Browsing by Author "Scifres, Christina M."

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    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
    (BMJ Publishing, 2023-10-29) de Jonge, Stijn W.; Hulskes, Rick H.; Nikoo, Maedeh Zokaei; Weenink, Robert P.; Meyhoff, Christian S.; Leslie, Kate; Myles, Paul; Forbes, Andrew; Greif, Robert; Akca, Ozan; Kurz, Andrea; Sessler, Daniel I.; Martin, Janet; Dijkgraaf, Marcel Gw.; Pryor, Kane; Belda, F. Javier; Ferrando, Carlos; Gurman, Gabriel M.; Scifres, Christina M.; McKenna, David S.; Chan, Matthew Tv.; Thibon, Pascal; Mellin-Olsen, Jannicke; Allegranzi, Benedetta; Boermeester, Marja; Hollmann, Markus W.; Obstetrics and Gynecology, School of Medicine
    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 (<35°C), fluid supplementation (<15 mL/kg/hour) and procedure duration (>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.
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    Customized versus Population Growth Standards for Morbidity and Mortality Risk Stratification Using Ultrasonographic Fetal Growth Assessment at 22 to 29 Weeks' Gestation
    (Thieme, 2021) Blue, Nathan R.; Grobman, William A.; Larkin, Jacob C.; Scifres, Christina M.; Simhan, Hyagriv N.; Chung, Judith H.; Saade, George R.; Haas, David M.; Wapner, Ronald; Reddy, Uma M.; Mercer, Brian; Parry, Samuel I.; Silver, Robert M.; Obstetrics and Gynecology, School of Medicine
    Objective: The aim of study is to compare the performance of ultrasonographic customized and population fetal growth standards for prediction adverse perinatal outcomes. Study design: This was a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, in which l data were collected at visits throughout pregnancy and after delivery. Percentiles were assigned to estimated fetal weights (EFWs) measured at 22 to 29 weeks using the Hadlock population standard and a customized standard (www.gestation.net). Areas under the curve were compared for the prediction of composite and severe composite perinatal morbidity using EFW percentile. Results: Among 8,701 eligible study participants, the population standard diagnosed more fetuses with fetal growth restriction (FGR) than the customized standard (5.5 vs. 3.5%, p < 0.001). Neither standard performed better than chance to predict composite perinatal morbidity. Although the customized performed better than the population standard to predict severe perinatal morbidity (areas under the curve: 0.56 vs. 0.54, p = 0.003), both were poor. Fetuses considered FGR by the population standard but normal by the customized standard had morbidity rates similar to fetuses considered normally grown by both standards.The population standard diagnosed FGR among black women and Hispanic women at nearly double the rate it did among white women (p < 0.001 for both comparisons), even though morbidity was not different across racial/ethnic groups. The customized standard diagnosed FGR at similar rates across groups. Using the population standard, 77% of FGR cases were diagnosed among female fetuses even though morbidity among females was lower (p < 0.001). The customized model diagnosed FGR at similar rates in male and female fetuses. Conclusion: At 22 to 29 weeks' gestation, EFW percentile alone poorly predicts perinatal morbidity whether using customized or population fetal growth standards. The population standard diagnoses FGR at increased rates in subgroups not at increased risk of morbidity and at lower rates in subgroups at increased risk of morbidity, whereas the customized standard does not.
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    The impact of setting a pregnancy weight gain goal on total weight gain
    (Wiley, 2021) Bodnar, Lisa M.; Abrams, Barbara; Simhan, Hyagriv N.; Scifres, Christina M.; Silver, Robert M.; Parry, Samuel; Crosland, Brian A.; Chung, Judith; Himes, Katherine P.; Obstetrics and Gynecology, School of Medicine
    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.
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    Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study
    (BMJ, 2024-02-29) Scifres, Christina M.; Battarbee, Ashley N.; Feghali, Maisa N.; Pierce, Stephanie; Edwards, Rodney K.; Smith, Emily M.; Guise, David; Bhamidipalli, Sruthi; Daggy, Joanne; Tuuli, Methodius G.; Obstetrics and Gynecology, School of Medicine
    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.
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    Navigating Automated Insulin Delivery for Type 1 Diabetes Management During Pregnancy
    (Sage, 2025-04-17) Scifres, Christina M.; Cleary, Erin M.; Sheerer, Madilyn; Bowdler, Marissa; Shah, Viral N.; Obstetrics and Gynecology, School of Medicine
    Achieving pregnancy-specific glucose targets is difficult in pregnant individuals with type 1 diabetes (T1D), and the rates of complications for mothers and their infants remain high. Currently marketed automated insulin delivery (AID) systems are hybrid closed-loop (HCL) systems in which basal insulin delivery (with or without automated correction boluses) is driven by algorithms, and users are required to initiate meal boluses. For non-pregnant people with T1D, HCL therapy has established benefits for glycemic outcomes and quality of life. While none of the currently available HCL systems were designed for pregnancy-specific glucose targets and outcomes, preliminary data suggest that the use of HCL systems may result in improved glycemia during pregnancy. There is an accumulating body of literature examining HCL systems in pregnancy, although there are still limited data regarding the impact of HCL systems on perinatal outcomes. Many individuals conceive while using clinically available HCL systems and may be hesitant to discontinue use during pregnancy, and clinicians may consider HCL therapy for pregnant individuals who are struggling to meet recommended glycemic levels during pregnancy. We therefore offer guidance on how to counsel patients on the risks and benefits of HCL therapy in pregnancy, how to identify appropriate candidates for HCL therapy in pregnancy, and how to manage commercially available HCL systems off-label throughout gestation.
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    Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial
    (Wolters Kluwer, 2021) Davis, Esa M.; Abebe, Kaleab Z.; Simhan, Hyagriv N.; Catalano, Patrick; Costacou, Tina; Comer, Diane; Orris, Steven; Ly, Kathleen; Decker, Alison; Mendez, Dara; Day, Nancy; Scifres, Christina M.; Obstetrics and Gynecology, School of Medicine
    Objective: To evaluate differences in short-term perinatal outcomes between the two prominent screening strategies for gestational diabetes mellitus, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and Carpenter-Coustan. Methods: In this single-site, blinded, randomized, comparative effectiveness trial, participants received a nonfasting 50-g oral glucose tolerance test and, if less than 200 mg/dL (less than 11.1 mmol/L), were randomized to further screening with either IADPSG or Carpenter-Coustan criteria. Gestational diabetes treatment occurred per routine clinical care. The primary outcome was incidence of large-for-gestational-age (LGA) neonates. Prespecified secondary outcomes included small-for-gestational-age (SGA) neonates, cesarean birth, and neonatal and maternal composites of adverse perinatal outcomes. Assuming a 15% incidence of LGA neonates in the Carpenter-Coustan group, 782 participants provided more than 80% power to detect a 7% absolute risk reduction with the use of IADPSG; planned recruitment was 920 for anticipated attrition. Results: From June 2015 to February 2019, 1,016 participants were enrolled and 921 were randomized to IADPSG (n=461) or Carpenter-Coustan (n=460) groups. Gestational diabetes incidence (14.4% vs 4.5%, P<.001) and diabetes medication use (9.3% vs 2.4%; P<.001) were more common in the IADPSG group; there were no differences in LGA neonates, either overall (risk reduction 0.90, 97.5% CI 0.53-1.52) or among women without gestational diabetes (risk reduction 0.85, 97.5% CI 0.49-1.48). Those screened with IADPSG had higher rates of neonatal morbidity but fewer study-related adverse events. Rates of SGA neonates, cesarean birth, and maternal morbidity composite did not differ significantly between study groups. Conclusions: The IADPSG screening criteria resulted in more women diagnosed and treated for gestational diabetes than Carpenter-Coustan without reducing the incidence of LGA birth weight or maternal or neonatal morbidity.
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    Short- and Long-Term Outcomes Associated with Large for Gestational Age Birth Weight
    (Elsevier, 2021-06) Scifres, Christina M.; Obstetrics and Gynecology, School of Medicine
    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.
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    The association between personal weight gain goals, provider recommendations, and appropriate gestational weight gain
    (Elsevier, 2020) Dude, Annie M.; Plunkett, Beth; Grobman, William; Scifres, Christina M.; Mercer, Brian M.; Parry, Samuel; Silver, Robert M.; Wapner, Ronald; Wing, Deborah A.; Saade, George; Reddy, Uma; Iams, Jay; Simhan, Hyagriv; Kominiarek, Michelle A.; Obstetrics and Gynecology, School of Medicine
    Background: Nearly half of all women exceed the 2009 Institute of Medicine guidelines for gestational weight gain. Excess gestational weight gain is associated with adverse pregnancy outcomes. Objective: Our objective was to determine whether having a personal gestational weight gain goal consistent with the Institute of Medicine's recommendations for appropriate gestational weight gain and whether having a discussion with one's obstetrical provider regarding that goal were associated with appropriate gestational weight gain. Study design: This is a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be study, a prospective cohort study of nulliparous women. We asked women at their first study visit (between 6 and 13 weeks' gestation) whether they had a gestational weight gain goal and what that goal was. Furthermore, we asked whether their provider discussed a gestational weight gain goal and what that goal was. We classified personal and provider-recommended gestational weight gain goals as consistent or inconsistent with the Institute of Medicine guidelines, taking into account a woman's initial body mass index category (underweight, normal weight, overweight, and obese). We included women with live singleton term deliveries (between 37 and 43 weeks' gestation) in this analysis. We classified the primary outcome, which was gestational weight gain (defined as the difference between first visit weight and final weight before delivery), as inadequate, appropriate, or excessive, based on the Institute of Medicine guidelines and initial body mass index category. We used Student t, Wilcoxon rank-sum, and chi-square tests for bivariable analyses, and multinomial logistic regression was performed to control for confounding variables. Results: Of 6727 eligible women, 3799 (56.5% of all eligible women) stated they had a gestational weight gain goal. Of the 3799 women with a stated goal, 2589 (38.5% of all women) had a goal consistent with the Institute of Medicine's recommendations. In addition, of the 6727 eligible women, 2188 (32.5%) reported that they discussed gestational weight gain with their provider, and 1548 of these (23.0% of all women) recalled that their provider gave a gestational weight gain goal in accordance with the Institute of Medicine guidelines. Although having any gestational weight gain goal was not associated with appropriate gestational weight gain, having a gestational weight gain goal that was consistent with the Institute of Medicine's recommendations was associated with a reduced risk of excessive (adjusted relative risk ratio, 0.77; 95% confidence interval, 0.64-0.92) and inadequate weight gain (adjusted relative risk ratio, 0.66; 95% confidence interval, 0.53-0.82). Conversely, discussing gestational weight gain goals with a provider was not associated with either inadequate or excessive gestational weight gain even if the provider's recommendations for gestational weight gain were consistent with the guidelines. Conclusion: Nulliparas who delivered singleton pregnancies at term who had a personal gestational weight gain goal consistent with the Institute of Medicine's recommendations were less likely to have excessive or inadequate gestational weight gain. Further study is required to evaluate the most effective way to communicate this information to patients.