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Item 786 Neonatal outcomes in pregnant women with diagnosis of COVID-19(Elsevier, 2021) Izewski, Joanna; Boudova, Sarah; Rouse, Caroline E.; Ibrahim, Sherrine A.; Shanks, Anthony L.; Reinhardt, Jeff C.; Scifres, Christina; Haas, David M.; Peipert, Jeffrey F.; Tuuli, Methodius G.; Obstetrics and Gynecology, School of MedicineObjective It is unclear whether infection with COVID-19 during pregnancy increases the risk of adverse neonatal outcomes. We tested the hypothesis that a diagnosis of COVID-19 during pregnancy increases the risk of neonatal respiratory morbidity and other adverse neonatal outcomes. Study Design: Retrospective analysis of prospectively collected data from two labor and delivery units with universal COVID-19 testing policy between March 1 and May 31, 2020. Pregnant women with singleton pregnancies who delivered during the study period and underwent testing for COVID-19 at any point in their pregnancy were eligible. The primary outcome was a composite of neonatal respiratory morbidity defined as the occurrence of any one of the following: respiratory distress syndrome, transient tachypnea of the newborn, and need for respiratory support. The risk of neonatal morbidity with and without a COVID-19 diagnosis were compared using univariable and multivariable analyses. Stratified analysis compared the risks of adverse neonatal outcomes in symptomatic and asymptomatic patients with COVID-19 to those without COVID-19. Results: Of 515 subjects meeting inclusion criteria, 55 (10.7%) tested positive for COVID-19; 19 (34.6%) were asymptomatic and 36 (65.4%) were symptomatic. No neonate tested positive for COVID-19. Rates of the primary outcome, composite neonatal respiratory morbidity, were not significantly different in patients with and without COVID-19 (21.8% vs 19.6%, P=0.692). There was no significant difference in the risk of neonatal respiratory morbidity in a Cox regression model accounting for time from diagnosis to delivery, and adjusting for gestational age at delivery, mode of delivery, and maternal diabetes (adjusted hazard ratio: 0.62; 95% CI 0.35, 1.09). There were no significant differences in any of the secondary outcomes in patients with COVID-19 who were asymptomatic or symptomatic (Table). Conclusion: A diagnosis of COVID-19 during pregnancy does not appear to increase the risk of neonatal morbidity. These data may be useful in counseling women diagnosed with COVID-19 during pregnancy.Item 975 ABO blood group, rhesus type and risk of COVID-19 in pregnant women(Elsevier, 2021) Ibrahim, Sherrine A.; Boudova, Sarah; Rouse, Caroline E.; Shanks, Anthony L.; Reinhardt, Jeffrey; Scifres, Christina; Haas, David M.; Peipert, Jeffrey F.; Tuuli, Methodius G.; Obstetrics and Gynecology, School of MedicineObjective: 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.Item Alterations in endogenous progesterone metabolism associated with spontaneous very preterm delivery(Oxford University Press, 2020) Patil, Avinash S.; Gaikwad, Nilesh W.; Grotegut, Chad A.; Dowden, Shelley D.; Haas, David M.; Medicine, School of MedicineStudy question: Do maternal serum levels of progesterone metabolites early in pregnancy correspond to an increased risk for very preterm delivery prior to 32 weeks? Summary answer: Maternal serum levels of 11-deoxycorticosterone (DOC) measured during the late first trimester or early second trimester correlate with an increased risk for preterm delivery prior to 32 weeks, and the correlation becomes stronger when the ratio of DOC to 16-alpha-hydroxyprogesterone was measured. What is known already: Progesterone is a pro-gestational steroid hormone that has been shown to decrease the risk of preterm birth in some pregnant women. Progesterone is metabolized by the body into various metabolites including members of the mineralocorticoid and glucocorticoid families. Our group has previously demonstrated that some progesterone metabolites enhance myometrial contractility in an ex vivo system, while others result in myometrial relaxation. The current exploratory study was designed to determine if pre-specified metabolites of progesterone measured early in pregnancy were associated with a woman's risk for delivery prior to 32 weeks, which is referred to as a very preterm delivery. Study design size duration: The Building Blocks of Pregnancy Biobank (BBPB) is a biorepository at Indiana University (IU) that follows women prospectively through their pregnancy. A variety of biospecimens are collected at various time points during a woman's pregnancy. Women participating in the IU BBPB who were enrolled after 8 weeks' gestation with pregnancy outcome data were eligible for participation. Participants/materials setting methods: Women delivering prior to 37 weeks (preterm) and at or after 37 weeks (term) who had blood samples collected during the late first trimester/early second trimester and/or during the early third trimester were identified. These samples were then processed for mass spectroscopy, and the amount of progesterone and progesterone metabolites in the samples were measured. Mean values of each measured steroid metabolite were calculated and compared among women delivering at less than 32 weeks, less than 37 weeks and greater than or equal to 37 weeks. Receiver operating characteristic (ROC) curves were constructed and threshold levels determined for each compound to identify a level above or below which best predicted a woman's risk for delivery prior to 32 and prior to 37 weeks. Mann-Whitney U nonparametric testing with Holm-Bonferroni correction for multiple comparisons was utilized to identify steroid ratios that could differentiate women delivering spontaneously at less than 32 weeks from all other pregnancies. Main results and the role of chance: Steroid hormone levels and pregnancy outcome data were available for 93 women; 28 delivering prior to 32 weeks, 40 delivering between 32 0/7 and 36 6/7 weeks and 25 delivering at or greater than 37 weeks: the mean gestational age at delivery within the three groups was 27.0, 34.4 and 38.8 weeks, respectively. Among women delivering spontaneously at less than 37 weeks, maternal 11-deoxycorticosterone (DOC) levels drawn in the late first trimester/early second trimester were significantly associated with spontaneous preterm delivery prior to 32 weeks; a threshold level of 47.5 pg/ml had 78% sensitivity, 73% specificity and an AUC of 0.77 (P = 0.044). When DOC levels were analyzed as a ratio with other measured steroid hormones, the ratio of DOC to 16-alpha-hydroxyprogesterone among women delivering spontaneously prior to 37 weeks was able to significantly discriminate women delivering prior to 32 weeks from those delivering at or greater than 32 weeks, with a threshold value of 0.2 with 89% sensitivity, 91% specificity and an AUC of 0.92 (P = 0.002). When the entire study cohort population was considered, including women delivering at term and women having an iatrogenic preterm delivery, the ratio of DOC to 16-alpha-hydroxyprogesterone was able to discriminate women delivering spontaneously prior to 32 weeks from the rest of the population at a threshold of 0.18 and 89% sensitivity, 59% specificity and an AUC of 0.81 (P = 0.003). Limitations reasons for caution: This is a discovery study, and the findings have not been validated on an independent cohort. To mitigate issues with multiple comparisons, we limited our study to pre-specified metabolites that are most representative of the major metabolic pathways for progesterone, and adjustments for multiple comparisons were made. Wider implications of the findings: Spontaneous preterm birth is increasingly being recognized to represent a common end pathway for a number of different disease phenotypes that include infection, inflammation, premature rupture of the membranes, uterine over distension, cervical insufficiency, placental dysfunction and genetic predisposition. In addition to these phenotypes, longitudinal changes in the maternal-fetal hypothalamic-pituitary-adrenal (HPA) axis also likely contribute to a significant proportion of the disease burden of spontaneous preterm birth. Here, we demonstrate that differential production of steroid metabolites is associated with very early preterm birth. The identified biomarkers may hint at a pathophysiologic mechanism and changes in the maternal-fetal dyad that result in preterm delivery. The early identification of abnormal changes in HPA axis metabolites may allow for targeted interventions that reverse the aberrant steroid metabolic profile to a more favorable one, thereby decreasing the risk for early delivery. Further research is therefore required to validate and extend the results presented here. Study funding/competing interests: Funding for this study was provided from the Office of the Vice Chancellor for Research at IUPUI, 'Funding Opportunities for Research Commercialization and Economic Success (FORCES) grant'.Both A.S.P. and C.A.G. are affiliated with Nixxi, a biotech startup. The remaining authors report no conflict of interest.Item Antenatal corticosteriods decrease forced vital capacity in infants born fullterm(Wiley, 2020-10) Bandyopadhyay, Anuja; Slaven, James E.; Evrard, Cindy; Tiller, Christina; Haas, David M.; Tepper, Robert S.; Pediatrics, School of MedicineAntenatal corticosteroids (ACS) administration to pregnant women for threatened preterm labor is standard obstetric care to reduce neonatal respiratory distress syndrome and the associated respiratory morbidity. While ACS stimulates surfactant production in the fetal lung, the effects of ACS upon the subsequent growth and development of the lung are unclear. Follow-up studies outside of the neonatal period have been primarily limited to spirometry, and most subjects evaluated were born prematurely. To our knowledge, no study has assessed both airway and parenchymal function in infants or adults following ACS exposure. We hypothesized that ACS impairs lung growth and performed infant pulmonary function testing, which included spirometry, alveolar volume (VA ) and lung diffusion (DL ). As a pilot study, we limited our assessment to infants whose mothers received ACS for threatened preterm labor, but then proceeded to full term delivery. This approach evaluated a more homogenous population and eliminated the confounding effects of preterm birth. We evaluated 36 full-term infants between 4 to 12 months of age; 17 infants had ACS exposure and 19 infants had no ACS exposure. Infants exposed to ACS had a significantly lower forced vital capacity compared with non-ACS exposed infants (250 vs 313 mL; P = .0075). FEV0.5 tended to be lower for the ACS exposed group (205 vs 237 mL; P = .075). VA and DL did not differ between the two groups. These findings suggest that ACS may impair subsequent growth of the lung parenchyma.Item Antenatal corticosteroids for fetal lung maturation: an overview of Cochrane reviews(Wiley, 2016) McGoldrick, Emma; Brown, Julie; Middleton, Philippa; McKinlay, Christopher J. D.; Haas, David M.; Crowther, Caroline A.; Department of Obstetrics and Gynecology, IU School of MedicineThis is the protocol for a review and there is no abstract. The objectives are as follows: The objective is to summarise the available evidence from Cochrane systematic reviews for the effectiveness and safety of antenatal corticosteroid therapy to improve infant outcomes.Item Antenatal Fetal Adrenal Measurements at 22 to 30 Weeks' Gestation, Fetal Growth Restriction, and Perinatal Morbidity(Thieme, 2021) Blue, Nathan R.; Hoffman, Matthew; Allshouse, Amanda A.; Grobman, William A.; Simhan, Hyagriv N.; Turan, Ozhan M.; Parry, Samuel; Chung, Judith H.; Reddy, Uma; Haas, David M.; Myers, Stephen; Mercer, Brian; Saade, George R.; Silver, Robert M.; Obstetrics and Gynecology, School of MedicineObjective: Our objective was to test the association of fetal adrenal size with perinatal morbidity among fetuses with fetal growth restriction (FGR; estimated fetal weight [EFW] < 10th percentile). Study design: This was a secondary analysis of the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) adrenal study, which measured fetal adrenal gland size at 22 to 30 weeks' gestation. We analyzed the transverse adrenal area (TAA) and fetal zone area (absolute measurements and corrected for fetal size) and the ratio of the fetal zone area to the total transverse area using a composite perinatal outcome of stillbirth, neonatal intensive care unit admission, respiratory distress syndrome, necrotizing enterocolitis, retinopathy of prematurity, sepsis, mechanical ventilation, seizure, or death. Among fetuses with FGR, adrenal measurements were compared between those that did and did not experience the composite perinatal outcome. Results: There were 1,709 eligible neonates. Seven percent (n = 120) were diagnosed with FGR at the time of adrenal measurement, and 14.7% (n = 251) experienced perinatal morbidity. EFW-corrected and absolute adrenal measurements were similar among fetuses with and without FGR as well as among those who did and did not experience morbidity. The area under the curve for corrected TAA was 0.52 (95% confidence interval 0.38-0.67). Conclusion: In our cohort, adrenal size was not associated with risk of morbidity among fetuses with FGR.Item Are Newborn Outcomes Different for Term Babies Who Were Exposed to Antenatal Corticosteroids?(Elsevier, 2021) McKinzie, Alexandra H.; Yang, Ziyi; Teal, Evgenia; Daggy, Joanne K.; Tepper, Robert S.; Quinney, Sarah K.; Rhoads, Eli; Haneline, Laura S.; Haas, David M.; Obstetrics and Gynecology, School of MedicineBackground: Antenatal corticosteroids improve newborn outcomes for preterm infants. However, predicting which women presenting for threatened preterm labor will have preterm infants is inaccurate, and many women receive antenatal corticosteroids but then go on to deliver at term. Objective: This study aimed to compare the short-term outcomes of infants born at term to women who received betamethasone for threatened preterm labor with infants who were not exposed to betamethasone in utero. Study design: We performed a retrospective cohort study of infants born at or after 37 weeks' gestational age to mothers diagnosed as having threatened preterm labor during pregnancy. The primary neonatal outcomes of interest included transient tachypnea of the newborn, neonatal intensive care unit admission, and small for gestational age and were evaluated for their association with betamethasone exposure while adjusting for covariates using multiple logistic regression. Results: Of 5330 women, 1459 women (27.5%) received betamethasone at a mean gestational age of 32.2±3.3 weeks. The mean age of women was 27±5.9 years and the mean gestational age at delivery was 38.9±1.1 weeks. Women receiving betamethasone had higher rates of maternal comorbidities (P<.001 for diabetes mellitus, asthma, and hypertensive disorder) and were more likely to self-identify as White (P=.022). Betamethasone-exposed neonates had increased rates of transient tachypnea of the newborn, neonatal intensive care unit admission, small for gestational age, hyperbilirubinemia, and hypoglycemia (all, P<.05). Controlling for maternal characteristics and gestational age at delivery, betamethasone exposure was not associated with a diagnosis of transient tachypnea of the newborn (adjusted odds ratio, 1.10; 95% confidence interval, 0.80-1.51), although it was associated with more neonatal intensive care unit admissions (adjusted odds ratio, 1.49; 95% confidence interval, 1.19-1.86) and higher odds of the baby being small for gestational age (adjusted odds ratio, 1.78; 95% confidence interval, 1.48-2.14). Conclusion: Compared with women evaluated for preterm labor who did not receive betamethasone, women receiving betamethasone had infants with higher rates of neonatal intensive care unit admission and small for gestational age. Although the benefits of betamethasone to infants born preterm are clear, there may be negative impacts for infants delivered at term.Item Are Newborn Outcomes Different for Term Babies Who Were Exposed to Antenatal Corticosteroids?(American Journal of Obstetrics and Gynecology, 2021-05-03) McKinzie, Alexandra; Yang, Ziyi; Teal, Evgenia; Daggy, Joanne K.; Tepper, Robert S.; Quinney, Sarah K.; Rhoads, Eli; Haneline, Laura S.; Haas, David M.; Obstetrics and Gynecology, School of MedicineBackground Antenatal corticosteroids improve newborn outcomes for preterm infants. However, predicting which women presenting for threatened preterm labor will have preterm infants is inaccurate and many women receive antenatal corticosteroids but then go on to deliver at term. Objective The purpose of this study was to compare the short-term outcomes of infants born at term to women who received betamethasone (BMZ) for threatened preterm labor to infants who were not exposed to BMZ in utero. Study Design We performed a retrospective cohort study of infants born at or after 37 weeks’ gestational age (GA) to mothers diagnosed with threatened preterm labor during pregnancy. The primary neonatal outcomes of interest included transient tachypnea of the newborn (TTN), neonatal intensive care unit (NICU) admission, and small for gestational age (SGA), and were evaluated for their association with BMZ exposure while adjusting for covariates using multiple logistic regression. Results Of 5330 women, 1459 (27.5%) women received BMZ at a mean GA of 32.2±3.3 weeks. The mean age of women was 27±5.9 years-old and the mean GA at delivery was 38.9±1.1 weeks. Women receiving BMZ had higher rates of maternal comorbidities (P<0.001 for diabetes, asthma, and hypertensive disorder) and were more likely to self-identify as white (P=0.022). BMZ-exposed neonates had increased rates of TTN, NICU admission, SGA, hyperbilirubinemia, and hypoglycemia (all P-values <0.05). Controlling for maternal characteristics and GA at delivery, BMZ exposure was not significantly associated with diagnosis of TTN (aOR 1.10, 95% CI 0.80-1.51), though it was associated with more NICU admissions (aOR 1.49, 95% CI 1.19-1.86) and higher odds of the baby being small for gestational age (SGA, aOR 1.78, 95%CI 1.48 to 2.14). Conclusions Compared to women evaluated for preterm labor that did not receive BMZ, women receiving BMZ had infants with higher rates of NICU admission and SGA. While the benefits of BMZ to infants born preterm are clear, there may be negative impacts for infants delivered at term.Item Association between increasing agricultural use of 2,4-D and population biomarkers of exposure: findings from the National Health and Nutrition Examination Survey, 2001-2014(BMC, 2022-02-10) Freisthler, Marlaina S.; Robbins, C. Rebecca; Benbrook, Charles M.; Young, Heather A.; Haas, David M.; Winchester, Paul D.; Perry, Melissa J.; Obstetrics and Gynecology, School of MedicineBackground: 2,4-Dichlorophenoxyacetic acid (2,4-D) is one of the most extensively used herbicides in the United States. In 2012, 2,4-D was the most widely used herbicide in non-agricultural settings and the fifth most heavily applied pesticide in the US agricultural sector. The objective of this study was to examine trends in 2,4-D urinary biomarker concentrations to determine whether increases in 2,4-D application in agriculture are associated with increases in biomonitoring levels of urine 2,4-D. Methods: Data from the National Health and Nutrition Examination Survey (NHANES) with available urine 2,4-D biomarker measurements from survey cycles between 2001 and 2014 were utilized. Urine 2,4-D values were dichotomized using the highest limit of detection (LOD) across all cycles (0.40 μg/L or 0.4 ppb). Agricultural use of 2,4-D was estimated by compiling publicly available federal and private pesticide application data. Logistic regression models adjusted for confounders were fitted to evaluate the association between agricultural use of 2,4-D and urine 2,4-D level above the dichotomization threshold. Results: Of the 14,395 participants included in the study, 4681 (32.5%) had urine 2,4-D levels above the dichotomization threshold. The frequency of participants with high 2,4-D levels increased significantly (p < .0001), from a low of 17.1% in 2001-2002 to a high of 39.6% in 2011-2012. The adjusted odds of high urinary 2,4-D concentrations associated with 2,4-D agricultural use (per ten million pounds applied) was 2.268 (95% CI: 1.709, 3.009). Children ages 6-11 years (n = 2288) had 2.1 times higher odds of having high 2,4-D urinary concentrations compared to participants aged 20-59 years. Women of childbearing age (age 20-44 years) (n = 2172) had 1.85 times higher odds than men of the same age. Conclusions: Agricultural use of 2,4-D has increased substantially from a low point in 2002 and it is predicted to increase further in the coming decade. Because increasing use is likely to increase population level exposures, the associations seen here between 2,4-D crop application and biomonitoring levels require focused biomonitoring and epidemiological evaluation to determine the extent to which rising use and exposures cause adverse health outcomes among vulnerable populations (particularly children and women of childbearing age) and highly exposed individuals (farmers, other herbicide applicators, and their families).Item Association of a Mediterranean Diet Pattern With Adverse Pregnancy Outcomes Among US Women(American Medical Association, 2022-12-01) Makarem, Nour; Chau, Kristi; Miller, Eliza C.; Gyamfi-Bannerman, Cynthia; Tous, Isabella; Booker, Whitney; Catov, Janet M.; Haas, David M.; Grobman, Wiliam A.; Levine, Lisa D.; McNeil, Rebecca; Merz, C. Noel Bairey; Reddy, Uma; Wapner, Ronald J.; Wong, Melissa S.; Bello, Natalie A.; Obstetrics and Gynecology, School of MedicineImportance: The Mediterranean diet pattern is inversely associated with the leading causes of morbidity and mortality, including metabolic diseases and cardiovascular disease, but there are limited data on its association with adverse pregnancy outcomes (APOs) among US women. Objective: To evaluate whether concordance to a Mediterranean diet pattern around the time of conception is associated with lower risk of developing any APO and individual APOs. Design, setting, and participants: This prospective, multicenter, cohort study, the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be, enrolled 10 038 women between October 1, 2010, and September 30, 2013, with a final analytic sample of 7798 racially, ethnically, and geographically diverse women with singleton pregnancies who had complete diet data. Data analyses were completed between June 3, 2021, and April 7, 2022. Exposures: An Alternate Mediterranean Diet (aMed) score (range, 0-9; low, 0-3; moderate, 4-5; and high, 6-9) was computed from data on habitual diet in the 3 months around conception, assessed using a semiquantitative food frequency questionnaire. Main outcomes and measures: Adverse pregnancy outcomes were prospectively ascertained and defined as developing 1 or more of the following: preeclampsia or eclampsia, gestational hypertension, gestational diabetes, preterm birth, delivery of a small-for-gestational-age infant, or stillbirth. Results: Of 7798 participants (mean [SD] age, 27.4 [5.5] years), 754 (9.7%) were aged 35 years or older, 816 (10.5%) were non-Hispanic Black, 1294 (16.6%) were Hispanic, and 1522 (19.5%) had obesity at baseline. The mean (SD) aMed score was 4.3 (2.1), and the prevalence of high, moderate, and low concordance to a Mediterranean diet pattern around the time of conception was 30.6% (n=2388), 31.2% (n=2430), and 38.2% (n=2980), respectively. In multivariable models, a high vs low aMed score was associated with 21% lower odds of any APO (adjusted odds ratio [aOR], 0.79 [95% CI, 0.68-0.92]), 28% lower odds of preeclampsia or eclampsia (aOR, 0.72 [95% CI, 0.55-0.93]), and 37% lower odds of gestational diabetes (aOR, 0.63 [95% CI, 0.44-0.90]). There were no differences by race, ethnicity, and prepregnancy body mass index, but associations were stronger among women aged 35 years or older (aOR, 0.54 [95% CI, 0.34-0.84]; P = .02 for interaction). When aMed score quintiles were evaluated, similar associations were observed, with higher scores being inversely associated with the incidence of any APO. Conclusions and relevance: This cohort study suggests that greater adherence to a Mediterranean diet pattern is associated with lower risk of APOs, with evidence of a dose-response association. Intervention studies are needed to assess whether dietary modification around the time of conception can reduce risk of APOs and their downstream associations with future development of cardiovascular disease risk factors and overt disease.