Gestational diabetes is driven by microbiota-induced inflammation months before diagnosis.

OBJECTIVE: Gestational diabetes mellitus (GDM) is a condition in which women without diabetes are diagnosed with glucose intolerance during pregnancy, typically in the second or third trimester. Early diagnosis, along with a better understanding of its pathophysiology during the first trimester of pregnancy, may be effective in reducing incidence and associated short-term and long-term morbidities. DESIGN: We comprehensively profiled the gut microbiome, metabolome, inflammatory cytokines, nutrition and clinical records of 394 women during the first trimester of pregnancy, before GDM diagnosis. We then built a model that can predict GDM onset weeks before it is typically diagnosed. Further, we demonstrated the role of the microbiome in disease using faecal microbiota transplant (FMT) of first trimester samples from pregnant women across three unique cohorts. RESULTS: We found elevated levels of proinflammatory cytokines in women who later developed GDM, decreased faecal short-chain fatty acids and altered microbiome. We next confirmed that differences in GDM-associated microbial composition during the first trimester drove inflammation and insulin resistance more than 10 weeks prior to GDM diagnosis using FMT experiments. Following these observations, we used a machine learning approach to predict GDM based on first trimester clinical, microbial and inflammatory markers with high accuracy. CONCLUSION: GDM onset can be identified in the first trimester of pregnancy, earlier than currently accepted. Furthermore, the gut microbiome appears to play a role in inflammation-induced GDM pathogenesis, with interleukin-6 as a potential contributor to pathogenesis. Potential GDM markers, including microbiota, can serve as targets for early diagnostics and therapeutic intervention leading to prevention.

Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience.

PURPOSE: To provide a comprehensive report of the experience gained in the prenatal treatment of congenital diaphragmatic hernia (CDH) using fetoscopic endoluminal tracheal occlusion (FETO) following its implementation at a newly established specialized fetal medicine center. METHODS: Mothers of fetuses with severe CDH were offered prenatal treatment by FETO. RESULTS: Between 2018 and 2021, 16 cases of severe CDH underwent FETO. The median gestational age (GA) at balloon insertion was 28.4 weeks (IQR 27.8-28.6). The median GA at delivery was 37 weeks (IQR 34.4-37.8). The survival rate was 8/16 cases (50%). None of the survivors required home oxygen therapy at 6 months of age. Comparison between the survivors and deceased showed that survivors had balloon insertion 1 week earlier (27.8 vs. 28.4 weeks, p = 0.007), a higher amniotic fluid level change between pre- to post-FETO (3.4 vs 1.3, p = 0.024), a higher O/E LHR change between pre- to post-FETO (50.8 vs. 37.5, p = 0.047), and a GA at delivery that was 2 weeks later (37.6 vs. 35.4 weeks, p = 0.032). CONCLUSIONS: The survival rate at 6 months of age in cases of severe CDH treated with FETO in our center was 50%. Our new fetal medicine center matches the performance of other leading international centers.

Fetal congenital heart disease - mode of delivery and obstetrical complications.

BACKGROUND: The optimal mode of delivery in cases of fetal congenital heart disease (CHD) is not established. The few relevant studies did not address operative vaginal delivery. The aim of this study was to assess the impact of fetal CHD on mode of delivery during a trial of labor, and to secondarily describe some obstetric complications. METHODS: The database of a tertiary medical center was searched for women who gave birth to a singleton, liveborn neonate in 2015-2018. Mode of delivery was compared between women carrying a fetus with known CHD and women with a healthy fetus matched 1:5 for maternal age, parity, body mass index, and gestational age. RESULTS: The cohort included 616 women, 105 in the CHD group and 511 in the control group. The rate of operative vaginal delivery was significantly higher in the CHD group (18.09% vs 9.78%, OR 2.03, 95% CI 1.13-3.63, p = 0.01); the difference remained significant after adjustment for nulliparity and gestational age at delivery (aOR 2.58, 95% CI 1.36-4.9, p < 0.01). There was no difference between the CHD and control group in rate of intrapartum cesarean delivery (9.52% vs 10.76%, respectively, OR 0.97, 95% CI 0.47-1.98, p = 0.93). The most common indication for operative vaginal delivery was non-reassuring fetal heart rate (78.94% vs 64%, respectively). Median birth weight percentile was significantly lower in the CHD group (45th vs 53rd percentile, p = 0.04). CONCLUSIONS: Our findings suggest that operative vaginal delivery, performed mostly because of non-reassuring fetal heart rate, is more common in pregnancies complicated by a prenatal diagnosis of CHD than non-anomalous pregnancies.

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.

Modulation of cytokine patterns and microbiome during pregnancy in IBD.

OBJECTIVE: Pregnancy may affect the disease course of IBD. Both pregnancy and IBD are associated with altered immunology and intestinal microbiology. However, to what extent immunological and microbial profiles are affected by pregnancy in patients with IBD remains unclear. DESIGN: Faecal and serum samples were collected from 46 IBD patients (31 Crohn's disease (CD) and 15 UC) and 179 healthy controls during first, second and third trimester of pregnancy, and prepregnancy and postpartum for patients with IBD. Peripheral blood cytokine profiles were determined by ELISA, and microbiome analysis was performed by sequencing the V4 region of the bacterial 16S rRNA gene. RESULTS: Proinflammatory serum cytokine levels in patients with IBD decrease significantly on conception. Reduced interleukin (IL)-10 and IL-5 levels but increased IL-8 and interferon (IFN)γ levels compared with healthy controls were seen throughout pregnancy, but cytokine patterns remained stable during gestation. Microbial diversity in pregnant patients with IBD was reduced compared with that in healthy women, and significant differences existed between patients with UC and CD in early pregnancy. However, these microbial differences were no longer present during middle and late pregnancy. Dynamic modelling showed considerable interaction between cytokine and microbial composition. CONCLUSION: Serum proinflammatory cytokine levels markedly improve on conception in pregnant patients with IBD, and intestinal microbiome diversity of patients with IBD normalises during middle and late pregnancy. We thus conclude that pregnancy is safe and even potentially beneficial for patients with IBD.

Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia.

BACKGROUND: Preterm preeclampsia is an important cause of maternal and perinatal death and complications. It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of preterm preeclampsia. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1776 women with singleton pregnancies who were at high risk for preterm preeclampsia to receive aspirin, at a dose of 150 mg per day, or placebo from 11 to 14 weeks of gestation until 36 weeks of gestation. The primary outcome was delivery with preeclampsia before 37 weeks of gestation. The analysis was performed according to the intention-to-treat principle. RESULTS: A total of 152 women withdrew consent during the trial, and 4 were lost to follow up, which left 798 participants in the aspirin group and 822 in the placebo group. Preterm preeclampsia occurred in 13 participants (1.6%) in the aspirin group, as compared with 35 (4.3%) in the placebo group (odds ratio in the aspirin group, 0.38; 95% confidence interval, 0.20 to 0.74; P=0.004). Results were materially unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow-up. Adherence was good, with a reported intake of 85% or more of the required number of tablets in 79.9% of the participants. There were no significant between-group differences in the incidence of neonatal adverse outcomes or other adverse events. CONCLUSIONS: Treatment with low-dose aspirin in women at high risk for preterm preeclampsia resulted in a lower incidence of this diagnosis than placebo. (Funded by the European Union Seventh Framework Program and the Fetal Medicine Foundation; EudraCT number, 2013-003778-29 ; Current Controlled Trials number, ISRCTN13633058 .).

Pregnancy outcome following fetal reduction from dichorionic twins to singleton gestation.

BACKGROUND: There are still some controversies regarding the risks and benefits of fetal reduction from twins to singletons. We aimed to evaluate if fetal reduction from twins to singleton improves pregnancy outcome. METHODS: Retrospective analysis of all dichorionic-diamniotic twin pregnancies, who underwent fetal reduction. Pregnancy outcome was compared to ongoing, non-reduced, dichorionic-diamniotic gestations. Primary outcome was preterm birth prior to 37 gestational weeks. Secondary outcomes included: preterm birth prior to 34 gestational weeks, gestational age at delivery, birthweight, small for gestational age, hypertensive disorders, gestational diabetes and stillbirth. RESULTS: Ninety-eight reduced pregnancies were compared with 222 ongoing twins. Preterm birth < 37 gestational weeks (39.6% vs. 57.6%, p < 0.001) was significantly lower in the reduced group compared to the ongoing twins' group. A multivariate analysis, controlling for parity and mode of conception, demonstrated that fetal reduction independently and significantly reduced the risk for prematurity (aOR 0.495, 95% CI -0.299-0.819). Subgroup analysis, similarly adjusted demonstrated lower rates of preterm delivery in those undergoing elective reduction (aOR = 0.206, 95% CI 0.065-0.651), reduction due to fetal anomalies (aOR = 0.522, 95% CI 0.295-0.926) and 1st trimester reduction (aOR = 0.297, 95% Cl 0.131-0.674) all compared to ongoing twins. A Kaplan-Meier survival curve showed a significant proportion of non-delivered women at each gestational week in the reduced group compared to non-reduced twins, after 29 gestational weeks. CONCLUSIONS: Fetal reduction from twins to singleton reduces the risk of preterm birth < 37 gestational weeks, but not for more severe maternal and perinatal complications.

Primary, secondary, and tertiary preventions of preterm birth with cervical cerclage.

OBJECTIVE: To evaluate the efficacy of cerclage in preventing preterm birth according to indication. STUDY DESIGN: Retrospective analysis of all women who underwent cerclage to prevent preterm birth in a university-affiliated medical-center (2007-2017). Multiple gestations were excluded. Cohort was divided to three subgroups according to cerclage indication: group A-primary prevention cerclage, performed during the first trimester, based on a history of cervical insufficiency; group B-secondary prevention cerclage, performed after sonographic visualization of asymptomatic cervical length shortening and previous preterm birth; and group C-tertiary prevention cerclage, performed at mid-trimester in women presenting with asymptomatic cervical dilatation. Primary outcome was gestational age at delivery. Secondary outcomes were maternal and neonatal complications. RESULTS: During the study period 273 women underwent cervical cerclage: group A-215 (79%), group B-25 (9%), and group C-33 (12%). Patients in group C had significantly lower gravidity and parity. Gestational age at cerclage was highest in group C and lowest in group A (22 vs. 13 weeks p < 0.001). Median gestational age at delivery was 37 + 3 weeks in groups A and B and 34 + 3 in group C. This difference persisted after controlling for potential confounders (p < 0.0001). Preterm birth prior to 34 weeks of gestation were 10.7% in group A, 16% in group B, and 33.33% in group C (p = 0.0021). Neonatal complications including: respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis, were clmore prevalent in group C. CONCLUSION: Cerclage was shown to be an acceptable measure in cases of an anticipated increased risk of preterm birth with a low rate of procedure associated complications. However, the number-needed-to-treat cannot be determined from our data, because a control group was lacking.

Deviation of sonographic estimated fetal weight from actual birth weight in two consecutive pregnancies of the same parturients.

OBJECTIVE: To determine whether maternal features affect the accuracy of sonographic estimated fetal weight (SEFW) by evaluating the consistency of the systematic error of SEFW with regards to the birth weight (BW) in two consecutive pregnancies of the same gravida. METHODS: The cohort included women with SEFW within 1 week of delivery (32-42 weeks' gestation) in two consecutive singleton pregnancies from 2007 to 2012. The systematic error was calculated as (SEFW - BW)/BW × 100 and expressed as a percentage of the BW. RESULTS: A total of 636 pregnancies (318 gravidas) were eligible for analysis. The BW and SEFW were correlated in both first examined (r = 0.873, p < 0.001) and consecutive (r = 0.843, p < 0.001) pregnancies. There was a significant difference in mean systematic error between first examined and consecutive pregnancies (3.13 ± 8.95 vs. 0.34 ± 8.75%, p < 0.001), with a very weak correlation between the two (r = 0.135, p = 0.16). Nulliparity or multiparity at the first examined pregnancy was not found to be a significant factor, and in both groups the error was higher in the first examined pregnancy. There were no significant differences between parturients with a minor (10% and below) or major (>10%) difference in the systematic error between the two pregnancies. CONCLUSION: The systematic error between the SEFW and BW in two consecutive pregnancies is inconsistent, suggesting that it is unaffected by maternal biometric features.

Impact of maternal obesity on fetal health.

The obesity epidemic is a problem of global importance with a profound impact on maternal-fetal health. Maternal overweight and obesity causes pregnancy complications such as gestational diabetes, hypertension and preeclampsia and affects fetal growth. Maternal obesity offers an altered genetic, hormonal and biochemical environment for the developing fetus/embryo and influences fetal growth and organ development. Offspring of obese mothers are subject to an increased risk of fetal demise, congenital anomalies and disrupted growth patterns, causing an increase in perinatal mortality. The impact of maternal obesity extends beyond intrauterine and neonatal life to childhood, adolescence and adulthood.

"Residential greenness, gestational diabetes mellitus (GDM) and microbiome diversity during pregnancy".

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with reduced gut microbiota richness that was also reported to differ significantly between those living in rural compared to urban environments. Therefore, our aim was to examine the associations between greenness and maternal blood glucose levels and GDM, with microbiome diversity as a possible mediator in these associations. METHODS: Pregnant women were recruited between January 2016 and October 2017. Residential greenness was evaluated as mean Normalized Difference Vegetation Index (NDVI) within 100, 300 and 500 m buffers surrounding each maternal residential address. Maternal glucose levels were measured at 24-28 weeks of gestation and GDM was diagnosed. We estimated the associations between greenness and glucose levels and GDM using generalized linear models, adjusting for socioeconomic status and season at last menstrual period. Using causal mediation analysis, the mediation effects of four different indices of microbiome alpha diversity in first trimester stool and saliva samples were assessed. RESULTS: Of 269 pregnant women, 27 participants (10.04%) were diagnosed with GDM. Although not statistically significant, adjusted exposure to medium tertile levels of mean NDVI at 300 m buffer had lower odds of GDM (OR = 0.45, 95% CI: 0.16, 1.26, p = 0.13) and decreased change in mean glucose levels (ß = -6.28, 95% CI: 14.91, 2.24, p = 0.15) compared to the lowest tertile levels of mean NDVI. Mixed results were observed at 100 and 500 m buffers, and when comparing highest tertile levels to lowest. No mediation effect of first trimester microbiome on the association between residential greenness and GDM was observed, and a small, possibly incidental, mediation effect on glucose levels was observed. CONCLUSION: Our study suggests possible associations between residential greenness and glucose intolerance and risk of GDM, though without sufficient evidence. Microbiome in the first trimester, while involved in GDM etiology, is not a mediator in these associations. Future studies in larger populations should further examine these associations.

Fetal reduction from twin to singleton gestation: A meta-analysis.

OBJECTIVE: To evaluate outcomes of fetal reduction in twin pregnancy. SEARCH STRATEGY: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Google Scholar were searched from 1980 through December 2020. SELECTION CRITERIA: Prospective or retrospective studies of pregnant women with twin gestations who had a transabdominal reduction of twin to singleton pregnancy with a comparison group of ongoing twin gestations. DATA COLLECTION AND ANALYSIS: Outcomes were meta-analyzed only if reported in at least three studies. MAIN RESULTS: Six studies with a pooled sample of 2867 women with a twin pregnancy of whom 624 underwent 2-to-1 reduction and 2243 did not. In the fetal reduction group, the odds of preterm birth before 34 and 37 weeks of pregnancy were lower by 36% (odds ratio [OR] 0.64, 95% confidence interval [CI] 0.48-0.86, P < 0.003) and 77% (OR 0.23, 95% CI 0.12-0.44, P < 0.001), respectively, than in the control group, and the odds of hypertensive disorders and cesarean delivery were lower by 75% (OR 0.25, 95% CI 0.15-0.43, P < 0.001) and 65% (OR 0.35, 95% CI 0.20-0.62, P < 0.001), respectively. CONCLUSION: Twin reduction to singleton pregnancy decreased the possibility of preterm birth, hypertensive disorders in pregnancy and cesarean delivery. Sufficiently powered prospective studies are needed to support these findings.

Pregnancy outcome at extremely advanced maternal age.

OBJECTIVE: The purpose of this study was to evaluate pregnancy outcome in women at extremely advanced maternal age (≥ 45 years). STUDY DESIGN: We compared the condition of women aged ≥ 45 years (n = 177) in a 10:1 ratio (20-29, 30-39, and 40-44 years.). Subgroup analysis compared the condition of women aged 45-49 years with those women aged ≥ 50 years. RESULTS: The rates of gestational diabetes mellitus and hypertensive complications were higher for the study group, compared with the whole group (17.0% vs 5.6% and 19.7% vs 4.5%, respectively; P < .001), as was the rate of preterm delivery at <37 and <34 weeks of gestation (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.2-3.6 and OR, 3.5; 95% CI, 1.4-9.0, respectively). The rates of cesarean delivery (OR, 31.8; 95% CI, 18.0-56.1), placenta previa, postpartum hemorrhage, and adverse neonatal outcome were significantly higher among the study group. The risk for gestational diabetes mellitus, preeclampsia toxemia, preterm delivery, and neonatal intensive care unit admission was increased for women aged ≥ 50 years. CONCLUSION: Pregnancy at extreme advanced maternal age is associated with increased maternal and fetal risk.

First trimester biomarkers for prediction of gestational diabetes mellitus.

PURPOSE: To develop a first trimester prediction model for gestational diabetes mellitus (GDM) using obesity, placental, and inflammatory biomarkers. METHODS: We used a first trimester dataset of the ASPRE study to evaluate clinical and biochemical biomarkers. All biomarkers levels (except insulin) were transformed to gestational week-specific medians (MoMs), adjusted for maternal body mass index (BMI), maternal age, and parity. The MoM values of each biomarker in the GDM and normal groups were compared and used for the development of a prediction model assessed by area under the curve (AUC). RESULTS: The study included 185 normal and 20 GDM cases. In the GDM group, compared to the normal group BMI and insulin (P = 0.003) were higher (both P < 0.003). The MoM values of uterine artery pulsatility index (UtA-PI) and soluble (s)CD163 were higher (both P < 0.01) while pregnancy associated plasma protein A (PAPP-A), placental protein 13 (PP13), and tumor-necrosis factor alpha (TNFα) were lower (all P < 0.005). There was no significant difference between the groups in placental growth factor, interleukin 6, leptin, peptide YY, or soluble mannose receptor (sMR/CD206). In screening for GDM in obese women the combination of high BMI, insulin, sCD163, and TNFα yielded an AUC of 0.95, with detection rate of 89% at 10% false positive rate (FPR). In non-obese women, the combination of sCD163, TNFα, PP13 and PAPP-A yielded an AUC of 0.94 with detection rate of 83% at 10% FPR. CONCLUSION: A new model for first trimester prediction of the risk to develop GDM was developed that warrants further validation.

Elevated galectin-3 in women with gestational diabetes mellitus, a new surrogate for cardiovascular disease in women.

BACKGROUND: Gestational diabetes mellitus (GDM) is associated with future cardiovascular morbidity and recognized as a women-specific risk factor for cardiovascular disease. The mechanisms for this association are not well established. Therefore, we aimed to evaluate the cardiovascular-related biomarkers, galectin-3 (Gal-3) and protein convertase subtilisin/kexin (PCSK) type 9, in women with GDM. METHODS: Blood samples were drawn in the third trimester from 31 women diagnosed with GDM and from 35 women with normal pregnancies. Blood levels of Gal-3 and PCSK-9 were measured using a quantitative sandwich enzyme immunoassay. In addition, we measured Gal-3 levels in 24 pregnant women in the first trimester who later developed GDM and in 36 healthy controls. Continuous variables were compared using student's t-test and categorical variables by chi-square/fisher's exact tests. RESULTS: We found increased levels of Gal-3 in women diagnosed with GDM compared to women without GDM (124.6±32% versus control; pv = 0.001). Furthermore, we demonstrated elevated levels of Gal-3 during the first trimester among women who later developed GDM compared with women who did not develop any gestational morbidity (125.7±32% versus control; pv = 0.004). Third-trimester levels of PCSK-9 did not differ between women with and without GDM (560±45ng/mL versus 553±33ng/mL; pv = 0.4). CONCLUSIONS: The results suggest a possible mechanism that may link GDM to the future increased cardiovascular risk in these patients. Additionally, increased Gal-3 levels during the first trimester may suggest a new early predictor for GDM.

Short-term neonatal outcome in low-risk, spontaneous, singleton, late preterm deliveries.

OBJECTIVE: To estimate the effect of gestational age on short-term neonatal morbidity in cases of spontaneous, low-risk singleton late preterm deliveries and to identify predictors of adverse neonatal outcome. METHODS: This was a retrospective study of all spontaneous, low-risk late preterm deliveries (34 0/7 to 36 6/7 weeks of gestation) during the years 1997 to 2006 (n=2,478). Multiple gestations and pregnancies complicated by preterm premature rupture of membranes (PROM) or maternal or fetal complications were excluded. Short-term neonatal outcome was compared with a control group of full-term deliveries in a 3:1 ratio (n=7,434). Logistic regression analysis was used to identify risk factors for neonatal morbidity among late preterm infants. RESULTS: Compared with full-term infants, spontaneous late preterm delivery was independently associated with an increased risk of neonatal morbidity, including respiratory distress syndrome (4.2% compared with 0.1%, P<.001), sepsis (0.4% compared with 0.04%, P<.001), intraventricular hemorrhage (0.2% compared with 0.02%, P<.001), hypoglycemia (6.8% compared with 0.4%, P<.001), and jaundice requiring phototherapy (18% compared with 2.5%, P<.001). Cesarean delivery (odds ratio [OR] 2.1, 95% confidence interval [CI] 1.6-2.6), male sex (OR 1.4, 95% CI 1.1-1.8), and multiparity (OR 2.2, 95% CI 1.7-2.8) were independent risk factors for neonatal respiratory morbidity in cases of late preterm deliveries. The relationship between gestational age and neonatal morbidity was of continuous nature with a nadir at about 39 weeks rather than a term-preterm threshold phenomenon and was unrelated to birth weight. CONCLUSION: Late prematurity is associated with significant neonatal morbidity in cases of spontaneous low-risk singleton deliveries. This information is important for appropriate counseling and should stimulate efforts to decrease the rate of late preterm deliveries. LEVEL OF EVIDENCE: II.

Noninvasive, continuous, real-time glucose measurements compared to reference laboratory venous plasma glucose values.

Purpose: Current modalities for glucose monitoring are invasive and inconvenient. The search for a noninvasive technique is still ongoing, without a clinically viable product. The aim of our study was to evaluate the safety and accuracy of a novel non-invasive continuous glucometer - the Wizmi™ device. Methods: Prospective, observational, controlled clinical trial. We included healthy pregnant women designated to undergo a 3-hour oral glucose tolerance test. Each participant underwent synchronous and simultaneous glucose measurement by venous sampling of plasma glucose and non-invasive glucose by Wizmi device. Primary outcome was the accuracy of the Wizmi device as assessed by comparing between paired measurements, i.e. non-invasive glucose measurements by Wizmi versus standard plasma glucose levels, which were taken at the exact same time. Results: Thirty-two women underwent oral glucose tolerance test (OGTT), contributing 224 paired glucose measurements. Of the 224 paired measurements, all were within the clinically appropriate zones of the Clarke error grid analysis zones -208 (93%) in Zone A and 16 (7%) in zone B. Mean absolute relative difference of the Wizmi non-invasive glucose versus plasma glucose laboratory reference was 7.23% or 9.66 mg/dl. Overall, for all 224 paired measurements, across all Wizmi glucose ranges, the agreement was 86.6, 92.0, 97.8 and 99.5% for deviations within ±15, 20, 30, 40% (if glucose >80 mg/dl) or mg/dl (if glucose ≤80 mg/dl). Conclusions: Wizmi device is novel non-invasive continuous glucose monitor, safe to use, with overall high accuracy compared to a gold standard reference of plasma glucose.

Sonographic appearance of the uterus in the early puerperium in vaginal versus cesarean deliveries: a prospective study.

PURPOSE: The purpose of this study is to compare uterine sonographic characteristics in early puerperium, following vaginal versus cesarean deliveries; and in women with abnormal third stage of labor, compared to uncomplicated vaginal delivery. MATERIALS AND METHODS: This is a prospective study of women after delivery of singleton, appropriate-for-gestational-age weight, term neonates; 66 women delivered vaginally and 33 delivered by cesarean section. Sonographic uterine dimensions (height, length, and width), intracavitary thickness and its echogenicity (at level of fundus, midcavity and cervix) were recorded at less than and after 24 h from delivery, and compared between women delivered vaginally and by cesarean section. Among women delivered vaginally, data were further analyzed according to whether women underwent manual revision of the uterine cavity. RESULTS: Sonographic evaluations were taken at 15.4 (4.3-24.0) and 39.5 (28.8-108.8) hours after delivery (median, range). We found no clinically significant differences in uterine characteristics according to mode of delivery or according to manual revision of the uterine cavity. The sonographic appearance of the uterus was similar when performed at less than or after 24 h from delivery. CONCLUSIONS: Postpartum sonographic evaluation of the uterus appears similar after vaginal and cesarean deliveries.