Search

Objective: To test whether an individualized opioid-prescription protocol (IOPP) with a shared decision-making component can be used without compromising postcesarean pain management., Methods: In this multicenter randomized controlled noninferiority trial, we compared IOPP with shared decision making with a fixed quantity of opioid tablets at hospital discharge. We recruited at 31 centers participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Study participants had uncomplicated cesarean births. Follow-up occurred through 12 weeks postdischarge. Individuals with complicated cesarean births or history of opioid use in the pregnancy were excluded. Participants were randomized 1:1 to IOPP with shared decision making or fixed quantity (20 tablets of 5 mg oxycodone). In the IOPP group, we calculated recommended tablet quantity based on opioid use in the 24 hours before discharge. After an educational module and shared decision making, participants selected a quantity of discharge tablets (up to 20). The primary outcome was moderate to severe pain (score 4 or higher [possible range 0-10]) on the BPI (Brief Pain Inventory) at 1 week after discharge. A total sample size of 5,500 participants was planned to assess whether IOPP with shared decision making was not inferior to the fixed quantity of 20 tablets., Results: From September 2020 to March 2022, 18,990 individuals were screened and 5,521 were enrolled (n=2,748 IOPP group, n=2,773 fixed-quantity group). For the primary outcome, IOPP with shared decision making was not inferior to fixed quantity (59.5% vs 60.1%, risk difference 0.67%; 95% CI, -2.03% to 3.37%, noninferiority margin -5.0) and resulted in significantly fewer tablets received (median 14 [interquartile range 4-20] vs 20, P <.001) through 90 days postpartum., Conclusion: Compared with fixed quantity, IOPP with shared decision making was noninferior for outpatient postcesarean analgesia at 1 week postdischarge and resulted in fewer prescribed opioid tablets at discharge., Clinical Trial Registration: ClinicalTrials.gov, NCT04296396., Competing Interests: Financial Disclosure Unrelated to this work, Marcela C. Smid reports that she serves as a consultant for Gilead Science Inc and Alydia/Organon. Her institution receives research funding from both organizations. Rebecca Clifton reports payment from the University of Arkansas for Medical Sciences for DSMB reviews. Sindhu Srinivas reports receiving payments from Goodall, Decries, Leech & Dawn, LLP, and Huff Powell Bailey. Ruth Landau reports receiving payments from PACIRA Biosciences and Regional Anesthesia and Pain Medicine. Cora MacPherson reports receiving payments from PCORI and Natera. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Uterine sacculation refers to a temporary pouch or sac within the uterus that may contain the placenta or fetal parts and that may be diagnosed antepartum or after delivery. There is very limited published information about this rare condition and its management., Cases: We report two cases of uterine sacculation with entrapped placenta diagnosed immediately postpartum, managed with two different approaches. In one case, the patient underwent immediate laparotomy and placental extraction. In the second case, the patient was managed conservatively but ultimately developed signs of infection and underwent laparotomy., Conclusion: Uterine sacculation with entrapped placenta is a rare condition that is a potential etiology of retained placenta. Obstetric clinicians should be aware of this diagnosis and the management strategies available., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. 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.)

Background: Discovery of modifiable factors influencing subjective withdrawal experience might advance opioid use disorder (OUD) research and precision treatment. This study explores one factor - withdrawal catastrophizing - a negative cognitive and emotional orientation toward withdrawal characterized by excessive fear, worry or inability to divert attention from withdrawal symptoms. Objectives: We define a novel concept - withdrawal catastrophizing - and present an initial evaluation of the Withdrawal Catastrophizing Scale (WCS). Methods: Prospective observational study ( n  = 122, 48.7% women). Factor structure (exploratory factor analysis) and internal consistency (Cronbach's α) were assessed. Predictive validity was tested via correlation between WCS and next-day subjective opiate withdrawal scale (SOWS) severity. The clinical salience of WCS was evaluated by correlation between WCS and withdrawal-motivated behaviors including risk taking, OUD maintenance, OUD treatment delay, history of leaving the hospital against medical advice and buprenorphine-precipitated withdrawal. Results: WCS was found to have a two-factor structure (distortion and despair), strong internal consistency (α = .901), and predictive validity - Greater withdrawal catastrophizing was associated with next-day SOWS (r s (99) = 0.237, p  = .017). Withdrawal catastrophizing was also correlated with risk-taking behavior to relieve withdrawal (r s (119) = 0.357, p  < .001); withdrawal-motivated OUD treatment avoidance (r s (119) = 0.421, p  < .001), history of leaving the hospital against medical advice (r s (119) = 0.373, p  < .001) and buprenorphine-precipitated withdrawal (r s (119) = 0.369, p  < .001). Conclusion: This study provides first evidence of withdrawal catastrophizing as a clinically important phenomenon with implications for the future study and treatment of OUD.

Background: Pre-eclampsia with severe features (severe PreE) is associated with heart dysfunction, yet the impact beyond pregnancy, including its association with cardiomyopathic genetic polymorphisms, remains poorly understood., Objective: We aimed to characterize the temporal impact of severe PreE on heart function through the 4th trimester in women with and without deleterious cardiomyopathic genetic variants., Methods: Pregnant women were enrolled to undergo transthoracic echocardiography (TTE) in late pregnancy and 3 months postpartum. In women with severe PreE a targeted approach to identify pathogenic cardiomyopathic genetic polymorphisms was undertaken, and heart function was compared in carriers and noncarriers., Results: Pregnant women (32 ± 4 years old, severe PreE = 14, control = 8) were enrolled between 2019 - 2021. Women with severe PreE displayed attenuated myocardial relaxation (mitral e' = 11.0 ± 2.2 vs 13.2 ± 2.3 cm/sec, P < .05) in late pregnancy, and on in-silico analysis, deleterious cardiomyopathic variants were found in 58%. At 103 ± 33 days postpartum, control women showed stability in myocardial relaxation (Mitral e' Entry: 13.2 ± 2.3 vs Postpartum: 13.9 ± 1.7cm/sec, P = .464), and genetic negative severe PreE women (G-) demonstrated recovery of diastolic function to control level (Mitral e' Entry: 11.0 ± 3.0 vs Postpartum 13.7 ± 2.8cm/sec, P < .001), unlike their genetic positive (G+) counterparts (Mitral e' Entry: 10.5 ± 1.7 vs Postpartum 10.8 ± 2.4cm/sec, P = .853)., Conclusions: Postpartum recovery of heart function after severe PreE is attenuated in women with deleterious cardiomyopathic genetic polymorphisms., Competing Interests: Disclosure None reported., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: To estimate workplace productivity loss and indirect costs in the year after birth among individuals who deliver preterm in the United States., Methods: This retrospective, observational cohort study estimated workplace productivity loss and indirect costs for individuals aged 18-55 years with an inpatient delivery between January 1, 2016, and September 30, 2021, using data from the Merative MarketScan Commercial Claims and Encounters database and the Health and Productivity Management database. Workdays lost and costs attributable to medical-related absenteeism, workplace absenteeism (defined as sick leave, leave, recreational leave, Family Medical Leave Act); disability (defined as short-term and long-term disability), and aggregate workplace productivity loss, a combined outcome measure, were compared between propensity-score-matched birth cohorts: preterm birth (before 37 weeks of gestation) and full-term birth (at or after 37 weeks of gestation). Outcomes were also compared between the full-term birth cohort and preterm birth subgroups (before 32 weeks of gestation and before 34 weeks of gestation). Estimations of indirect costs assumed an 8-hour workday. Costs were inflated to December 2021 U.S. dollars., Results: In total, 37,522 individuals were eligible for medical-related absenteeism, 1,028 for workplace absenteeism, 7,880 for disability, and 396 for aggregate workplace productivity loss after propensity score matching. Compared with full-term birth, preterm birth was associated with more workdays lost and costs in the year after childbirth attributable to medical-related absenteeism (differences of 4.2 days and $1,045, P <.001) and disability (differences of 2.8 days and $422, P <.001). Preterm birth was not associated with workplace absenteeism (differences of 1.4 days and $347, P =.787) and aggregate workplace productivity loss (differences of 5.2 days [ P =.080] and $1,021 [ P =.093]). Numerical differences were greater in magnitude and inversely related to gestational age at birth across outcomes., Conclusion: Preterm birth was associated with medical-related absenteeism, disability claims, and indirect costs in the year after birth compared with full-term birth., Competing Interests: Financial Disclosure Vanessa Perez Patel, James Li, Seungyoung Hwang, and Damien Croft are employees of Organon. Organon provided consultancy fees to Matthew Davis and Scott Johnson (employees of Medicus Economics). Scott Johnson disclosed that money was paid to his institution from Acadia, Sunovion, and Vertex. He also disclosed having relationships with the following: Agios, Albireo, Alexion, Apellis, Argenx, Astellas, BCG, BeyondSpring, Boehringer-Ingelheim, Biohaven, BMS, Celgene, Decibel, Deciphera, Drexel, Esperion, FAST F2G, Fulcrum, Genentech, GRAIL, Include Health, IVI Kite, Madrigal, Morphosys, Novo Nordisk, Oncopeptides, Organon, Penn, Pfizer, PharmaEssentia, PTC, Rallybio, Reata, Regeneron, Sage, Sanofi, Sarepta, Snell, Spark, and SPR Therapeutics. Jane Kondejewski is an employee of Snell Medical Communication and disclosed the following: SNELL Medical Communication Inc. is a medical communications company that has provided medical writing and editorial services to the following clients: 3DS/Medidata Solutions, Analysis Group, BeiGene, BMS, Broadstreet, Eisai, Organon, Sage Therapeutics, Sarepta, Sunovion Pharmaceuticals, Takeda. Money was paid to her institution from 3DS/Medidata Solutions, Analysis Group, BeiGene, BMS, Broadstreet, Eisai, Organon, Sage Therapeutics, Sarepta, Sunovion Pharmaceuticals, and Takeda. Kara Rood is an employee of The Ohio State University. Hyagriv Simhan is an employee of the University of Pittsburgh and an advisor to Organon. The other authors did not report any potential conflicts of interest. The funding source conceptualized the study and contributed to the design, analysis, interpretation, and authoring of this study and reviewed the manuscript to ensure quality and protection of intellectual property; the authors were solely responsible for the final content of the manuscript and decision to submit for publication., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Enigma protein, encoded by the PDLIM7 gene, is overexpressed in thyroid cancer in a stage-dependent manner, suggesting a potential involvement in the initiation and progression of thyroid cancer. The Enigma interacts with several cellular pathways, including PI3K/AKT, MDM2, and BMP-1. The Enigma is regulated by microRNAs. Specifically, we showed that the Enigma protein upregulation corresponds to the downregulation of Let-7 family genes. There is limited research on the interactions and regulation of the Enigma with other proteins/genes in thyroid cancer tissues, indicating a gap in current knowledge. Our aim is to establish the Enigma as a biomarker. We also aim to study the interacting partners of the Enigma signaling pathways and their probable miRNA regulation in thyroid cancer progression. Using Western blotting, densitometric analysis, immunoprecipitation (IP), and reverse IP, we detected the protein expression and protein-protein interactions in the corresponding papillary thyroid carcinomas (PTCs). Utilizing real-time qPCR assay and Pearson's correlation test, we highlighted the correlation between PDLIM7 and Let-7g gene expression in the same tissues. The results showed the differential upregulations of the Enigma protein in different stages of PTCs compared to benign tissues along with AKT, VDR, BMP-1, and MDM2 proteins. Loss of DBP was observed in a subset of PTCs. Strong interactions of the Enigma with PI3K/AKT and MDM2 were noted, along with a weaker BMP-1 interaction. Pearson's correlation coefficient analysis between PDLIM7 and let-7g gene expression was significant ( p < 0.05); however, there was a weak inverse correlation (r = -0.27). The study suggests the potential utility of the PDLIM7-qPCR assay as a biomarker for thyroid cancer. The Enigma's interactions with key signaling pathways may provide valuable insights into the development of thyroid cancer. The study contributes to understanding the molecular mechanisms involving the Enigma protein in thyroid cancer and highlights its potential as a biomarker.

Purpose: The purpose of this study was to compare child language assessment practices of speech-language pathologists (SLPs) working in school and nonschool settings to determine if their place of employment impacts the diagnostic decision-making process., Method: School-based SLPs (e.g., direct service providers employed in preschool and/or K-12 schools; n = 382) and non-school-based SLPs (e.g., direct service providers employed in private practices, university clinics, and/or medical settings; n = 147) completed a web-based questionnaire. The questionnaire examined the types, frequency, and perceived importance of specific assessment tools and potential workplace factors that may impact their diagnostic decision-making process., Results: Both school-based and non-school-based SLPs reported using a combination of assessment tools when evaluating children with potential language disorders. School-based SLPs tended to rank the frequency of use and importance of most assessment tools similarly, while non-school-based SLPs ranked interviews as the most frequently used and most important assessment tool. Statistically significant group differences indicated that school-based SLPs ranked the frequency of use and importance of standardized testing higher compared to their non-school-based counterparts. Also, school-based SLPs rated employment-based factors impacting diagnostic decision making higher compared to non-school-based SLPs., Conclusions: SLPs practicing in school-based settings seem to handle more employment-based factors that impact independent diagnostic decision making than SLPs working in different employment settings when assessing children for potential language disorders. Clinical recommendations are provided, and implications for implementation-based assessment research in child language are discussed.

Background: Previous studies have suggested that acute mood states may influence levels of fetal activity. Because the fetal nonstress test relies on markers of fetal activity to suggest fetal wellbeing, its interpretation may be affected by maternal mood., Objective: This study sought to determine if there are differences in nonstress test characteristics between pregnant individuals with and without symptoms of mood disorder., Study Design: In this prospective cohort study, we recruited pregnant individuals undergoing nonstress test in the third trimester and compared the results of the nonstress test between pregnant individuals with scores above and below the cutoff values on validated screening questionnaires for depression and anxiety symptoms, the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder 7-item scale (GAD-7). Demographic information was collected from each participant at the time of recruitment, and medical information was extracted from the electronic medical record., Results: A total of 68 pregnant individuals were enrolled, 10 (15%) of which screened positive for perinatal mood disorders. There was no significant difference in means of time to reactivity (15.6 [4.8] minutes vs 15.0 [8.0] minutes, P=.77), number of accelerations (0.16/min [0.08] vs 0.16/min [0.10], P>.95), number of fetal movements (17.0 [14.7] vs 19.7 [20.4], P=.62), heart rate baseline (138.0 [7.5] bpm vs 139.2 [9.0] bpm, P=.67) or variability (8.5 [2.5] bpm vs 9.1 (4.3) bpm, P=.51) between pregnant individuals who screen positive for mood disorders and those who did not., Conclusion: Fetal heart rate patterns are similar in pregnant individuals with and without symptoms of mood disorder. The results provide reassurance that acute symptoms of anxiety and depression do not have significant effects on the fetal nonstress test., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The United States has one of the highest maternal mortality rates of developing countries, but the contribution of perinatal drug overdose is not known. Communities of color also have higher rates of maternal morbidity and mortality when compared to White communities, however the contribution due to overdose has not yet been examined in this population., Objectives: To quantify the years of life lost due to unintentional overdose in perinatal individuals from 2010 to 2019 and assess for disparity by race., Study Design: This was a cross-sectional retrospective study with summary-level mortality statistics for the years 2010-2019 obtained from the Centers for Disease Control (CDC) Wide-Ranging Online Data for Epidemiologic Research (WONDER) mortality file. A total of 1,586 individuals of childbearing age (15-44 years) who died during pregnancy or six weeks postpartum (perinatal) from unintentional overdose in the United States from January 1, 2010 to December 31, 2019 were included. Total years of life lost (YLL) was calculated and summated for White, Black, Hispanic, Asian/Pacific Islander, and American Indian/Native Alaska women. Additionally, the top three overall causes of death were also identified for women in this age group for comparison., Results: Unintentional drug overdose accounted for 1,586 deaths and 83,969.78 YLL in perinatal individuals from 2010 to 2019 in the United States. Perinatal American Indian/Native American individuals had a disproportionate amount of YLL when compared to other ethnic groups, with 2.39% of YLL due to overdose, while only making up 0.80% of the population. During the last two years of the study, only American Indian/Native American and Black individuals had increased rates of mortality when compared to other races. During the ten-year study period, when including the top three causes of mortality, unintentional drug overdoses made up 11.98% of the YLL overall and 46.39% of accidents. For the years 2016-2019, YLL due to unintentional overdose was the third leading cause of YLL overall for this population., Conclusions: Unintentional drug overdose is a leading cause of death for perinatal individuals in the United States, claiming nearly 84,000 years of life over a ten-year period. When examining by race, American Indian/Native American women are most disproportionately affected., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear., Methods: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed., Results: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups., Conclusions: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.)., (Copyright © 2023 Massachusetts Medical Society.)