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Pregnant and breastfeeding women are excluded from participating in the vast majority of clinical trials during the coronavirus 2019 (COVID-19) pandemic., Coronavirus disease 2019 (COVID-19) is a novel infectious disease that started in Wuhan, China, and has rapidly spread all across the world. With limited ability to contain the virus and relatively high transmissibility and case fatality rates, governmental institutions and pharmaceutical companies are racing to find therapeutics and vaccines that target this novel coronavirus. However, once again, pregnant and breastfeeding women are excluded from participating in clinical trials during this pandemic. This “protection by exclusion” of pregnant women from drug development and clinical therapeutic trials, even during epidemics and pandemics, is not unprecedented. Moreover, it is both misguided and not justifiable and may have excluded them from potentially beneficial interventions. This is another missed opportunity to obtain pregnancy-specific safety and efficacy data, because therapeutics developed for men and nonpregnant women may not be generalizable to pregnant women. Therefore, we recommend and urge the scientific community and professional societies that, without clear justification for exclusion, pregnant women should be given the opportunity to be included in clinical trials for COVID-19 based on the concepts of justice, equity, autonomy, and informed consent.

Objective: To compare maternal and neonatal outcomes by forceps vaginal delivery versus cesarean delivery during the second stage of labor.Methods: We conducted a retrospective cohort study...

The National Institute of Diabetes and Digestive and Kidney Diseases convened a workshop on research gaps in gestational diabetes mellitus (GDM) with a focus on 1) early pregnancy diagnosis and treatment and 2) pharmacologic treatment strategies. This article summarizes the proceedings of the workshop. In early pregnancy, the appropriate diagnostic criteria for the diagnosis of GDM remain poorly defined, and an effect of early diagnosis and treatment on the risk of adverse outcomes has not been demonstrated. Despite many small randomized controlled trials of glucose-lowering medication treatment in GDM, our understanding of medication management of GDM is incomplete as evidenced by discrepancies among professional society treatment guidelines. The comparative effectiveness of insulin, metformin, and glyburide remains uncertain, particularly with respect to long-term outcomes. Additional topics in need of further research identified by workshop participants included phenotypic heterogeneity in GDM and novel and individualized treatment approaches. Further research on these topics is likely to improve our understanding of the pathophysiology and treatment of GDM to improve both short- and long-term outcomes for mothers and their children.

OBJECTIVE: To determine the association of maternal glycemia with childhood obesity and metabolic dysfunction. STUDY DESIGN: Secondary analysis of follow-up data 5–10 years after a mild gestational diabetes mellitus (GDM) treatment trial. The relationship between maternal oral glucose tolerance testing (OGTT) at 24–31-week gestation and body mass index (BMI), fasting glucose, insulin, and anthropometric measurements (sum of skinfolds, subscapular/triceps ratio, and waist circumference) in the offspring of untreated mild GDM and non-GDM (abnormal 50-g screen/normal OGTT) women was assessed. Multivariable regression modeling controlling for maternal and neonatal characteristics was employed. RESULTS: A cohort of 236 untreated mild GDM and 480 non-GDM offspring were analyzed. In the combined cohort, significant correlations existed between fasting, 1, 2, and 3 h maternal glucose and subscapular/triceps ratio (all p < .04) and in all OGTT values other than the 2-hour value for homeostatic model assessment-estimated insulin resistance (HOMA-IR) (all p < .04) and sum of skinfold measurements (all p < .03). No correlation was found between OGTT values and childhood BMI Z-score. Multivariable regression modeling showed that OGTT values were associated with only sum of skinfolds and subscapular/triceps ratio and not with childhood BMI Z-score. Hispanic ethnicity and prepregnancy maternal BMI were most consistently related to childhood BMI Z-score and HOMA-IR, and Hispanic ethnicity with fasting glucose. CONCLUSIONS: Among women with untreated mild GDM and those without GDM, maternal glycemia is associated with childhood anthropometric measures of obesity but not childhood BMI, fasting glucose, or insulin resistance. Hispanic ethnicity, maternal BMI, and gestational weight gain were consistently related to childhood BMI.

Objective To evaluate whether pregnancy-associated hypertension (gestational hypertension and preeclampsia) was associated with the cardiometabolic health of young offspring. Methods This was a prospective observational follow-up study from 2012 to 2013 of children born to women previously enrolled in a mild gestational diabetes mellitus treatment trial or nongestational diabetes mellitus observational study. At 5-10 years after birth, children were examined and fasting blood samples obtained to determine the following cardiometabolic risk factors: blood pressure (BP), high-density lipoprotein cholesterol, triglycerides, glucose, homeostatic model assessment of insulin resistance, waist circumference, and body mass index (BMI). Results This analysis included 979 children evaluated at a median 7 years of age. Twenty-three (2%) were born preterm from a hypertensive pregnancy, 73 (7%) were born at term from a hypertensive pregnancy, 58 (6%) were born preterm from a normotensive pregnancy, and 825 (84%) were born at term from a normotensive pregnancy (reference group). After adjusting for confounding factors, mean adjusted systolic BP was significantly higher in the children who were born at term to mothers who experienced pregnancy-associated hypertension compared with those born at term to normotensive mothers (systolic BP of 104 mm Hg, 95% CI 101-106 vs systolic BP of 99 mm Hg, 95% CI 99-100, P=.001). No other significant differences were observed. Conclusion Pregnancy-associated hypertension in women who deliver at term was associated with higher systolic BP in the offspring, but not with their measures of diastolic BP, BMI, waist circumference, homeostatic model assessment of insulin resistance, glucose, or lipids. Clinical trial registration ClinicalTrials.gov, NCT00069576.

Investigators have attempted to derive tools that could provide clinicians with an easily obtainable estimate of the chance of vaginal birth after cesarean delivery for those who undertake trial of labor after cesarean delivery. One tool that has been validated externally was derived from data from the Maternal-Fetal Medicine Units Cesarean Registry. However, concern has been raised that this tool includes the socially constructed variables of race and ethnicity.This study aimed to develop an accurate tool to predict vaginal birth after cesarean delivery, using data easily obtainable early in pregnancy, without the inclusion of race and ethnicity.This was a secondary analysis of the Cesarean Registry of the Maternal-Fetal Medicine Units Network. The approach to the current analysis is similar to that of the analysis in which the previous vaginal birth after cesarean delivery prediction tool was derived. Specifically, individuals were included in this analysis if they were delivered on or after 37 0/7 weeks' gestation with a live singleton cephalic fetus at the time of labor and delivery admission, had a trial of labor after cesarean delivery, and had a history of 1 previous low-transverse cesarean delivery. Information was only considered for inclusion in the model if it was ascertainable at an initial prenatal visit. Model selection and internal validation were performed using a cross-validation procedure, with the dataset randomly and equally divided into a training set and a test set. The training set was used to identify factors associated with vaginal birth after cesarean delivery and build the logistic regression predictive model using stepwise backward elimination. A final model was generated that included all variables found to be significant (P.05). The accuracy of the model to predict vaginal birth after cesarean delivery was assessed using the concordance index. The independent test set was used to estimate classification errors and validate the model that had been developed from the training set, and calibration was assessed. The final model was then applied to the overall analytical population.Of the 11,687 individuals who met the inclusion criteria for this secondary analysis, 8636 (74%) experienced vaginal birth after cesarean delivery. The backward elimination variable selection yielded a model from the training set that included maternal age, prepregnancy weight, height, indication for previous cesarean delivery, obstetrical history, and chronic hypertension. Vaginal birth after cesarean delivery was significantly more likely for women who were taller and had a previous vaginal birth, particularly if that vaginal birth had occurred after a previous cesarean delivery. Conversely, vaginal birth after cesarean delivery was significantly less likely for women whose age was older, whose weight was heavier, whose indication for previous cesarean delivery was arrest of dilation or descent, and who had a history of medication-treated chronic hypertension. The model had excellent calibration between predicted and empirical probabilities and, when applied to the overall analytical population, an area under the receiver operating characteristic curve of 0.75 (95% confidence interval, 0.74-0.77), which is similar to the area under the receiver operating characteristic curve of the previous model (0.75) that included race and ethnicity.We successfully derived an accurate model (available at https://mfmunetwork.bsc.gwu.edu/web/mfmunetwork/vaginal-birth-after-cesarean-calculator), which did not include race or ethnicity, for the estimation of the probability of vaginal birth after cesarean delivery.

Objective The objective was to estimate the optimal screen-positive 1-hour 50 g glucose challenge test (GCT) threshold for gestational diabetes (GDM) and predictive characteristics of increasing screen-positive GCT threshold values (135–199 mg/dL) for GDM. Study Design It is a secondary analysis of a multicenter mild GDM study. At 24 to 30 weeks' gestation, women with elevated GCT (135–199 mg/dL) completed a diagnostic 3-hour oral glucose tolerance test (OGTT). A novel change-point analysis method was used to compare the GDM rates for the adjacent GCT values, delineating categories of changing risk such that values within categories have equal risk for GDM. Positive (PPV) and negative (NPV) predictive values for GDM were computed for increasing GCT cut-offs. Results In 7,280 women with both GCT (135–199 mg/dL) and OGTT results, 4 GDM risk-equivalent GCT categories were identified with escalations at 144, 158, and 174 mg/dL (all p-values Conclusion Elevated GCT cut-off values between 135 and 143 mg/dL may carry equivalent GDM risk. No threshold GCT value

Background In the US, at the time of discharge from the hospital, 79% of women had initiated breastfeeding. Intention to breastfeed is a strong predictor of breastfeeding initiation; however, we reported initiation failure in 45% of women with pregestational diabetes who intended to breastfeed. Information regarding intention and initiation among women with other high risk obstetrical conditions (HROB) remains scarce. Objective To ascertain demographic and clinical factors associated with breastfeeding initiation failure among women with HROB conditions who intended to breastfeed. Methods The study population is comprised of 89 women with diabetes (DM), 57 who were receiving treatment for substance abuse (SA), 51 women diagnosed with miscellaneous (MISC) conditions and 32 with history of preterm labor/delivery (PTL/D). Intention to exclusively breastfeed or in combination with formula (breastfed/FF) was ascertained prenatally. Breastfeeding was considered initiated if at discharge ≥50% of their infant feedings were maternal milk. Statistics include chi-square, Wilcoxon's and logistic regression (p Results Of all women, 59% initiated any breastfeeding. Intention to breastfeed/FF, lack of mother-infant contact during the first hour following birth and limited lactation consultation were predictive of initiation failure. The odds of initiation failure were 2.3 times higher among women who wished to breastfeed/FF as compared to those who wished to exclusively breastfeed. Women from the SA group had lower rates of initiation failure than the other three HROB groups. Conclusion Intention to breastfeed among women with diverse HROB conditions is similar to that of the general population; however, initiation rates are disappointingly low. Intention to exclusively breastfeed results in fewer initiation failures. Prenatal intention to combine breast and formula feeding characterize women who may benefit from specific educational programs.

Background Although an elevated early pregnancy hemoglobin A1c has been associated with both spontaneous abortion and congenital anomalies, it is unclear whether A1c assessment is of value beyond the first trimester in pregnancies complicated by pregestational diabetes. Objective We sought to investigate the prognostic ability of longitudinal A1c assessment to predict obstetric and neonatal adverse outcomes based on degree of glycemic control in early and late pregnancy. Materials and Methods This was a retrospective cohort study of all pregnancies complicated by pregestational diabetes from January 2012 to December 2016 at The Ohio State University Wexner Medical Center with both an early A1c ( 26 weeks’ gestation) available for analysis. Patients were categorized by good (early and late A1c 6.5% and late A1c 6.5%) glycemic control. A multivariate regression model was used to calculate adjusted odds ratios for each identified obstetric and neonatal outcome, controlling for maternal age, body mass index, race/ethnicity, type of diabetes, and gestational age at delivery compared to good control as the referent group. Results A total of 341 patients met inclusion criteria during the study period. The median A1c values improved from early to late gestation in the good (5.7% [interquartile range, 5.4−6.1%] versus 5.4%; [interquartile range, 5.2−5.7%]), improved (7.5% [interquartile range, 6.7−8.5] versus 5.9% [interquartile range, 5.6−6.1%]) and poor (8.3% [interquartile range, 7.1−9.6%] versus 7.3% [interquartile range, 6.8−7.9%]) glycemic control groups. There were no statistically significant differences in the rate of adverse outcomes between the good and improved groups except for an increased rate of neonatal intensive care unit (NICU) admissions in the improved group (adjusted odds ratio, 3.7; confidence interval, 1.9−7.3). In contrast, the poor control group had an increased rate of shoulder dystocia (adjusted odds ratio, 6.8; confidence interval, 1.4−34.0), preterm delivery (adjusted odds ratio, 3.9; confidence interval, 2.1−7.3), neonatal intensive care unit admission (adjusted odds ratio, 2.8; confidence interval, 1.4−5.3), respiratory distress syndrome (adjusted odds ratio, 3.0; confidence interval, 1.1−8.0), hypoglycemia (adjusted odds ratio, 3.2; confidence interval, 1.5−6.9), large for gestational age weight at birth (adjusted odds ratio, 2.5; confidence interval, 1.4−4.4), neonatal length of stay >4 days (adjusted odds ratio, 4.2; confidence interval, 1.9−9.6) and preeclampsia (adjusted odds ratio, 2.4; confidence interval, 1.2−4.6). There were no differences in rates of cesarean delivery, umbilical artery pH Conclusion Antenatal hemoglobin A1c values are useful for objective risk stratification of patients with pregestational diabetes. Strict glycemic control throughout pregnancy with a late pregnancy A1c target of

Objective To evaluate the accuracy of antenatal diagnosis of congenital heart disease (CHD) using screening methods including a combination of elevated hemoglobin A1c, detailed anatomy ultrasound, and fetal echocardiography. Study Design This is a retrospective cohort study of all pregnancies complicated by pregestational diabetes from January 2012 to December 2016. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for each screening regimen. The incremental cost-effectiveness ratio (ICER) was calculated for each regimen with effectiveness defined as additional CHD diagnosed. Results A total of 378 patients met inclusion criteria with an overall prevalence of CHD of 4.0% (n = 15). When compared with a detailed ultrasound, fetal echocardiography had a higher sensitivity (73.3 vs. 40.0%). However, all cases of major CHD were detected by detailed ultrasound (n = 6). Using an elevated early A1c > 7.7% and a detailed ultrasound resulted in a sensitivity and specificity of 60.0 and 99.4%, respectively. The use of selective fetal echocardiography for an A1c > 7.7% or abnormal detailed anatomy ultrasound would result in a 63.3% reduction in cost per each additional minor CHD diagnosed (ICER: $18,290.52 vs. $28,875.67). Conclusion Fetal echocardiography appears to have limited diagnostic value in women with pregestational diabetes. However, these results may not be generalizable outside of a high-volume academic setting.

Objective To ascertain the rate of in-hospital supplementation as it relates to early breastfeeding (BF) and early formula feeding (FF) and its effects on BF (exclusive and partial) at the time of discharge for infants born to women with pregestational diabetes mellitus (PGDM). Methods Retrospective cohort investigation of 282 women with PGDM who intended to BF and their asymptomatic infants admitted to the newborn nursery for blood glucose monitoring and routine care. Early feeding was defined by the initial feeding if given within four hours of birth. Results Of the 282 mother-infant dyads, for 134 (48%) early feeding was BF and for 148 (52%) early feeding was FF. Times from birth to BF and FF (median 1 hr, 0.3-6) were similar, while the time to first BF for those who FF and supplemented was longer (median 6 hr., 1-24). Ninety-seven infants (72%) who first BF also supplemented. Of these, 22 (23%) BF exclusively, 67 (69%) BF partially and 8 (8%) FF at discharge. One hundred seventeen (79%) who first FF also supplemented. Of these, 21 (18%) BF exclusively, 76 (65%) BF partially and 20 (17%) FF at discharge. Conclusion Regardless of the type of first feeding, the majority of infants born to women with PGDM require supplementation. Even when medically indicated, in-hospital supplementation is an obstacle, albeit not absolute, to exclusive BF at discharge. Parents should be reminded that occasional supplementation should not deter resumption and continuation of BF.

Gestational diabetes mellitus (GDM) is associated with adverse perinatal outcomes, with risks not only associated with more severe forms of GDM, but milder forms of GDM as well. Treatment of mild GDM with dietary intervention and insulin when necessary has proven to be effective in reducing the risks of several, but not all, adverse perinatal outcomes. Less is known about the long-term benefits of mild GDM treatment. This article will review the benefits of mild GDM treatment, and related risk factors, on short-term and long-term maternal and neonatal/child outcomes, with an emphasis on research conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network.

We performed RNA sequencing with the primary goal of discovering key placental villous trophoblast (VT) and decidua basalis (DB) transcripts differentially expressed in intra-amniotic infection (IAI)-induced preterm birth (PTB).RNA was extracted from 15 paired VT and DB specimens delivered of women with: 1) spontaneous PTB in the setting of amniocentesis-proven IAI and histological chorioamnionitis (n = 5); 2) spontaneous idiopathic PTB (iPTB, n = 5); and 3) physiologic term pregnancy (n = 5). RNA sequencing was performed using the Illumina HiSeq 2500 platform, and a spectrum of computational tools was used for gene prioritization and pathway analyses.In the VT specimens, 128 unique long transcripts and 7 mature microRNAs differed significantly between pregnancies complicated by IAI relative to iPTB (FDR0.1). The up-regulated transcripts included many characteristic of myeloblast-derived cells, and bioinformatic analyses revealed enrichment for multiple pathways associated with acute inflammation. In an expanded cohort including additional IAI and iPTB specimens, the expression of three proteins (cathepsin S, lysozyme, and hexokinase 3) and two microRNAs (miR-133a and miR-223) was validated using immunohistochemistry and quantitative PCR, respectively. In the DB specimens, only 11 long transcripts and no microRNAs differed significantly between IAI cases and iPTB controls (FDR0.1). Comparison of the VT and DB specimens in each clinical scenario revealed signatures distinguishing these placental regions.IAI is associated with a transcriptional signature consistent with acute inflammation in the villous trophoblast. The present findings illuminate novel signaling pathways involved in IAI, and suggest putative therapeutic targets and potential biomarkers associated with this condition.

OBJECTIVE To evaluate whether pregnancy-associated hypertension (preeclampsia or gestational hypertension) among women with varying degrees of glucose intolerance during pregnancy is associated with maternal metabolic syndrome 5-10 years later. METHODS This was an observational cohort study of women previously enrolled in a treatment trial of mild gestational diabetes mellitus or an observational study of lesser degrees of glucose intolerance evaluated 5-10 years after their index pregnancy. At follow-up, women underwent anthropometric and blood pressure measurements and analysis of fasting glucose and serum lipids. RESULTS A total of 825 women (47% of eligible women from the original study) were included in this analysis and evaluated at a median 7 years after their index pregnancy at a median age of 35 years. Overall, 239 (29%) had subsequent metabolic syndrome. The frequency of metabolic syndrome and its components was highest in the women who had pregnancy-associated hypertension and delivered preterm. After adjusting for confounding factors, pregnancy-associated hypertension in women who delivered preterm was associated with subsequent hypertension (130/85 mm Hg or greater; relative risk 3.06, 95% confidence interval [CI] 1.95-4.80, P

Background Low-dose aspirin is used for preeclampsia prevention in high-risk women, but the precise mechanism and optimal dose are unknown. Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TXA2) plays a key role in the pathogenesis of preeclampsia. Aspirin has a dose-dependent effect blocking production of TXA2, a potent stimulator of platelet aggregation and promoter of vasoconstriction. Incomplete inhibition of platelet aggregation, designated aspirin resistance, can be reduced by increasing the aspirin dose. Evidence in the nonobstetric literature suggests that aspirin resistance may be more common among patients with a high body mass index. Objective To investigate the association of obesity on platelet-derived thromboxane inhibition in high-risk women treated with low-dose aspirin. Materials and Methods This was a secondary analysis of a prospective multi-centered study investigating the effect of low-dose aspirin (60-mg) administration in women at high risk for preeclampsia. Maternal serum TXB2 (an indirect measure of TxA2) levels were drawn at 3 time points: randomization (13–26 weeks’ gestation), second trimester (at least 2 weeks after randomization and 24–28 weeks’ gestation), and third trimester (34–38 weeks’ gestation). Patients were included in the analysis if a TXB2 level was recorded at randomization and at least 1 time point thereafter. Patients were stratified by body mass index category and treatment arm. Median TXB2 levels were calculated at each time point, as well as rates of complete TXB2 inhibition ( Results A total of 1002 patients were included in the analysis, 496 (49.5%) and 506 (50.5%) in the low-dose aspirin and placebo groups respectively. There were substantial decreases in TXB2 levels among low-dose aspirin-treated women in all body mass index categories. In contrast, women assigned to placebo did not show a marked decrease in TXB2 levels after randomization, and obese women had higher median TXB2 levels in both the second (16.5, interquartile range [IQR] 8.0–31.8 vs 14.0, IQR 6.9–26.7, ng/mL; P = .032) and third (15.7, IQR 7.6-28.5 vs 11.9, IQR 4.6-25.9, ng/mL; P = .043) trimesters. When comparing among stratified body mass index low-dose aspirin groups, women with class III obesity had the lowest odds of undetectable TXB2 levels in the second trimester (adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.15–0.72) and third trimester (aOR, 0.30; 95% CI, 0.11–0.78) as well as at both time points (aOR, 0.09; 95% CI, 0.02–0.41). Conclusion High-risk obese women receiving low-dose aspirin for the prevention of preeclampsia have lower rates of complete inhibition of TXB2. These data suggest that an increase in aspirin dosing or frequency may be necessary in this population.

To review the current evidence of the safety and efficacy of the use of oral agents for treatment of gestational diabetes (GDM). The use of metformin and glyburide in pregnancy for treatment of GDM has dramatically increased since the early 2000s. Meta-analyses suggest that glyburide may increase the risk for large for gestational (LGA) infants and neonatal hypoglycemia. Conversely, metformin may potentially decrease rates of pregnancy-induced hypertension, LGA, neonatal hypoglycemia, and maternal weight gain. However, recent long-term offspring studies indicate a potential detrimental effect of metformin on fat mass that suggests an effect of such medication on fetal programming. While there have been several novel oral anti-diabetes medications brought to market in the past decade, there is minimal data to guide use and in particular data regarding long-term safety for the exposed offspring of treated women. Most professional societies recommend insulin as first-line treatment of gestational diabetes after failure of lifestyle modification. Both metformin and glyburide cross the placenta and long-term safety data is limited. However, patient satisfaction is substantially higher with use of oral agents, and the current literatures suggest that metformin may reduce several common short-term adverse outcomes related to GDM.

OBJECTIVE To examine the effects of early breastfeeding (eBF) or early formula feeding (eFF) on hypoglycemia and on BF initiation in infants born to women with pregestational diabetes mellitus (PGDM) who intended to BF. METHODS Retrospective cohort investigation of 554 women with PGDM and their infants (IDMs) who delivered during 2008-2016. The first feeding (BF or FF) was considered early if given within 4 hours from birth. RESULTS 282 (51%) IDMs were admitted to the Well Baby Nursery. Of the 134 IDMs whose early feeding was BF, hypoglycemia affected 30% which was corrected with oral feedings in 78% of the cases. At discharge, 49% BF exclusively while 45% BF partially. Of the 148 IDMs whose early feeding was FF, hypoglycemia affected 40% which was corrected with oral feedings in 69% of the cases. At discharge, 14% BF exclusively while 48% BF partially. There were 272 (49%) IDMs admitted to the NICU. Their early feeding was BF (14%) and FF (86%). Hypoglycemia developed in 50% and 43% of these groups, respectively. Benefits of early feedings on hypoglycemia were masked by the routine use of IV dextrose infusions. At discharge, early BF led to exclusive BF in 45% and partial BF in 50% of the cases. Early FF led to exclusive BF in 17% and partial BF in 42% of the cases. CONCLUSIONS Early and continued feeding (BF preferably or FF if BF is not feasible) should be the first line of treatment for hypoglycemia. Early BF is paramount for BF initiation. Early FF is an obstacle, albeit not absolute, to BF initiation, thus it should not deter continued efforts to start or resume BF.

BACKGROUND Asymptomatic infants born to women with pregestational diabetes mellitus (PGDM) are usually admitted to the well baby nursery (WBN) while those who are symptomatic or in need of specialized care are admitted to the neonatal intensive care unit (NICU). OBJECTIVE To determine if changes in the NICU admission rate of asymptomatic infants born to women with PGDM during two different epochs affected breastfeeding (BF) initiation rates. DESIGN/METHODS Retrospective cohort investigation of 386 women with PGDM and their infants who delivered in 2008-11 (epoch 1) and 457 who delivered in 2013-16 (epoch 2) at a single institution. RESULTS NICU admissions: Comparison between epoch 1 and epoch 2 showed a decrease in the number of admissions from 243 (63%) to 175 (38%) *(chi square *p < 0.05). Respiratory distress (39 and 43%) and prematurity (28 and 23%) as admission diagnoses remained unchanged. Admissions for prevention of hypoglycemia declined (32% to 21%)*. At discharge from the NICU, exclusive BF (12 to 19%)* and any BF increased (41 to 55%)* while formula feeding (FF) decreased (59 to 45%)*. Admission to the NICU remained a strong predictor of BF initiation failure (a OR 0.6, 95% , CI 0.4-0.9, p 0.005).WBN admissions: Comparison between epoch 1 and epoch 2 showed an increase in the number of admissions from 143 (37%) to 282 (62%)*. The incidence of hypoglycemia (31% and 38%) and its correction with oral feedings (76% and 71%) remained unchanged. At discharge from the WBN, exclusive BF (15 to 27%)* and any BF (52 to 62%)* increased while FF decreased (48 to 38%)*. CONCLUSIONS A decrease in the number of NICU admissions of asymptomatic infants born to women with PGDM is associated with improvements in BF initiation rates.

OBJECTIVE We sought to identify fetal heart rate (FHR) characteristics that are associated with neonatal encephalopathy (NE). DESIGN Retrospective case-control study. SETTING A single medical centre in Shanghai, China, 2006-2015. SAMPLE Women delivering a singleton, non-anomalous infant at ≥36 weeks' gestation diagnosed with NE (cases, n = 109) were compared with a group of women with unaffected infants (controls, n = 233). METHODS Two physicians blinded to the outcome independently reviewed FHR tracings during the last 30 minutes of tracing prior to delivery. FHR characteristics were compared in the two groups and multivariable logistic regression was used to adjust for confounding. MAIN OUTCOME MEASURES Adjusted odds ratio (aOR) and 95% confidence interval (CI) for the presence of specific FHR categories and characteristics. RESULTS Category II FHR tracings were observed in 89% of women prior to delivery and were not independently associated with NE. Notably, a category III FHR was observed in 17.4% of women in the NE group compared with 0.9% of women in the control group (aOR 44.99, 95% CI 7.23-279.97). Bradycardia, minimal/absent variability, late decelerations and prolonged decelerations were independently associated with NE, whereas accelerations were protective. Similar findings were found when the cases were limited to NE with arterial cord pH

To describe perinatal outcomes of twin pregnancies complicated by intrahepatic cholestasis of pregnancy (ICP).We conducted a retrospective cohort study of women delivered at a large tertiary obstetric center in Shanghai, China from January 2006 to May 2014. Delivery data were abstracted from medical records of all twin gestations delivered at the hospital.A total of 129/1922(6.7%) twin and 1190/92 273 singleton (1.3%) pregnancies were complicated by ICP. An increased risk of stillbirth among twin pregnancies was observed (3.9% and 0.8% in the ICP and non-ICP groups, respectively; aOR 5.75, 95% CI 2.00-16.6). Stillbirths with ICP and twins occurred between 33 and 35 weeks gestation compared to 36-38 weeks gestation among singletons. ICP in twins was also associated with an increased risk of preterm birth (37 weeks) with an aOR of 4.17 (95% CI 2.47-7.04) and an aOR of 1.89 (95% CI 1.26-2.85) for delivery35 weeks. Twin pregnancies complicated by ICP also had increased meconium staining of amniotic fluid and lower birth weight.Twin pregnancies with ICP have significantly increased risks of adverse perinatal outcomes including stillbirth and preterm birth. Stillbirth occurs at an earlier gestational age in twin gestation compared to singletons, suggesting that earlier scheduled delivery should be considered in these women.

Objective This study aims to determine whether there is a threshold 3-hour oral glucose tolerance test (OGTT) value associated with accelerated risk of adverse pregnancy outcomes. Study Design In a secondary analysis of a cohort of women with untreated mild gestational glucose intolerance, we used generalized additive models with smoothing splines to explore nonlinear associations between each of the 3-hour OGTT values (fasting, 1-hour, 2-hour, and 3-hour) and adverse pregnancy outcomes, including the study's composite outcome (perinatal mortality, hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia, and/or birth trauma), large for gestational age birth weight, small for gestational age birth weight, shoulder dystocia, neonatal hypoglycemia, gestational hypertension (gHTN), and preeclampsia. Results Among the 1,360 eligible women, each timed OGTT value was linearly associated with increased odds of composite adverse outcome. We found evidence of a departure from linearity only for the association between fasting glucose and gHTN/preeclampsia, with a stronger association for values of 85 to 94 mg/dL ( p = 0.03). We found no evidence of departure from linearity for any other OGTT values and measured outcomes (all chi-square test p -values ≥ 0.05). Conclusion In a population of untreated women with mild gestational glucose intolerance and fasting OGTT

OBJECTIVE: To assess the association of subsequent pregnancy with subsequent metabolic syndrome and type II diabetes mellitus after a pregnancy complicated by mild gestational diabetes mellitus (GDM). METHODS: We conducted a prospective observational follow-up study of women with mild GDM randomized from 2002 to 2007 to usual care or dietary intervention and glucose self-monitoring. Women were evaluated 5–10 years after the parent study. Participants were grouped according to the number of subsequent pregnancies (group A, none [reference]; group B, one; group C, two or greater). Serum triglycerides, glucose tolerance, high-density lipoprotein cholesterol, blood pressure, and waist circumference were assessed. Metabolic syndrome was diagnosed by American Heart Association and National Heart Lung and Blood Institute criteria. Multivariable regression was used to estimate adjusted relative risks (RRs) and 95% confidence intervals (CIs). RESULTS: Of 905 eligible women from the original trial, 483 agreed to participate, 426 of whom were included in this analysis. Groups A, B, and C consisted of 212, 143, and 71 women, respectively. Of women with subsequent pregnancies, 32% (69/214) had another pregnancy complicated with GDM. No difference between groups was observed for metabolic syndrome (group A, 34%; group B, 33%; group C, 30%). Subsequent pregnancies were associated with diabetes mellitus outside of pregnancy (group A, 5.2%; group B, 10.5%, RR 2.62, 95% CI 1.16–5.91; group C, 11.3%, RR 2.83, 95% CI 1.06–7.59), and if complicated with GDM (no subsequent GDM pregnancy, RR 1.99, 95% CI 0.82–4.84; subsequent GDM pregnancy, RR 3.75, 95% CI 1.60–8.82). CONCLUSION: In women with prior mild GDM, subsequent pregnancies did not increase the frequency of metabolic syndrome, but subsequent pregnancies with GDM increased the risk of diabetes mellitus outside of pregnancy.

OBJECTIVE To evaluate whether treatment of mild gestational diabetes mellitus (GDM) confers sustained offspring health benefits, including a lower frequency of obesity. RESEARCH DESIGN AND METHODS Follow-up study of children (ages 5–10) of women enrolled in a multicenter trial of treatment versus no treatment of mild GDM. Height, weight, blood pressure, waist circumference, fasting glucose, fasting insulin, triglycerides, and HDL cholesterol were measured. RESULTS Five hundred of 905 eligible offspring (55%) were enrolled. Maternal baseline characteristics were similar between the follow-up treated and untreated groups. The frequencies of BMI ≥95th (20.8% and 22.9%) and 85th (32.6% and 38.6%) percentiles were not significantly different in treated versus untreated offspring (P = 0.69 and P = 0.26). No associations were observed for BMI z score, log waist circumference, log triglycerides, HDL cholesterol, blood pressure, or log HOMA-estimated insulin resistance (HOMA-IR). The effect of treatment was different by sex for fasting glucose and log HOMA-IR (P for interaction = 0.002 and 0.02, respectively) but not by age-group (5–6 and 7–10 years) for any outcomes. Female offspring of treated women had significantly lower fasting glucose levels. CONCLUSIONS Although treatment for mild GDM has been associated with neonatal benefits, no reduction in childhood obesity or metabolic dysfunction in the offspring of treated women was found. However, only female offspring of women treated for mild GDM had lower fasting glucose.