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Objective:  This study aimed to compare maternal and neonatal outcomes between labor induction versus cesarean delivery (CD) without labor among nulliparous individuals with class III obesity (body mass index [BMI] ≥40 kg/m 2 )., Study Design:  A retrospective cohort study of all nulliparous singleton deliveries at ≥37 weeks with a BMI of ≥40 kg/m 2 at delivery between March 2020 and February 2022. We excluded individuals with spontaneous labor, fetal malformations, and stillbirths. The primary outcome was a composite of maternal mortality and morbidity, including infectious and hemorrhagic morbidity. The secondary outcome was a neonatal composite. A subgroup analysis evaluated patients with a BMI of ≥50 kg/m 2 . Another subgroup analysis compared outcomes between CD without labor and an indicated CD following induction. A multivariable logistic regression was applied. For adjustment, we used possible confounders identified in a univariate analysis., Results:  Among 8,623 consecutive deliveries during the study period, 308 (4%) met the inclusion criteria. Among them, 250 (81%) underwent labor induction, and 58 (19%) had a CD without labor. The most common indications for CD without labor were fetal malpresentation (26; 45%), suspected macrosomia (8; 14%), and previous myomectomy (5; 9%). Indicated CD occurred in 140 (56%) of the induced individuals, with the two leading indications being labor arrest (87; 62%) and non-reassuring fetal heart rate tracing (51; 36%). The rates of composite maternal morbidity (adjusted odds ratio [aOR] = 2.14, 95% confidence interval [CI]: 0.64-7.13) and composite neonatal morbidity (aOR = 3.62, 95% CI: 0.42-31.19) did not differ following a CD without labor compared to labor induction. The subgroup analyses did not demonstrate different outcomes between groups., Conclusion:  Among nulliparous individuals with class III obesity at term who underwent induction, more than 50% had indicated CD; the rate of short-term maternal and neonatal morbidity, however, did not differ between labor induction and CD without labor., Key Points: · The rate of unplanned CD among those who underwent labor induction was relatively high (56.0%).. · Outcomes did not differ between those who underwent CD without labor and those who were induced.. · Outcomes also did not differ between those who underwent CD without labor and those with CD in labor.., Competing Interests: None declared., (Thieme. All rights reserved.)

Individuals with class III obesity (body mass index [BMI] > 40 kg/m2) are at increased risk of cesarean delivery and peripartum complications. We ascertained compositive neonatal and maternal adverse outcomes among individuals with class III obesity who labored versus had planned cesarean delivery (CD). This was a retrospective cohort study from 2016-2021 using the National Vital Statistics System database. Nulliparous individuals with class III obesity pre-pregnancy were included if they had singleton, non-anomalous pregnancies and delivered at 37 to 41 weeks of gestation. Individuals were excluded if they had hypertensive disorders or diabetes. The primary outcome was a composite neonatal adverse outcome (CNAO), consisting of Apgar score less than 5 at 5 minutes, assisted ventilation > 6 hours, neonatal seizure, or neonatal death. The secondary outcome was a composite maternal adverse outcome (CMAO) that included admission to the intensive care unit (ICU), maternal transfusion, uterine rupture, or unplanned hysterectomy. A sensitivity analysis using a CMAO without transfusion was performed. A multivariable Poisson regression model was performed to calculate adjusted relative risks (RR) with 95% confidence intervals (CI). Of 192,298 individuals who met inclusion criteria, 169,676 (88.2%) labored and 22,622 (11.8%) had a planned CD. Compared to neonates delivered by planned CD, the risk of CNAO was significantly lower in those who delivered after labor (aRR 0.79, 95% CI 0.71 - 0.87). There was no significant difference in the risk of CMAO between groups (aRR 1.11, 95% CI 0.87-1.41). However, the risk of CMAO without transfusion was lower in individuals who labored (aRR 0.57, 95% CI 0.40 - 0.83). In nulliparous individuals with class III obesity, the risk of CNAO and of CMAO without transfusion were significantly lower in individuals who labored, versus those who had a planned cesarean delivery., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Objective:  The study's primary objective was to evaluate adverse outcomes among reproductive-age hospitalizations with diabetic ketoacidosis (DKA), comparing those that are pregnancy-related versus nonpregnancy-related and evaluating temporal trends., Study Design:  We conducted a retrospective cross-sectional study using the National Inpatient Sample to identify hospitalizations with DKA among reproductive-age women (15-49 years) in the United States (2016-2020). DKA in pregnancy hospitalizations was compared with DKA in nonpregnant hospitalizations. Adverse outcomes evaluated included mechanical ventilation, coma, seizures, renal failure, prolonged hospital stay, and in-hospital death. Multivariable Poisson regression models with robust error variance were used to estimate adjusted relative risk (aRR) and 95% confidence interval (CI). Annual percent change (APC) was used to calculate the change in DKA rate over time., Results:  Among 35,210,711 hospitalizations of reproductive-age women, 447,600 (1.2%) were hospitalized with DKA, and among them, 13,390 (3%) hospitalizations were pregnancy-related. The rate of nonpregnancy-related DKA hospitalizations increased over time (APC = 3.8%, 95% CI = 1.5-6.1). After multivariable adjustment, compared with pregnancy-related hospitalizations with DKA, the rates of mechanical ventilation (aRR = 1.56, 95% CI = 1.18-2.06), seizures (aRR = 2.26, 95% CI = 1.72-2.97), renal failure (aRR = 2.26, 95% CI = 2.05-2.50), coma (aRR = 2.53, 95% CI = 1.68-3.83), and in-hospital death (aRR = 2.38, 95% CI = 1.06-5.36) were higher among nonpregnancy-related hospitalizations with DKA., Conclusion:  A nationally representative sample of hospitalizations indicates that over the 5-year period, the rate of nonpregnancy-related DKA hospitalizations increased among reproductive age women, and a higher risk of adverse outcomes was observed when compared with pregnancy-related DKA hospitalizations., Key Points: · Over 5 years, the rate of pregnancy-related DKA hospitalizations was stable.. · Over 5 years, the rate of nonpregnancy-related DKA hospitalizations increased.. · There is a higher risk of adverse outcomes with DKA outside of pregnancy.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective:  To examine the association of adverse outcomes among parturients with large for gestational age (LGA; birth weight ≥ 90 th ) newborns, stratified by diabetes status. Additionally, we described the temporal trends of adverse outcomes among LGA neonates., Study Design:  This retrospective cohort study used the U.S. Vital Statistics dataset between 2014 and 2020. The inclusion criteria were singleton, nonanomalous LGA live births who labored and delivered at 24 to 41 weeks with known diabetes status. The coprimary outcomes were composite neonatal adverse outcomes of the following: Apgar score < 5 at 5 minutes, assisted ventilation > 6 hours, seizure, or neonatal or infant mortality, and maternal adverse outcomes of the following: maternal transfusion, ruptured uterus, unplanned hysterectomy, admission to intensive care unit, or unplanned procedure. Multivariable Poisson regression models were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI). Average annual percent change (AAPC) was calculated to assess changes in rates of LGA and morbidity over time., Results:  Of 27 million births in 7 years, 1,843,467 (6.8%) met the inclusion criteria. While 1,656,888 (89.9%) did not have diabetes, 186,579 (10.1%) were with diabetes. Composite neonatal adverse outcomes (aRR = 1.48, 95% CI = 1.43, 1.52) and composite maternal adverse outcomes (aRR = 1.37, 95% CI = 1.36, 1.38) were significantly higher among individuals with diabetes, compared with those without diabetes. From 2014 to 2020, the LGA rate was stable among people without diabetes. However, there was a downward trend of LGA in people with diabetes (AAPC = - 2.4, 95% CI = - 3.5, -1.4)., Conclusion:  In pregnancies with LGA newborns, composite neonatal and maternal morbidities were higher in those with diabetes, compared with those without diabetes., Key Points: · Large for gestational age stratified by diabetes status.. · Composite neonatal and maternal adverse outcomes are worse among individuals with diabetes as compared to those without.. · During 2014 to 2020, the trend of LGA in individuals without diabetes increased.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objectives: The objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction., Materials and Methods: Secondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8 kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine >5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure ( p  < 0.05) in univariate analysis., Results: Of 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55-4.20), but the difference was not significantly different (adjusted odds ratio [aOR] = 1.0, 95% CI 0.30-3.31). This association was similar when exposure was stratified as heavy (>100 ng/mL, aOR 0.72, 95% CI 0.15-3.51) or mild (5-100 ng/mL, aOR 1.28, 95% CI 0.33-4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude., Conclusion: In a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs., Key Points: · Nicotine exposure was quantified from maternal urine.. · Nicotine exposure was identified in 30% of the cohort.. · Exposure was not associated with offspring hearing dysfunction.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: The aim of the study is to determine the relation between education and adverse outcomes in individuals with pregestational or gestational diabetes., Study Design: This population-based cohort study, using the U.S. vital statistics datasets, evaluated individuals with pregestational or gestational diabetes who delivered between 2016 and 2019. The primary outcome was composite neonatal adverse outcome including any of the following: large for gestational age (LGA), Apgar's score 6 hours, neonatal seizure, or neonatal death. The secondary outcome was composite maternal adverse outcomes including any of the following: admission to intensive care unit, transfusion, uterine rupture, or unplanned hysterectomy. Multivariable analysis was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CIs)., Results: Of 15,390,962 live births in the United States, 858,934 (5.6%) were eligible for this analysis. Compared with individuals with a college education and above, the risk of composite neonatal adverse outcome was higher in individuals with some college (aRR = 1.08, 95% CI = 1.07-1.09), high school (aRR = 1.06, 95% CI = 1.04-1.07), and less than high school (aRR = 1.05, 95% CI = 1.03-1.07) education. The components of composite neonatal adverse outcome that differed significantly between the groups were LGA, Apgar's score 6 hours. Infant death differed when stratified by education level. An increased risk of composite maternal adverse outcome was also found with a lower level of education., Conclusion: Among individuals with diabetes, lower education was associated with a modestly higher risk of adverse neonatal and maternal outcomes., Key Points: · Education levels were associated with adverse outcomes among individuals with diabetes.. · Lower education is associated with multiple neonatal complications, including infant death.. · Individuals with varying levels of education are at higher risk for adverse maternal outcomes.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to ascertain the outcomes associated with a cervical cerclage among individuals with a history of previable prelabor rupture of membranes (PROM)., Study Design: This study was a retrospective cohort study conducted at a single tertiary center between 2011 and 2021. We included individuals with a history of previable (before 24 weeks) PROM and the subsequent viable pregnancy. Women with multifetal gestation, preterm birth (PTB) or cerclage in previous gestation, or abdominal cerclage after trachelectomy were excluded. Primary outcome was PTB rate (delivery <37 weeks). Recurrence of preterm PROM and adverse composite maternal and neonatal outcomes (CMO and CNO) were evaluated as secondary outcomes. CMO included any of the following: suspected chorioamnionitis, endometritis, red blood cell transfusion, uterine rupture, unplanned hysterectomy, or death. CNO included any of the following: previable PTB (<24 weeks of gestation), bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, mechanical ventilation, seizures, hypoxic ischemic encephalopathy, or death., Results: During the study period, 118 individuals had a history of previable PROM and a documented subsequent pregnancy, out of which 74 (62.7%) met inclusion criteria. Nineteen (25.7%) of eligible individuals underwent a cerclage for prior previable PROM and were compared with controls ( n  = 55, 74.3%). Women who underwent a cerclage had higher rates of PTB < 37 weeks (63.2 vs. 10.9%, p  < 0.001; odds ratio [OR]: 14.00, 95% confidence interval [CI]: 3.97-49.35) and < 34 weeks (21.1 vs. 3.6%, p  = 0.03; OR: 7.07, 95% CI: 1.18-42.39) compared with those without cerclage. Furthermore, recurrent preterm PROM and previable PTB rates were higher among patients who underwent cerclage. The survival curve further indicated that individuals with cerclage delivered earlier. CMO and CNO rates were similar in those with and without cerclage., Conclusion: Cerclage placement in individuals with prior previable PROM was associated with higher rates of recurrent preterm PROM and PTB., Key Points: · The management of individuals in a subsequent pregnancy following previable PROM is a conundrum.. · Cerclage following previable PROM is associated with higher rates of recurrent preterm PROM and PTB.. · Composite maternal and neonatal outcome rates were similar in those with and without cerclage.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This work aimed to study the effect of sustained hypotension after spinal on neonatal acidosis and adverse outcomes in those undergoing scheduled cesarean delivery (CD) with universal prophylactic vasopressor exposure and to examine differences in spinal-to-delivery time by neonatal acidosis status., Study Design: This retrospective cohort study conducted at a quaternary care center from January 2019 to December 2021 included singleton, term, nonanomalous pregnancies, with scheduled CD under spinal anesthesia. Hypotension was defined as a systolic blood pressure (SYS-BP) < 100 mm Hg (SYS-BP100) or a >20% drop from baseline blood pressure (SYS-BP20). Both the occurrence of hypotension and its magnitude and duration were studied; the latter through the development of a hypotension index. The 90th and 95th percentiles of the hypotension index for SYS-BP20 and SYS-BP100, respectively, were used to define sustained hypotension. The primary outcome was neonatal acidosis (umbilical artery pH ≤ 7.1 or base excess ≤ -12 mmol). Secondary outcomes were composites of neonatal (CNAO) and maternal (CMAO) adverse outcomes. Multivariable Poisson regression models with robust error variance analysis was used to estimate adjusted relative risks (aRRs) and 95% confidence intervals (CIs)., Results: Our study included 332 individuals who underwent scheduled CD; among them 330 (99.4%) received prophylactic vasopressors. The rate of neonatal acidosis was 4.2%. Sustained hypotension after spinal anesthesia, which occurred in 12.3% of the cohort, was associated with increased risk for neonatal acidosis (aRR 3.96, 95% CI 1.21-12.98), but was not associated with CNAO or CMAO. Time from spinal-to-delivery was not different in those with and without neonatal acidosis., Conclusion: Despite universal exposure to prophylactic vasopressors, sustained hypotension after spinal anesthesia was still associated with neonatal acidosis, but no other adverse perinatal outcomes. Our findings may provide additional support for the adoption of prophylactic vasopressors to reduce spinal hypotension and downstream effects on the neonate from intraoperative hemodynamic instability., Key Points: · Despite prophylactic vasopressors during scheduled CD, neonatal acidosis occurred in 4% of subjects.. · Sustained hypotension after spinal anesthesia was associated with neonatal acidosis, but not adverse neonatal outcomes.. · Spinal-to-delivery time was not associated with neonatal acidosis in scheduled CD.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: Continuous glucose monitoring (CGM) has become available for women with type 2 diabetes mellitus (T2DM) or gestational diabetes mellitus (GDM) during pregnancy. The recommended time in range (TIR, blood glucose 70-140 mg/dL) and its correlation with adverse pregnancy outcomes in this group is unknown. Our aim was to compare maternal and neonatal outcomes in pregnant people with T2DM or GDM with average CGM TIR values >70 versus ≤70%., Study Design: We conducted a retrospective cohort study of all individuals using CGM during pregnancy from January 2017 to June 2022. Individuals with type 1 diabetes mellitus, or those missing CGM or delivery data were excluded. Primary composite neonatal outcome included any of the following: large for gestational age, NICU admission, need for intravenous glucose, respiratory support, or neonatal death. Secondary outcomes included other maternal and neonatal outcomes. Regression models were used to estimate adjusted odds ratio (aOR) and 95% confidence interval (CI)., Results: During the study period, 141 individuals with diabetes utilized CGM during pregnancy, with 65 (46%) meeting inclusion criteria. Of the study population, 28 (43%) had TIR ≤70% and 37 (57%) had TIR > 70%. Compared with those with TIR > 70%, the primary composite outcome occurred more frequently in neonates of individuals TIR ≤70% (71.4 vs. 37.8%, aOR: 4.8, 95% CI: 1.6, 15.7). Furthermore, individuals with TIR ≤70% were more likely to have hypertensive disorders (42.9 vs. 16.2%, OR: 3.9, 95% CI: 1.3, 13.0), preterm delivery (54 vs. 27%, OR: 3.1, 95% CI: 1.1, 9.1): , and cesarean delivery (96.4 vs. 51.4%, OR: 4.6, 95% CI: 2.2, 15.1) compared with those with TIR >70%., Conclusion: Among people with T2DM or GDM who utilized CGM during pregnancy, 4 out 10 individuals had TIR ≤70% and, compared with those with TIR > 70%, they had a higher likelihood of adverse neonatal and maternal outcomes., Key Points: · Time in range can be utilized as a metric for pregnant patients using continuous glucose monitor.. · Time in range >70% is achievable by 6 out of 10 patients.. · Time in range below goal is associated with adverse neonatal and maternal outcomes.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: We aimed to ascertain whether the risk of adverse pregnancy outcomes in the United States among individuals with chronic hypertension differed by maternal race and ethnicity and to assess the temporal trend., Study Design: Population-based retrospective study using the U.S. Vital Statistics datasets evaluated pregnancies with chronic hypertension, singleton live births that delivered at 24 to 41 weeks. The coprimary outcomes were a composite maternal adverse outcome (preeclampsia, primary cesarean delivery, intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy) and a composite neonatal adverse outcome (preterm birth, small for gestational age, Apgar's score <5 at 5 minutes, assisted ventilation> 6 hours, seizure, or death). Multivariable Poisson regression models were used to estimate adjusted relative risks (aRRs) and 95% confidence intervals (CIs)., Results: Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased from 1.6 to 2.2%. After multivariable adjustment, an increased risk for the composite maternal adverse outcome was found in Black (aRR = 1.10, 95% CI = 1.09-1.11), Hispanic (aRR = 1.04, 95% CI = 1.02-1.05), and Asian/Pacific Islander (aRR = 1.07, 95% CI = 1.05-1.10), compared with White individuals. Compared with White individuals, the risk of the composite neonatal adverse outcome was higher in Black (aRR = 1.39, 95% CI = 1.37-1.41), Hispanic (aRR = 1.15, 95% CI = 1.13-1.16), Asian/Pacific Islander (aRR = 1.34, 95% CI = 1.31-1.37), and American Indian (aRR = 1.12, 95% CI = 1.07-1.17). The racial and ethnic disparity remained unchanged during the study period., Conclusion: We found a racial and ethnic disparity with maternal and neonatal adverse outcomes in pregnancies with chronic hypertension that remained unchanged throughout the study period., Key Points: · Between 2014 and 2019, the rate of chronic hypertension in pregnancy increased.. · Among people with chronic hypertension, there are racial and ethnic disparities in adverse outcomes.. · Black, Hispanic, and Asian/Pacific Islander have a higher risk of the adverse neonatal outcomes.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery., Study Design: This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative [CMQCC]) and two regression models (Ahmadzia et al and Albright et al). The primary outcome was intrapartum or postpartum red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared., Results: Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low risk, 5,259 (48.8%) as medium risk, and 3,556 (33.0%) as high risk with corresponding transfusion rates of 2.1% (95% confidence interval [CI]: 1.5-2.9%), 2.2% (95% CI: 1.8-2.6%), and 7.5% (95% CI: 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI: 0.76-0.81) and 0.79 (95% CI: 0.77-0.82), respectively ( p  = 0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion., Conclusion: Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S., Cohort: Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed., Key Points: · A total of 3.9% of individuals received a blood transfusion during cesarean delivery admission.. · Three models used in clinical practice are externally valid for blood transfusion prediction.. · Institutional model selection should be based on ease of application until further research identifies the optimal approach.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to ascertain whether the length of time to complete the gestational diabetes mellitus (GDM) screening was associated with adverse neonatal outcomes., Study Design: This was a retrospective cohort study of singleton, nonanomalous individuals who were screened for GDM at ≥24 weeks' gestation at an academic hospital system. We compared outcomes among people who were diagnosed with GDM and completed the 3-hour glucose tolerance test (GTT) ≤14 second versus >14 days from the 1-hour glucose challenge test (GCT). The primary outcome was a composite adverse neonatal outcome of the following: large for gestational age, shoulder dystocia, birth injury, respiratory distress, hypoglycemia, or fetal/neonatal death. The secondary outcomes included several individual neonatal and maternal morbidities. Multivariable Poisson's regression models were used to evaluate the association. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated., Results: Among the 313 individuals who completed the two-step screening for GDM and had an 1-hour GCT ≥ 135 mg/dL; of them, 171 (54.6%) completed the 3-hour GTT ≤14 days, 142 (45.4%) completed the 3-hour GTT > 14 days. Overall rate of the primary outcome was 44.1%. After multivariable adjustment, the risk of the primary outcome was similar between people who completed the two-step method in ≤14 versus >14 days (aRR = 1.11, 95% CI = 0.81-1.52). There was no significant difference in all secondary adverse outcomes between the two groups. Subgroup analyses, limited to people diagnosed with GDM ( N  = 89, 23.4%), also found similar results as the full analyses., Conclusion: Among individuals who completed the two-step screening for GDM, completion of the 3-hour GTT within ≤14 versus ≥ 14 days was not associated with an increase rate of the adverse outcomes., Key Points: · Among pregnant people in an academic practice, 50% of people with abnormal 1-hour GTT completed GDM two-step screening in 14 days.. · Longer length of time to completion of diagnostic testing for GDM was not associated with an increased rate of adverse outcomes.. · Pregnant people that were diagnosed with GDM and completed the two-step method in >14 days did not have worse perinatal outcomes.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective:  We aimed to determine the composite maternal hemorrhagic outcome (CMHO) among individuals with and without hypertensive disorders of pregnancy (HDP), stratified by disease severity. Additionally, we investigated the composite neonatal adverse outcome (CNAO) among individuals with HDP who had postpartum hemorrhage (PPH) versus did not have PPH., Study Design:  Our retrospective cohort study included all singletons who delivered at a Level IV center over two consecutive years. The primary outcome was the rate of CMHO, defined as blood loss ≥1,000 mL, use of uterotonics, mechanical tamponade, surgical techniques for atony, transfusion, venous thromboembolism, intensive care unit admission, hysterectomy, or maternal death. A subgroup analysis was performed to investigate the primary outcome stratified by (1) chronic hypertension, (2) gestational hypertension and preeclampsia without severe features, and (3) preeclampsia with severe features. A multivariable regression analysis was performed to investigate the association of HDP with and without PPH on a CNAO which included APGAR <7 at 5 minutes, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, seizures, neonatal sepsis, meconium aspiration syndrome, ventilation >6 hours, hypoxic-ischemic encephalopathy, or neonatal death., Results:  Of 8,357 singletons, 2,827 (34%) had HDP. Preterm delivery <37 weeks, induction of labor, prolonged oxytocin use, and magnesium sulfate usage were more common in those with versus without HDP ( p  < 0.001). CMHO was higher among individuals with HDP than those without HDP (26 vs. 19%; adjusted relative risk [aRR] 1.11, 95% CI 1.01-1.22). In the subgroup analysis, only individuals with preeclampsia with severe features were associated with higher CMHO ( n  = 802; aRR 1.52, 95% CI 1.32-1.75). There was a higher likelihood of CNAO in individuals with both HDP and PPH compared to those with HDP without PPH (aRR 1.49, 95% CI 1.06-2.09)., Conclusion:  CMHO was higher among those with HDP. After stratification, only those with preeclampsia with severe features had an increased risk of CMHO. Among individuals with HDP, those who also had a PPH had worse neonatal outcomes than those without hemorrhage., Key Points: · Individuals with HDP had an 11% higher likelihood of CMHO.. · After stratification, increased CMHO was limited to those with preeclampsia with severe features.. · There was a higher likelihood of CNAO in those with both HDP and PPH compared to HDP without PPH.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals., Study Design: This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics., Results: Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE., Conclusion: In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin., Key Points: · Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial.., Competing Interests: None declared., (Thieme. All rights reserved.)

Sepsis is a life-threatening syndrome caused by the body's response to infection. The Global Maternal Sepsis Study (GLOSS) suggests sepsis plays a larger role in maternal morbidity and mortality than previously thought. We therefore sought to compare national and international guidelines for maternal sepsis to determine their consistency with each other and the Third International Consensus for Sepsis and Septic Shock (SEPSIS-3). Using Cochrane Database of Systematic Reviews, PubMed, Google Scholar, and organization Web sites, we identified seven guidelines on maternal sepsis in the English language-The American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Society of Obstetric Medicine of Australia and New Zealand, Royal College of Obstetricians and Gynaecologists, Royal College of Physicians of Ireland Institute of Obstetricians and Gynaecologists, and World Health Organization. Guidelines were reviewed to ascertain the commonality and variation, if any, in definitions of maternal sepsis, tools and criteria utilized for diagnosis, obstetric warning systems used, as well as evaluation and management of maternal sepsis. These variables were also compared with SEPSIS-3. All guidelines provided definitions consistent with a version of the SEPSIS, although the specific version utilized were varied. Clinical variables and tools employed for diagnosis of maternal sepsis were also varied. Evaluation and management of maternal sepsis and septic shock were similar. In conclusion, national and international maternal sepsis guidelines were incongruent with each other and SEPSIS-3 in diagnostic criteria and tools but similar in evaluation and management recommendations. KEY POINTS: · Definitions for maternal sepsis and septic shock are varied.. · Maternal sepsis guidelines differ in proposed criteria and tools.. · Maternal sepsis guidelines have similar management recommendations.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to develop and evaluate a scoring system-called the Sepsis-Associated Adverse Outcomes in Pregnancy (SAAP) Score-to identify individuals with maternal infection that have composite maternal adverse outcomes (CMAO)., Study Design: Using the International Classification of Disease codes, we identified pregnant and postpartum (up to 6 weeks after birth) individuals admitted at our center with a primary diagnosis of infection. The primary outcome was CMAO which included any of the following: maternal intensive care unit admission, surgical intervention, vasopressor use, acute respiratory distress syndrome, pulmonary edema, mechanical ventilation, high-flow nasal cannula, disseminated intravascular coagulation, dialysis, organ failure, venous thromboembolism, or maternal death. Regularized logistic regression was used to identify variables that best discriminate CMAO status. Variables were chosen for inclusion following evaluation of statistical and clinical significance. Model performance was evaluated using area under the curve (AUC) with 95% confidence intervals (CIs), sensitivity, specificity, and predictive values., Results: Of the 23,235 deliveries during the study period, 227 (0.9%) individuals met inclusion criteria and among them CMAO occurred in 39.2% (95% CI: 33.1-45.7%). The SAAP score consisted of six variables (white blood cell count, systolic blood pressure, respiratory rate, heart rate, lactic acid, and abnormal diagnostic imaging) with scores ranging from 0 to 11 and a score of ≥7 being abnormal. An abnormal SAAP score had an AUC of 0.80 (95% CI: 0.74-0.86) for CMAO. The sensitivity and specificity of the SAAP score for CMAO was 0.71 (95% CI: 0.60-0.80) and 0.73 (95% CI: 0.64-0.80), respectively. The positive predictive value was 0.62 (95% CI: 0.52-0.72) and negative predictive value was 0.79 (95% CI: 0.71-0.86)., Conclusion: Pending external validation, the sixth variable SAAP score may permit early recognition of pregnant and postpartum individuals with infection who are likely to develop adverse maternal outcomes., Key Points: · Sepsis is a leading cause of maternal morbidity and mortality.. · Early recognition improves maternal sepsis outcomes.. · The SAAP score may permit early recognition of maternal adverse outcomes due to infection.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: Women with placenta accreta spectrum (PAS) having an unplanned delivery may have worse outcome compared with women with a planned delivery. The primary objective of this study was to compare severe maternal morbidity among women with PAS who had a planned scheduled delivery versus an unplanned delivery. Secondary objective was to compare neonatal outcomes., Study Design: Retrospective cohort study at two tertiary centers (January 2009 to June 2019) of all women who underwent a hysterectomy with a histologic proven PAS. Primary outcome was severe maternal morbidity which defined as any of the following: transfusion of ≥4 RBC units or ureter/bowel injury. Neonatal outcome was a composite neonatal morbidity defined as any of the following: Apgar score's < 5 at 5 minutes, mechanical ventilation, or respiratory distress syndrome. Maternal demographic, clinical, and sonographic characteristics were compared between the two groups (planned vs. unplanned). Descriptive statistics were used as appropriate, and a statistical significance was established if p -value was < 0.05., Results: Of 109 women who underwent cesarean hysterectomy for PAS, 41 (37.6%) had an unplanned delivery. There was no significant difference in the number of previous cesarean deliveries or ultrasound findings between the two groups. Women with an unplanned delivery were more likely to bleed during pregnancy than those that had a planned delivery ( p  = 0.04). Women with unplanned delivery had lower gestational age at delivery (30.3 vs. 33.8 weeks, p  = 0.001) had a 75% higher rate of the primary outcome (63 vs. 36%, p  = 0.007) and had a higher rate of intensive care unit admissions (39 vs. 17.7%, p  = 0.01) compared with women with a planned delivery. The neonatal morbidity did not differ between the two groups., Conclusion: Since unplanned cesarean hysterectomy among women with PAS occurs in 40% and is associated with significantly higher morbidity, interventions are needed to mitigate the rate of adverse outcomes., Key Points: · Only 60% of women with PAS reached planned delivery at 34 weeks.. · PAS unplanned delivery is associated with high morbidity.. · Some women with PAS may need a scheduled earlier delivery.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: To determine the accuracy and reliability of remotely directed and interpreted ultrasound (teleultrasound) as compared with standard in-person ultrasound for the detection of fetal anomalies, and to determine participants' satisfaction with teleultrasound., Study Design: This was a single-center, randomized (1:1) noninferiority study. Individuals referred to the maternal-fetal medicine (MFM) ultrasound clinic were randomized to standard in-person ultrasound and counseling or teleultrasound and telemedicine counseling. The primary outcome was major fetal anomaly detection rate (sensitivity). All ultrasounds were performed by registered diagnostic medical sonographers and interpretations were done by a group of five MFM physicians. After teleultrasound was completed, the teleultrasound patients filled out a satisfaction survey using a Likert scale. Newborn data were obtained from the newborn record and statewide birth defect databases., Results: Of 300 individuals randomized in each group, 294 were analyzed in the remotely interpreted teleultrasound group and 291 were analyzed in the in-person ultrasound group. The sensitivity of sonographic detection of 28 anomalies was 82.14% in the control group and of 20 anomalies in the telemedicine group, it was 85.0%. The observed difference in sensitivity was 0.0286, much smaller than the proposed noninferiority limit of 0.05. Specificity, negative predictive value, positive predictive value, and accuracy were more than 94% for both groups. Patient satisfaction was more than 95% on all measures, and there were no significant differences in patient satisfaction based on maternal characteristics., Conclusion: Teleultrasound is not inferior to standard in-person ultrasound for the detection of fetal anomalies. Teleultrasound was uniformly well received by patients, regardless of demographics. These key findings support the continued expansion of telemedicine services., Key Points: · For detection of major anomalies, teleultrasound is comparable to standard ultrasound.. · Teleultrasound was well accepted by patients.. · Teleultrasound use should be expanded.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to assess the risk of adverse outcomes among low-risk pregnancies at 39 to 41 weeks, stratified by birth weight percentile., Study Design: This retrospective cohort study utilized the U.S. vital statistics datasets (2013-2017) and evaluated low-risk women with nonanomalous cephalic singleton gestations who labored and delivered at 39 to 41 weeks, regardless of ultimate mode of delivery. Newborns were categorized as small (<10th percentile), large (>90th percentile), or appropriate (10-90th percentile) for gestational ages (SGA, LGA, and AGA, respectively). The primary outcome, composite neonatal adverse outcome (CNAO), included Apgar's score <5 at 5 minutes, assisted ventilation >6 hours, seizure, or neonatal death. The secondary outcome, composite maternal adverse outcome (CMAO), included intensive care unit admission, blood transfusion, uterine rupture, or unplanned hysterectomy. Multivariable Poisson's regression was used to estimate the association (using adjusted relative risk [aRR] and 95% confidence interval [CI])., Results: Of 19.8 million live births during the study interval, approximately 8.9 million (44.9%) met the inclusion criteria, with 9.9% being SGA, 9.2% being LGA, and 80.9% being AGA. SGA newborns delivered at 40 (aRR = 1.17; 95% CI: 1.12-1.23) and at 41 weeks (aRR = 1.55; 95% CI: 1.45-1.66) had a higher risk of CNAO than at 39 weeks. Similarly, LGA newborns delivered at 40 (aRR = 1.13; 95% CI: 1.07-1.19) and 41 weeks (aRR = 1.44; 95% CI: 1.35-1.54) and AGA newborns delivered at 40 (aRR = 1.24; 95% CI: 1.21-1.26) and 41 weeks (aRR = 1.57; 95% CI: 1.53-1.61) also had a higher risk of CNAO than at 39 weeks. CMAO was also significantly higher at 40 and 41 weeks than at 39 weeks, regardless of whether the mothers delivered SGA, LGA, or AGA newborns., Conclusion: Among low-risk pregnancies, the risks of composite neonatal and maternal adverse outcomes increase from 39 through 41 weeks' gestation, irrespective of whether newborns are SGA, LGA, or AGA., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: The aim of the study is to evaluate the association between amniotomy at various time points during labor induction and maternal and neonatal outcomes among term, nulliparous women., Study Design: Secondary analysis of a randomized trial of term labor induction versus expectant management in low-risk, nulliparous women (2014-2017) was conducted. Women met inclusion criteria if they underwent induction ≥38 weeks' gestation using oxytocin with documented time and type of membrane rupture. Women with antepartum stillbirth or fetal anomaly were excluded. The primary outcome was cesarean delivery. Secondary outcomes included maternal and neonatal complications. Maternal and neonatal outcomes were compared among women with amniotomy versus women with intact membranes and no amniotomy at six 2-hour time intervals: before oxytocin initiation, 0 to <2 hours after oxytocin, 2 to <4 hours after, 4 to <6 hours after, 6 to <8 hours after, and 8 to <10 hours after. Multivariable logistic regression adjusted for maternal age, body mass index, race/ethnicity, modified Bishop score on admission, treatment group, and hospital (as a random effect)., Results: Of 6,106 women in the parent trial, 2,854 (46.7%) women met inclusion criteria. Of these 2,340 (82.0%) underwent amniotomy, and majority of the women had amniotomy performed between 2 and <6 hours after oxytocin. Cesarean delivery was less frequent among women with amniotomy 6 to <8 hours after oxytocin compared with women without amniotomy (21.9 vs. 29.7%; adjusted odds ratio 0.61, 95% confidence interval 0.42-0.89). Amniotomy at time intervals ≥4 hours after oxytocin was associated with lower odds of labor duration >24 hours. Amniotomy at time intervals ≥2 hours and <8 hours after oxytocin was associated with lower odds of maternal hospitalization >3 days. Amniotomy was not associated with postpartum or neonatal complications., Conclusion: Among a contemporary cohort of nulliparous women undergoing term labor induction, amniotomy was associated with either lower or similar odds of cesarean delivery and other adverse outcomes, compared with no amniotomy., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: Nulliparous obese women are at increased risk of labor induction and cesarean delivery (CD). We sought to determine whether the combination of a transvaginal Foley balloon plus misoprostol prostaglandin E1 (PGE1) is superior to misoprostol alone in reducing the risk for CD., Study Design: We undertook a multicenter, open-label, comparative-effectiveness randomized clinical trial of nulliparous obese women with unfavorable cervix (Bishop's score ≤ 6) undergoing labor induction from January 2016 to June 2018 at three tertiary centers. Those at <32 weeks' gestation, premature rupture of membranes, stillbirth, and major fetal anomalies were excluded. Women were randomized 1:1 to either a combination of Foley balloon and misoprostol or misoprostol alone. Once Bishop's score was >6, further management was deferred to treating physicians. Primary outcome was the rate of CD. Secondary maternal outcomes included duration of induction-to-delivery interval, occurrence of tachysystole, clinical chorioamnionitis, need for operative vaginal delivery, as well as a composite of maternal morbidity (postpartum endometritis, surgical-site infection, venous thromboembolism, need for transfusion, intensive care unit admission, and maternal death). Secondary neonatal outcomes included need for neonatal intensive care unit admission, transient tachypnea of the newborn, respiratory distress syndrome, meconium aspiration syndrome, culture-proven sepsis, neonatal seizures, and a composite of neonatal morbidity (Apgar's score ≤7 at 5 minutes, umbilical artery cord pH ≤7.10, birth injury, perinatal death). With the rate of CD rate being 53% at Children's Memorial Herman Hospital among nulliparous obese women who underwent induction of labor at ≥32 weeks and met our inclusion criteria; 250 women (125 women per group) were required to answer the study question. All analyses were by intention to treat., Results: Of the 236 women randomized, 113 (48%) were allocated to group 1 (combined Foley and PGE1) and 123 (52%) to group 2 (PGE1 alone). The rate of CD was similar between the groups (45 vs. 43%, p  = 0.84, relative risk [RR]: 1.03, 95% CI: 0.75-1.42). There was no difference in the occurrence of tachysystole that resulted in fetal heart rate abnormalities between the groups (8.8 vs. 16.2%, p  = 0.09, RR: 0.54, 95% CI: 0.27-1.11). The total duration of the induction-to-delivery interval was also similar between the groups (24.8 ± 13.8 vs. 24.5 ± 14.0 hours, p  = 0.87) regardless of the mode of delivery. No differences were seen in the indications for CD and secondary maternal or neonatal outcomes., Conclusion: In this trial of nulliparous obese women undergoing labor induction, cervical ripening with combined Foley balloon and PGE1 resulted in similar CD rates than ripening with vaginal PGE1 alone., Key Points: · Nulliparous obese women are at increased risk for cesarean delivery.. · Combined intravaginal misoprostol-Foley balloon versus misoprostol alone resulted in similar rates of cesarean delivery.. · Further research is warranted to determine the optimal cervical ripening strategy in this population.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to compare the perinatal outcomes among U.S.-born and foreign-born Hispanics and Caucasians and ascertain if length of time in the US was associated with the rate of adverse outcomes., Study Design: Retrospective cohort analysis of gravidae enrolled in our institutional perinatal database. Women delivering a non-anomalous, singleton, at 24 weeks or more and self-identified as Caucasian or Hispanic were included. Women were stratified by country of birth and ethnicity into U.S.-born Caucasian, U.S.-born Hispanic, and U.S. foreign-born Hispanic. Composite maternal (CMM) and neonatal (CNM) morbidity was assessed., Results: Of 20,422 women, 21% were Caucasian, 15% were U.S.-born Hispanics, and 64% were U.S. foreign-born Hispanics. Compared to Caucasians, U.S.-born and foreign-born Hispanic were older, more likely to be a grand multiparous, obese and less likely to be married. Compared to Caucasians, foreign-born Hispanics had a 1.42-fold increased risk of CMM (95% CI 1.26-1.30). Paradoxically, the rate of CNM was 40% lower among neonates born to foreign-born Hispanics (95% CI 0.51-0.74). A significant direct relationship was noted between time in the USA and CMM but not CNM among foreign-born Hispanics., Conclusion: Despite less favorable baseline characteristics, U.S. foreign-born Hispanics have 40% less CNM compared to both Caucasians and U.S.-born Hispanics., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to compare morbidities among nonmacrosomic versus macrosomic singleton live births of nondiabetic women who labored., Study Design: This retrospective study utilized the 2003 revision of U.S. birth certificate data of singleton live births (2011-2013) at 37 to 41 weeks who labored. The primary outcomes were composite maternal and neonatal morbidities (CMM and CNM, respectively). We compared these outcomes by birth weight, 2,500 to 3,999 g (group 1; reference), 4,000 to 4,449 g (group 2), and 4,500 to 5,999 g (group 3). We used multivariable Poisson regression analyses to examine the association between birth weight groups and the outcomes., Results: Among 6,691,338 live births, 92.0% were in group 1, 7.1% in group 2, and 0.9% in group 3. The overall CMM and CNM rates were 4.4 and 6.8 per 1,000 live births, respectively. Compared with group 1, the risk of CMM was significantly higher in group 2 (adjusted risk ratio [aRR] = 1.50; 95% confidence interval [CI]: 1.44-1.56) and group 3 (aRR = 2.00; 95% CI: 1.82-2.19). Likewise, the risk of CNM was significantly higher in group 2 (aRR = 1.38; 95% CI: 1.33-1.43) and group 3 (aRR = 2.57; 95% CI: 2.40-2.75) than in group 1., Conclusion: Nondiabetic women who labor with a macrosomic newborns have a significantly higher rate of adverse outcomes than nonmacrosomic., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: This study aimed to compare the maternal and neonatal adverse outcomes among singletons delivered at 36 weeks or later with cerclage during index pregnancy versus those without cerclage., Study Design: This retrospective cohort study utilized the U.S. vital statistics datasets from 2011 to 2013. Inclusion criteria were women with nonanomalous singletons, with and without cerclage placement, without diabetes or hypertensive disorders, and delivered at 36 to 41 weeks. The coprimary outcomes were composite maternal and neonatal adverse outcomes. Composite maternal adverse outcome included admission to intensive care unit, maternal transfusion, ruptured uterus, unplanned hysterectomy, or unplanned operating room procedure. Composite neonatal adverse outcome included Apgar score less than 5 at 5 minutes, assisted ventilation for more than 6 hours, neonatal seizure, birth injury, or neonatal death. Secondary outcomes were chorioamnionitis and cesarean delivery. Multivariable Poisson's regression models with error variance were used while adjusting for confounders. Adjusted relative risk (aRR) with 95% confidence intervals (CIs) were calculated., Results: Of the 8,508,228 women who met inclusion criteria, 0.2% had a cerclage and reached 36 weeks. Composite maternal (aRR: 2.04; 95% CI: 1.76-2.36) and neonatal (aRR: 1.28; 95% CI: 1.11-1.47) adverse outcomes were significantly higher among those with cerclage than those without cerclage. Chorioamnionitis (aRR: 1.47; 95% CI: 1.30-1.67) and cesarean delivery (aRR: 1.10; 95% CI: 1.08-1.12) were also significantly higher in women with cerclage than those without cerclage., Conclusion: There is an association between increased composite maternal and neonatal adverse outcomes among women with cerclage who delivered at 36 to 41 weeks as compared with those without cerclage., Key Points: · Cerclage is associated with increased composite maternal adverse outcome in women at 36-41 weeks.. · Cerclage is associated with increased composite neonatal adverse outcome in women at 36-41 weeks.. · Increased chorioamnionitis and cesarean delivery rates are associated with cerclage in women at 36-41 weeks.., Competing Interests: None declared., (Thieme. All rights reserved.)

Objective: Late preterm births (delivery at 34-36 weeks) account for nearly three quarters of the preterm births and among them there is a knowledge gap about an important aspect of infant care: breast versus formula feeding. The aim of this study was to assess factors associated with formula feeding in late preterm neonates., Study Design: Secondary analysis of a multicenter randomized trial of antenatal corticosteroids for women at risk for late preterm birth. All women with a singleton pregnancy who delivered at 34 0/7 to 36 6/7 weeks were included. Women with no information on neonatal feeding or known fetal anomalies were excluded. The outcome evaluated was the type of neonatal feeding during hospital stay. Maternal and neonatal characteristics were compared among women who initiated breast versus formula feeding. Adjusted relative risks (aRRs) for formula feeding with 95% confidence intervals (CIs) were calculated., Results: Of the 2,831 women in the parent trial, 2,329 (82%) women met inclusion criteria and among them, 696 (30%) were formula feeding. After multivariable regression, the following characteristics were associated with an increased risk of formula feeding: maternal age < 20 years (aRR: 1.47, 95% CI: 1.20-1.80) or ≥35 years (aRR: 1.19, 95% CI: 1.02-1.40), never married status (aRR: 1.39, 95% CI: 1.20-1.60), government-assisted insurance (aRR: 1.41, 95% CI: 1.16-1.70), chronic hypertension (aRR: 1.19, 95% CI: 1.01-1.40), smoking (aRR: 1.51, 95% CI: 1.31-1.74), cesarean delivery (aRR: 1.16, 95% CI: 1.03-1.32), and admission to neonatal intensive care unit (aRR: 1.31, 95% CI: 1.16-1.48). Hispanic ethnicity (aRR: 0.78, 95% CI: 0.64-0.94), education >12 years (aRR: 0.81, 95% CI 0.69-0.96), and nulliparity (aRR 0.71, 95% CI: 0.62-0.82) were associated with a reduced risk for formula feeding., Conclusion: In this geographically diverse cohort of high-risk deliveries, 3 out 10 late preterm newborns were formula fed. Smoking cessation was a modifiable risk factor that may diminish the rate of formula feeding among late preterm births., Key Points: · Three of ten late preterm do not benefit from breastfeeding.. · Demographic characteristics are associated with type of feeding.. · Smoking cessation may improve the rate of breastfeeding.., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due to a large treatment benefit., Objective: This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation., Study Design: This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB ( clinicaltrials.gov : NCT01004029). Women were enrolled at 93 clinical centers (41 in the United States and 52 outside the United States) between 16 0/7 to 20 6/7 weeks in a 2:1 ratio, to receive either weekly intramuscular (IM) injections of 250 mg of 17-OHPC or an inert oil placebo; treatment was continued until delivery or 36 weeks. Co-primary outcomes were PTB < 35 weeks and a neonatal morbidity composite index. The composite included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, or proven sepsis. A planned sample size of 1,707 patients was estimated to provide 98% power to detect a 30% reduction in PTB < 35 weeks (30% to 21%) and 90% power to detect a 35% reduction in neonatal composite index (17%-11%) using a two-sided type-I error of 5%. Finally, this sample size would also provide 82.8% power to rule out a doubling in the risk of fetal/early infant death assuming a 4% fetal/early infant death rate. Analysis was performed according to the intention-to-treat principle., Results: Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71-1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68-1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4-1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States ( n  = 391; 23% of all patients), although the rate of PTB < 35 weeks was higher than the overall study population, there were no statistically significant differences between groups (15.6% vs. 17.6%; relative risk = 0.88 [95% CI: 0.55, 1.40]., Conclusion: In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death., Competing Interests: P.N., J.B., O.M.Y., G.I.R., N.Y.R., O.P., N.T. are PROLONG clinical site investigators.C.G.-B. and J.R.B. have received grant funding for other project(s) from the sponsor (AMAG Pharmaceuticals, Inc.).G.R.S. and H.S.M. have received consulting fees from AMAG Pharmaceuticals, Inc.A.F.D. has received consulting/personal fees related to her work on the project from the sponsor (AMAG Pharmaceuticals, Inc.).J.G., R.B., M.J.J., M.D., L.W., J.K. are current or former employees of AMAG Pharmaceuticals, Inc., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: To determine whether basal insulin analogs reduce the rate of composite neonatal morbidity compared with neutral protamine Hagedorn (NPH) in women with type 2 diabetes mellitus (T2DM)., Study Design: This was a retrospective cohort study of women with T2DM and singleton pregnancy at a single tertiary center. Primary outcome was a composite neonatal morbidity of any of the following: shoulder dystocia, large for gestational age, neonatal intensive care unit admission, neonatal hypoglycemia, or respiratory distress syndrome. Secondary outcomes were rates of maternal hypoglycemic events, hypertensive disorders, preterm birth, and primary cesarean delivery. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated., Results: Of 233 women with T2DM that met the inclusion criteria, 114 (49%) were treated with basal insulin analogs and 119 (51%) with NPH. The rate of composite neonatal morbidity was similar between groups (73 vs. 60%; aRR: 1.18; 95% CI: 0.92-1.51). There were no differences in the rates of maternal adverse outcomes between the groups. Basal insulin analog was associated with a lower rate of primary cesarean delivery as compared with NPH (21 vs. 36%; aRR: 0.44; 95% CI: 0.25-0.78)., Conclusion: Among pregnant women with T2DM managed with either basal or NPH insulin regimen, the rates of composite neonatal morbidity and maternal complications were similar., Competing Interests: None declared., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: To compare neonatal and infant mortality rates stratified by gestational age (GA) between singletons and twins and examine the three leading causes of death among them., Study Design: This was a retrospective cohort study using the U.S. vital statistics datasets. The study was restricted to nonanomalous live births at 24 to 40 weeks delivered in 2005 to 2014. We used multivariable Poisson regression models with robust error variance to examine the association between birth plurality (singleton vs. twin) and mortality outcomes within each GA, while adjusting for confounders. The results were presented as adjusted risk ratios (aRRs) with 95% confidence intervals (CIs)., Results: Of 26,292,747 live births, 96.6% were singletons and 3.4% were twins. At 29 to 36 weeks of GA, compared with singletons, twins had a lower risk of neonatal mortality (aRR: 0.37-0.78) and infant mortality (aRR: 0.54-0.86). When examined by GA, the three leading causes of neonatal and infant mortality varied between singletons and twins., Conclusion: When stratified by GA, the risk of neonatal and infant mortality was lower at 29 to 36 weeks in twins than in singletons, though the cause of death varied., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: To assess the ability of customized and population growth nomograms in identifying newborns with composite neonatal morbidity (CNM)., Study Design: This study included women who participated in the 10 Maternal-Fetal Medicine Units (MFMU) trials and delivered a nonanomalous singleton with a known gestational age (GA) of 24 weeks or more and documented birthweight. Population nomograms were based on Alexander's nomogram, whereas customized nomograms used publicly available softwares. Random-effect logistic regression was used to estimate the adjusted odds ratio (aOR). Positive and negative likelihood ratios (LRs) were calculated to assess nomogram performance., Results: Of 92,225 women, 85% met the inclusion criteria. Using the population nomogram, 12% were small for gestational age (SGA) and 10% were large for gestational age (LGA), and using customized nomograms, 15% were SGA and 16% LGA. SGA newborns had a higher likelihood of CNM (aOR: 2.62; 95% confidence interval [CI]: 2.48-2.76) for population nomograms and 3.22 (95% CI: 3.07-3.39) for customized nomograms. LGA newborns had a similar CNM with population nomogram but significantly higher with customized nomogram (aOR: 1.42; 95% CI: 1.34-1.50). For the adverse outcomes among SGA and LGA, the positive LRs for the two nomograms were similar with overlapping 95% CI., Conclusion: Though both SGA and LGA are associated with adverse perinatal outcomes, the detection using both nomograms was similar., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objectives: To estimate the prevalence of gestational weight gain (GWG) adequacy according to the 2009 guidelines, and to examine the association between GWG adequacy and the adverse outcomes, stratified by prepregnancy body mass index (BMI)., Study Design: A retrospective cohort study, using the 2011 to 2013 U.S. linked birth/infant death datasets, restricted to nonanomalous singleton live births at 37 to 41 weeks. The adverse outcomes included composite maternal morbidity (CMM), composite neonatal morbidity (CNM), and neonatal and infant mortalities. We used multivariable Poisson's regression models with robust error variance to examine the association between GWG adequacy and adverse outcomes., Results: Of 8,656,791 singleton live births, 20, 32, and 48% had inadequate, adequate, and excessive GWG, respectively. After multivariable regression adjustment, compared with adequate GWG, excessive GWG had 1.10 (1.08-1.13) and 1.12 (1.10-1.14) times higher risk of CMM and CNM, respectively; similar findings were observed in BMI subgroups. Compared with adequate GWG, inadequate GWG had 1.14 (1.03-1.26) and 1.12 (1.07-1.18) times higher risk of neonatal and infant mortalities, respectively. Similar results were noted among women with normal weight., Conclusion: Excessive GWG was associated with an increased risk of CMM and CNM, while inadequate GWG was associated with a higher risk of neonatal and infant mortalities., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: The objective of this study was to estimate the contemporary national rate of severe maternal morbidity (SMM) and its associated hospital cost during delivery hospitalization., Study Design: We conducted a retrospective study identifying all delivery hospitalizations in the United States between 2011 and 2012. We used data from the National (Nationwide) Inpatient sample of the Healthcare Cost and Utilization Project. The delivery hospitalizations with SMM were identified by having at least one of the 25 previously established list of diagnosis and procedure codes. Aggregate and mean hospital costs were estimated. A generalized linear regression model was used to examine the association between SMM and hospital costs., Results: Of 7,438,946 delivery hospitalizations identified, the rate of SMM was 154 per 10,000 delivery hospitalizations. Without any SMM, the mean hospital cost was $4,300 and with any SMM, the mean hospital cost was $11,000. After adjustment, comparing to those without any SMM, the mean cost of delivery hospitalizations with any SMM was 2.1 (95% confidence interval: 2.1-2.2) times higher, and this ratio increases from 1.7-fold in those with only one SMM to 10.3-fold in those with five or more concurrent SMM., Conclusion: The hospital cost with any SMM was 2.1 times higher than those without any SMM. Our findings highlight the need to identify interventions and guide research efforts to mitigate the rate of SMM and its economic burden., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

The objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, placebo-controlled, randomized clinical trial (RCT) designed to assess the safety and efficacy of Makena (hydroxyprogesterone caproate injection, 250 mg/mL) in reducing the risk of preterm birth (PTB) and neonatal morbidity/mortality in women pregnant with a singleton gestation who had a previous singleton spontaneous PTB. The total sample size of the RCT will include 1,707 women. The trial has two coprimary outcomes: PTB less than 35 weeks and a composite neonatal morbidity and mortality index. This study sample size will provide 90% power to assess for a 35% reduction in neonatal morbidity and mortality. Secondary outcomes will include 2-year follow-up of infants. The trial is ongoing and targeted to complete recruitment in 2018., Competing Interests: C.G.-B. reports grants from AMAG Pharmaceuticals, during the conduct of the study. A.F.D. reports personal fees from InClin, personal fees from personal consulting, during the conduct of the study; personal fees from Hologic, outside the submitted work. R.B. and M.J.J. report being employed by AMAG Pharmaceuticals, who sponsored this clinical trial. J.R.B., S.P.C., B.L.H., J.M.L., T.M., S.C.B., and H.S.M. have nothing to disclose., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: The objective of this study was to investigate the relationship between preterm birth in a prior pregnancy and preterm birth in a twin pregnancy., Study Design: We performed a secondary analysis of a randomized controlled trial evaluating 17-α-hydroxyprogesterone caproate in twins. Women were classified as nulliparous, multiparous with a prior term birth, or multiparous with a prior preterm birth. We used logistic regression to examine the odds of spontaneous preterm birth of twins before 35 weeks according to past obstetric history., Results: Of the 653 women analyzed, 294 were nulliparas, 310 had a prior term birth, and 49 had a prior preterm birth. Prior preterm birth increased the likelihood of spontaneous delivery before 35 weeks (adjusted odds ratio [aOR]: 2.44, 95% confidence interval [CI]: 1.28-4.66), whereas prior term delivery decreased these odds (aOR: 0.55, 95% CI: 0.38-0.78) in the current twin pregnancy compared with the nulliparous reference group. This translated into a lower odds of composite neonatal morbidity (aOR: 0.38, 95% CI: 0.27-0.53) for women with a prior term delivery., Conclusion: For women carrying twins, a history of preterm birth increases the odds of spontaneous preterm birth, whereas a prior term birth decreases odds of spontaneous preterm birth and neonatal morbidity for the current twin pregnancy. These results offer risk stratification and reassurance for clinicians., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: The objective of this study was to compare adverse pregnancy outcomes between fetuses with estimated fetal weight (EFW) < 10 to > 10% in women with preterm preeclampsia (PE) with severe features., Materials and Methods: All women with preterm PE with severe features and nonanomalous singletons with EFW were identified at a tertiary center. Women with oligohydramnios or absent/reversed umbilical Doppler velocimetry were excluded. Using multivariable analysis, we compared the composite maternal and neonatal morbidities (CMM and CNM) between those with appropriate for gestational age (AGA) fetal growth, defined as EFW at 10 to 90th versus those with fetal growth restriction (FGR), defined as EFW < 10th percentile for gestational age (GA)., Results: In this study, 165 patients were included; 112 had EFW at 10th to 90th percentile, and 53 had FGR. Of the 53 with FGR, 33 (62%) had EFW at 5 to 9% for GA and 20 (38%) had EFW < fifth percentile for GA. The CMM was significantly higher among women with FGR versus AGA (29 vs. 7%; p  < 0.001). The CNM was significantly higher with FGR versus AGA (20 vs. 6%; p  = 0.01)., Conclusion: Women with preterm PE with severe features and FGR, when compared with those with AGA, have significantly higher risk of CMM and CNM., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: The objective of this study was to ascertain the likelihood of isolated maternal fever and suspected intrauterine inflammation or infection or both (Triple I) among cases of histologic chorioamnionitis with funisitis (HCF) at term., Study Design: In this case-control study, placental pathology records were reviewed to identify term singleton laboring patients with HCF. Controls (1:1) were matched for gestational age., Results: During the 6-month period, there were 2,399 term deliveries of laboring women. Of 1,552 (65%) term placentas examined, 4% ( n  = 60) had HCF.Features of Triple I were significantly more common among cases than controls: (1) isolated maternal fever of ≥100.4°F, twice, at least 30 minutes apart ( p  = 0.014); (2) fever with fetal tachycardia ( p  = 0.029); 3) fever with either fetal tachycardia or white blood cell count greater than 15,000 per mm 3 ( p  = 0.034). The feature of Triple I with the highest sensitivity at 10% (95% confidence intervals [CI] 4-21%) was isolated maternal fever using ≥100.4°F on two occasions. The specificity for all features was consistently 100% (95% CI 91-100%)., Conclusion: To our knowledge, this is the first report on HCF and Triple I features. Though the sensitivity of Triple I to identify HCF is low, specificity is excellent., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Objective:  This article aims to compare the composite maternal and neonatal morbidities (CMM and CNM, respectively) between macrosomic (≥4,000 g) and nonmacrosomic (<4,000 g) newborns among women with diabetes mellitus (DM)., Methods:  Maternal demographic and peripartum outcome data ( N  = 1,260) were collected from a retrospective cohort. CMM included chorioamnionitis/endometritis, wound infection, shoulder dystocia, eclampsia, pulmonary edema, admission for hypoglycemia, 3rd/4th degree perineal laceration, and death. CNM included 5-minute Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score of <4, neonatal intensive care unit (NICU) admission, respiratory distress syndrome, mechanical ventilation, intraventricular hemorrhage grade III/IV, necrotizing enterocolitis stage II/III, hypoglycemia, hypocalcemia, bronchopulmonary dysplasia, sepsis, seizures, hyperbilirubinemia, and death. Multivariable Poisson regression models with robust error variance were used to calculate adjusted relative risk (aRR) and 95% confidence interval (CI)., Results:  The study population consisted of 967 subjects, including 854 (88.3%) nonmacrosomic and 113 (11.7%) macrosomic infants. After adjustment, the risk of CMM was higher among macrosomic deliveries (aRR = 4.08, 95% CI = 2.45-6.80). The risk of CNM was also higher among macrosomic deliveries (aRR = 1.77, 95% CI = 1.39-2.24). Macrosomia was associated with an increased risk in NICU admission, hypoglycemia, and hyperbilirubinemia., Conclusion:  Among DM deliveries, macrosomia was associated with a fourfold higher risk of CMM and almost twofold higher risk of CNM., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective:  We hypothesized that utilization of a twin-specific nomograms, when compared with one based on singleton data, is less likely to classify twins as having abnormal growth and more likely to identify perinatal morbidity and mortality., Materials and Methods:  Data were culled from seven Maternal-Fetal Medicine Units (MFMU) studies, the included twin gestations in their study population. Each newborn twin's birth weight percentile was categorized using Alexander et al (singleton data) and Ananth et al (twin data) nomogram. Logistic regression models were adjusted for maternal race and body mass index, neonatal sex, study, and twin correlation., Results:  More twins were categorized as small for gestational age (SGA) when singleton nomogram was used (33%) compared with twin nomogram (4%). The use of singleton nomogram revealed a higher composite neonatal morbidity (CNM) and stillbirth rates among SGA twins but a similar neonatal mortality rate when compared with appropriate for gestational age. Correspondingly, when twin-specific nomogram was utilized, the CNM, odds of stillbirth, and neonatal mortality were higher among SGA twins. The rate of large for gestational age among twins was increased with the use of twin-specific nomograms., Conclusion:  Utilization of twin-specific nomogram is less likely to categorize twins as SGA and more likely to identify those at risk for stillbirth and neonatal mortality., Competing Interests: Conflict of Interest: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective:  The objective of this study was to compare national guidelines on the prevention of RhD alloimmunization., Study Design:  We performed a review of four national guidelines on prevention of alloimmunization from the American Congress of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynaecologists, Society of Obstetricians and Gynaecologists of Canada, and The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. We compared the indications/contraindications, timing, dosing, formulation and route of anti-D immune globulin, and management of unique circumstances. The references were compared with regard to the number of randomized control trials, Cochrane Reviews, and systematic reviews/meta-analyses cited., Results:  Variation exists in recommendations on the timing and need for consent prior to routine antenatal anti-D immune globulin administration, prophylaxis for unique circumstances (e.g., threatened abortion < 12 weeks, complete molar pregnancy), and the use of cell-free fetal DNA testing for fetal RhD genotype., Conclusion:  These variations in recommendations reflect the heterogeneity of the literature on the prevention of alloimmunization and highlight the need for synthesis of evidence to create an international guideline on prevention of alloimmunization. This may improve safety, quality, optimize outcomes, and stimulate future trials., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Competing Interests: Conflict of Interest: None.

Competing Interests: Conflict of Interest: None.

Background  While traumatic delivery with large for gestational age (LGA; birth weight above 90%) is acknowledged, there is paucity of data regarding other morbidity and mortality associated with LGA. Our hypothesis was that compared with appropriate for gestational age (AGA), LGA have a significantly higher rate of composite neonatal morbidity (CNM). Objective  Our objective was to compare the CNM among uncomplicated LGA versus AGA at term (37 weeks or more) among all available Maternal-Fetal Medicine Units (MFMU) databases. We excluded women who delivered before 37 weeks, those with hypertension or diabetes, multiple gestations, and known anomalies, and those with birth weight less than 10% for GA. Using multivariable analysis, we compared the CNM between LGA and AGA. Random-effect logistic regressions were used to account for study heterogeneity, with adjustment for potential confounders. We calculated adjusted odds ratio (aOR) and 95% confidence intervals (CI). Results  Approximately 60% ( n  = 50,734) of all participants met inclusion criteria. Among uncomplicated pregnancies, the rate of LGA was 12.1%. The rate of CNM was 15% in LGA and 10% in AGA (aOR: 1.58; 95% CI: 1.46-1.70). The likelihood of stillbirth and neonatal mortality was similar among both groups. Subgroup analysis revealed that CNM was increased among both birth weight > 95% and birth weight 90 to 95% and at different GA at delivery. Conclusion  Among uncomplicated pregnancies at term, LGA newborns, compared with AGA, have a significantly higher likelihood of CNM but similar stillbirth and neonatal death risk. Trials are warranted to determine appropriate management of LGA to decrease these risks., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Background  Antenatal detection of fetal growth restriction (FGR) prompts antepartum surveillance to reduce perinatal mortality, yet most cases of FGR are undetected. Objective  This study aims to compare rates of adverse neonatal outcomes when FGR is detected versus undetected. Study Design  Small-for-gestational-age (SGA) newborns (birth weight < 10% for gestational age) delivered at the Magee-Women's Hospital in Pittsburgh, PA from 2003 to 2010 were divided into three groups: those whom did not undergo third-trimester fetal growth ultrasound (SGA-no US), were appropriate for gestational age (AGA) by ultrasound (SGA-undetected), or were FGR by ultrasound (SGA-detected). We then compared rates of 5-minute Apgar < 4 and neonatal death (ND), with AGA newborns as the referent. Results  Out of 29,885 neonates, 2,475 (8.3%) were SGA. Out of the 826 (33%) SGA neonates who underwent growth ultrasound, 185 (22%) were considered FGR. In the SGA-no US group, the adjusted odds ratio (aOR) for Apgar < 4 was 2.84 (95% confidence interval (CI): 1.28-6.29) and 3.87 (95% CI: 2.09-7.18) for ND. The risk of Apgar < 4 (aOR: 3.10, 95% CI: 0.93-10.28) and ND (aOR: 2.16, 95% CI: 0.66-7.14) were not significantly elevated for SGA-undetected neonates, while SGA-detected neonates were most at risk, with an aOR of 18.20 (95% CI: 6.82-48.60) for Apgar < 4 and 18.24 (95% CI: 7.90-42.13) for ND. Conclusion  Fetal growth ultrasound effectively stratifies risk amongst SGA neonates., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective  To compare the neonatal morbidity and mortality among small-for-gestational-age (SGA; birth weight < 10% for estimated gestational age [EGA]) versus appropriate-for-gestational-age (AGA; birth weight at 10-89%) newborns. Methods  Data from nine Maternal-Fetal Medicine Units Network studies were used and included nonanomalous singletons at 24 weeks or more and birth weight < 90% for EGA. Using multivariable analysis, we compared the morbidity and mortality between SGA and AGA. Random-effect logistic regressions were utilized with adjustment for 10 variables. Results  Among the nine studies 71,744 singletons met the inclusion criteria, with 13% ( n  = 9,415) SGA and 87% ( n  = 62,329) AGA. Among SGA, the likelihood of stillbirth (8.8 vs. 2.5 per 1,000 births; adjusted odds ratio [aOR] 3.98, 95% confidence interval [CI]: 2.92-5.42) and neonatal mortality (14.0 vs. 5.5 per 1,000 births; aOR 3.18, 95% CI: 2.55-3.95) was threefold higher compared with AGA. For the subgroup of newborns of EGA of 32 weeks or more, SGA, compared with AGA, had significantly higher risk of stillbirth (aOR 3.32, 95% CI: 2.16-5.12) and neonatal mortality (aOR 2.50; 95% CI: 1.38-4.54). From 35 weeks onward, the risk of stillbirth among SGA is almost four times higher than for AGA. Conclusion  The risk of stillbirth and neonatal mortality is significantly higher with SGA than with AGA. Modification in practice or new management schema may be warranted., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective  To compare the effectiveness of intravenous acetaminophen with that of morphine in reducing pain in the first stage of labor. Methods  An open-label, randomized controlled trial of women ≥ 34 weeks gestation in the first stage of labor, assigned to either intravenous acetaminophen or morphine. The primary outcome was improved analgesia measured by difference of visual analog scale (VAS) score at 120 minutes from baseline. Secondary outcomes were request for rescue analgesia, maternal side effects, and fetal heart rate changes. Statistical analyses performed were chi-square, Student's t -test, and Kaplan-Meier survival analysis. Results  Of 40 women randomized, 18 received acetaminophen (2 did not receive study drug), and 20 received morphine. Because of difficulties in recruitment, the sample size of 88 was not achieved. The primary outcome was similar between groups ( p  = 0.53). Within 120 minutes of initial treatment, more women receiving intravenous acetaminophen required rescue analgesia (acetaminophen: 52.9% vs. morphine: 17.6%, p  < 0.01). Maternal and fetal side effects were similar between groups. Conclusion  There was no difference in VAS scores between groups. However, as half of women receiving intravenous acetaminophen required rescue analgesia within 120 minutes of treatment, intravenous acetaminophen may be less effective for analgesia in early labor compared with intravenous morphine., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective The factors associated with persistent neonatal brachial plexus palsy (PNBPP) are unknown. Our objectives are to compare PNBPP at 1 and 2 years in children delivered via vaginal delivery (VD) versus cesarean delivery (CD) and in children delivered via VD with or without reported shoulder dystocia (SD). Study Design Retrospective cohort of children diagnosed with neonatal brachial plexus palsy (NBPP). Maternally reported delivery history and presence of SD were recorded with Student t-test, chi-square test, and odds ratio (OR) with 95% confidence intervals (CI) calculated for comparisons. Results Of 387 cases of NBPP, 8% (30) delivered via CD. Rates of PNBPP were higher in the VD group at 1 and 2 years (60% of CD and 85% of VD; OR, 0.26; 95% CI, 0.11-0.62 at 1 year; 33% of CD and 73% of VD; OR, 0.15; 95% CI, 0.05-0.39 at 2 years). There was no difference in PNBPP in women with VD with or without maternally reported SD (87 vs. 85%, p = 0.68 at 1 year; 64 vs. 61%, p = 0.61 at 2 years). Conclusion PNBPP is possible with CD, and there is no difference in PNBPP in VD with or without maternally reported SD. A prospective study is warranted to ascertain associative factors., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective The objective of this study was to use data from the 20-center beneficial effect of antenatal magnesium sulfate (BEAM) trial to assess the external validity of the Neonatal Research Network (NRN) estimator, a widely employed web-based counseling tool to estimate the probability of an adverse outcome for periviable infants given intensive care. Study Design The probability of different adverse outcomes predicted from the NRN estimator was compared with observed rates at 18 to 22 months for ventilated, nonanomalous infants born at 23 to 25 weeks and assessed in BEAM as in the NRN. Results were assessed using rigorous validation methods for prediction models. Results Among 289 eligible infants, 26% died, 40% died or had profound neurodevelopmental impairment (PNDI), and 71% died or had NDI. The area under the receiver operating characteristic curve was 0.70 (95% confidence interval [CI], 0.63-0.78) for death, 0.64 (95% CI, 0.56-0.71) for death or NDI, and 0.71 (95% CI, 0.65-0.78) for death or PNDI. Observed and predicted rates were somewhat different for death or NDI but quite similar for death and for death or PNDI in different risk groups. Brier scores for accuracy were favorable (0.17-0.22) for all outcomes. Conclusion Our results provide external validation of the NRN estimator for assessing the probability of adverse outcomes at 18 to 22 months for periviable infants given intensive care., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objectives: The objectives of this review are to (1) ascertain the frequency with which odd ratio (OR) and relative risk (RR) are in the zone of potential bias or interest in the American College of Obstetricians and Gynecologists (ACOG) practice bulletins (PB); (2) the likelihood that false alarms have been linked to recommendations; and (3) if there are differences in obstetric versus gynecological PB, vis-à-vis OR and RR in the zone of bias or interest., Data Sources: We reviewed all ACOG PBs published between May 1999 and March 2014., Methods: Documents were searched for statements with mention of OR and RR. When the reported ORs fell between 0.33 and 3.0, it was categorized as "zone of potential bias"; if ORs fell outside the interval 0.25 to 4.0, it was "zone of potential interest." With RRs, the zones of bias and interest were 0.5 to 2.0 and 0.33 to 3.0, respectively., Results: Of the 79 PBs reviewed, 22% (n = 17) had 44 statements with OR, with 41% (n = 18) of the ORs being in the zone of bias and 54% (n = 24) in the zone of potential interest. Overall, 84% of the ORs did not lead to an actual recommendation by ACOG. In 28% (n = 22) of PBs, there were 67 statements with RRs, with 58% (n = 39) of them being in the zone of bias and 28% (n = 19) were in the zone of interest. In 73% of the PBs the RR citations did not lead to any recommendations. Across the 79 PBs, ACOG made 733 recommendations, and among them only 1 and 2% were linked with ORs and RRs, respectively., Conclusions: Over 70% of ACOGPBs did not cite OR and RR. To better understand the evidence, ACOG should increase citation of OR and RR; whenever applicable OR and RR should be part of graded recommendations., Level of Evidence: Level C., Précis: Less than a third of ACOG practice bulletins mention odds ratios or relative risks and over 95% of recommendations in them remain unsubstantiated., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: This study aims to compare how national guidelines approach the management of obesity in reproductive age women., Study Design: We conducted a search for national guidelines in the English language on the topic of obesity surrounding the time of a pregnancy. We identified six primary source documents and several secondary source documents from five countries. Each document was then reviewed to identify: (1) statements acknowledging increased health risks related to obesity and reproductive outcomes, (2) recommendations for the management of obesity before, during, or after pregnancy., Results: All guidelines cited an increased risk for miscarriage, birth defects, gestational diabetes, hypertension, fetal growth abnormalities, cesarean sections, difficulty with anesthesia, postpartum hemorrhage, and obesity in offspring. Counseling on the risks of obesity and weight loss before pregnancy were universal recommendations. There were substantial differences in the recommendations pertaining to gestational weight gain goals, nutrient and vitamin supplements, screening for gestational diabetes, and thromboprophylaxis among the guidelines., Conclusion: Stronger evidence from randomized trials is needed to devise consistent recommendations for obese reproductive age women. This research may also assist clinicians in overcoming one of the many obstacles they encounter when providing care to obese women., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: This study aims to compare neonatal and long-term outcomes among preterm newborns from women with reported versus those who did not report substance abuse., Study Design: Secondary analysis of a trial of magnesium sulfate for cerebral palsy prevention. Cases were pregnant women who reported substance abuse, controls were those who denied it. Study outcomes included (1) composite neonatal morbidity, defined as any of the following: Apgar score ≤ 3 at 5 minutes, seizures, culture-proven sepsis, necrotizing enterocolitis grades 2 or 3, intraventricular hemorrhage grades 3 or 4, and/or death before discharge; (2) infant and childhood morbidity, defined as stillbirth or death by 1 year, or moderate/severe cerebral palsy by age of 2., Results: Among 1,972 women meeting the inclusion criteria, 197 (10%) reported substance abuse. Composite neonatal, infant, and childhood morbidity rates were similar between cases and controls. However, women reporting substance abuse who delivered between 32(0/7) and 36(6/7) weeks had a higher frequency of composite infant and childhood morbidity (6.5 vs. 1.0%; adjusted odds ratio, 6.5; 95% confidence interval, 1.14-36.99)., Conclusions: Preterm birth was associated with similar composite neonatal morbidity between cases and controls. After 32 weeks, self-reported substance abuse was associated with a sevenfold increase in the rates of stillbirth and long-term infant morbidity., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)