Mobile Self-Operated Home Ultrasound System for Remote Fetal Assessment During Pregnancy.

Background: Mobile medical devices for self-patient use are a rapidly evolving section of telehealth. We examined the INSTINCT® ultrasound system, a portable, self-operated ultrasound device attached to a commercial smartphone for remote fetal assessment. We aimed to evaluate whether it is feasible to use remote fetal assessment during pregnancy. Materials and Methods: This is an observational noninterventional trial. We included women with a singleton fetus at 14 + 0 to 39 + 6 gestational weeks. Each participant received the device for a self-use period of 7-14 days and was instructed to perform one to three scans a day. Participants completed a self-assessment questionnaire to evaluate safety and usability (i.e., user experience and satisfaction). Each scan was evaluated for fetal heart activity, amniotic fluid volume, fetal tone, fetal body, and breathing movements. Results: One hundred women, completing 1,360 self scans, used the device for 8.1 ± 1.5 days, performing an average of 13.6 ± 6.2 scans each. There were no device-related serious adverse events. Success in detection was 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 92.2% for normal amniotic fluid volume, and 23.8% for breathing movements. Interobserver agreement was 94.4% for fetal heart rate activity, 85.9% for body movements, 69.5% for fetal tone, 86.9% for amniotic fluid volume, and 94.0% for breathing movements. Self-assessed user experience was rated at 4.4/5, whereas device satisfaction was rated at 3.9/5. Conclusion: The INSTINCT ultrasound system is a feasible solution for remote sonographic fetal assessment. Further studies are needed to assess its role and impact in telehealth antenatal care and fetal surveillance.

Characterization of women with gestational diabetes who failed to achieve glycemic control by lifestyle modifications.

PURPOSE: To identify specific characteristics of women diagnosed with gestational diabetes who failed to achieve good glycemic control by lifestyle modifications only. METHODS: Retrospective analysis of women carrying a singleton pregnancy diagnosed with gestational diabetes. The cohort included 314 women who achieved good glycemic control by lifestyle modifications and 328 women who required anti-diabetic medications. Lifestyle modifications included medical nutrition therapy and physical exercise recommendations. Anti-diabetic medications included either oral treatment with metformin or glyburide and\or insulin. RESULTS: Women in the lifestyle modifications group were younger (32.87 vs. 33.79 years, p = 0.012) and had lower pre-pregnancy body-mass-index (25.86 vs. 27.93 kg/m2, p < 0.001). Glucose challenge test (GCT) was significantly lower in the lifestyle modifications group (158.31 vs. 171.04 mg/dL in the anti-diabetic treatment group, p < 0.001). Moreover, fasting oral-glucose-tolerance-test (fOGTT) results were significantly lower in the lifestyle modifications group (88.22 vs. 96.34 mg/dL in the anti-diabetic treatment group, p < 0.001). In a receiver-operator-curve analysis, GCT + 4*fOGTT, was the best model to predict lifestyle modifications failure with an area under the curve of 0.7419. Higher rates of vaginal delivery and lower rates of maternal hypoglycemia in the lifestyle modifications group were observed. CONCLUSIONS: Maternal baseline characteristics and diabetes diagnostic parameters may predict which women will fail to achieve good glycemic control solely by lifestyle modifications.

Pharmacological therapy in gestational diabetes - a comparison between insulin and oral therapy.

BACKGROUND: The appropriate medical treatment for gestational diabetes mellitus (GDM) is controversial and recommendations vary between different organizations. OBJECTIVE: To compare the safety and efficacy of glyburide and insulin as treatments for GDM. METHODS: Retrospective analysis of all pregnant women diagnosed with GDM and treated with either glyburide or insulin. Demographic features, clinical characteristics, maternal and neonatal outcomes were compared according to type of pharmacological treatment. RESULTS: Included in the study were 323 women, of whom 269 (83.28%) were treated with glyburide and 54 (16.72%) with insulin. There were no significant differences between the groups, apart from a higher one-hour oral glucose tolerance test (OGTT) value (191.80 mg/dl in the glyburide group, 204.33 in the insulin group, p = .01). Optimal glucose control was achieved in 130 women in the glyburide group (48.32%) and 15 in the insulin group (27.77%), p = .007. This difference remained significant after adjustment for age, BMI, and fasting glucose during OGTT (aOR = 2.22). Mean gestational weight gain was lower in the glyburide group vs. insulin group (10.01 vs. 11.99 kg, p = .048). Apart from higher maternal hypoglycemia rate (12.64% in glyburide group vs. 1.85% in insulin group, p = .016), there were no other differences in maternal and neonatal outcomes between the groups. Glyburide failure rate was 13.38%, and associated with higher fasting OGTT value (100.70 mg/dl in glyburide failure group vs. 94.67 mg/dl in the glyburide treatment until delivery group, p = .041). CONCLUSIONS: Glyburide is at least as safe and effective as insulin except for higher rates of maternal hypoglycemia. Considering its advantages compared to insulin (ease of use and storage, increased patient responsiveness, and lower cost), it may be considered as first line treatment in GDM, especially when fasting OGTT value is not high.

Surgically treated ovarian endometriosis association with BRCA1 and BRCA2 mutations.

Endometriosis is associated with an increased risk of ovarian cancer. Few studies have also shown increased risk of breast cancer. BRCA1/2 mutations are linked to an increased risk of breast and ovarian cancers but their relation to endometriosis is unknown. The objective of this study was to examine the mutation rate of BRCA1/2 among women with surgically treated ovarian endometriosis. We collected 126 specimens from Jewish Ashkenazi women with endometriotic (76) and control non-endometriotic (50) ovarian cysts, reviewed the pathological diagnoses and extracted DNA from all samples. Using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), samples were examined for the founder germline mutations of BRCA1/2, most common among Ashkenazi Jews. The rate of mutations in each group was calculated and compared. BRCA1/2 mutation rate was 1/76 (1.3%) in the endometriotic cyst study group and 1/50 (2%) in the control non-endometriotic cysts, showing no statistically significant difference between the groups (p=0.84). BRCA1/2 mutation rate was similar to the previously reported rate among Jewish Ashkenazi women. BRCA1/2 mutation rates in patients with endometriotic ovarian cysts and with non-endometriotic ovarian cysts are similar. A larger cohort is required to completely exclude the possibility of an association between BRCA1/2 mutations and surgically treated endometriosis.