Short- and Long-Term Outcomes Associated with Large for Gestational Age Birth Weight

Large for gestational age (LGA) birth weight is associated with multiple adverse short- and long-term outcomes. Infants born with LGA birth weight are at increased risk for NICU admission, respiratory distress, neonatal metabolic abnormalities including hypoglycemia, birth trauma, and even stillbirth or neonatal death. The risk for many of these complications increases with higher birth weights. Individuals with LGA birth weight also appear to be at subsequent increased risk for overweight/obesity, diabetes, cardiovascular disease, and even some childhood cancers. These data highlight the need for effective interventions to reduce risk across the lifespan

The impact of setting a pregnancy weight gain goal on total weight gain

Background: Expert groups recommend that women set a pregnancy weight gain goal with their care provider to optimise weight gain. Objective: Our aim was to describe the concordance between first-trimester personal and provider pregnancy weight gain goals with the Institute of Medicine (IOM) recommendations and to determine the association between these goals and total weight gain. Methods: We used data from 9353 women in the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be. In the first trimester, women reported their personal pregnancy weight gain goal and their provider weight gain goal, and we categorised personal and provider weight gain goals and total weight gain according to IOM recommendations. We used log-binomial or linear regression models to relate goals to total weight gain, adjusting for confounders including race/ethnicity, maternal age, education, smoking, marital status and planned pregnancy. Results: Approximately 37% of women reported no weight gain goals, while 24% had personal and provider goals, 31% had only a personal goal, and 8% had only a provider goal. Personal and provider goals were outside the recommended ranges in 12%-23% of normal-weight women, 31%-41% of overweight women and 47%-63% of women with obesity. Women with both personal and provider pregnancy weight gain goals were 6%-14% more likely than their counterparts to have a goal within IOM-recommended ranges. Having any goal or a goal within the IOM-recommended ranges was unrelated to pregnancy weight gain. Excessive weight gain occurred in approximately half of normal-weight or obese women and three-quarters of overweight women, regardless of goal setting group. Conclusions: These findings do not support the effectiveness of early-pregnancy personal or provider gestational weight gain goal setting alone in optimising weight gain. Multifaceted interventions that address a number of mediators of goal setting success may assist women in achieving weight gain consistent with their goals

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\u27 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 -\u3c23 \u3eweeks) 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\u27 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

Benefits and harms of perioperative high fraction inspired oxygen for surgical site infection prevention: a protocol for a systematic review and meta-analysis of individual patient data of randomised controlled trials.

INTRODUCTION The use of high fraction of inspired oxygen (FiO2) intraoperatively for the prevention of surgical site infection (SSI) remains controversial. Promising results of early randomised controlled trials (RCT) have been replicated with varying success and subsequent meta-analysis are equivocal. Recent advancements in perioperative care, including the increased use of laparoscopic surgery and pneumoperitoneum and shifts in fluid and temperature management, can affect peripheral oxygen delivery and may explain the inconsistency in reproducibility. However, the published data provides insufficient detail on the participant level to test these hypotheses. The purpose of this individual participant data meta-analysis is to assess the described benefits and harms of intraoperative high FiO2compared with regular (0.21-0.40) FiO2 and its potential effect modifiers. METHODS AND ANALYSIS Two reviewers will search medical databases and online trial registries, including MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov and WHO regional databases, for randomised and quasi-RCT comparing the effect of intraoperative high FiO2 (0.60-1.00) to regular FiO2 (0.21-0.40) on SSI within 90 days after surgery in adult patients. Secondary outcome will be all-cause mortality within the longest available follow-up. Investigators of the identified trials will be invited to collaborate. Data will be analysed with the one-step approach using the generalised linear mixed model framework and the statistical model appropriate for the type of outcome being analysed (logistic and cox regression, respectively), with a random treatment effect term to account for the clustering of patients within studies. The bias will be assessed using the Cochrane risk-of-bias tool for randomised trials V.2 and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. Prespecified subgroup analyses include use of mechanical ventilation, nitrous oxide, preoperative antibiotic prophylaxis, temperature (2.5 hour). ETHICS AND DISSEMINATION Ethics approval is not required. Investigators will deidentify individual participant data before it is shared. The results will be submitted to a peer-review journal. PROSPERO REGISTRATION NUMBER CRD42018090261

The impact of setting a pregnancy weight gain goal on total weight gain

BackgroundExpert groups recommend that women set a pregnancy weight gain goal with their care provider to optimise weight gain.ObjectiveOur aim was to describe the concordance between first-trimester personal and provider pregnancy weight gain goals with the Institute of Medicine (IOM) recommendations and to determine the association between these goals and total weight gain.MethodsWe used data from 9353 women in the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be. In the first trimester, women reported their personal pregnancy weight gain goal and their provider weight gain goal, and we categorised personal and provider weight gain goals and total weight gain according to IOM recommendations. We used log-binomial or linear regression models to relate goals to total weight gain, adjusting for confounders including race/ethnicity, maternal age, education, smoking, marital status and planned pregnancy.ResultsApproximately 37% of women reported no weight gain goals, while 24% had personal and provider goals, 31% had only a personal goal, and 8% had only a provider goal. Personal and provider goals were outside the recommended ranges in 12%-23% of normal-weight women, 31%-41% of overweight women and 47%-63% of women with obesity. Women with both personal and provider pregnancy weight gain goals were 6%-14% more likely than their counterparts to have a goal within IOM-recommended ranges. Having any goal or a goal within the IOM-recommended ranges was unrelated to pregnancy weight gain. Excessive weight gain occurred in approximately half of normal-weight or obese women and three-quarters of overweight women, regardless of goal setting group.ConclusionsThese findings do not support the effectiveness of early-pregnancy personal or provider gestational weight gain goal setting alone in optimising weight gain. Multifaceted interventions that address a number of mediators of goal setting success may assist women in achieving weight gain consistent with their goals

975 ABO blood group, rhesus type and risk of COVID-19 in pregnant women

Objective: There is controversy regarding the association of ABO blood group, Rhesus (Rh) type and risk of COVID-19. We tested the hypothesis that ABO blood group and Rh type are associated with COVID-19 diagnosis and symptoms during pregnancy. Study Design: Retrospective analysis of prospectively collected data from two labor and delivery units with universal SARS-CoV-2 testing policy between March 1 and May 31, 2020. All pregnant women tested during the study period were eligible. The primary outcome was COVID-19 diagnosis. Secondary outcomes were measures of COVID-19 severity, including symptoms, ICU admission, respiratory support and treatment for COVID-19. Outcomes were compared across ABO blood groups. Women with blood group O or Rh positive blood type were compared with non-O groups and Rh negative, respectively, using univariable and multivariable analyses. Results: Of 586 pregnant women tested, 66 (11.3%) were positive. The most common ABO blood group in the cohort was O (52.2%) and 87.4% were Rh positive. Rates of the primary outcome, COVID-19 diagnosis, were not significantly different across ABO blood groups (P=0.47). There were also no significant differences in measures of COVID-19 severity among blood groups (Table). Compared to other blood groups, the risk of COVID-19 diagnosis was not significantly different in women with group O (13.1% vs 9.3%, adjusted OR 1.43; 95% CI 0.84, 2.4). Rh positive women were at a significantly higher risk of COVID-19 diagnosis (12.3% vs 4.1%, adjusted OR 3.38; 95% CI 1.03, 11.07) and a non-significant increased risk of symptoms (6.8% vs 2.7%, adjusted OR 2.67; 95% CI 0.63, 11.32), after adjusting for ABO blood group (Figure). Conclusion: We found no association between ABO blood group and diagnosis or severity of COVID-19 in pregnant women. However, Rhesus positive women may be at a higher risk of COVID-19

Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study

Introduction The prevalence of both obesity and gestational diabetes mellitus (GDM) has increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy and caesarean delivery. Women with GDM who are also overweight or obese have higher rates of pregnancy complications when compared with normal-weight women with GDM, which may occur in part due to suboptimal glycaemic control. The current recommendations for glycaemic targets in pregnant women with diabetes are based on limited evidence and exceed the mean fasting (70.9±7.8 mg/dL) and 1-hour postprandial (108.9±12.9 mg/dL) glucose values in pregnant individuals without diabetes. Our prior work demonstrated that the use of intensive (fasting <90 mg/dL and 1-hour postprandial <120 mg/dL) compared with standard (fasting <95 mg/dL and 1-hour postprandial <140 mg/dL) glycaemic targets resulted in improved glycaemic control without increasing the risk for hypoglycaemia in pregnant individuals with GDM, but the impact of intensive glycaemic targets on perinatal outcomes is unknown.Methods and analysis The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomised clinical trial designed to investigate the impact of intensive versus standard glycaemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from five medical centres representing regions of the USA with high rates of obesity will randomise 828 overweight and obese women with GDM to either intensive or standard glycaemic targets. We will test the central hypothesis that intensive glycaemic targets will result in lower rates of neonatal composite morbidity including large for gestational age birth weight, neonatal hypoglycaemia, respiratory distress syndrome and need for phototherapy when compared with standard glycaemic targets using the intention-to-treat approach to analysis.Ethics and dissemination The Institutional Review Board (IRB) at Indiana University School of Medicine approved this study (IRB# 11435; initial approval date 25 August 2021). We will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.Trial registration number NCT05124808