Subsidized gestational diabetes mellitus screening and management program in rural China: a pragmatic multicenter, randomized controlled trial.

BACKGROUND: The increasing prevalence of gestational diabetes mellitus (GDM) is a major challenge, particularly in rural areas of China where control rates are suboptimal. This study aimed to evaluate the effectiveness of a GDM subsidy program in promoting GDM screening and management in these underserved regions. METHODS: This multicenter, randomized controlled trial (RCT) was conducted in obstetric clinics of six rural hospitals located in three provinces in China. Eligible participants were pregnant women in 24-28 weeks' gestation, without overt diabetes, with a singleton pregnancy, access to a telephone, and provided informed consent. Participants were randomly assigned in a 1:1 ratio to either the intervention or control groups using an internet-based, computer-generated randomization system. The intervention group received subsidized care for GDM, which included screening, blood glucose retesting, and lifestyle management, with financial assistance provided to health care providers. In contrast, the control group received usual care. The primary outcomes of this study were the combined maternal and neonatal complications associated with GDM, as defined by the occurrence of at least one pre-defined complication in either the mother or newborn. The secondary outcomes included the GDM screening rate, rates of glucose retesting for pregnant women diagnosed with GDM, dietary patterns, physical activity levels, gestational weight gain, and antenatal visit frequency for exploratory purposes. Primary and secondary outcomes were obtained for all participants with and without GDM. Binary outcomes were analyzed by the generalized linear model with a link of logistic, and odds ratios (OR) with 95% confidence intervals (CIs) were reported. Count outcomes were analyzed by Poisson regression, and incidence rate ratios with 95% CIs were reported. RESULTS: A total of 3294 pregnant women were randomly assigned to either the intervention group (n = 1649) or the control group (n = 1645) between 15 September 2018 and 30 September 2019. The proportion of pregnant women in the intervention group who suffered from combined maternal and/or neonatal complications was lower than in the control group with adjusted OR = 0.86 (0.80 to 0.94, P = 0.001), and a more significant difference was observed in the GDM subgroup (adjusted OR = 0.66, 95% CI 0.47 to 0.95, P = 0.025). No predefined safety or adverse events of ketosis or ketoacidosis associated with GDM management were detected in this study. Both the intervention and control groups had high GDM screening rates (intervention: 97.2% [1602/1649]; control: 94.5% [1555/1645], P < 0.001). Moreover, The intervention group showed a healthier lifestyle, with lower energy intake and more walking minutes (P values < 0.05), and more frequent blood glucose testing (1.5 vs. 0.4 visits; P = 0.001) compared to the control group. CONCLUSION: In rural China, a GDM care program that provided incentives for both pregnant women and healthcare providers resulted in improved maternal and neonatal health outcomes. Public health subsidy programs in China should consider incorporating GDM screening and management to further enhance reproductive health. TRIAL REGISTRATION: China Clinical Trials Registry ChiCTR1800017488. https://www.chictr.org.cn/.

Risk of Adverse Neonatal Events in Pregnancies Complicated by Severe Maternal Morbidity.

OBJECTIVE: To investigate the risk of adverse neonatal events after a pregnancy complicated by severe maternal morbidity. STUDY DESIGN: We analyzed a population-based cohort of deliveries in Quebec, Canada, between 2006 and 2021. The main exposure measure was severe maternal morbidity, comprising life-threatening conditions such as severe hemorrhage, cardiac complications, and eclampsia. The outcome included adverse neonatal events such as very preterm birth (gestational age <32 weeks), bronchopulmonary dysplasia, hypoxic ischemic encephalopathy, and neonatal death. Using log-binomial regression models, we estimated adjusted relative risks (RRs) and 95% confidence intervals (CIs) for the association between severe maternal morbidity and adverse neonatal events. RESULTS: Among 1 199 112 deliveries, 29 992 (2.5%) were complicated by severe maternal morbidity and 83 367 (7.0%) had adverse neonatal events. Severe maternal morbidity was associated with 2.96 times the risk of adverse neonatal events compared with no morbidity (95% CI 2.90-3.03). Associations were greatest for mothers who required assisted ventilation (RR 5.86, 95% CI 5.34-6.44), experienced uterine rupture (RR 4.54, 95% CI 3.73-5.51), or had cardiac complications (RR 4.39, 95% CI 3.98-4.84). Severe maternal morbidity was associated with ≥3 times the risk of neonatal death and hypoxic-ischemic encephalopathy and ≥10 times the risk of very preterm birth and bronchopulmonary dysplasia. CONCLUSIONS: Severe maternal morbidity is associated with an elevated risk of adverse neonatal events. Better prevention of severe maternal morbidity may help reduce burden of severe neonatal morbidity.

Earlier detection of gestational diabetes impacts on medication requirements, neonatal and maternal outcomes.

AIM: Gestational diabetes (GD) is a global health concern with significant implications for maternal and neonatal outcomes. This study investigates the association between early GD (eGD) diagnosis (<24 weeks), pharmacotherapy requirements and adverse neonatal outcomes. MATERIALS AND METHODS: A cohort of 369 pregnant women underwent a 75-g oral glucose tolerance test. Maternal variables, pharmacotherapy prescriptions and neonatal outcomes were analysed employing t-tests, χ2 tests, and logistic regression. A p < .05 was considered significant. RESULTS: Early GD increased the odds of neonatal hypoglycaemia [odds ratio (OR): 18.57, p = .013] and respiratory distress syndrome (OR: 4.75, p = .034). Nutritional therapy prescription by an accredited nutritionist was the most common treatment in women diagnosed after 24 weeks, but those with eGD required more frequently specialized nutritional consulting + metformin to achieve glycaemic control (p = .027). eGD was associated with a higher requirement of nutritional therapy prescription + metformin (OR: 2.26, 95% confidence interval: 1.25-4.09, p = .007) and with maternal hyperglycaemia during the post-partum period at 2 h of the oral glucose tolerance test (OR: 1.03, 95% confidence interval: 1.02-1.13, p = .024). CONCLUSION: Timely diagnosis and personalized treatment of GD are desirable because an earlier presentation is related to a higher risk of adverse neonatal and maternal outcomes.

The association between pre-eclampsia and neonatal complications in relation to gestational age.

AIM: There has been limited research about the associations between pre-eclampsia and neonatal complications in relation to gestational age. This register-based study aimed to address that gap in our knowledge. METHODS: We used Swedish Medical Birth Register to carry out a population-based study on primiparas with singleton pregnancies from 1999 to 2017. Descriptive statistics and logistic regressions were used to study the associations between pre-eclampsia and neonatal complications in different gestational ages. The data is presented as adjusted odds ratios (aORs) with 95% CI. RESULTS: The study comprised 805 591 primiparas: 2.9% had mild to moderate pre-eclampsia and 1.4% had severe pre-eclampsia. Neonates born to women with pre-eclampsia had increased risks of several complications compared to those born to mothers without pre-eclampsia. After adjustment for confounding variables, the risk of being small for gestational age (aOR 5.3, CI: 5.1-5.5) and needing resuscitation (aOR 2.6, CI: 2.4-2.7) were increased. The risk of a low Apgar score and convulsions/hypoxic ischemic encephalopathy was increased at 32-41 weeks of gestation. Moreover, the overall risk of sepsis (aOR 1.9. CI: 1.8-2.1) and perinatal death (aOR 1.2, CI: 1.1-1.5) was also increased. CONCLUSION: Compared with infants of mothers without pre-eclampsia, those exposed to pre-eclampsia had higher risks of all the studied neonatal complications.

Using latent variable modelling to identify etiological heterogeneity in preterm delivery.

AIMS: To identify a subgroup of mothers at high risk of preterm delivery, defined by empirical classes of multimorbidity and recurrence across three consecutive births. METHODS: The data were extracted from the perinatal data collection (PDC) of all inpatient live births (n = 435 912) occurring in the Australian state of Queensland between January 2009 and December 2015. Within this data, a total of 7714 primiparous mothers delivered three consecutive singleton live births (total births = 23 142), and comprise the sample for all analyses. RESULTS: The LCA indicated a four-class solution fit the data best at each time point, including (i) a 'normative' or healthy class with little morbidity (including >80% of the sample at each birth); (ii) a preterm, high morbidity class (<2% of the sample); (ii) a delivery morbidity class (4-8% of the sample); and (iii) preterm, low morbidity class (5-6% of the sample). Each group exhibited unique and consistent associations with maternal and pregnancy-related factors across births. After accounting for these factors, the high morbidity class and preterm, low morbidity class strongly predicted these same classes across consecutive births, and from birth 1 to birth 3 (second-order transition). CONCLUSIONS: A small but highly morbid class of neonatal deliveries emerged, exhibiting strong continuity across consecutive births (odds ratios >10), independent of a range of maternal and pregnancy-related factors. This group of women, if subject to further investigation, could provide valuable insight into the aetiology of prematurity and associated morbidity, perhaps providing information to improve birth outcomes among all women.

Timing of planned cesarean delivery among patients with two previous cesarean sections.

OBJECTIVES: The timing of planned repeat cesarean delivery (CD) is debateful in clinical practice. Planned repeat CD is typically scheduled before the spontaneous onset of labor to minimize the risk of uterine rupture during labor and the associated risk for fetal compromise. This timing should be balanced with the potential risk of delivering an infant who could benefit from additional maturation in utero. We aim to study the influence of gestational age at the time of repeat CD on maternal and fetal complications. STUDY DESIGN: A population-based retrospective cohort study including all term singleton third CDs (≥ 37 weeks of gestation), between February-2020 and January-2022 at a tertiary medical center was conducted. Maternal and neonatal adverse outcomes were compared by gestational age at the time of the CD. A logistic regression models were constructed to adjust for confounders. RESULTS: The study population included624 third CDs. Among them, two study groups were defined: 199 were at 37 + 0 to 37 + 6 weeks of gestation, and 44 were at ≥ 39 weeks of gestation at the time of delivery. 381 were at 38 + 0 to 38 + 6 weeks. Since our routine practice is to schedule elective CD at 38 + 0 to 38 + 6 weeks of gestation, we defined this group as the comparison group. In a multivariate analysis, both study groups were associated with significantly higher rates of emergent CDs after adjusting for maternal age, parity, ethnicity, premature rapture of membranes, spontaneous onset of labor and birthweight. After adjusting also for emergent CDs, CDs at 37 + 0 to 37 + 6 weeks of gestation were significantly associated with maternal and neonatal length of stay exceeding 4 days. Additionally, CDs at 37 + 0 to 37 + 6 weeks of gestation were also associated with composite of adverse neonatal and maternal outcomes. CONCLUSIONS: Our study demonstrated that scheduling third CD at 38 + 0 to 38 + 6 weeks is associated with reduced risk of emergent CD, as well as beneficial maternal and neonatal outcomes.

Association between foetal sex and adverse neonatal outcomes in women with gestational diabetes.

AIMS: Foetal male sex is associated with adverse perinatal outcomes. However, studies evaluating the impact of foetal sex on perinatal outcomes in women with gestational diabetes (GDM) are scarce. We studied whether male new-born sex is associated with neonatal outcomes, in women with GDM. METHODS: This is a retrospective study based on the national Portuguese register of GDM. All women with live-born singleton pregnancies between 2012 and 2017 were eligible for study inclusion. Primary endpoints under analysis were neonatal hypoglycaemia, neonatal macrosomia, respiratory distress syndrome (RDS) and neonatal intensive care unit (NICU) admission. We excluded women with missing data on the primary endpoint. Pregnancy data and neonatal outcomes between female and male new-borns were compared. Multivariate logistic regression models were built. RESULTS: We studied 10,768 new-borns in mothers with GDM, 5635 (52.3%) male, 438 (4.1%) had neonatal hypoglycaemia, 406 (3.8%) were macrosomic, 671 (6.2%) had RDS, and 671 (6.2%) needed NICU admission. Male new-borns were more frequently small or large for gestational age. No differences were observed on maternal age, body mass index, glycated haemoglobin, anti-hyperglycaemic treatment, pregnancy complications or gestational age at delivery. In the multivariate regression analysis, male sex was independently associated with neonatal hypoglycaemia [OR 1.26 (IC 95%: 1.04-1.54), p = 0.02], neonatal macrosomia [1.94 (1.56-2.41), p < 0.001], NICU admission [1.29 (1.07-1.56), p = 0.009], and RDS [1.35 (1.05-1.73, p = 0.02]. CONCLUSIONS: Male new-borns have an independent 26% higher risk of neonatal hypoglycaemia, 29% higher risk of NICU admission, 35% higher risk of RDS, and almost twofold higher risk of macrosomia, compared to female new-borns.

Adverse pregnancy outcomes associated with endometriosis in Ukraine: results a multicenter study.

OBJECTIVE: Aim: To estimate pregnancy outcomes associated with endometriosis in Ukraine. PATIENTS AND METHODS: Materials and Methods: We performed the multicentre prospective cohort study during the period from January 1st, 2019 to December 31st, 2021. The study included pregnant women aged ≥18 years hospitalized in 17 hospitals from 15 regions of Ukraine. Logistic regression analysis provided odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Results: Of the 27,558 women, 990 (3,6%) reported a diagnosis of endometriosis before pregnancy. In 990 deliveries, women with endometriosis had a higher risk of hypertension in pregnancy (OR 1.2, 95% CI 1.0-1.3), preeclampsia (OR 1.4, 95% CI 1.3-1.5), severe preeclampsia (OR 1.7, 95% CI 1.5-2.3), hemorrhage in pregnancy (OR 2.3, 95% CI 2.0-2.5), placental abruption (OR 2.0, 95% CI 1.7-2.3), placenta previa (OR 3.9, 95% CI 3.5-4.3), premature rupture of membranes (OR 1.7, 95% CI 1.5-1.8), and retained placenta (OR 3.1, 95% CI 1.4-6.6). The neonates had increased risks of preterm birth before 28 weeks (OR 3.1, 95% CI 2.7-3.6), birth before 34 weeks (OR 3.2, 95% CI 2.8-3.6), being small for gestational age (OR 1.5, 95% CI 1.4-1.6), being diagnosed with congenital malformations (OR 1.3, 95% CI 1.3-1.4), and neonatal death (OR 1.8, 95% CI 1.4-2.1). CONCLUSION: Conclusions: Pregnant women with endometriosis are at elevated risk for serious and important adverse maternal, fetal and neonatal outcomes. The magnitude of these complications calls for more intensive antenatal care of pregnant women with endometriosis.

Associations between maternal metabolic conditions and neurodevelopmental conditions in offspring: the mediating effects of obstetric and neonatal complications.

BACKGROUND: Maternal pre-gestational diabetes (PGDM), gestational diabetes mellitus (GDM), and overweight/obesity have been associated with increased risks of offspring neurodevelopmental conditions (NDCs) including autism, intellectual disability (ID), and attention deficit/hyperactivity disorder (ADHD). Less is known about whether and how obstetric and neonatal complications (e.g., preterm birth, neonatal asphyxia) could mediate these associations. METHODS: In this Swedish register-based cohort study, we examined complications during pregnancy, delivery, and the neonatal period as potential mediators of the relationships between maternal metabolic conditions and offspring NDCs. We quantified the extent to which these obstetric and neonatal factors could mediate the associations of maternal metabolic conditions with offspring NDCs by applying parametric regression models for single mediation analyses and weighting-based methods for multiple mediation analyses under counterfactual frameworks. RESULTS: The study sample included 2,352,969 singleton children born to 1,299,692 mothers from 1987-2010 who were followed up until December 31, 2016, of whom 135,832 children (5.8%) were diagnosed with at least one NDC. A substantial portion of the association between maternal PGDM and children's odds of NDCs could be explained by the combined group of obstetric and neonatal complications in the multiple mediation analysis. For instance, these complications explained 44.4% of the relationship between maternal PGDM and offspring ID risk. The proportion of the relationship between maternal overweight/obesity and children's risk of NDCs that could be explained by obstetric and neonatal complications was considerably smaller, ranging from 1.5 to 8.1%. Some complications considered on their own, including pregnancy hypertensive diseases, preterm birth, neonatal asphyxia, and hematological comorbidities, could explain at least 10% of the associations between maternal PGDM and offspring NDCs. Complications during the neonatal period showed a stronger joint mediating effect for the relationship between PGDM and offspring NDCs than those during pregnancy or delivery. CONCLUSIONS: Obstetric and neonatal complications could explain nearly half of the association between maternal PGDM and offspring risk of NDCs. The mediating effects were more pronounced for complications during the neonatal period and for specific complications such as pregnancy hypertensive diseases, preterm birth, neonatal asphyxia, and hematological comorbidities. Effective preventive strategies for offspring NDCs should holistically address both the primary metabolic issues related to PGDM and the wide array of potential complications, especially those in the neonatal period.

Maternal and neonatal outcomes after benzodiazepine and benzodiazepine agonist exposure during pregnancy in women with mental disorders.

AIMS: To compare the gestational age of neonates in utero exposed to benzodiazepines (BDZs) with nonexposed controls. Secondary objectives were birth weight, presence of congenital malformations, APGAR score and the need for >3 months (prolonged) maternal psychiatric care. METHODS: A retrospective cohort study of women and neonates from 2013 to 2021 with univariate and multivariable analysis to study the associations between BDZ exposure and gestational age compared to nonexposed women with mental health problems. RESULTS: We found that BDZ exposure was not associated with a lower gestational age. We found that women in the exposed group had an increased risk of psychiatric care (adjusted odds ratio 2.58 [95% confidence interval 1.71-3.91], P < .001). CONCLUSION: We found that in utero BDZ exposure was not associated with a significantly lower gestational age of the neonates and was associated with prolonged psychiatric care of their mothers.

Concordance of neonatal critical condition data between secondary databases: Florida and Texas birth certificate Linkage with medicaid analytic extract.

BACKGROUND: Limited information is available about neonates' critical conditions data quality. The study aim was to measure the agreement regarding presence of neonatal critical conditions between Medicaid Analytic eXtract claims data and Birth Certificate (BC) records. METHODS: Claims data files of neonates born between 1999-2010 and their mothers were linked to birth certificates in the states of Texas and Florida. In claims data, neonatal critical conditions were identified using medical encounter claims records within the first 30 days postpartum, while in birth certificates, the conditions were identified based on predetermined variables. We calculated the prevalence of cases within each data source that were identified by its comparator, in addition to calculating overall agreement and kappa statistics. RESULTS: The sample included 558,224 and 981,120 neonates in Florida and Texas, respectively. Kappa values show poor agreement (< 20%) for all critical conditions except neonatal intensive care unit (NICU) admission, which showed moderate (> 50%) and substantial (> 60%) agreement in Florida and Texas, respectively. claims data resulted in higher prevalences and capture of a larger proportion of cases than the BC, except for assisted ventilation. CONCLUSIONS: Claims data and BC showed low agreement on neonatal critical conditions except for NICU admission. Each data source identified cases most of which the comparator failed to capture, with higher prevalences estimated within claims data except for assisted ventilation.

Death and severe morbidity in isolated periviable small-for-gestational-age fetuses.

OBJECTIVE: This study aims to predict perinatal death or severe sequelae in isolated small-for-gestational-age fetuses, diagnosed at a periviable gestational age, based on ultrasound and Doppler parameters at diagnosis. DESIGN: Observational study. SETTING: A tertiary perinatal centre. POPULATION: A cohort of singleton non-malformed fetuses suspected to be small for gestational age (estimated fetal weight, EFW, <10th centile) diagnosed at 22.0-25.6 weeks of gestation. The following parameters were recorded at diagnosis: severe smallness (<3rd centile); absent or reversed end-diastolic velocity in umbilical artery; abnormal middle cerebral artery Doppler; abnormal cerebroplacental ratio; abnormal uterine artery Doppler; and absent or reversed end-diastolic velocity in the ductus venosus. METHODS: Logistic regression analysis. MAIN OUTCOME MEASURES: Predictive performance of EFW and Doppler parameters for short-term adverse outcome of perinatal morbimortality and composite serious adverse outcomes (death, neurological impairment or severe bronchopulmonary dysplasia). RESULTS: A total of 155 pregnancies were included. There were 13 (8.4%) intrauterine and 11 (7.7%) neonatal deaths. A short-term adverse perinatal outcome occurred in 40 (25.8%) pregnancies. There were 31 (20%) cases of serious adverse outcomes. For the prediction of serious adverse outcomes, the combination of absent or reversed end-diastolic velocity in the umbilical artery and impaired middle cerebral artery detected by Doppler evaluation achieved a detection rate of 87%, with a false-positive rate of 14% (accuracy 86%). CONCLUSION: In periviable isolated small-for-gestational-age fetuses, a Doppler evaluation of the umbilical and fetal brain circulation can accurately predict short-term adverse perinatal complications and serious adverse outcomes.

Maternal and neonatal complications after IVF/ICSI-fresh embryo transfer in low-prognosis women under the POSEIDON criteria: a retrospective cohort study.

BACKGROUND: Several studies on pregnancy complications of poor ovarian response (POR) patients did not draw a consistent conclusion. The POSEIDON criteria introduces the concept of "low prognosis" and divides POR patients into four groups based on age, AFC and AMH for individualized management. We analyzed low-prognosis population and patients with regular ovarian response, compared maternal and neonatal complications and discussed the relevant risk factors. METHODS: A retrospective cohort study was conducted of females who achieved a singleton clinical pregnancy after IVF / ICSI-fresh embryo transfer in a single center from January 2014 to March 2019. Participants with low prognosis, as defined by the POSEIDON criteria, were enrolled in the study groups. The controls were defined as AFC ≥ five and number of retrieved oocytes > nine. Maternal and neonatal complications were compared among those groups. RESULTS: There were 2554 cycles in POSEIDON group 1, 971 in POSEIDON group 2, 141 in POSEIDON group 3, 142 in POSEIDON group 4, and 3820 in Control. Univariate analysis roughly showed that Groups 2 and 4 had an increased tendency of pregnancy complications. Multi-variable generalized estimating equations (GEE) analysis showed that the risks of GDM, total pregnancy loss, and first-trimester pregnancy loss in Groups 2 and 4 were significantly higher than in Control. The risk of hypertensive disorders of pregnancy (HDP) in Groups 2 and 3 increased, and Group 4 had an increased tendency without statistical significance. After classification by age, GEE analysis showed no significant difference in risks of all complications among groups ≥ 35 years. In patients < 35 years, the risk of HDP in POSEIDON group 3 was significantly higher than in controls (< 35 years), and there was no significant increase in the risk of other complications. CONCLUSION: Compared to patients with regular ovarian response, low-prognosis population have increased tendency of maternal and neonatal complications. In low-prognosis patients, advanced age (≥ 35 years) might be the predominant risk factor for pregnancy complications. In those < 35 years, poor ovarian reserve could contribute to HDP.

PREGNANCY AND BIRTH OUTCOMES IN FEMALE WITH AND WITHOUT ASSISTED REPRODUCTIVE TECHNOLOGY IN UKRAINE.

OBJECTIVE: The aim: To assess and compare the risk of maternal/perinatal complications and adverse outcomes in pregnancy and childbirth conceived by ART with those conceived naturally in Ukraine. PATIENTS AND METHODS: Materials and Methods: We conducted a retrospective multicenter cohort study from January 1st, 2019 to December 31st, 2021. This study included pregnant women who delivered at 14 Women's Hospitals from 8 regions of Ukraine. RESULTS: Results: A total of 21,162 pregnancies were included. Of these, there were 19,801 natural pregnancies and 1,361 pregnancies after ART. The proportion of ART. pregnancies has increased every year in during study period, peaking in 2021 (6.7%). Data analysis showed that the risks of gestational diabetes, preeclampsia, moderate or severe anemia, liver-related diseases, thyroid-related diseases, preterm birth, placenta previa, postpartum hemorrhage, and cesarean section were significantly increased in ART pregnancy. For neonatal outcomes, women conceived by ART were more likely to have twins. The effects of ART on the risk of premature rupture of membrane, cord entanglement, intrapartum fever, and cesarean section were more pronounced in singletons pregnancies. CONCLUSION: Conclusions: Women conceived by ART were at increased risks of several adverse pregnancy outcomes compared with women conceived naturally. Therefore, prenatal and intrapartum monitoring should be strengthened, and neonatal outcomes should be closely observed for ART pregnancy.

Outcomes in neonates born to mothers with COVID-19 during the second wave in India.

COVID-19 pandemic has affected all age groups globally including pregnant women and their neonates. The aim of the study was to understand outcomes in neonates of mothers with COVID-19 during the first and second waves of COVID-19 pandemic. A retrospective analysis of 2524 neonates born to SARS-CoV-2-infected mothers was conducted during the first wave (n = 1782) and second wave (n = 742) of the COVID-19 pandemic at five study sites of the PregCovid registry in Maharashtra, India. A significant difference was noted in preterm birth, which was higher in the second wave (15.0%, 111/742) compared to the first wave (7.8%, 139/1782) (P < 0.001). The proportion of neonates requiring NICU admission was significantly higher in the second wave (19.0%, 141/742) as compared to that in the first wave (14.8%, 264/1782) (P < 0.05). On comparing regional differences, significantly higher neonatal complications were reported from Mumbai metropolitan region (P < 0.05). During the second wave of COVID-19, birth asphyxia and prematurity were 3.8- and 2.1-fold higher respectively (P < 0.001). Neonatal resuscitation at birth was significantly higher in second wave (3.4%, 25/742 vs 1.8%, 32/1782) (P < 0.05). The prevalence of SARS-CoV-2 infection in neonates was comparable (4.2% vs 4.6%) with no significant difference between the two waves. CONCLUSION: Higher incidence of adverse outcomes in neonates born to SARS-CoV-2-infected mothers in the second wave of COVID-19 as compared to the first wave. TRIAL REGISTRATION: PregCovid study is registered with the Clinical Trial Registry of India (CTRI/2020/05/025423, Registered on 28/05/2020). WHAT IS KNOWN: • The second wave of COVID-19 was more lethal to pregnant women than the first wave. Newborns are at risk of developing complications. WHAT IS NEW: • Birth asphyxia, prematurity, and neonatal resuscitation at birth were significantly higher in the second wave as compared to those in the first wave of the COVID-19 pandemic in India.

Galactokinase deficiency: lessons from the GalNet registry.

PURPOSE: Galactokinase (GALK1) deficiency is a rare hereditary galactose metabolism disorder. Beyond cataract, the phenotypic spectrum is questionable. Data from affected patients included in the Galactosemias Network registry were collected to better characterize the phenotype. METHODS: Observational study collecting medical data of 53 not previously reported GALK1 deficient patients from 17 centers in 11 countries from December 2014 to April 2020. RESULTS: Neonatal or childhood cataract was reported in 15 and 4 patients respectively. The occurrence of neonatal hypoglycemia and infection were comparable with the general population, whereas bleeding diathesis (8.1% versus 2.17-5.9%) and encephalopathy (3.9% versus 0.3%) were reported more often. Elevated transaminases were seen in 25.5%. Cognitive delay was reported in 5 patients. Urinary galactitol was elevated in all patients at diagnosis; five showed unexpected Gal-1-P increase. Most patients showed enzyme activities ≤1%. Eleven different genotypes were described, including six unpublished variants. The majority was homozygous for NM_000154.1:c.82C>A (p.Pro28Thr). Thirty-five patients were diagnosed following newborn screening, which was clearly beneficial. CONCLUSION: The phenotype of GALK1 deficiency may include neonatal elevation of transaminases, bleeding diathesis, and encephalopathy in addition to cataract. Potential complications beyond the neonatal period are not systematically surveyed and a better delineation is needed.

Predictors of maternal and neonatal complications in women with severe valvular heart disease during pregnancy in Tunisia: a retrospective cohort study.

BACKGROUND: Severe valvular heart disease, especially stenosis, is a contraindication for conception according to the World Health Organization. This is still encountered in countries with a high rheumatic fever prevalence. The objective of this study was to determine predictors of maternal cardiac, obstetric and neonatal complications in pregnant women with severe valve disease. METHODS: This is an observational retrospective cohort study of all pregnant women with severe heart valvulopathy who gave birth between 2010 and 2017. RESULTS: We included 60 pregnancies in 54 women. Cardiac complications occurred during 37 pregnancies (61%). In multivariate analysis, parity (aOR =2.41, 95% CI[1.12-5.16]), revelation of valvulopathy during pregnancy (aOR = 6.34; 95% CI[1.26-31.77]), severe mitral stenosis (aOR = 6.98, 95% CI[1.14-41.05],) and systolic pulmonary arterial pressure (aOR =1.08, 95% CI[1.01-1.14]) were associated with cardiac complications. Obstetrical complications were noted during 19 pregnancies (31.8%). These complications were associated with nulliparity (aOR = 5.22; 95% CI[1.15-23.6]), multiple valve disease (aOR = 5.26, 95% CI[1.19-23.2]), systolic pulmonary arterial pressure (aOR =1.04, 95% CI[1.002-1.09]), and treatment with vitamin K antagonists (aOR = 8.71, 95% CI[1.98-38.2]). Neonatal complications were noted in 39.3% of newborns (n = 61) and these were associated with occurrence of obstetric complications (aOR = 16.47, 95% CI[3.2-84.3]) and revelation of valvulopathy during pregnancy (aOR = 7.33, 95% CI[1.4-36.1]). CONCLUSIONS: Revelation of valvular heart disease during pregnancy is a predictor of not only cardiac but also neonatal complications. Valvular heart disease screening during pre-conceptional counseling is thus crucial.

Intrapartum zigzag pattern of fetal heart rate is an early sign of fetal hypoxia: A large obstetric retrospective cohort study.

INTRODUCTION: The aim of the present study was to identify possible associations of fetal heart rate (FHR) patterns during the last 2 hours of labor with fetal asphyxia expressed by umbilical artery acidemia at birth and with neonatal complications in a large obstetric cohort. MATERIAL AND METHODS: Cardiotocographic recordings from 4988 singleton term childbirths over 1 year were evaluated retrospectively and blinded to the pregnancy and neonatal outcomes in a university teaching hospital in Helsinki, Finland. Umbilical artery pH, base excess and pO2 , low Apgar scores at 5 minutes, need for intubation and resuscitation, early neonatal hypoglycemia, and neonatal encephalopathy were used as outcome variables. According to the severity of the neonatal complications at birth, the cohort was divided into three groups: no complications (Group 1), moderate complications (Group 2) and severe complications (Group 3). RESULTS: Of the 4988 deliveries, the ZigZag pattern (FHR baseline amplitude changes of >25 bpm with a duration of 2-30 minutes) occurred in 11.7%, late decelerations in 41.0%, bradycardia episodes in 52.9%, reduced variability in 36.7%, tachycardia episodes in 13.9% and uterine tachysystole in 4.6%. No case of saltatory pattern (baseline amplitude changes of >25 bpm with a duration of >30 minutes) was observed. The presence of the ZigZag pattern or late decelerations, or both, was associated with cord blood acidemia (odds ratio [OR] 3.3, 95% confidence interval [CI] 2.3-4.7) and severe neonatal complications (Group 3) (OR 3.3, 95% CI 2.4-4.9). In contrast, no significant associations existed between the other FHR patterns and severe neonatal complications. ZigZag pattern preceded late decelerations in 88.7% of the cases. A normal FHR preceded the ZigZag pattern in 90.4% of the cases, whereas after ZigZag episodes, a normal FHR pattern was observed in only 0.9%. CONCLUSIONS: ZigZag pattern and late decelerations during the last 2 hours of labor are significantly associated with cord blood acidemia at birth and neonatal complications. The ZigZag pattern precedes late decelerations, and the fact that normal FHR pattern precedes the ZigZag pattern in the majority of the cases suggests that the ZigZag pattern is an early sign of fetal hypoxia, which emphasizes its clinical importance.

Analysis of Maternal and Neonatal Complications in a Group of Patients with Gestational Diabetes Mellitus.

Background and Objectives: Gestational diabetes mellitus (GDM) represents one of the most common complications during pregnancy, being associated with numerous maternal and neonatal complications. The study aimed to analyze maternal and neonatal complications associated with GDM. The risk factors of GDM and of the maternal and neonatal complications were studied in order to prevent their occurrence. Materials and Methods: The study included 97 women in the study, who underwent an oral glucose tolerance test (OGTT) between weeks 24-28 of pregnancy, consequently being divided into two groups: pregnant women with and without GDM. Statistical analysis was performed using the SPSS 26.0 software and MATLAB fitglm, the results being considered statistically significant if p < 0.05. Results: We observed statistically significant differences between the group of women with and without GDM, regarding gestational hypertension (17.6% vs. 0%), preeclampsia (13.72% vs. 0%), and cesarean delivery (96.1% vs. 78,3%). Data on the newborn and neonatal complications: statistically significant differences were recorded between the two groups (GDM vs. no GDM) regarding the average weight at birth (3339.41 ± 658.12 g vs. 3122.83 ± 173.67 g), presence of large for gestational age (21.6% vs. 0%), macrosomia (13.7% vs. 0%), excessive fetal growth (35.3% vs. 0%), respiratory distress (31.4% vs. 0%), hospitalization for at least 24 h in the Neonatal Intensive Care Unit (9.80% vs. 0%), and APGAR score <7 both 1 and 5 min following birth (7.8% vs. 0%). Additionally, the frequency of neonatal hypoglycemia and hyperbilirubinemia was higher among newborns from mothers with GDM. Conclusions: The screening and diagnosis of GDM is vital, and appropriate management is required for the prevention of maternal and neonatal complications associated with GDM. It is also important to know the risk factors for GDM and attempt to prevent their appearance.

Increased risk of maternal and neonatal complications in hormone replacement therapy cycles in frozen embryo transfer.

BACKGROUND: The endometrial preparation during frozen embryo transfer (FET) can be performed by natural cycle (NC), hormone replacement therapy (HRT) cycle and cycle with ovulation induction (OI). Whether different FET preparation protocols can affect maternal and neonatal outcomes is still inconclusive. METHODS: This was a retrospective cohort study that included 6886 women who delivered singleton live birth babies after 28 weeks of pregnancy underwent FET from January, 2015 to July, 2018. Women were divided into three groups according to the protocols used for endometrial preparation during FET: NC group (N = 4727), HRT group (N = 1642) and OI group (N = 517). RESULTS: After adjusting for the effect of age, body mass index (BMI), irregular menstruation, antral follicle count (AFC), endometrial thickness, the levels of testosterone, anti-Müllerian hormone (AMH), preconceptional fasting glucose (PFG), systolic and diastolic pressure et al., the HRT group had higher risk of hypertensive disorders of pregnancy (HDP) compared with the NC group (adjusted odds ratio (aOR) 2.00, 95% confidence interval (CI) 1.54-2.60). Singletons born after HRT FET were at increased risk of low birth weight (LBW) compared to NC group (aOR 1.49, 95%CI 1.09-2.06). The risks of preterm birth (PTB) in the HRT and OI group were elevated compared with the NC group (aOR 1.78, 95%CI 1.39-2.28 and aOR 1.51, 95%CI 1.02-2.23, respectively). CONCLUSIONS: The HRT protocol for endometrial preparation during frozen embryo transfer of blastocysts was associated with increased risk of maternal and neonatal complications, compared to the NC and OI protocol.