Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes.

OBJECTIVE: We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. STUDY DESIGN: We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed. RESULTS: In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group. CONCLUSION: IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.

Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone.

OBJECTIVE: We sought to compare the efficacy of the double-balloon catheter and dinoprostone for induction of labor among nulliparous women with an unfavorable cervix. STUDY DESIGN: Nulliparous women with a Bishop score <6 were randomized to receive a 10-mg intra-vaginal dinoprostone insert or a double-balloon catheter. Primary outcome was time to delivery. Statistical analyses were performed by intention to treat using the chi-square, Fisher's exact, and Student's t-test, as appropriate. RESULTS: The mean induction-to-delivery time was shorter in the double-balloon group as compared to the dinoprostone group (17.9±5.8 vs. 26.3±9.7 h) as was the time from induction to vaginal delivery (19.13±5 vs. 24.45±8.7 h, respectively). More women in the catheter group were delivered within 24 h compared to the dinoprostone group (87.1% vs. 47.4%). Approximately 50% of women in both groups delivered by cesarean section. CONCLUSION: Induction of labor with the double-balloon catheter in nulliparous women with an unfavorable cervix is associated with a shorter time to delivery compared to dinoprostone.

Trial of labor versus repeat cesarean: are patients making an informed decision?

OBJECTIVE: Most women eligible for a trial of labor after a cesarean (TOLAC) undergo an elective repeat cesarean section (ERCS). We hypothesized that this is largely because of poor patient education. STUDY DESIGN: This was a prospective study of women who presented to our hospital from November 2010 through July 2011 who were candidates for TOLAC. Women filled out a questionnaire prior to their scheduled ERCS or upon admission for TOLAC. A χ(2) and a Student t test were used, as appropriate. RESULTS: The study included 155 women, 87 for TOLAC and 68 for ERCS. Women in both groups demonstrated a lack of knowledge on the risks and benefits of TOLAC and ERCS. When patients perceived their providers as having a preference for ERCS, very few chose TOLAC, whereas the majority chose TOLAC if this was their provider's preference. CONCLUSION: Candidates for TOLAC appear to know little about the risks and benefits associated with their mode of delivery, and provider preference affects this choice.

Anthropometric models to estimate fat mass at 3 days, 15 and 54 weeks.

BACKGROUND: Currently available infant body composition measurement methods are impractical for routine clinical use. The study developed anthropometric equations (AEs) to estimate fat mass (FM, kg) during the first year using air displacement plethysmography (PEA POD® Infant Body Composition System) and Infant quantitative magnetic resonance (Infant-QMR) as criterion methods. METHODS: Multi-ethnic full-term infants (n = 191) were measured at 3 days, 15 and 54 weeks. Sex, race/ethnicity, gestational age, age (days), weight-kg (W), length-cm (L), head circumferences-cm (HC), skinfold thicknesses mm [triceps (TRI), thigh (THI), subscapular (SCP), and iliac (IL)], and FM by PEA POD® and Infant-QMR were collected. Stepwise linear regression determined the model that best predicted FM. RESULTS: Weight, length, head circumference, and skinfolds of triceps, thigh, and subscapular, but not iliac, significantly predicted FM throughout infancy in both the Infant-QMR and PEA POD models. Sex had an interaction effect at 3 days and 15 weeks for both the models. The coefficient of determination [R2 ] and root mean square error were 0.87 (66 g) at 3 days, 0.92 (153 g) at 15 weeks, and 0.82 (278 g) at 54 weeks for the Infant-QMR models; 0.77 (80 g) at 3 days and 0.82 (195 g) at 15 weeks for the PEA POD models respectively. CONCLUSIONS: Both PEA POD and Infant-QMR derived models predict FM using skinfolds, weight, head circumference, and length with acceptable R2 and residual patterns.

Feasibility of Closed-Loop Insulin Delivery with a Pregnancy-Specific Zone Model Predictive Control Algorithm.

Objective: Evaluating the feasibility of closed-loop insulin delivery with a zone model predictive control (zone-MPC) algorithm designed for pregnancy complicated by type 1 diabetes (T1D). Research Design and Methods: Pregnant women with T1D from 14 to 32 weeks gestation already using continuous glucose monitor (CGM) augmented pump therapy were enrolled in a 2-day multicenter supervised outpatient study evaluating pregnancy-specific zone-MPC based closed-loop control (CLC) with the interoperable artificial pancreas system (iAPS) running on an unlocked smartphone. Meals and activities were unrestricted. The primary outcome was the CGM percentage of time between 63 and 140 mg/dL compared with participants' 1-week run-in period. Early (2-h) postprandial glucose control was also evaluated. Results: Eleven participants completed the study (age: 30.6 ± 4.1 years; gestational age: 20.7 ± 3.5 weeks; weight: 76.5 ± 15.3 kg; hemoglobin A1c: 5.6% ± 0.5% at enrollment). No serious adverse events occurred. Compared with the 1-week run-in, there was an increased percentage of time in 63-140 mg/dL during supervised CLC (CLC: 81.5%, run-in: 64%, P = 0.007) with less time >140 mg/dL (CLC: 16.5%, run-in: 30.8%, P = 0.029) and time <63 mg/dL (CLC: 2.0%, run-in:5.2%, P = 0.039). There was also less time <54 mg/dL (CLC: 0.7%, run-in:1.6%, P = 0.030) and >180 mg/dL (CLC: 4.9%, run-in: 13.1%, P = 0.032). Overnight glucose control was comparable, except for less time >250 mg/dL (CLC: 0%, run-in:3.9%, P = 0.030) and lower glucose standard deviation (CLC: 23.8 mg/dL, run-in:42.8 mg/dL, P = 0.007) during CLC. Conclusion: In this pilot study, use of the pregnancy-specific zone-MPC was feasible in pregnant women with T1D. Although the duration of our study was short and the number of participants was small, our findings add to the limited data available on the use of CLC systems during pregnancy (NCT04492566).

Hypoglycemia in Prospective Multicenter Study of Pregnancies with Pre-Existing Type 1 Diabetes on Sensor-Augmented Pump Therapy: The LOIS-P Study.

Background: Pregnancies in type 1 diabetes are high risk, and data in the United States are limited regarding continuous glucose monitoring (CGM)-based hypoglycemia throughout pregnancy while on sensor-augmented insulin pump therapy. Materials and Methods: Pregnant women with type 1 diabetes in the LOIS-P Study (Longitudinal Observation of Insulin use and glucose Sensor metrics in Pregnant women with type 1 diabetes using continuous glucose monitors and insulin pumps) were enrolled before 17 weeks gestation at three U.S. centers and we used their personal insulin pump and a study Dexcom G6 CGM. We analyzed data of 25 pregnant women for CGM hypoglycemia based on international consensus guidelines for percentage time <63 and 54 mg/dL, hypoglycemic events and prolonged hypoglycemia events for 24-h, daytime, and overnight periods, and severe hypoglycemia (SH) episodes. Results: For a 24-h period, biweekly median percentage of time <63 mg/dL ranged from 0.8% at biweek 4-5 to 3.7% at biweek 14-15 with high variability throughout pregnancy. Median percentage of time <63 and 54 mg/dL was higher overnight than daytime (P < 0.01). Hypoglycemic events occurred throughout the pregnancy, ranged 1-4 events per 2 weeks, significantly decreased after the 20th week, and occurred predominantly during daytime (P < 0.01). For overnight period, hypoglycemia and events were more concentrated from 12 to 3 am. Seven prolonged hypoglycemia events without any associated SH occurred in four participants (16%), primarily overnight. Three participants experienced a single episode of SH. Conclusions: Our results suggest a higher overall risk of hypoglycemia throughout pregnancy during the overnight period with continued daytime risk of hypoglycemic events in pregnancies complicated by type 1 diabetes.

Higher infant body fat with excessive gestational weight gain in overweight women.

OBJECTIVE: Gestational weight gain (GWG) is positively associated with birthweight and maternal prepregnancy body mass index (BMI) is directly related to infant fat mass (FM). This study examined whether differences exist in infant body composition based on 2009 GWG recommendations. STUDY DESIGN: Body composition was measured in 306 infants, and GWG was categorized as appropriate or excessive. Analysis of covariance was used to investigate the effects of GWG and prepregnancy BMI and their interaction on infant body composition. RESULTS: Within the appropriate group, infants from obese mothers had greater percent fat (%fat) and FM than offspring from normal and overweight mothers. Within the excessive group, infants from normal mothers had less %fat and FM than infants from overweight and obese mothers. A difference was found for %fat and FM within the overweight group between GWG categories. CONCLUSION: Excessive GWG is associated with greater infant body fat and the effect is greatest in overweight women.

No sustained effects of an intervention to prevent excessive GWG on offspring fat and lean mass at 54 weeks: Yet a greater head circumference persists.

BACKGROUND: LIFT (Lifestyle Intervention for Two) trial found that intervening in women with overweight and obesity through promoting healthy diet and physical activity to control gestational weight gain (GWG) resulted in neonates with greater weight, lean mass and head circumference and similar fat mass at birth. Whether these neonate outcomes are sustained at 1-year was the focus of this investigation. METHODS: Measures included body composition by PEA POD air displacement plethysmography (ADP) and Echo Infant quantitative magnetic resonance (QMR) and head circumference at birth (n = 169), 14 (n = 136) and 54 weeks (n = 137). Differences in fat and lean mass between lifestyle intervention (LI) and Usual care (UC) groups were examined using ANCOVA adjusting for maternal age and BMI, GWG, offspring sex and age. RESULTS: Compared to UC, LI infants had similar weight (112 ± 131 g; P = .40), fat mass (14 ± 80 g; P = .86), lean mass (100 ± 63 g; P = .12) at 14 weeks and similar weight (168 ± 183 g; P = .36), fat mass (148 ± 124 g; P = .24), lean mass (117 ± 92 g; P = .21) at 54 weeks. Head circumference was greater in LI at 54 weeks (0.46 ± 2.1 cm P = .03). CONCLUSIONS: Greater lean mass observed at birth in LI offspring was not sustained at 14 and 54 weeks, whereas the greater head circumference in LI offspring persisted at 54 weeks.

Longitudinal Observation of Insulin Use and Glucose Sensor Metrics in Pregnant Women with Type 1 Diabetes Using Continuous Glucose Monitors and Insulin Pumps: The LOIS-P Study.

Background: Suboptimal glycemic control is associated with maternal and neonatal morbidity and mortality in pregnancy complicated by type 1 diabetes (T1D). Prospective analysis of continuous glucose monitoring (CGM) metrics, insulin pump settings, and insulin delivery can better characterize the changes in glycemic levels and insulin use throughout pregnancy with T1D. Materials and Methods: Prescribed parameters, insulin delivery, carbohydrate intake, and CGM data for 25 pregnant women with T1D from three U.S. sites were collected. Participants enrolled before 17 weeks gestation and used personal insulin pumps and study CGM. Mean daily total, basal, and bolus insulin doses (units/kg), CGM time in range (TIR: 63-140 mg/dL), and pump-entered carbohydrates were analyzed for every 2-week gestational interval. Linear mixed-effects regression models were used to evaluate changes across gestational ages compared to 12-14 weeks. Results: Basal insulin was higher during weeks 6-12 and 24-40. Daily bolus and total insulin were higher during weeks 20-40. Pump parameters were adjusted to intensify insulin therapy from 22 weeks onward. Average TIR across pregnancy was 59% ± 14%. Between 18 and 30 weeks, TIR was significantly lower, and time above range was significantly higher compared to the reference biweek. Time below target was lower between 22 and 34 weeks. Seven participants achieved >70% recommended TIR for pregnancy. Participants with maternal complications or infant neonatal intensive care unit admissions had lower TIR. Conclusion: While insulin dosing changed significantly with advancing gestation, most participants did not achieve >70% TIR. Customized anticipatory pump setting adjustments and automated systems aimed toward the designated TIR are needed to improve outcomes for this population. NCT03761615.

Increased Visceral Adipose Tissue Without Weight Retention at 59 Weeks Postpartum.

OBJECTIVE: This study aimed to determine whether controlling maternal gestational weight gain (GWG) influences adipose tissue distribution at 1 year postpartum. METHODS: Women with overweight or obesity (n = 210, BMI ≥ 25 or ≥ 30) were randomized to a lifestyle intervention (LI) designed to control GWG or to usual obstetrical care (UC). Measures included anthropometry, whole-body magnetic resonance imaging for visceral (VAT), intermuscular, and subcutaneous adipose tissue, and cardiometabolic risk factors in pregnancy (15 and 35 weeks) and after delivery (15 and 59 weeks). RESULTS: Baseline (15 weeks) characteristics were similar (mean [SD]: age, 33.8 [4.3] years; weight, 81.9 [13.7] kg; BMI, 30.4 [4.5]; gestational age at randomization, 14.9 [0.8] weeks). LI had less GWG (1.79 kg; P = 0.003) and subcutaneous adipose tissue gain at 35 weeks gestation (P < 0.01). UC postpartum weight (2.92 kg) was higher at 15 weeks but not different from baseline or LI at 59 weeks postpartum. Postpartum VAT increased from baseline in LI by 0.23 kg at 15 weeks and 0.55 kg at 59 weeks; in UC, it increased by 0.34 kg at 15 and 59 weeks. Intermuscular adipose tissue remained elevated in LI (0.22 kg) at 59 weeks. VAT was associated with several cardiometabolic risk factors at 59 weeks. CONCLUSIONS: Despite no weight retention at 59 weeks postpartum, women had increased VAT by ~30%. Postpartum modifiable behaviors are warranted to lower the risk of VAT retention.

Obesity and diabetes: A recipe for obstetric complications.

The prevalence of obesity has been increasing worldwide and has reached epidemic proportions in the United States, where well over 20% of the population have a body mass index (BMI) within the obese range. Obesity is associated with a wide spectrum of obstetric and perinatal complications, including increased risks of fetal mortality and morbidity, congenital malformations, maternal hypertensive disorders, gestational diabetes, excessive fetal growth and cesarean delivery. The odds ratios for these risks increase in direct correlation with the severity of obesity, and are significant even among women who are overweight without meeting criteria for obesity. Although obesity is closely associated with diabetes which, in itself, is associated with similar perinatal complications, diabetes and obesity are independent risk factors for adverse pregnancy outcome. Moreover, improving glycemic control in the pregnant woman with diabetes may mitigate the additive adverse effects of diabetes and obesity on pregnancy outcome.

Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial.

OBJECTIVE: To test the hypothesis that cervical ripening using a combination of misoprostol and a transcervical Foley bulb leads to delivery within a shorter time compared with misoprostol alone. METHODS: This randomized controlled trial was offered to women admitted for cervical ripening. Inclusion criteria were gestational age 37 weeks or greater with intact membranes, singleton fetus, cephalic presentation, and Bishop score 6 or less. Exclusion criteria included, among others, prior uterine surgery, ruptured membranes, and any contraindication to vaginal delivery. Patients were randomized to cervical ripening using misoprostol and a transcervical Foley bulb simultaneously or misoprostol alone. Primary outcome was time from placement of the misoprostol to delivery. Secondary outcomes included time to active phase, time from active phase to delivery, cesarean delivery rate, uterine tachysystole, estimated blood loss, chorioamnionitis, cord pH, 5-minute Apgar score, and neonatal intensive care unit admission. Sample size calculation revealed that 94 participants were required in each group to detect a 3-hour difference with 80% power and α error of 0.05. Intention-to-treat analysis was performed. RESULTS: From September 2015 to July 2016, a total of 200 patients were randomized, 100 to each group. There were no differences between groups with respect to parity, body mass index, gestational age, Bishop score, birth weight, or indication for induction. Time to delivery was significantly shorter in the combined misoprostol-transcervical Foley group: 15.0 (11.0-21.8) hours (median [interquartile range]) vs 19.0 (14.0-27.3) hours in the misoprostol-only group (P=.001). This time difference remained significant after subanalysis by parity or after excluding cesarean deliveries. There was no difference between groups with respect to the rate or indication for cesarean delivery, estimated blood loss, rate of tachysystole, chorioamnionitis, or neonatal outcomes. CONCLUSION: Cervical ripening using misoprostol in combination with a transcervical Foley bulb is an effective method to shorten the course of labor compared with misoprostol alone. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02566005.

Greater Neonatal Fat-Free Mass and Similar Fat Mass Following a Randomized Trial to Control Excess Gestational Weight Gain.

OBJECTIVE: The objective of this study was to determine the effectiveness of controlling maternal gestational weight gain (GWG) in the second and third trimesters on neonate body composition. METHODS: Two hundred ten healthy women with overweight (25 > BMI < 30) or obesity (BMI ≥ 30) were randomly assigned to a lifestyle intervention (LI) program focused on controlling GWG through nutrition and activity behaviors or to usual obstetrical care (UC). Infant fat and fat-free mass (FFM) at birth were measured by using air displacement plethysmography (PEA POD) and by using quantitative magnetic resonance (QMR). RESULTS: At baseline, there were no between-group differences in maternal characteristics (mean [SD]): age: 33.8 (4.3) years, weight: 81.9 (13.7) kg, BMI: 30.4 (4.5), and gestational age at randomization: 14.9 (0.8) weeks. GWG was less in the LI group by 1.79 kg (P = 0.003) or 0.0501 kg/wk (P = 0.002). Compared with UC infants, LI infants had greater weight (131 ± 59 g P = 0.03), FFM (98 ± 45 g; P = 0.03) measured by PEA POD, and lean mass (105 ± 38 g; P = 0.006) measured by QMR. Fat mass and percent fat were not significantly different. CONCLUSIONS: Intervening in women with overweight and obesity through behaviors promoting healthy diet and physical activity to control GWG resulted in neonates with similar fat and greater FFM.

Troponins, heat shock proteins and glycogen phosphorylase BB in umbilical cord blood of complicated pregnancies.

PURPOSE OF THE STUDY: Heat shock proteins (Hsp) are evolutionary conserved molecules with a chaperone role in cell survival. We hypothesized that cord blood concentrations of molecules reflecting fetal cardiac muscle insult, including Hsp, troponins cTnI and cTnT, and glycol-phosphorylase BB (GP-BB) would be elevated in pregnancies complicated by gestational diabetes (GDM) or preeclampsia (PIH) compared to healthy controls. MATERIALS AND METHODS: Pregnant women admitted for delivery at >28 weeks were divided into four groups: healthy patients delivered vaginally (VAG), healthy patients delivered by c-section (CS), patients with PIH, and patients with GDM. Demographics, clinical characteristics, and cord blood concentrations of Hsp, troponins cTnI and cTnT, and GP-BB were compared between groups. Statistical analyses included t-test, Chi square, and Wilcoxon rank sum as appropriate. RESULTS: cTnI concentrations were significantly higher in the PIH group compared to the GDM and VAG groups and they were higher in the CS group compared to the VAG group. Concentrations of Hsp70 were higher in the GDM group compared to the VAG and CS groups. Concentration of GP-BB was higher in the PIH group compared to the VAG group. CONCLUSIONS: GP-BB and cTNI are the most sensitive markers for PIH-related fetal myocyte injury as is Hsp70 in pregnancies complicated by GDM.

Current trends in the diagnosis and management of gestational diabetes mellitus in the United States.

OBJECTIVE: To assess current practice patterns among members of the Society for Maternal-Fetal Medicine (SMFM) with respect to the diagnosis and management of gestational diabetes mellitus (GDM). METHODS: A 38 question survey on GDM diagnosis and management was distributed to SMFM members. RESULTS: 2330 SMFM members were surveyed with a 40% response rate. Overall, 90.6% of respondents recommend a 2-step (versus a 1-step) diagnostic test. Cutoff values for the 1-h-50 g glucose challenge test vary from 130-140 mg/dL, but the majority (83%) adopts Carpenter Coustan criteria for the 3-h-100 g oral glucose tolerance test. The majority recommend glucose testing four times a day, with 55% preferring post-prandial testing at 2 h. Glyburide is used by 57% as a first-line agent, while 4% use metformin. Long-acting insulin analogs (glargine and/or detemir) are used by 46% and 33.6% of respondents, respectively. Antenatal testing is recommended by 38.7% for diet-controlled GDM compared to 98.7% for pharmacologically controlled GDM, with 56% starting by 34 weeks gestation. Most respondents recommend delivery of diet-controlled GDM at 40 weeks and pharmacologically controlled GDM at 39 weeks. Most (69%) offer elective cesarean section for an estimated fetal weight of >4500 g. CONCLUSIONS: There is significant variation in the diagnosis and management of GDM among SMFM members.

Can a single preterm ultrasound accurately predict birth weight in gestational diabetes?

OBJECTIVE: To evaluate the accuracy of the gestation-adjusted projection method of birth weight prediction, as compared to near delivery ultrasound estimated fetal weight, in a gestational diabetic population. METHODS: A retrospective cohort was conducted including all women with gestational diabetes who had an ultrasound estimated fetal weight (EFW) between 34(0/7) and 36(6/7) weeks and an additional ultrasound EFW within 7 d of delivery at term. The gestation-adjusted projection (GAP) method was applied to the earlier sonogram, resulting in the GAP predicted birth weight. The GAP predicted weight and the term ultrasound EFW were compared to the actual birth weight. Absolute and percent birth weight errors were compared using paired t-tests. RESULTS: The mean absolute percent errors and mean absolute errors for the GAP method and term ultrasound were 7.7 ± 5.6% versus 7.1 ± 5.1% and 256 ± 184 g versus 236 ± 169 g respectively (p = 0.22 and p = 0.29). The sensitivity of predicting birth weight ≥4000 g was 22% for the GAP method and 28% for term ultrasound, with specificity reaching 97% for both the methods. CONCLUSION: The GAP method is as accurate as term ultrasound in predicting birth weight in gestational diabetes.

The association between glucose challenge test, obesity and pregnancy outcome in 6390 non-diabetic women.

OBJECTIVE: To evaluate the association between obesity, glucose challenge test (GCT) and pregnancy outcome. METHODS: A prospective cohort study of 6854 consecutive gravid patients screened for gestational diabetes (GDM) using 50-gram GCT, at 24-28 weeks' gestation was performed. A screening value 130 mg/dl was followed by 100 gr oral GTT. Patients who were diagnosed with GDM were excluded. For purpose of analysis patients were categorized by prepregnancy BMI and by different GCT thresholds. Maternal outcome was defined by rate of preeclampsia, gestational age at delivery, cesarean section (CS) rate and the need for labor induction. Neonatal outcome was defined by fetal size (macrosomia/LGA), arterial cord pH, respiratory complications and neonatal intensive care unit (NICU) admission. RESULTS: Overall, a positive GCT result (GCT > or = 130 mg/dl) was identified in 2541/6854 (37%) women. GDM was further diagnosed in 464/6854 (6.8%) of subjects. In both groups of screening results ( > 130 mg/dl and < 130 mg/dl), the obese women were significantly older, gained more weight during pregnancy and had a lower rate of nulliparity in comparison to the non obese women. The obese women had higher rates of macrosomia, LGA and induction of labor. No difference was found in mean birth weight, the total rate of cesarean section, preterm delivery, 5 minute Apgar score < or = 7, mean arterial cord pH, NICU admission and a need for respiratory support in comparison to non obese women in both groups of screening results. A gradual increase in the rate of macrosomia, LGA and cesarean section was identified in both obese and non-obese women in relation to increasing GCT severity categories. CONCLUSION: Fetal size and cesarean section rate are associated with the degree of carbohydrate intolerance (screening results). Furthermore, obesity remains the main contributor impacting fetal size.

Glyburide transport across the human placenta.

OBJECTIVE: To estimate the magnitude of transplacental transfer of glyburide in women with gestational diabetes mellitus (GDM). METHODS: A prospective, observational study was conducted on women with GDM on glyburide therapy. On delivery admission, the glyburide dose and time of last dose were recorded. Immediately postdelivery, maternal and umbilical venous blood samples were obtained and the concentrations of glyburide were determined by high-performance liquid chromatography-mass spectrometry with a limit of detection of 0.25 ng/mL. RESULTS: Nineteen patient dyads were analyzed. The mean total daily maternal glyburide dose was 6.6±6.3 mg per day and the mean time between last dose and sampling was 13.3±6.5 hours. The mean maternal serum glyburide level at birth was 15.4±20.8 ng/mL, whereas the mean umbilical glyburide level was 7.5±8.2 ng/mL, which showed a statistical correlation (r=0.72, P<.01). There were statistically significant relationships between total maternal glyburide dose (1.25-20 mg per day) and maternal glyburide levels (0.93-70.71 ng/mL; r=0.46, P≤.01) and between total maternal glyburide dose and umbilical glyburide levels (0.95-32.41 ng/mL; r=0.43, P≤.01) However, we observed wide variability in maternal and umbilical glyburide levels at both extremes of the total glyburide dose. Seventy-nine percent of cord samples (15/19) had glyburide levels less than 10 ng/mL (the limit of detection reported in earlier studies) and 37% (7/19) were higher than the corresponding maternal samples. CONCLUSION: Transplacental transfer of glyburide is highly variable among patients, corroborating ex vivo placental perfusion studies showing a transport-mediated glyburide efflux from the fetal to the maternal circulation. In most neonates (79%), glyburide levels were below 10 ng/mL. LEVEL OF EVIDENCE: III.