Oxytocin versus oral misoprostol for PROM induction in nulliparas with unfavorable cervix: A randomized trial.

BACKGROUND: Induction of labor (IOL) is recommended following prelabor rupture of membranes (PROM). The optimal method for IOL and need for cervical ripening in those with PROM and an unfavorable cervical examination is unclear. OBJECTIVE: To determine if oxytocin or oral misoprostol results in a shorter time to delivery among nulliparous patients with an unfavorable cervical examination and PROM diagnosis and to evaluate patient satisfaction with both methods. STUDY DESIGN: This is a randomized clinical trial conducted at an urban tertiary care center from 2019-2023. Subjects were nulliparas ≥ 36 weeks with an unfavorable starting cervical exam (≤ 2 cm and Bishop < 8). The primary outcome was time from IOL to delivery in hours compared between oxytocin versus oral misoprostol. Secondary outcomes included suspected intraamniotic infection, cesarean delivery, composite maternal and neonatal morbidity, and patient satisfaction (assessed by Birth Satisfaction Scale-Revised (BSS-R)). Sub-group analyses for those with BMI ≥ 30kg/m2 and cervical dilation ≥ 1cm were performed. We required 148 subjects to have 80% power to detect a 2-hour difference in time to delivery. The study was stopped early by the DSMB due to feasibility concerns in recruiting desired sample size Results: 108 subjects were randomized: 56 oxytocin; 52 oral miso. The median gestational age at induction was 39.5 weeks; the mean starting cervical dilation was 1.1 cm. There was no statistical difference in time to delivery between groups overall: 14.9 hours oxytocin v. 18.1 hours oral misoprostol (p=0.06). In sub-group analyses, there was a 5h shorter time to delivery with oxytocin for those with a BMI ≥ 30kg/m2 (16.6 hours oxytocin v. 21.8 hours oral misoprostol, p 0.04) and 4.5h shorter time to delivery with oxytocin for those with cervix ≥ 1cm (12.9 hours oxytocin v. 17.3 hours oral misoprostol, p 0.04). There were no differences in intraamniotic infection, cesarean delivery, maternal or neonatal morbidity between the groups. Patient satisfaction was higher for those receiving oxytocin compared to misoprostol (29.0 vs. 26.3, p=0.03). CONCLUSIONS: Among nulliparas with PROM and an unfavorable cervix, there was no difference in overall time to delivery between oxytocin and oral misoprostol. This result should be interpreted with caution given early study discontinuation and inadequate power. However, a shorter time to delivery with oxytocin was noted in obese patients and those with cervical dilation of at least 1 cm. Furthermore, patient satisfaction was higher in the oxytocin group, and there was no increased risk of neonatal or maternal morbidity with oxytocin.

Characteristics and management of pediatric medial subperiosteal orbital abscesses.

INTRODUCTION: Subperiosteal orbital abscesses (SPOA) are the most common suppurative complications of acute bacterial sinusitis. Medial SPOAs arise from infection of the ipsilateral ethmoid sinus and favor initial conservative management reserving surgical drainage for patients who do not demonstrate clinical improvement. No standard algorithm defining medical versus surgical treatment of medial SPOAs exist in the pediatric population. OBJECTIVES: To identify a size cutoff for medial SPOAs to predict the likelihood for surgical drainage. METHODS: This is a retrospective review of patients with medial SPOAs at a tertiary care center from 2003 to 2017. Diagnosis of SPOA was based on radiographic findings. Variables included are patient demographics, antibiotic therapy, surgical intervention, and length of stay. RESULTS: 82 patients with a medial SPOA were included with an average age at presentation of 6.27 (range 0-15) years were included in this study. 62 patients were male (75.6 %), and 20 were female (24.4 %). The average abscess length was 16.1 mm, range 4.5-30.7 mm. The average abscess width was 4.17 mm, range 1.5-14.6 mm. The odds ratio for surgical treatment with every 1 mm increase in abscess width was 1.89 (95CI:1.33-2.69, p < 0.001). Abscesses over 3.6 mm width were 6.65 times more likely to undergo surgical drainage than those less than 3.6 mm (OR:6.65, 95CI:2.52-17.54, p < 0.001). The average(SD) length of stay was 5.4(3.0) days for patients who underwent surgery and 4.0(0.9) days for patients treated with conservative measures, p < 0.001. CONCLUSION: Medial SPOAs greater than 3.6 mm were more likely to undergo surgical drainage; however there was no difference in the likelihood of drainage between anteriorly and posteriorly based medial abscesses. These findings help further characterize the landscape of pediatric subperiosteal abscesses that are managed with surgical drainage.

Association between Group B Streptococcus and Clinical Chorioamnionitis by Gestational Week at Delivery-A Multicenter Cohort Study.

OBJECTIVE: In the era of group B Streptococcus (GBS) screening and intrapartum antibiotic prophylaxis (IAP), GBS colonization has been associated with a lower risk of chorioamnionitis, possibly due to a protective effect of IAP. We sought to confirm this finding and assess whether this association varies by gestational week at delivery. STUDY DESIGN: We performed a retrospective cohort study of term (37.0-42.6 weeks), singleton parturients with known GBS status who delivered from 2005 to 2021 at two academic medical centers in Israel. We excluded patients who underwent planned cesarean, out of hospital birth, or had a fetal demise. Patients received GBS screening and IAP for GBS positivity as routine clinical care. The primary outcome was a diagnosis of clinical chorioamnionitis as determined by the International Classification of Diseases 10th Revision code, compared between GBS-positive and -negative groups, and assessed by gestational week at delivery. RESULTS: Of 292,126 deliveries, 155,255 met inclusion criteria. In total, 30.1% were GBS positive and 69.9% were negative. GBS-positive patients were 21% less likely to be diagnosed with clinical chorioamnionitis than GBS-negative patients, even after controlling for confounders (1.5 vs. 2.2%, adjusted odds ratio: 0.79, 95% confidence interval: 0.68-0.92). When assessed by gestational week at delivery, there was a significantly greater difference in rates of clinical chorioamnionitis between GBS-positive versus GBS-negative groups with advancing gestational age: 1.5-fold difference at 38 to 40 weeks, but a twofold difference at 42 weeks. The risk of clinical chorioamnionitis remained stable in the GBS-positive group, but increased significantly in the GBS-negative group at 41- and 42-week gestation (2.0 vs. 2.9%, p < 0.01 at 41 weeks; up to 3.9% at 42 weeks, p < 0.01). CONCLUSION: In a large multicenter cohort with universal GBS screening and IAP, GBS positivity was associated with a lower risk of chorioamnionitis, driven by an increasing rate of chorioamnionitis among GBS-negative patients after 40 weeks. KEY POINTS: · GBS positivity and IAP may be associated with lower risk of chorioamnionitis.. · GBS-positive patients were less likely to be diagnosed with chorioamnionitis.. · This difference increased with advancing gestational age after 40 weeks..

Resource Utilization and Risk Factors for Esophageal Injury in Pediatric Esophageal Foreign Bodies.

OBJECTIVE: While management protocols of pediatric esophageal foreign bodies (EFBs) are well-delineated, resource utilization can be improved. This study's objectives were to explore hospital charges/costs for pediatric patients who present with EFBs and to identify patient risk factors associated with esophageal injury. METHODS: A retrospective chart review of patients undergoing aerodigestive foreign body removal at a tertiary-care children's hospital from 2018 to 2021 was conducted. Data collected included demographics, medical history, presenting symptoms, EFB type, surgical findings, and hospital visit charges/costs. RESULTS: 203 patients were included. 178 of 203 (87.7%) patients were admitted prior to operation. Unwitnessed EFB ingestion (p < 0.001, OR = 15.1, 95% CI = 5.88-38.6), experiencing symptoms for longer than a week (p < 0.001, OR = 11.4, 95% CI = 3.66-38.6) and the following presenting symptoms increased the odds of esophageal injury: dysphagia (p = 0.04, OR = 2.45, 95% CI = 1.02-5.85), respiratory distress (p = 0.005, OR = 15.5, 95% CI = 2.09-181), coughing (p < 0.001, OR = 10.1, 95% CI = 3.73-28.2), decreased oral intake (p = 0.001, OR = 6.60, 95% CI = 2.49-17.7), fever (p = 0.001, OR = 5.52, 95% CI = 1.46-19.6), and congestion (p = 0.001, OR = 8.15, 95% CI = 2.42-27.3). None of the 51 asymptomatic patients had esophageal injury. The median total charges during the encounter was $20,808 (interquartile range: $18,636-$24,252), with operating room (OR) (median: $5,396; 28.2%) and inpatient admission (median: $5,520; 26.0%) contributing the greatest percentage. CONCLUSIONS: Asymptomatic patients with EFBs did not experience esophageal injury. The OR and inpatient observation accounted for the greatest percentage of the hospital charges. These results support developing a potential algorithm to triage asymptomatic patients to be managed on a same-day outpatient basis to improve the value of care. LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2024.

Intrapartum electronic fetal heart rate monitoring to predict acidemia at birth with the use of deep learning.

BACKGROUND: Electronic fetal monitoring is used in most US hospital births but has significant limitations in achieving its intended goal of preventing intrapartum hypoxic-ischemic injury. Novel deep learning techniques can improve complex data processing and pattern recognition in medicine. OBJECTIVE: This study aimed to apply deep learning approaches to develop and validate a model to predict fetal acidemia from electronic fetal monitoring data. STUDY DESIGN: The database was created using intrapartum electronic fetal monitoring data from 2006 to 2020 from a large, multisite academic health system. Data were divided into training and testing sets with equal distribution of acidemic cases. Several different deep learning architectures were explored. The primary outcome was umbilical artery acidemia, which was investigated at 4 clinically meaningful thresholds: 7.20, 7.15, 7.10, and 7.05, along with base excess. The receiver operating characteristic curves were generated with the area under the receiver operating characteristic assessed to determine the performance of the models. External validation was performed using a publicly available Czech database of electronic fetal monitoring data. RESULTS: A total of 124,777 electronic fetal monitoring files were available, of which 77,132 had <30% missingness in the last 60 minutes of the electronic fetal monitoring tracing. Of these, 21,041 were matched to a corresponding umbilical cord gas result, of which 10,182 were time-stamped within 30 minutes of the last electronic fetal monitoring reading and composed the final dataset. The prevalence rates of the outcomes in the data were 20.9% with a pH of <7.2, 9.1% with a pH of <7.15, 3.3% with a pH of <7.10, and 1.3% with a pH of <7.05. The best performing model achieved an area under the receiver operating characteristic of 0.85 at a pH threshold of <7.05. When predicting the joint outcome of both pH of <7.05 and base excess of less than -10 meq/L, an area under the receiver operating characteristic of 0.89 was achieved. When predicting both pH of <7.20 and base excess of less than -10 meq/L, an area under the receiver operating characteristic of 0.87 was achieved. At a pH of <7.15 and a positive predictive value of 30%, the model achieved a sensitivity of 90% and a specificity of 48%. CONCLUSION: The application of deep learning methods to intrapartum electronic fetal monitoring analysis achieves promising performance in predicting fetal acidemia. This technology could help improve the accuracy and consistency of electronic fetal monitoring interpretation.

Pregnancy-related cardiac outcomes among patients with congenital heart disease after formalization of a cardio-obstetrics program.

BACKGROUND: The prevalence of pregnant patients with congenital heart disease (CHD) is increasing, and these patients are at high risk for cardiac morbidity. OBJECTIVE: This study aimed to examine the pregnancy outcomes in patients with congenital heart disease before and after the establishment of formal cardio-obstetrics collaboration between adult congenital heart disease and maternal-fetal medicine programs. STUDY DESIGN: This was a retrospective cohort study of pregnant patients with congenital heart disease from 2002 to 2020 at a single urban academic institution in the United States. This study included patients with a singleton pregnancy who continued a pregnancy beyond 20 weeks of gestation. The primary outcome was a composite adverse maternal cardiac outcome, compared before (2002-2010) and after (2011-2020) the program. The secondary outcomes included gestational age at delivery, mode of delivery, rate of labor induction, use of diuresis after delivery, and a composite maternal morbidity outcome. RESULTS: The number of pregnant patients with congenital heart disease increased after formalization of the cardio-obstetrics program (200 [postprogram group] vs 84 [preprogram group]; 0.48% of all deliveries in the postprogram group vs 0.25% of all deliveries in the preprogram group; P<.001). The postprogram group was more likely to undergo labor induction than the preprogram group (126 [63%] vs 34 [41%], respectively; P<.001). There were fewer patients in the postprogram group than in the preprogram group who were New York Heart Association class II to IV (23 [12%] vs 17 [22%], respectively; P=.04) or with systemic ventricular dysfunction (8 [4%] vs 12 [16%], respectively; P=.001). There was no difference in the primary outcome (38 [19%] in the postprogram group vs 14 [17%] in the preprogram group; P=.64), even after adjusting for confounders, including New York Heart Association class >I and systemic ventricular dysfunction (adjusted odds ratio, 2.3; 95% confidence interval, 0.96-5.4). Patients in the postprogram group were more likely to receive diuresis after delivery than patients in the preprogram group, even in the absence of heart failure or pulmonary edema (9 [4.5%] vs 0 [0.0%], respectively; P=.04). CONCLUSION: In the period after the establishment of a formal cardio-obstetrics program between adult congenital heart disease and maternal-fetal medicine, the number of patients with congenital heart disease delivering at our institution increased significantly. Overall, fewer patients entered pregnancy with advanced-stage heart failure or systemic ventricular dysfunction, possibly suggesting improved prepregnancy cardiac care or improved preconception counseling. Composite maternal cardiac outcomes were similar, but the rates of postpartum diuresis increased significantly, suggesting increased attention to volume status in the postpartum period. Formalized collaboration between congenital heart disease and maternal-fetal medicine may help better optimize patients' care before conception, during pregnancy, and after delivery.

Effect of Speaking Valves on Tracheostomy Decannulation.

Introduction Despite several pediatric tracheostomy decannulation protocols there remains tremendous variability in practice. The effect of tracheostomy capping on decannulation has been studied but the role of speaking valves (SVs) is unknown. Objective Given the positive benefits SVs have on rehabilitation, we hypothesized that SVs would decrease time to tracheostomy decannulation. The purpose of the present study was to evaluate this in a subset of patients with chronic lung disease of prematurity (CLD). Methods A retrospective chart review was performed at a tertiary care children's hospital. A total of 105 patients with tracheostomies and CLD were identified. Data collected included demographics, gestational age, congenital cardiac disease, airway surgeries, granulation tissue excisions, SV and capping trials, tracheitis episodes, and clinic visits. Statistics were performed with logistic and linear regression. Results A total of 75 patients were included. The mean gestational age was 27 weeks (standard deviation [SD] = 3.6) and the average birthweight was 1.1 kg (SD = 0.6). The average age at tracheostomy was 122 days (SD = 63). A total of 70.7% of the patients underwent decannulation and the mean time to decannulation (TTD) was 37 months (SD = 19). A total of 77.3% of the patients had SVs. Those with an SV had a longer TTD compared to those without (52 versus 35 months; p = 0.008). Decannulation was increased by 2 months for every increase in the number of hospital presentations for tracheitis ( p = 0.011). Conclusion The present study is the first, to our knowledge, to assess the effect of SVs on tracheostomy decannulation in patients with CLD showing a longer TTD when SVs are used.

Are Racial Disparities in Cesarean Due to Differences in Labor Induction Management?

OBJECTIVE: While there are known racial disparities in cesarean delivery (CD) rates, the exact etiologies for these disparities are multifaceted. We aimed to determine if differences in induction of labor (IOL) management contribute to these disparities. STUDY DESIGN: This retrospective cohort study evaluated all nulliparous patients with an unfavorable cervix and intact membranes who underwent IOL of a term, singleton gestation at a single institution from October 1, 2018, to September 30, 2020. IOL management was at clinician discretion. Patients were classified as Black, Indigenous, and People of Color (BIPOC) or White based on self-report. Overall rates of CD were compared for BIPOC versus White race. Chart review then evaluated various IOL management strategies as possible contributors to differences in CD by race. RESULTS: Of 1,261 eligible patients, 915 (72.6%) identified as BIPOC and 346 (27.4%) as White. BIPOC patients were more likely to be younger (26 years interquartile range (IQR) [22-30] vs. 32 years IQR [30-35], p < 0.001) and publicly insured (59.1 vs. 9.9%, p < 0.001). Indication for IOL and modified Bishop score also differed by race (p < 0.001; p = 0.006). There was 40% increased risk of CD for BIPOC patients, even when controlling for confounders (30.7 vs. 21.7%, p = 0.001; adjusted relative risk (aRR) 1.41, 95% confidence interval (CI) [1.06-1.86]). Despite this difference in CD, there were no identifiable differences in IOL management prior to decision for CD by race. Specifically, there were no differences in choice of cervical ripening agent, cervical dilation at or time to amniotomy, use and maximum dose of oxytocin, or dilation at CD. However, BIPOC patients were more likely to undergo CD for fetal indications and failed IOL. CONCLUSION: BIPOC nulliparas are 40% more likely to undergo CD during IOL than White patients within our institution. These data suggest that the disparity is not explained by differences in IOL management prior to cesarean, indicating that biases outside of induction management may be important to target to reduce CD disparities. KEY POINTS: · The etiologies for racial disparities in cesarean are likely multifaceted.. · In this work, there were no differences by race in measures of labor induction management.. · Biases outside of induction management during labor may be targeted to reduce CD disparities..

Use of botox for sialorrhea and dysphagia in the neonatal population.

INTRODUCTION: Botox is frequently used for sialorrhea in patients with compromised airways and those with etiologies causing difficulty with secretion management (i.e. strokes, neurologic disorders, etc.). There are no published studies regarding the use of botulinum toxin (BoNT) in the neonate population. We aim to discuss our experience and safety of BoNT use in the neonate population in regards to alleviating secretion management and airway protection. METHODS: Retrospective review of neonates admitted to the neonatal intensive care unit (NICU) ≤12 months of age who received BoNT injection to submandibular (SMG) and parotid (PG) glands for sialorrhea/dysphagia. BoNT was administered under ultrasound (u/s) guidance by interventional radiology. RESULTS: 6 children were examined. 2 (33 %) were male. Avg NICU stay was 87.5 ± 33.1 days. 2 underwent surgical airway intervention prior to injection. Mean age at initial BoNT was 1.5 ± 0.7 months. Avg weight at injection was 4 ± 1.1 kg. Each PG and SMG were injected in 5/6 cases. Bilateral SMG were unidentified on u/s in 1 case and thus not injected. Dose range injected per gland was 5-15u. 100 % required tube feeds, 50 % with tubes distal to stomach (NJT/NDT). 83 % were completely NPO prior to injection and there was no noted clinical improvement in oral skills post injection. All had noted desats/apneas prior to injection and 83 % had reported decreased events post injection. 50 % had reported decrease O2 requirements and frequent suctioning 2wks after injection, however 2 (33 %) required surgical airway intervention after injection (trach, SGP/MDO). 4/6 (67 %) trialed medical therapy, anticholinergics being the most common. 50 % underwent 2nd injection (age = 6.5 ± 0.3 months) avg. 4.7 ± 0.7mo after 1st injection, and the same 3pts underwent 3rd injection (age = 12.5 ± 2.4 months) avg. 6.1 ± 2.5mo after 2nd injection. 1 pt. had a total 6 injections. There were no injection related complications. CONCLUSION: BoNT injection is a safe, non-invasive alterative for management of sialorrhea in neonates. Further extensive study needs to be performed to identify the optimal dose per gland in this population.

Socioeconomic Barriers to Care for Pediatric Airways Utilizing Geographic Information Systems.

OBJECTIVE: Geographic information systems (GIS) provide a unique set of tools to spatially analyze health care and identify patterns of health outcomes to help optimize delivery. Our goal is to create maps of pediatric tracheostomy patients using GIS to assess socioeconomic and other factors that impact postoperative care after discharge to home. METHODS: A retrospective study was performed on patients (≤21 years old) who underwent tracheostomy at a tertiary care pediatric hospital from January 1, 2015 to December 31, 2020. Using GIS, we geocoded patient addresses and conducted spatial analyses of the relationship between patients and access to health care providers as well as vulnerable population factors including poverty, educational attainment, and single-parent households. RESULTS: A total of 156 patients were included. Patients initially discharged to transitional care (108/156, 69.2%) had significantly higher likelihood of presenting to the ED regardless of socioeconomic status (OR: 2.28, 95% CI: 1.03-5.05; p = 0.042). There was no relationship between ED visit rate and median household income, poverty level, and percentage of uneducated adults (p = 0.490; p = 0.424; p = 0.752). Median distance to the tertiary care pediatric hospital was significantly longer for patients with no ED visit (median = 61.28 miles; SD = 50.90) compared with those with an ED visit (median = 37.75 miles; SD = 35.92) (p = 0.002). CONCLUSION: The application of GIS could provide geo-localized data to better understand the healthcare barriers to access for children with tracheostomies. This study uniquely integrates medical record data with socioeconomic factors and social determinants of health. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1919-1925, 2024.

Effect of Speaking Valves on Tracheostomy Decannulation

Abstract Introduction Despite several pediatric tracheostomy decannulation protocols there remains tremendous variability in practice. The effect of tracheostomy capping on decannulation has been studied but the role of speaking valves (SVs) is unknown. Objective Given the positive benefits SVs have on rehabilitation, we hypothesized that SVs would decrease time to tracheostomy decannulation. The purpose of the present study was to evaluate this in a subset of patients with chronic lung disease of prematurity (CLD). Methods A retrospective chart review was performed at a tertiary care children's hospital. A total of 105 patients with tracheostomies and CLD were identified. Data collected included demographics, gestational age, congenital cardiac disease, airway surgeries, granulation tissue excisions, SV and capping trials, tracheitis episodes, and clinic visits. Statistics were performed with logistic and linear regression. Results A total of 75 patients were included. The mean gestational age was 27 weeks (standard deviation [SD] =3.6) and the average birthweight was 1.1 kg (SD = 0.6). The average age at tracheostomy was 122 days (SD = 63). A total of 70.7% of the patients underwent decannulation and the mean time to decannulation (TTD) was 37 months (SD = 19). A total of 77.3% of the patients had SVs. Those with an SV had a longer TTD compared to those without (52 versus 35 months; p = 0.008). Decannulation was increased by 2 months for every increase in the number of hospital presentations for tracheitis (p =0.011). Conclusion The present study is the first, to our knowledge, to assess the effect of SVs on tracheostomy decannulation in patients with CLD showing a longer TTD when SVs are used.

Developing a brief assessment of social risks for the Veterans Health Administration Survey of Healthcare Experiences of Patients.

OBJECTIVE: To determine whether a 6- or 12-month look-back period affected rates of reported social risks in a social risk survey for use in the Veterans Health Administration and to assess associations of social risks with overall health and mental health. STUDY DESIGN: Cross-sectional survey of respondents randomized to 6- or 12-month look-back period. DATA SOURCES AND STUDY SETTING: Online survey with a convenience sample of Veterans in June and July 2021. DATA COLLECTION/EXTRACTION METHODS: Veteran volunteers were recruited by email to complete a survey assessing social risks, including financial strain, adult caregiving, childcare, food insecurity, housing, transportation, internet access, loneliness/isolation, stress, discrimination, and legal issues. Outcomes included self-reported overall health and mental health. Chi-squared tests compared the prevalence of reported social risks between 6- and 12-month look-back periods. Spearman correlations assessed associations among social risks. Bivariate and multivariable logistic regression models estimated associations between social risks and fair/poor overall and mental health. PRINCIPAL FINDINGS: Of 3418 Veterans contacted, 1063 (31.10%) responded (87.11% male; 85.61% non-Hispanic White; median age = 70, interquartile range [IQR] = 61-74). Prevalence of most reported social risks did not significantly differ by look-back period. Most social risks were weakly intercorrelated (median |r| = 0.24, IQR = 0.16-0.31). Except for legal issues, all social risks were associated with higher odds of fair/poor overall health and mental health in bivariate models. In models containing all significant social risks from bivariate models, adult caregiving and stress remained significant predictors of overall health; food insecurity, housing, loneliness/isolation, and stress remained significant for mental health. CONCLUSIONS: Six- and 12-month look-back periods yielded similar rates of reported social risks. Although most individual social risks are associated with fair/poor overall and mental health, when examined together, only adult caregiving, stress, loneliness/isolation, food, and housing remain significant.

Association between intracervical Foley balloon and clinical chorioamnionitis among patients with group B streptococcus colonization undergoing induction with standardized labor management.

BACKGROUND: Intracervical Foley balloons are commonly used for cervical ripening, but there has been a historical concern regarding an increased risk of clinical chorioamnionitis with Foley balloon use in patients with group B streptococcus. OBJECTIVE: This study aimed to determine whether intracervical Foley balloon use in patients with group B streptococcus is associated with an increased risk of clinical chorioamnionitis. STUDY DESIGN: This was a secondary analysis of a randomized controlled trial Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial that compared cervical ripening agents within a standardized labor protocol. Foley balloon (alone, with oxytocin, or with misoprostol) was compared with misoprostol only to evaluate the primary outcome of clinical chorioamnionitis, defined based on the American College of Obstetricians and Gynecologists guidelines. Patients with a term, singleton pregnancy with intact membranes and an unfavorable cervix (Bishop score of ≤6 and dilation ≤2 cm) and a known group B streptococcus status were included. The secondary outcomes included a composite postpartum maternal infectious outcome consisting of any occurrence of endometritis, wound infection, postpartum urinary tract infection, or maternal sepsis; additional secondary outcomes included neonatal outcomes. Binomial regression with robust error variance was used to evaluate whether group B streptococcus status modified the relationship between Foley balloon use and clinical chorioamnionitis and to adjust for confounders. RESULTS: A total of 491 patients were enrolled in the original trial. Of these patients, 467 had a known group B streptococcus status and underwent cervical ripening: 182 (39.0%) had group B streptococcus, and 285 (61.0%) did not have group B streptococcus. Moreover, 73.0% of patients received a Foley balloon, and 27.0% of patients did not receive a Foley balloon. There was no difference in the demographic or clinical characteristics between groups. The overall rate of clinical chorioamnionitis was 12.2%, with no difference between those with and without a Foley balloon (12.6% vs 11.1%, respectively; P=.66). Group B streptococcus status did not modify the association between Foley balloon use and clinical chorioamnionitis (relative risk, 0.93; 95% confidence interval, 0.50-1.72). This remained unchanged after adjusting for gestational age (adjusted relative risk, 0.87; 95% confidence interval, 0.45-1.67). Furthermore, other maternal and neonatal outcomes were similar between groups. CONCLUSION: In this secondary analysis of a large randomized trial using a standardized labor protocol, there was no increased risk of infectious morbidity with Foley balloon use in patients overall and in patients with group B streptococcus. Our findings support that a Foley balloon can be safely used for cervical ripening in patients with group B streptococcus colonization.

Impact of puberty on procedure frequency for treatment of simple head and neck lymphatic and venous malformations.

OBJECTIVE: Puberty has been shown to accelerate growth of vascular malformations, including lymphatic (LM) and venous malformations (VM). This study aims to compare the number of procedures performed before and after puberty in patients with LM and VM to assess whether the onset of puberty results in higher treatment frequency. METHODS: A retrospective review of head and neck LM and VM patients who were evaluated between January 2009 and December 2019 was performed. Patient demographics, lesion characteristics, and procedural details were recorded. For the purposes of this study, 11 years or older in females and 12 years or older in males were the established cut-offs for the onset of puberty. RESULTS: After initial screening of 357 patients, 83 patients were included in the study based on inclusion criteria. There were 34 patients with LM (41 %) and 49 with VM (59 %). The mean age at diagnosis was 6.1 ± 10.9 years (LM: 4.2 ± 7.0, VM: 7.4 ± 12.9, p = 0.489). 68 patients underwent treatments, which included sclerotherapy, surgical excision, and/or laser. For all patients, the average number of lifetime treatments when initiated before puberty was 3.78 ± 2.81 and when initiated after puberty was 2.17 ± 1.37 (p = 0.022). Patients diagnosed pre-puberty were more likely to undergo treatments vs. those diagnosed after puberty (OR 10.00, 95 % CI: 2.61-38.28, p < 0.001). CONCLUSION: We found that the number of treatments was fewer in those who started treatment after puberty. This finding suggests that providers may elect to proceed with observation in asymptomatic patients, given that waiting until after the onset of puberty has not shown an increase in the procedural load on patients.

Cervicovaginal Microbial-Immune State and Group B Streptococcus Colonization in Pregnancy.

OBJECTIVE: Maternal colonization with Group B Streptococcus (GBS) is a significant risk factor for serious neonatal morbidity. There are limited data on how the cervicovaginal (CV) microbiota and host immune factor ß-defensin-2 might influence GBS colonization in pregnant individuals. This study sought to determine if the CV microbiota is associated with GBS colonization in pregnant individuals, and if ß-defensin-2 modifies this relationship. STUDY DESIGN: This was a secondary analysis of a prospective cohort study of pregnant individuals with singleton pregnancies who had CV microbiota specimens analyzed at 16 to 20, 20 to 24, and 24 to 28 weeks' gestation, along with a third trimester GBS rectovaginal (RV) culture (n = 492). Microbiota data were analyzed with 16S rRNA gene sequencing and classified into community state types (CSTs). Log-binomial multivariable regression was used to model associations between CST and GBS RV status and to calculate risk ratios. ß-defensin-2, an immune factor known to modulate the relationship between CST and pregnancy outcomes, was examined as an effect modifier. RESULTS: Of 492 individuals, 34.3% were GBS RV + . Compared with individuals with CST I at 16 to 20 weeks, individuals with CST IV-A and CST II had a significantly elevated relative risk of subsequent GBS RV+ status. When stratified by high and low ß-defensin-2 levels, ß-defensin-2 was found to be an effect modifier of the association between CST IV-A and GBS RV+ status. In individuals with low ß-defensin-2 levels, CST VI-A was associated with GBS RV+ status, but among individuals with high ß-defensin-2 levels, there was no such association (interaction p-value = 0.03). CONCLUSION: Pregnant individuals with CV microbiota characterized by CST IV-A and CST II had significantly elevated risk of GBS RV colonization in the third trimester compared with those with CST I, and ß-defensin-2 was an effect modifier of the association between CST IV-A and GBS RV+ status. Future research should investigate if manipulation of the CV microbiota can prevent GBS colonization, thereby reducing intrapartum antibiotic prophylaxis and the risks of neonatal GBS infection. KEY POINTS: · The relationship between the CV microbiota and GBS RV colonization is unknown.. · A Lactobacillus-deficient, anaerobic rich vaginal community, CST IV-A, is associated with increased risk of GBS RV colonization.. · ß-defensin-2 is an effect modifier of the association between CST IV-A and GBS RV+ status..

Pediatric Tracheostomy Safety: Implementation of an Airway Safety Placard.

BACKGROUND: First health care professionals arriving at the bedside in tracheostomy-related emergencies are rarely the surgical subspecialists who placed the tracheostomy and are unfamiliar with the relevant anatomy and tracheostomy specifications for the individual patient. We hypothesized that implementing a bedside airway safety placard would increase caregiver confidence, understanding of airway anatomy, and management of patients with a tracheostomy. METHODS: A prospective survey study was performed by distributing a tracheostomy airway safety survey before and after implementation of an airway safety placard in a 6-month study period. Placards emphasizing critical airway anomalies as well as emergency management algorithm suggestions designed by the otolaryngology team at the time of tracheostomy were placed at the head of the bed and traveled with the patient during transport around the hospital. RESULTS: Of 377 staff members requested to complete the surveys, 165 (43.8%) responses were obtained, and 31 (8.2% [95% CI 5.7-11.5]) paired pre- and post-implementation responses were recorded. Differences were found in the paired responses, including increases in the domains of confidence (P = .009) and experience (P = .01) post implementation. Less experienced providers (≤ 5 y of experience) (P = .005) and providers from neonatology (P = .049) demonstrated improved confidence post implementation, which was not observed in their more experienced (> 5 y) or respiratory therapy counterparts. CONCLUSIONS: Given the limitations of a low survey response rate, our findings suggest that an educational airway safety placard initiative can be a simple, feasible, and low-cost quality improvement tool to enhance airway safety and possibly decrease potentially life-threating complications among pediatric patients with a tracheostomy. The implementation of the tracheostomy airway safety survey at our single institution warrants a larger multi-center study and validation of the survey.

Social Determinants of Health in Early Otologic and Audiologic Evaluation in an Interdisciplinary Cleft-Craniofacial Clinic.

OBJECTIVE: Investigate associations between socioeconomic indicators of healthcare access with family compliance with cleft-related otologic and audiologic care within an interdisciplinary model. DESIGN: Retrospective case series. SUBJECTS AND SETTING: Children born 2005-2015 who presented to the Cleft-Craniofacial Clinic (CCC) at a quaternary care children's hospital. INTERVENTIONS: Associations between main outcome measures and Area Deprivation Index (ADI), median household income for zip code, distance from hospital, and insurance status were evaluated. MAIN OUTCOME MEASURES: Cleft types, ages at presentation to outpatient clinic (cleft, otolaryngology, and audiology), and ages at procedures (first tympanostomy tube insertion (TTI), lip repair, and palatoplasty) were measured. RESULTS: Most patients were male (147/230, 64%) with cleft lip and palate (157/230, 68%). Median age at first cleft, otolaryngology, and audiology visits were 7 days, 86 days, and 5.9 months, respectively. Private insurance predicted lower no-show rates (p = .04). Age at first CCC visit was younger for patients with private insurance (p = .04) and older for those who lived further from the hospital (p = .002). Age at lip repair was positively correlated with national ADI (p = .03). However, no socioeconomic status (SES) proxy or proximity to hospital was associated with delays in first otolaryngology or audiology examination or TTI. CONCLUSION: Once children become established within an interdisciplinary CCC, SES appears to bear little influence on cleft-related otologic and audiologic care. Future efforts should aim to elucidate which aspects of the interdisciplinary model maximize multisystem cleft care coordination and increase access for higher risk populations.

Commercially Available Prenatal Vitamins Do Not Meet American College of Obstetricians and Gynecologists Nutritional Guidelines.

OBJECTIVE: This study aimed to evaluate the reported amount of the American College of Obstetricians and Gynecologists (ACOG) recommended nutrients in commercially available, over-the-counter prenatal vitamins (PNVs) in the United States, to assess their adequacy compared with the ACOG guidelines, and to compare these supplements by cost. STUDY DESIGN: The top 30 online Amazon and Google shopping items found using "prenatal vitamins" in September 2022 were included for analysis if they included the words "prenatal" and "vitamin" in the label and contained multiple nutrients. Duplicates between Amazon and Google were excluded as well as vitamins that did not list all ingredients. The reported amounts of 11 key nutrients, as recommended by the ACOG, for each product were recorded, as well as supplemental form and cost per 30-day supply. A cost analysis was done of PNVs that met the ACOG recommendations for the highlighted nutrients compared with those that did not. Five out of the 11 key nutrients (folic acid, iron, docosahexaenoic acid, vitamin D, and calcium) were specifically highlighted, as deficiencies in these nutrients are known to correlate with significant clinical outcomes in pregnancy. RESULTS: A total of 48 unique PNVs were included for final analysis. Of these PNVs, none were compliant with suggested amounts of all five key vitamins and nutrients. No products met daily recommendations for calcium. Only five PNVs were compliant with recommendations with ⅘ key nutrients. Of note, 27% of PNVs did not have the recommended amount of folic acid (13/48). The median cost of PNVs that were not compliant with the four nutrients mentioned above was $18.99 (interquartile range [IQR]: $10.00-$30.29), which was not statistically different from the median cost of the PNVs that did meet compliance with the four nutrients, which was $18.16 (IQR: $9.13-$26.99), p = 0.55. CONCLUSION: There were significant variations in the level of nutrients and cost of commercially available, over-the-counter PNVs in the United States. This raises concern that there should be more regulation of PNVs. KEY POINTS: · Commercially available over the counter PNVs vary in their content of the ACOG recommended nutrients and vitamins for pregnancy.. · None of these studied PNVs contain adequate amounts of all five key nutrients.. · Cost is not correlated with more compliance with the ACOG recommendations..

Efficacy of Propranolol to Reduce Cesarean Delivery in Prolonged Labor: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the rates of cesarean delivery in patients with prolonged labor randomized to receive intravenous (IV) propranolol compared with placebo. METHODS: A double-blind, placebo-controlled, randomized trial was conducted at two hospitals within a large academic health system. Eligible patients were at 36 weeks or more with a singleton gestation and prolonged labor , defined as: 1) prolonged latent phase of labor (dilation less than 6 cm after 8 hours or more with ruptured membranes and receiving oxytocin infusion) or 2) prolonged active phase of labor (dilation 6 cm or greater and less than 1-cm cervical dilation change over 2 hours or more with ruptured membranes and receiving oxytocin infusion). Patients were excluded for severe preeclampsia, maternal heart rate less than 70 beats per minute, maternal blood pressure less than 90/50 mm Hg, asthma, diabetes requiring insulin during labor, or a cardiac contraindication to ß-blockade. Patients were randomized to propranolol (2 mg IV) compared with placebo (2 mL normal saline IV), with one possible repeat dose. The primary outcome was cesarean delivery; secondary outcomes included labor duration, shoulder dystocia, and maternal and neonatal morbidity. With an estimated cesarean delivery rate of 45%, α 0.05, and 80% power, we required 163 patients per group to detect a 15% absolute reduction in cesarean delivery rate. A planned interim analysis was performed, and the trial was stopped for futility. RESULTS: From July 2020 to June 2022, 349 patients were eligible and approached; 164 were enrolled and randomized, with 84 in the propranolol group and 80 in the placebo group. The rate of cesarean delivery was not different between groups (57.1% propranolol vs 57.5% placebo, relative risk [RR] 0.99, 95% CI 0.76-1.29). Results were similar by subgroup of prolonged latent (n=123) and active (n=41) phases of labor and nulliparous (n=137) and multiparous (n=27) patients. Though not statistically significant, the frequency of postpartum hemorrhage was higher in the propranolol group (20% vs 10%, RR 2.02, 95% CI 0.93-4.43). CONCLUSION: In this multisite, double-blind, placebo-controlled randomized trial, there was no difference in cesarean delivery rate for patients who received propranolol compared with those who received placebo for management of prolonged labor. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04299438.

Association between intrapartum antibiotic prophylaxis for Group B Streptococcus colonization and clinical chorioamnionitis among patients undergoing induction of labor at term.

BACKGROUND: Rectovaginal colonization with Group B Streptococcus during pregnancy has historically been shown to be associated with an increased risk of clinical chorioamnionitis and peripartum infectious morbidity. OBJECTIVE: Newer observational data in the era of intrapartum antibiotic prophylaxis suggest a possible reversal of this association; however, it is unclear if this is related to differences in labor management for those with and without Group B Streptococcus colonization. We therefore sought to assess the association between intrapartum antibiotic prophylaxis for Group B Streptococcus colonization and clinical chorioamnionitis within the context of a randomized induction of labor trial with a standardized labor protocol. STUDY DESIGN: We performed an exploratory secondary analysis of a randomized trial of patients undergoing term induction at a tertiary care center. Patients received third trimester Group B Streptococcus screening and intrapartum antibiotic prophylaxis as routine care. Group B Streptococcus detection was performed using a carrot broth-enhanced subculture to Group B Streptococcus Detect approach (Hardy Diagnostics, Santa Maria, CA). Labor management was protocolized per the trial. Patients with unknown Group B Streptococcus status or who did not receive intrapartum antibiotic prophylaxis, if indicated, were excluded. The primary outcome was diagnosis of clinical chorioamnionitis, compared between patients who received intrapartum antibiotic prophylaxis for known Group B Streptococcus positive status (by culture, history, or Group B Streptococcus bacteriuria) and those who were Group B Streptococcus negative and did not receive intrapartum antibiotic prophylaxis. Secondary outcomes included postpartum endometritis, wound infection, a composite maternal peripartum infectious morbidity, and neonatal outcomes. RESULTS: A total of 491 patients were enrolled in the trial. Of these, 466 had a known Group B Streptococcus status and received or did not receive intrapartum antibiotic prophylaxis accordingly and were included in this analysis: 292 (62.7%) were Group B Streptococcus negative and did not receive intrapartum antibiotic prophylaxis, and 174 (37.3%) were Group B Streptococcus positive and received intrapartum antibiotic prophylaxis. The majority of patients were Non-Hispanic Black (78.1%) and nulliparous (59.7%). There were no differences in demographic, clinical, induction or labor characteristics between groups. Patients who were Group B Streptococcus positive had a 49% lower rate of clinical chorioamnionitis (8.1% vs 14.7%, odds ratio, 0.51; P=.03) and a lower rate of peripartum infectious morbidity (8.1% vs 15.8%, odds ratio, 0.47; P=.02) compared to those who were Group B Streptococcus negative. Infants born to patients who were Group B Streptococcus positive were significantly less likely to be admitted to the neonatal intensive care unit (3.4% vs 15.1%, P<.001). CONCLUSION: Although Group B Streptococcus colonization has historically been considered a risk factor for clinical chorioamnionitis, in the era of universal antibiotic prophylaxis for Group B Streptococcus positive patients, our findings support the point that intrapartum antibiotic prophylaxis for Group B Streptococcus positivity is associated with lower rates of clinical chorioamnionitis and peripartum infectious morbidity among patients undergoing induction with protocolized labor management. These findings demonstrate that intrapartum antibiotic prophylaxis for Group B Streptococcus may protect against perinatal infectious morbidity, a phenomenon that warrants further investigation.