated treatment difference [ETD] −1·9 kg, 95% CI −2·6 to −1·2; p&lt;0·0001; and trial product estimand: −2·9 kg [SE 0·3] vs −0·8 kg [SE 0·3], ETD −2·2 kg, −2·9 to −1·5; p&lt;0·0001). Adverse events occurred in 197 (78%) of 253 participants in the oral semaglutide group versus 172 (69%) of 250 in the sitagliptin group, and nausea was the most common adverse event with oral semaglutide (53 [21%]). Two deaths occurred in the sitagliptin group during the trial. Interpretation: Oral semaglutide, with flexible dose adjustment, based on efficacy and tolerability, provided superior glycaemic control and weight loss compared with sitagliptin, and with a safety profile consistent with subcutaneous GLP-1 receptor agonists. Funding: Novo Nordisk A/S

Three-dimensional ultrasonography in the evaluation of the uterine cavity

Objective: To evaluate the use of three-dimensional transvaginal ultrasound (3D TVS) in the assessment of uterine cavity pathology and uterine congenital anomalies. Materials and methods: One hundred and twenty three patients were studied. All cases were subjected to 2D TVS, 3D TVS and hysterosalpingography (HSG). Hysteroscopy / Laparoscopy were done for all patients to whom ultrasound and radiology results were compared. Results: Out of 123 cases studied, 102 were found to have: a. uterine cavity anomalies (n=38, Group I), b. uterine myomas, and c. polyps (n=52, Group II) and intrauterine adhesions (n=12, Group III). In Group I, sensitivity, specificity and predictive values were higher for 3D TVS compared to 2D TVS or HSG but comparable to both techniques combined. Also, the positive and negative likelihood ratios were strong and comparable for 3D TVS and 2D TVS + HSG. In Group II, 3D TVS showed highest sensitivity, specificity and predictive values which were similar to 2D TVS + HSG but higher than each technique alone. In Group III, all tests showed low sensitivity and positive predictive value. The negative likelihood ratio was poor for all methods. Conclusions: The use of 3D TVS is a valuable non-invasive method for assessment of uterine cavity pathology and is more useful than HSG and 2D TVS combined in cases of uterine anomalies, submucous myomas and polyps. However, its value in the assessment of intrauterine adhesions is limited

Three Dimentional Transvaginal ultrasound in the assessment of uterine lesions: when do we really need it?

Objective: To evaluate the use of Transvaginal 3D U/S in the assessment of uterine pathology and uterine cavity abnormalities. Materials and methods: We included 65 patients in our study, age range between 21-47. The main complaint of these patients was either vaginal bleeding, reproductive failure, recurrent abortion or infertility. Procedures Done were: -2D TVS -3D TVS for all cases -HSG -Sonohysterography using saline - Hysteroscopy -Laparoscopy done only in uterine cavity abnormalities. Results:65 cases were examined by both Transvaginal 2Dand 3D U/S. 9 cases showed normal uterine cavity and no uterine pathology. Twenty nine cases had myomas either single or multiple. From the 29 cases, 8 cases had submucus myomas. There were 7 cases had endometrial polyps, 12 cases had thickened endometrium. 6 cases had uterine cavity anomalies (septate or bicornuate). Two cases had intrauterine adhesions. There were 4 cases (2 cases with Mullerian anomalies both were septate uterus and 2 cases with intrauterine adhesions) all were diagnosed by Transvaginal 3D U/S, while being missed by 2D U/S (4 false negative cases). 2 cases of endometrial polyps were missed by HSG and diagnosed by Transvaginal 3D U/S (-2 false negative cases). Transvaginal 3D U/S correlated well with HSG and hysteroscopy in the diagnosis of Mullerian anomalies however with an additional information concerning the visualization of the surrounding myometrium and the accurate differentiation between septate and Bicornuate uterus. Conclusion: TVS is an excellent tool that provides valuable information in investigating the uterine cavity abnormalities. 3D TVS allows surface and volume rendering that can produce photographic images. It is much advantageous than HSG and Hysteroscopy in the differentiation between different types of uterine anomalies. It is of great value in delineating with certain the exact position of the submucous myomas or endometrial polypi in relation to the cavity. It is believed that, in the near future, 3D U/S equipment will be less expensive, which will allow its wide spread application