Evaluation of Maternal Risk Factors for Neonatal Hypernatremic Dehydration: A Systematic Review.

BACKGROUND: Neonatal hypernatremic dehydration (NHD) is a severe condition associated with neonatal morbidity and mortality. PURPOSE: The present study evaluated maternal risk factors, including duration of maternal hospitalisation, primiparity, caesarean section, and pregnancy complications, as well as social factors, such as depression, fatigue, and inadequate support for NHD. DATA SOURCES: PubMed, Cochrane Library, International Scientific Indexing, Scopus, and Google Scholar were the databases searched until 2023. STUDY SELECTION: Articles written in English or Persian focusing on the relationship between maternal risk factors and NHD among neonates and providing sufficient information on NHD were included in this study. On the other hand, articles whose abstracts were only available were excluded. DATA EXTRACTION: The extracted data were presented in Excel software with the following titles: authors' names, year, type of study, study location, and maternal risk factors. The methodological quality of the articles was determined using the quality assurance tool for the diagnostic accuracy score (QUADAS). RESULTS: Of the 58 searched articles, 16 were investigated, which included five prospective, seven cross-sectional, and four retrospective articles. Maternal risk factors for NHD included labour and delivery complications, childbirth complications, factors causing insufficient breast milk intake (including breast milk insufficiency, nipple problems, wrong breastfeeding techniques, breast disorders, types of feeding, and breastfeeding training/counselling in pregnancy), as well as delivery and the postpartum period. IMPLICATIONS FOR PRACTICE AND RESEARCH: Maternal problems in pregnancy and delivery, breast disorders, breastfeeding status, maternal knowledge, and lactation skills are the most common maternal risk factors for NHD. Timely (antenatal) identification and proper management of maternal risk factors help reduce the incidence and severity of NHD complications.

Prevalence of macrosomic newborn and maternal and neonatal complications in a high-risk maternity.

Objective: Evaluate the prevalence of macrosomic newborns (birth weight above 4000 grams) in a high-risk maternity from 2014 to 2019, as well as the maternal characteristics involved, risk factors, mode of delivery and associated outcomes, comparing newborns weighing 4000-4500 grams and those weighing above 4500 grams. Methods: This is an observational study, case-control type, carried out by searching for data in hospital's own system and clinical records. The criteria for inclusion in the study were all patients monitored at the service who had newborns with birth weight equal than or greater than 4000 grams in the period from January 2014 to December 2019, being subsequently divided into two subgroups (newborns with 4000 to 4500 grams and newborns above 4500 grams). After being collected, the variables were transcribed into a database, arranged in frequency tables. For treatment and statistical analysis of the data, Excel and R software were used. This tool was used to create graphs and tables that helped in the interpretation of the results. The statistical analysis of the variables collected included both simple descriptive analyzes as well as inferential statistics, with univariate, bivariate and multivariate analysis. Results: From 2014 to 2019, 3.3% of deliveries were macrosomic newborns. The average gestational age in the birth was 39.4 weeks. The most common mode of delivery (65%) was cesarean section. Diabetes mellitus was present in 30% of the deliveries studied and glycemic control was absent in most patients. Among the vaginal deliveries, only 6% were instrumented and there was shoulder dystocia in 21% of the cases. The majority (62%) of newborns had some complication, with jaundice (35%) being the most common. Conclusion: Birth weight above 4000 grams had a statistically significant impact on the occurrence of neonatal complications, such as hypoglycemia, respiratory distress and 5th minute APGAR less than 7, especially if birth weight was above 4500 grams. Gestational age was also shown to be statistically significant associated with neonatal complications, the lower, the greater the risk. Thus, macrosomia is strongly linked to complications, especially neonatal complications.

Infant of a diabetic mother: clinical presentation, diagnosis and treatment.

An infant of a diabetic mother is defined as a newborn born to a mother who has diabetes during pregnancy. The term diabetic mother refers to pregnant women with diabetes diagnosed either before (type 1 or 2 diabetes) or during pregnancy (gestational diabetes). Rising incidence of type 1 and type 2 diabetes in young women and increasing maternal age at conception account for the higher risk of birth complications and adverse maternal and infant outcomes. Infants of diabetic mothers (IDMs) because of mother's diabetes are prone to developing complications and the most common include: large birth weight and complications resulting from it (i.e. birth injuries, perinatal asphyxia), cardiovascular and respiratory insufficiency (poor tolerance of labor stress), neonatal hypoglycemia and it's complications, delayed lung maturity (fetal hyperinsulinism and the opposite function of insulin to cortisol), cardiomegaly and hypertrophy of the intraventricular septum (functional narrowing of the outflow of the left ventricle and cardiac failure), congenital malformations (most often of the central nervous system and heart). Less common complications in IDMs are: persistent pulmonary hypertension, hyperbilirubinemia, renal vein thrombosis, small left colon syndrome, intrauterine death, polycythemia, and a predisposition to obesity, insulin resistance and diabetes later in life. This article presents current knowledge about pathological conditions and the recommended management for IDMs.

Neonatal complications and risk factors associated with assisted vaginal delivery.

To investigate neonatal injuries, morbidities and risk factors related to vaginal deliveries. This retrospective, descriptive study identified 3500 patients who underwent vaginal delivery between 2020 and 2022. Demographic data, neonatal injuries, complications arising from vaginal delivery and pertinent risk factors were documented. Neonatal injuries and morbidities were prevalent in cases of assisted vacuum delivery, gestational diabetes mellitus class A2 (GDMA2) and pre-eclampsia with severe features. Caput succedaneum and petechiae were observed in 291/3500 cases (8.31%) and 108/3500 cases (3.09%), respectively. Caput succedaneum was associated with multiparity (adjusted odds ratio [AOR] 0.36, 95% confidence interval [CI] 0.22-0.57, P < 0.001) and assisted vacuum delivery (AOR 5.18, 95% CI 2.60-10.3, P < 0.001). Cephalohaematoma was linked to GDMA2 (AOR 11.3, 95% CI 2.96-43.2, P < 0.001) and assisted vacuum delivery (AOR 16.5, 95% CI 6.71-40.5, P < 0.001). Scalp lacerations correlated with assisted vacuum and forceps deliveries (AOR 6.94, 95% CI 1.85-26.1, P < 0.004; and AOR 10.5, 95% CI 1.08-102.2, P < 0.042, respectively). Neonatal morbidities were associated with preterm delivery (AOR 3.49, 95% CI 1.39-8.72, P = 0.008), night-time delivery (AOR 1.32, 95% CI 1.07-1.63, P = 0.009) and low birth weight (AOR 7.52, 95% CI 3.79-14.9, P < 0.001). Neonatal injuries and morbidities were common in assisted vacuum delivery, maternal GDMA2, pre-eclampsia with severe features, preterm delivery and low birth weight. Cephalohaematoma and scalp lacerations were prevalent in assisted vaginal deliveries. Most morbidities occurred at night.Clinical trial registration: Thai Clinical Trials Registry 20220126004.

A live attenuated vaccine to prevent severe neonatal Escherichia coli K1 infections.

Preterm birth is currently the leading cause of neonatal morbidity and mortality. Genetic, immunological and infectious causes are suspected. Preterm infants have a higher risk of severe bacterial neonatal infections, most of which are caused by Escherichia coli an in particular E. coli K1strains. Women with history of preterm delivery have a high risk of recurrence and therefore constitute a target population for the development of vaccine against E. coli neonatal infections. Here, we characterize the immunological, microbiological and protective properties of a live attenuated vaccine candidate in adult female mice and their pups against after a challenge by K1 and non-K1 strains of E. coli. Our results show that the E. coli K1 E11 ∆aroA vaccine induces strong immunity, driven by polyclonal bactericidal antibodies. In our model of meningitis, mothers immunized prior to mating transfer maternal antibodies to pups, which protect newborn mice against various K1 and non-K1 strains of E. coli. Given the very high mortality rate and the neurological sequalae associated with neonatal E. coli K1 meningitis, our results constitute preclinical proof of concept for the development of a live attenuated vaccine against severe E. coli infections in women at risk of preterm delivery.

Association Between Intrapartum Nitrous Oxide for Labor Analgesia and Short-Term Neonatal Outcomes.

OBJECTIVE: To evaluate the association between intrapartum nitrous oxide use and adverse short-term neonatal outcomes. METHODS: This was a retrospective cohort study of individuals with singleton gestations at 35 or more weeks who attempted labor and delivered at an academic hospital between June 1, 2015, and February 28, 2020. Data were extracted from the electronic medical record using billing and diagnostic codes. Patients were classified based on whether they received no intrapartum analgesia or received nitrous oxide only. Those who received other analgesia types were excluded. The primary outcome was neonatal intensive care unit (NICU) admission. Secondary outcomes included Apgar score less than 7 at 1 minute and 5 minutes, respiratory composite outcome (including meconium aspiration syndrome, neonatal bronchopulmonary disorders, neonatal transient tachypnea, and other neonatal respiratory distress that required NICU admission), hypoglycemia, and hyperbilirubinemia. Univariable and multivariable analyses were used to estimate the association between nitrous oxide exposure intrapartum and the selected outcomes. RESULTS: Of 6,047 included, 4,153 (68.7%) received no analgesia, and 1,894 (31.3%) received nitrous oxide only. In comparison with individuals who received no analgesia, those who received nitrous oxide were more likely to be nulliparous, be of Black racial identity, have noncommercial insurance, and be less likely to deliver by intrapartum cesarean. The reception of nitrous oxide, compared with the reception of no analgesia, was associated with a lower likelihood of NICU admission (6.4% vs 8.1%; adjusted odds ratio [aOR] 0.77, 95% CI, 0.62-0.96) and an increased likelihood of neonatal hyperbilirubinemia (aOR 1.23, 95% CI, 1.08-1.41). Inhaled nitrous oxide exposure, in comparison with the reception of no analgesia, was not associated with the other secondary outcomes, including Apgar score less than 7 at 1 minute (odds ratio [OR] 0.74, 95% CI, 0.50-1.10) or 5 minutes (OR 0.91, 95% CI, 0.32-2.60), respiratory composite outcome (OR 0.91, 95% CI, 0.70-1.17), and hypoglycemia (OR 0.82, 95% CI, 0.64-1.05). CONCLUSION: In this single-center retrospective cohort of low-risk patients, intrapartum inhaled nitrous oxide, compared with the reception of no analgesia, was associated with a decreased risk for NICU admission but with an increased risk for hyperbilirubinemia; other outcomes did not differ. These findings may be used to counsel patients when considering nitrous oxide for labor analgesia.

Indications affect neonatal outcomes following early rescue ICSI: a retrospective study.

PURPOSE: To investigate the impact of heterogeneity in patient indications or insemination protocols on neonatal outcomes of singletons following early rescue ICSI (rICSI) treatments. METHODS: A retrospective study was conducted. Propensity score matching and multivariable logistic regression were used to adjust for confounders and biases. RESULTS: A total of 9095 IVF patients, 2063 ICSI patients, and 642 early rICSI patients were included in the study. No differences were detected in neonatal outcomes except small for gestational age (SGA) which increased in early rICSI patients compared with both unmatched and matched IVF groups with the risk ratio (RR) of 1.31 (95% CI: 1.05, 1.64) and 1.49 (95% CI: 1.05, 2.12). Further analysis showed that SGA increased significantly in partial fertilization failure (PFF) cycles with RRs of 1.56 (95% CI: 1.08, 2.27) and 1.78 (95% CI: 1.22, 2.59) compared with both unmatched and matched IVF patients but not in TFF patients. A positive association between fertilization rate via IVF and birth weight z-score was revealed in the PFF patients. CONCLUSION: Early rICSI in patients with total fertilization failure (TFF) appeared to be safe in terms of neonatal outcomes. However, when expanding the indications of rICSI to PFF patients, the SGA in the offspring increased, suggesting a potential effect on long-term health. Since other treatment options, such as using only the IVF-origin embryos still exist for these patients, further studies were needed to confirm the optimal decision for these patients.

Neonatal Outcomes After COVID-19 Vaccination in Pregnancy.

Importance: Better knowledge about neonatal adverse events after COVID-19 vaccination during pregnancy could help address concerns about vaccine safety. Objective: To evaluate the risks of neonatal adverse events after exposure to COVID-19 vaccination during pregnancy. Design, Setting, and Participants: Population-based cohort study including all infants in Sweden and Norway born from June 2021 to January 2023. Unique personal identity numbers were used to link individual information from different national registers. Exposure: Administration of any mRNA vaccine against COVID-19 during pregnancy, irrespective of previous vaccination, number of doses during pregnancy, or vaccine manufacturer. Main Outcomes and Measures: Outcomes were neonatal conditions with bleeding/thrombosis or inflammation/infection; disorders of the central nervous system; circulatory, respiratory, or gastrointestinal problems; and neonatal mortality. Statistical methods included logistic regression adjusted for characteristics of the pregnant individuals, with additional restricted and stratified analyses. Results: Of 196 470 newborn infants included (51.3% male, 93.8% born at term, 62.5% born in Sweden), 94 303 (48.0%) were exposed to COVID-19 vaccination during pregnancy. Exposed infants exhibited no increased odds of adverse neonatal outcomes, and they exhibited lower odds for neonatal nontraumatic intracranial hemorrhage (event rate, 1.7 vs 3.2/1000; adjusted odds ratio [aOR], 0.78 [95% CI, 0.61-0.99]), hypoxic-ischemic encephalopathy (1.8 vs 2.7/1000; aOR, 0.73 [95% CI, 0.55-0.96]), and neonatal mortality (0.9 vs 1.8/1000; aOR, 0.68 [95% CI, 0.50-0.91]). Subgroup analyses found a similar association between vaccination during pregnancy and lower neonatal mortality; subgroups were restricted to infants delivered by individuals unvaccinated before pregnancy, individuals vaccinated before pregnancy, individuals vaccinated after a general recommendation of vaccination during pregnancy was issued, and individuals without COVID-19 infection during pregnancy. Analyses restricted to term infants, singleton births, or infants without birth defects yielded similar results. Stratifying the analysis by vaccine manufacturer did not attenuate the association between vaccination and low neonatal mortality. Conclusions and Relevance: In this large population-based study, vaccination of pregnant individuals with mRNA COVID-19 vaccines was not associated with increased risks of neonatal adverse events in their infants.

Neonatal lupus erythematosus as a rare trigger of gastrointestinal involvement in neonates.

Cutaneous and cardiac involvement in neonatal lupus erythematosus (NLE) has been extensively studied; however, gastrointestinal system involvement (GSI) remains unexplored. This study aimed to investigate the clinical features of GSI in patients with NLE with a particular focus on feeding intolerance (FI) and diarrhea. We conducted a retrospective analysis of the clinical data of patients diagnosed with NLE at the Children's Hospital of Soochow University between 2011 and 2022. In this study, of 39 patients diagnosed with NLE, 27 presented with GSI. 9 patients who presented with FI or diarrhea as the primary manifestation were positive for anti-SSA antibody, and 5 were dual positive for anti-SSA and anti-SSB antibodies. Among the mothers of the NLE patients with GSI, 18 had systemic lupus erythematosus, 3 had Sjogren's syndrome, 2 had mixed connective tissue disease, and one each had autoantibody abnormalities and photosensitivity symptoms; 4 mothers denied having any autoimmune disease. In this study, 69.23% of patients with NLE exhibited GSI, which was linked to hypocomplementemia and anti-SSA antibodies. Thus, clinicians should remain vigilant for NLE in neonates, particularly when accompanied with rash and other organ dysfunction and when the high-risk factors of FI and diarrhea have been excluded.

[Analysis of clinical characteristics and risk factors of postoperative complications in infants with early-onset necrotizing enterocolitis after enterostomy].

Objective: To investigate the clinical characteristics of children with early-onset necrotizing enterocolitis (NEC) undergoing enterostomy and analyze the risk factors for postoperative complications. Methods: Retrospective analysis was conducted on the clinical data (perinatal conditions, clinical characteristics, clinical outcomes, etc.) of NEC patients who underwent enterostomy at Beijing Children's Hospital from May 2016 to May 2023. The patients were divided into two groups based on the age of onset: an early-onset enterostomy group (<14 days) and a late-onset enterostomy group (≥14 days). Furthermore, the children with NEC were categorized into complication group and non-complication group based on whether there were complications after enterostomy. The differences in clinical data between these groups were analyzed, and the clinical characteristics of children with early-onset NEC and enterostomy were summarized. Multivariate logistic regression model was employed to analyze the risk factors for postoperative complications in NEC children with enterostomy. Results: A total of 68 cases were enrolled, including 43 cases in the early-onset enterostomy group [26 males and 17 females, aged (6.5±3.0) days] and 25 cases in the late-onset enterostomy group [15 males and 10 females, aged (21.0±3.0) days]. There were 28 cases (17 males and 11 females), age [M (Q1, Q3)] 9 (5, 14) days in the complication group and 33 cases (22 males and 11 females), aged of 14 (6, 21) days in the non-complication group. Compared to the late-onset enterostomy group, the early-onset enterostomy group had significantly higher rates of intraventricular hemorrhage [30.2% (13/43) vs 8.0% (2/25)], hemodynamically significant patent ductus arteriosus [37.2% (16/43) vs 12.0% (3/25)], mechanical ventilation≥72 hours after birth [39.5% (17/43) vs 16.0% (4/25)], stage Ⅲ NEC [(69.8% (30/43) vs 40.0% (10/25)], extensive NEC [27.9% (12/43) vs 8.0% (2/25)], and short-term postoperative complications [56.8% (21/37) vs 29.2% (7/24)] (all P<0.05).Multivariate logistic regression model analysis revealed that residual length of proximal small intestine was a protective factor for postoperative complications after enterostomy in NEC infants (OR=0.764, 95%CI: 0.648-0.901, P=0.001), but stage Ⅲ NEC was a risk factor (OR=1.042, 95%CI: 1.004-5.585, P=0.017). Conclusions: The incidence of postoperative complications is high, and the prognosis is poor in children with early-onset NEC enterostomy. The residual length of proximal enterostomy is a protective factor for postoperative complications of NEC enterostomy, but stage Ⅲ NEC is a risk factor.

Cholestasis is associated with a higher rate of complications in both medical and surgical necrotizing enterocolitis.

OBJECTIVE: To evaluate the relationship between cholestasis and outcomes in medical and surgical necrotizing enterocolitis (NEC). STUDY DESIGN: A retrospective analysis of prospectively collected data from 1472 infants with NEC [455 medical (mNEC) and 1017 surgical (sNEC)] from the Children's Hospital Neonatal Database. RESULTS: The prevalence of cholestasis was lower in mNEC versus sNEC (38.2% vs 70.1%, p < 0.001). In both groups, cholestasis was associated with lower birth gestational age [mNEC: OR 0.79 (95% CI 0.68-0.92); sNEC: OR 0.86 (95% CI 0.79-0.95)] and increased days of parenteral nutrition [mNEC: OR 1.08 (95% CI 1.04-1.13); sNEC: OR 1.01 (95% CI 1.01-1.02)]. For both groups, the highest direct bilirubin was associated with the composite outcome mortality or length of stay >75th percentile [mNEC: OR 1.21 (95% CI 1.06-1.38); sNEC: OR 1.06 (95% CI 1.03-1.09)]. CONCLUSION: Cholestasis with both medical NEC and surgical NEC is associated with adverse patient outcomes including increased mortality or extreme length of stay.

Pre-labour Rupture of Membranes at Term in Women With Gestational Diabetes and the Risk of Neonatal Hypoglycemia.

OBJECTIVES: The management for improving maternal and neonatal outcomes of women with gestational diabetes mellitus (GDM) arriving at the delivery ward with pre-labour rupture of membranes (PROM) has not been elucidated. We tested the hypothesis that prolonged PROM in women with GDM would result in higher rates of neonatal hypoglycemia. METHODS: We retrospectively enrolled women with diet or insulin-controlled GDM who presented with spontaneous clear PROM. Each woman was allocated into one of two groups based on the PROM-delivery time: <18 hours (group 1) and ≥18 hours (group 2). The primary outcome was the incidence of neonatal hypoglycemia, defined as glucose <40 mg/dL (2.2 mmol/L) within 24 hours of birth. RESULTS: We ultimately analyzed 631 cases of GDM (6.7%), 371 with PROM-delivery <18 hours, and 260 with PROM-delivery ≥18 hours. The incidence of neonatal hypoglycemia did not differ between the two groups, reaching 7.3%. Women in group 2 were at increased risk of both cesarean delivery (20% vs. 12.4%, P < 0.01) and maternal chorioamnionitis morbidity (6.5% vs. 1.3%, P < 0.001). CONCLUSIONS: In a sub-group of women with GDM, a PROM-delivery time ≥18 hours is not associated with higher rates of neonatal hypoglycemia, but higher rates of chorioamnionitis and cesarean delivery were noted. Therefore, we suggest consideration for early delivery when managing women with GDM and PROM.

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.

Outcomes in low-risk patients before and after an institutional policy offering 39-week elective induction of labor.

OBJECTIVE: Elective induction of labor versus expectant management at 39 weeks gestation in low-risk nulliparous patients was shown in the ARRIVE randomized trial of over 6000 patients to decrease risks of cesarean delivery without significant change in the composite perinatal outcome. We aimed to pragmatically analyze the effect of offering elective induction of labor (eIOL) to all low-risk patients. METHODS: Retrospective cohort study of low-risk nulliparous and multiparous patients delivering live, non-anomalous singletons at a single center at greater than or equal to 39 0/7 weeks gestational age. Those with prior or planned cesarean delivery, ruptured membranes, medical comorbidities, or contraindications to vaginal delivery were excluded. Patients were categorized as before (pre-eIOL; 1/2012-3/2014) or after (post-eIOL; 3/2019-12/2021) an institution-wide policy offering eIOL at 39 0/7 weeks. Births occurring April 2014 to December 2018 were allocated to a separate cohort (during-eIOL) given increased exposure to eIOL as our center recruited participants for the ARRIVE trial. The primary outcome was cesarean birth. Secondary outcomes included select maternal (e.g. chorioamnionitis, operative delivery, postpartum hemorrhage) and neonatal morbidities (e.g. birthweight, small- and large-for gestational age, hypoglycemia). Characteristics and outcomes were compared between the pre and during-eIOL, and pre and post-eIOL groups; adjusted OR (95% CI) were calculated using multivariable regression. Subgroup analysis by parity was planned. RESULTS: Of 10,758 patients analyzed, 2521 (23.4%) were pre-eIOL, 5410 (50.3%) during-eIOL, and 2827 (26.3%) post-eIOL. Groups differed with respect to labor type, age, race/ethnicity, marital and payor status, and gestational age at care entry. Post-eIOL was associated with lower odds of cesarean compared to pre-eIOL (aOR 0.83 [95% CI 0.72-0.96]), which was even lower among those specifically undergoing labor induction (aOR 0.58 [0.48-0.70]. During-eIOL was also associated with lower odds of cesarean compared to pre-eIOL (aOR 0.79 [0.69-0.90]). Both during and post-eIOL groups were associated with higher odds of chorioamnionitis, operative delivery, and hemorrhage compared to pre-eIOL. However, only among post-eIOL were there fewer neonates weighing ≥4000 g, large-for-gestational age infants, and neonatal hypoglycemia compared to pre-IOL. CONCLUSION: An institutional policy offering eIOL at 39 0/7 to low-risk patients was associated with a lower cesarean birth rate, lower birthweights and lower neonatal hypoglycemia, and an increased risk of chorioamnionitis and hemorrhage.

Metformin Plus Insulin for Preexisting Diabetes or Gestational Diabetes in Early Pregnancy: The MOMPOD Randomized Clinical Trial.

Importance: Insulin is recommended for pregnant persons with preexisting type 2 diabetes or diabetes diagnosed early in pregnancy. The addition of metformin to insulin may improve neonatal outcomes. Objective: To estimate the effect of metformin added to insulin for preexisting type 2 or diabetes diagnosed early in pregnancy on a composite adverse neonatal outcome. Design, Setting, and Participants: This randomized clinical trial in 17 US centers enrolled pregnant adults aged 18 to 45 years with preexisting type 2 diabetes or diabetes diagnosed prior to 23 weeks' gestation between April 2019 and November 2021. Each participant was treated with insulin and was assigned to add either metformin or placebo. Follow-up was completed in May 2022. Intervention: Metformin 1000 mg or placebo orally twice per day from enrollment (11 weeks -<23 weeks) through delivery. Main Outcome and Measures: The primary outcome was a composite of neonatal complications including perinatal death, preterm birth, large or small for gestational age, and hyperbilirubinemia requiring phototherapy. Prespecified secondary outcomes included maternal hypoglycemia and neonatal fat mass at birth, and prespecified subgroup analyses by maternal body mass index less than 30 vs 30 or greater and those with preexisting vs diabetes early in pregnancy. Results: Of the 831 participants randomized, 794 took at least 1 dose of the study agent and were included in the primary analysis (397 in the placebo group and 397 in the metformin group). Participants' mean (SD) age was 32.9 (5.6) years; 234 (29%) were Black, and 412 (52%) were Hispanic. The composite adverse neonatal outcome occurred in 280 (71%) of the metformin group and in 292 (74%) of the placebo group (adjusted odds ratio, 0.86 [95% CI 0.63-1.19]). The most commonly occurring events in the primary outcome in both groups were preterm birth, neonatal hypoglycemia, and delivery of a large-for-gestational-age infant. The study was halted at 75% accrual for futility in detecting a significant difference in the primary outcome. Prespecified secondary outcomes and subgroup analyses were similar between groups. Of individual components of the composite adverse neonatal outcome, metformin-exposed neonates had lower odds to be large for gestational age (adjusted odds ratio, 0.63 [95% CI, 0.46-0.86]) when compared with the placebo group. Conclusions and Relevance: Using metformin plus insulin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy did not reduce a composite neonatal adverse outcome. The effect of reduction in odds of a large-for-gestational-age infant observed after adding metformin to insulin warrants further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02932475.

Neonatal seizures: Etiologies, clinical characteristics, and radiological features: A cross-sectional study.

Seizures are a common clinical indication of central nervous system damage or abnormality in neonates. We aimed to identify the etiologies, clinical characteristics, and radiological features of neonatal seizures. This is a cross-sectional, retrospective, descriptive study using data obtained from the neonatal intensive care unit in King Abdulaziz Medical City (KAMC), a governmental, academic tertiary hospital in Riyadh, Saudi Arabia. The population of interest were neonates diagnosed with a neonatal seizure at KAMC between April 2015 and March 2019. A total of 61 patients with neonatal seizures were included in the study. The most common etiology was hypoxic-ischemic encephalopathy (43%). A total of 32 patients were full-term (52.5%). Around one-fifth of the study sample (21.3%) had a family history of neonatal seizures. Around 43.0% of the patients had epilepsy episodes. More than half of the patients (57.0%) were on one anti-seizure medication. Patients were followed up after 1 year, they had multiple comorbidities, including developmental delay, epilepsy, and cerebral palsy. Developmental delay was identified in 62.3% of the patients. A total of 19 patients have passed away (31%). Neonatal seizures are a common manifestation of neurologic disorders in neonates and are associated with high morbidity and mortality. Therefore, early identification of seizure etiology and proper management may help to improve the outcome.

Development of a prediction model for neonatal hypoglycemia risk factors: a retrospective study.

Background: It's challenging for healthcare workers to detect neonatal hypoglycemia due to its rapid progression and lack of aura symptoms. This may lead to brain function impairment for the newborn, placing a significant care burden on the family and creating an economic burden for society. Tools for early diagnosis of neonatal hypoglycemia are lacking. This study aimed to identify newborns at high risk of developing neonatal hypoglycemia early by developing a risk prediction model. Methods: Using a retrospective design, pairs (470) of women and their newborns in a tertiary hospital from December 2021 to September 2022 were included in this study. Socio-demographic data and clinical data of mothers and newborns were collected. Univariate and multivariate logistic regression were used to screen optimized factors. A neonatal hypoglycemia risk nomogram was constructed using R software, and the calibration curve and receiver operator characteristic curve (ROC) was utilized to evaluate model performance. Results: Factors integrated into the prediction risk nomogram were maternal age (odds ratio [OR] =1.10, 95% CI: 1.04, 1.17), fasting period (OR=1.07, 95% CI: 1.03, 1.12), ritodrine use (OR=2.00, 95% CI: 1.05, 3.88), gestational diabetes mellitus (OR=2.13, 95% CI: 1.30, 3.50), gestational week (OR=0.80, 95% CI: 0.66, 0.96), fetal distress (OR=1.76, 95% CI: 1.11, 2.79) and neonatal body mass index (OR=1.50, 95% CI: 1.24, 1.84). The area under the curve (AUC) was 0.79 (95% confidence interval [CI]: 0.75, 0.82), specificity was 0.82, and sensitivity was 0.62. Conclusion: The prediction model of this study demonstrated good predictive performance. The development of the model identifies advancing maternal age, an extended fasting period before delivery, ritodrine use, gestational diabetes mellitus diagnosis, fetal distress diagnosis and an increase in neonatal body mass index increase the probability of developing neonatal hypoglycemia, while an extended gestational week reduces the probability of developing neonatal hypoglycemia.

Obstetric and perinatal outcome in short-stature patients.

OBJECTIVE: Scarce data exist regarding obstetric complications of short-stature patients. This study aimed to investigate obstetric and perinatal outcomes in women with short stature; specifically, to investigate whether short-stature patients are at an increased risk for cesarean delivery. METHODS: A population-based cohort study was conducted, including all singletons born between the years 1991 and 2021 at a tertiary medical center. Obstetric and perinatal outcomes of short-stature patients were compared with those of non-short patients. A generalized estimation equation binary logistic model was constructed to adjust for confounders and maternal recurrence in the cohort. RESULTS: The study population included 356 356 parturient; among them, 14 035 (3.9%) were short-stature patients. Short-stature patients had significantly higher rates of cesarean delivery (20.7% vs 13.7%, odds ratio = 1.64, 95% confidence interval 1.57-1.71, P < 0.001), induction of labor, pathologic presentations, prolonged second stage of labor, non-reassuring fetal monitoring, and meconium-stained amniotic fluid. Newborns of short-stature patients had a significantly higher risk of being small for gestational age as compared with those of non-short patients. In the generalized estimation equation models, the association between short stature and risk of cesarean delivery remained significant (adjusted odds ratio = 1.32, 95% confidence interval 1.27-1.38, P < 0.001), as well as the risk of small for gestational age newborns (adjusted odds ratio = 1.51, 95% confidence interval 1.40-1.63, P < 0.001), but not for the other adverse outcomes. CONCLUSIONS: Maternal short stature is an independent risk factor for cesarean delivery and is associated with small for gestational age newborns.