Objectives. To investigate the best time of examination and section chosen of routine prenatal ultrasound screening for external ear abnormalities and evaluate the feasibility of examining the fetal external ear with ultrasonography. Methods. From July 2010 until August 2011, 42118 pregnant women with single fetus during 16–40 weeks of pregnancy were enrolled in the study. Fetal auricles and external auditory canal in the second trimester of pregnancy were evaluated by routine color Doppler ultrasound screening and systematic screening. Ultrasound images of fetal external ears were obtained on transverse-incline view at cervical vertebra level and mandible level and on parasagittal view and coronal view at external ear level. Results. Five fetuses had anomalous ears including bilateral malformed auricles with malformed external auditory canal, unilateral deformed external ear, and unilateral microtia. The detection rate of both auricles was negatively correlated with gestational age. Of the 5843 fetuses undergoing a routine ultrasound screening, 5797 (99.21%) had bilateral auricles. Of the 4955 fetuses following systematic screening, all fetuses (100%) had bilateral auricles. The best time for fetal auricles observation with ultrasonography is 20–24 weeks of pregnancy. Conclusions. Detection of external ear abnormalities may assist in the diagnosis of chromosomal abnormalities.
Purpose To determine the association between levator avulsion and urinary stress incontinence (USI) by 3/4D transperineal ultrasound. Materials and Methods 842 patients who were admitted to our hospital from 2016 to 2019 were recruited for our study. 3D/4D transperineal ultrasound was performed. After standard interview and clinical evaluation, general conditions and levator hiatus data were collected and measured to compare with each group. The odds ratio (OR) of USI symptoms or ultrasound features with levator avulsion were calculated. Results A total of 593 women were studied: 204 suffered from levator avulsion (96 cases of left-side avulsion, 80 cases of right-side avulsion and 28 cases of bilateral avulsion) and 389 women had no avulsion. The gravidity and episiotomy conditions of the avulsion groups were significantly different from the no-avulsion group. Significant differences were found in the transverse diameters and anteroposterior diameters between the levator avulsion group and the no-avulsion group, but there was no difference among the avulsion groups, regardless of whether the patient was at rest or performing the Valsalva maneuver. Interestingly, a significant difference was found in the presence of USI symptoms between the uni-avulsion group and the no-avulsion group. The odds ratio (OR) of USI symptoms in the uni-avulsion group is 2.786 (95 %CI, 1.663–4.669), but 0.939 (95 %CI, 0.276–3.199) for the bilateral avulsion and no-avulsion groups. Conclusion Unilateral levator avulsion may be a risk factor for urinary stress incontinence.
Background Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric clinical trials conducted in China to provide reference for research and development of pediatric drugs and formulation of relevant policies. Methods We conducted a cross-sectional observational study of pediatric trials registered in the Drug Trial Registration and Information Publication Platform before Oct. 31, 2021. All trials that recruited children (under 18 years old as defined in China) were retrieved and general characteristics of the trials and the research drugs were extracted and analyzed. The data were extracted and statistically analyzed by excel 2010 and SPSS 22.0, respectively. Results There were 588 registered pediatric clinical trials, which accounted for 3.94% of the total registered trials. The overall average annual growth rate of the number of trials from 2013 to 2020 was 14.47% (P < 0.01). Of the 588 trials included, there were 312 trials (53.06%) with only children as subjects, 127 trials (21.60%) with research drugs only for children use, and the median of target subject number was 320 with the range of 8 to 600,000. The sponsors and the principal investigators were mainly located in the eastern and northern China. 325 trials were vaccine trials, and the dosage form was mainly injection. There were 98 non-vaccine biological product trials (mainly injections), 135 chemical compound drug trials (mainly tablets), 30 traditional Chinese medicine/natural drugs (mainly granules). Indications of the non-vaccine drugs were mainly diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Conclusion The number of pediatric clinical trials in China has increased these years. To further promote pediatric clinical trials and motivate pediatric appropriate drug marketing application and administrative approval, conducting large pediatric clinical trials, further development of dosage forms suitable for children with special attention to neonates and prematurity, and improving uneven geographical distribution of sponsors and researchers are the current challenges.
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