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Background: Treatment of gestational diabetes mellitus has been demonstrated to improve perinatal outcomes. However, the role of the Special Supplemental Nutrition Program for Women, Infants, and Children in maternal and neonatal outcomes for qualifying patients with gestational diabetes mellitus is less understood., Objective: The objective of this study is to observe the relationship of enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children with pregnancy outcomes in patients with gestational diabetes., Study Design: This was a retrospective cohort study using National Vital Statistics Birth Data of pregnant persons diagnosed with gestational diabetes mellitus between 2014 and 2018. The study population was composed of patients who had Medicaid coverage for maternity care; patients with Medicaid are automatically qualified for the Special Supplemental Nutrition Program for Women, Infants, and Children. The study groups were defined as those who enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children vs those who did not enroll. In addition, maternal and neonatal outcomes for these groups were analyzed. Univariate and multivariable logistic regression analyses adjusted for significant covariates were performed., Results: Of 460,377 pregnant persons with pregnancies complicated by gestational diabetes mellitus, 73% were enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children, and 27% were not. Pregnant persons with gestational diabetes mellitus enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children had decreased odds of preterm delivery before 34 and 37 weeks of gestation. Although the Special Supplemental Nutrition Program for Women, Infants, and Children group had higher odds of large-for-gestational-age neonates and cesarean delivery, the overall rates of these outcomes in both cohorts were high., Conclusion: The Special Supplemental Nutrition Program for Women, Infants, and Children provides a resource for perinatal support, supplemental food, and nutritional education. The decrease in the rates of preterm deliveries in pregnant persons with gestational diabetes mellitus that enroll in the Special Supplemental Nutrition Program for Women, Infants, and Children, Infants, and Children relative to those that qualified for the program but did not enroll suggested that having access to available education and food sources may influence perinatal outcomes., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To evaluate the cost-effectiveness of universal screening for HCV among all pregnant women in the United States., Methods: We designed a decision-analytic model to evaluate the cost-effectiveness and outcomes associated with universal HCV screening in pregnancy compared to no screening. A theoretical cohort of 3.9 million women, the approximate number of annual live births in the United States was used. Outcomes included hepatocellular carcinoma, decompensated cirrhosis, liver transplant and death, in addition to cost and quality-adjusted life years (QALYs). Model inputs were derived from the literature and the willingness-to-pay threshold was $100,000 per QALY. Sensitivity analysis were conducted to evaluate the robustness of the results., Results: In a theoretical cohort of 3.9 million women, universal HCV screening resulted in 3003 fewer cases of hepatocellular carcinoma, 1484 fewer decompensated cirrhosis, 46 fewer liver transplants and 2665 fewer deaths from HCV when compared to no screening. Universal HCV screening was found to be the dominant strategy, meaning it resulted in lower costs and higher QALYs. Sensitivity analyses showed our model was robust over a wide range of assumptions., Conclusion: Among pregnant women in the United States, universal HCV screening is cost effective compared with no screening.

Objective: To assess the cost-effectiveness of influenza vaccination for all pregnant patients in the United States., Methods: We designed a cost-effectiveness model to compare outcomes and costs in pregnant patients who received the inactivated, trivalent influenza vaccine to those who did not. We used a theoretical cohort of 4 million patients, the number of individuals giving birth in the United States per year. We assumed that H1N1 and A or B type influenza were of equal incidence based on seasonal variation from the past ten years. Our outcomes include acquiring H1N1, acquiring A or B type influenza, maternal death, stillbirth, infant death, preterm birth, and cerebral palsy in addition to cost and quality-adjusted life years (QALYs). Probabilities were derived from the literature and QALYs generated at a discount rate of 3%. Sensitivity analyses were performed to assess the robustness of our model., Results: In our theoretical cohort of 4 million pregnant patients, the influenza vaccination strategy was associated with 1632 fewer stillbirths (24,332 in the vaccine strategy vs. 25,964 in the no vaccine strategy), 120 fewer maternal deaths (284 vs. 404), 340 fewer infant deaths (5608 vs. 5948), 32,856 fewer preterm births (403,896 vs. 436,752), and 641 fewer cases of moderate cerebral palsy (12,388 vs. 13,029). Additionally, the vaccination strategy corresponded to savings of $3.7 billion ($63.3 billion vs. $67.0 billion) and increased QALYs of 81,696 (226,852,076 vs 226,770,380). Therefore, it was considered a dominant strategy. Univariate sensitivity analysis demonstrated that the vaccine is cost saving until vaccine cost passes $900, far above the current cost of $12.16. In addition, we used sensitivity analysis to vary seasonal proportions of H1N1 to A or B type influenza. The vaccine was cost saving and increased QALYs for any proportion of H1N1 to A or B type influenza including when H1N1 was absent., Conclusion: We demonstrate that in a cohort of 4 million patients, the influenza vaccine may save $3.7 billion per year, improve maternal and infant outcomes, and reduce morbidity and mortality. Our study provides further evidence that providers should strongly recommend that pregnant patients receive their annual influenza vaccine.

Background: The primary concern for a trial of labor after cesarean (TOLAC) is a uterine rupture leading to neonatal injury or mortality and maternal mortality. In individuals who have a term stillbirth, the neonatal concern is absent, yet repeat cesarean delivery remains common in this setting. Given the increased maternal risks from cesarean, it is important to evaluate obstetric management options in the population of women who have a term stillbirth and prior cesarean delivery (CD)., Objectives: To examine the outcomes and costs of a TOLAC via induction of labor verses a repeat CD for cases of stillbirth occurring near term., Study Design: A decision-analytic model incorporating the current and a subsequent delivery using TreeAge software was designed to compare outcomes in women induced for a TOLAC to those undergoing repeat CD in the setting of stillbirth at 34-41 weeks' gestation. We used a theoretical cohort of 6000 women, the estimated annual number of women a prior cesarean who experience a stillbirth in the United States. Outcomes included quality-adjusted life years (QALY) for both modes of delivery with consideration of future pregnancy risks. Future pregnancy risks included uterine rupture, hysterectomy, placenta accreta, maternal death, neonatal death, and neonatal neurological deficits. Probabilities were derived from the literature, and a cost-effectiveness threshold was set at $100,000/QALY., Results: In our theoretical cohort of 6000 women with a prior CD and current stillbirth, induction of labor resulted in 4836 fewer cesarean deliveries during stillbirth management, 1040 fewer cesarean deliveries in the subsequent pregnancy, and 14 fewer cases of placenta accreta in the subsequent pregnancy, despite 29 additional uterine ruptures across both pregnancies. Induction of labor was found to be the dominant strategy, resulting in decreased costs and increased QALYs. Univariate sensitivity analyses demonstrated that induction of labor was cost effective until the risk of uterine rupture in the first delivery exceeded 0.83% (baseline estimate: 0.38%). Additional univariate sensitivity analyses found that induction of labor was cost effective until the risk of IOL failure in the first delivery exceeded 64% (baseline estimate: 19%)., Conclusion: In our theoretical cohort, induction of labor for TOLAC in the setting of a stillbirth with a history of prior CD is cost effective compared to a repeat CD. The results of this analysis demonstrate the benefit of induction of labor among women in this scenario who desire a future pregnancy.

Background: The American College of Obstetricians and Gynecologists (ACOG) provides numerous narrative documents containing formal recommendations and additional narrative guidance within the text. These guidelines are not intended to provide a complete "care pathway" for patient management, but these elements of guidance can be useful for clinical decision support (CDS) in obstetrical and gynecologic care and could be exposed within electronic health records (EHRs). Unfortunately, narrative guidelines do not easily translate into computable CDS guidance., Objective: This study aimed to describe a method of translating ACOG clinical guidance into clear, implementable items associated with specific obstetrical problems for integration into the EHR., Methods: To translate ACOG clinical guidance in Obstetrics into implementable CDS, we followed a set of steps including selection of documents, establishing a problem list, extraction and classification of recommendations, and assigning tasks to those recommendations., Results: Our search through ACOG clinical guidelines produced over 500 unique documents. After exclusions, and counting only sources relevant to obstetrics, we used 245 documents: 38 practice bulletins, 113 committee opinions, 16 endorsed publications, 1 practice advisory, 2 task force and work group reports, 2 patient education, 2 obstetric care consensus, 60 frequently asked questions (FAQ), 1 women's health care guidelines, 1 Prolog series, and 9 others (non-ACOG). Recommendations were classified as actionable ( n  = 576), informational ( n  = 493), for in-house summary ( n  = 124), education/counseling ( n  = 170), policy/advocacy ( n  = 33), perioperative care ( n  = 4), delivery recommendations ( n  = 50), peripartum care ( n  = 13), and non-ACOG ( n  = 25)., Conclusion: We described a methodology of translating ACOG narrative into a semi-structured format that can be more easily applied as CDS in the EHR. We believe this work can contribute to developing a library of information within ACOG that can be continually updated and disseminated to EHR systems for the most optimal decision support. We will continue documenting our process in developing executable code for decision support., Competing Interests: None declared., (Thieme. All rights reserved.)

Importance: Hundreds of gene therapies are undergoing clinical testing and are likely to be priced more than $1 million per course of treatment. The association that high prices will have with insurance coverage of gene therapy remains unclear. Gene therapy for sickle cell disease has shown early success and would be one of the first gene therapies available for a relatively large population., Objectives: To estimate the budget impact and affordability of a gene therapy for severe sickle cell disease from the perspective of US Medicaid programs with the highest prevalence of sickle cell disease while exploring the impact of an annuity payment model., Design, Setting, and Participants: A budget impact analysis was performed from January 1 to May 31, 2020, for a sickle cell disease gene therapy from the perspective of 10 state Medicaid plans with a 5-year time horizon, using state-level disease prevalence data from 2012. Disease prevalence, Medicaid enrollment, and expenditures were derived from the available literature. The eligible population was based on modified clinical trial inclusion criteria including individuals aged 13 to 45 years with severe disease., Exposures: The gene therapy was assumed to be administered to 7% of the eligible population annually and was curative (no subsequent disease-related expenditures). The gene therapy price was $1.85 million in the base case, and baseline disease-related expenditures were $42 200 per year., Main Outcomes and Measures: The main outcomes were total budget impact and budget impact per member per month in years 1 through 5. One-way sensitivity analysis was used to evaluate uncertainty of market diffusion, size of eligible population, price of therapy, and cost of routine care., Results: An estimated 5464 Medicaid enrollees would be eligible for the gene therapy nationally, with 2315 individuals in the 10 Medicaid programs of interest (16 per 100 000 enrollees). The model projected a mean 1-year budget impact of $29.96 million per state Medicaid program in the sample ($1.91 per member per month). A 5-year annuity payment reduced the short-term budget impact., Conclusions and Relevance: This study suggests that a gene therapy for severe sickle cell disease is likely to produce a considerable budget impact for many Medicaid plans while potentially offering substantial benefit to patients. Payers may need to take steps to ensure affordability and access. Gene therapy for sickle cell disease is likely to provide an early demonstration of the unique financial challenges associated with this emerging drug class.

Objective: To examine the cost effectiveness of using behavioral smoking cessation counseling during pregnancy., Methods: We designed a decision-analytic model using TreeAge Pro 2020 software to compare the cost effectiveness and outcomes among women who received behavioral smoking cessation counseling compared with women who received usual care during pregnancy. We used a theoretical cohort of 285,000 women, the approximate number of pregnant women who smoke each year in the United States. Outcomes included maternal abstinence from smoking, fetal growth restriction, stillbirth, preterm delivery, neonatal death, and cerebral palsy, in addition to cost and quality-adjusted life-years (QALYs) for both the woman and the neonate. All model inputs were derived from the literature, and a willingness-to-pay threshold was set at $100,000 per QALY. Sensitivity analyses were performed to determine the robustness of baseline assumptions., Results: In our theoretical cohort, behavioral smoking cessation counseling compared with usual care was associated with 9,019 additional women stopping smoking during pregnancy (34,604 vs 25,585). Smoking cessation counseling also resulted in 911 fewer cases of fetal growth restriction, 20 fewer stillbirths, 250 fewer preterm deliveries, 11 fewer neonatal deaths, and one less case of cerebral palsy. Using behavioral smoking cessation counseling interventions during pregnancy led to better outcomes despite higher costs, with an incremental cost-effectiveness ratio of $71,658 per QALY, which was below our willingness-to-pay threshold of $100,000 per QALY, making the intervention cost effective. Sensitivity analyses demonstrated that the counseling intervention was cost effective at probabilities of smoking cessation greater than 11.6% (baseline input: 12.1%) or the cost of the behavioral intervention was less than $475.21 (baseline input: $368.78)., Conclusion: Behavioral smoking cessation counseling during pregnancy was associated with fewer adverse neonatal outcomes and was cost effective. Increasing utilization of such interventions and increasing insurance coverage of this care are important initiatives to improve outcomes in this at-risk population., Competing Interests: Financial Disclosure Dr. Aaron Caughey has served as a Medical Advisor to Celmatix. The other authors did not report any potential conflicts of interest., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Pharmacist prescription of contraception is becoming increasingly common in the United States (US). Limited information exists on whether this is improving access to contraception in underserved areas, including rural America., Objective: We sought to determine whether there were differences by rural location in pharmacists' willingness to prescribe hormonal contraception and perceived barriers to doing so., Methods: We conducted a cross-sectional survey of pharmacists eligible to prescribe hormonal contraception in New Mexico in March and May 2020. The survey consisted of demographic data, pharmacists' experience prescribing hormonal contraception, and questions regarding perceived barriers to pharmacist-prescribed hormonal contraception. Descriptive statistics assessed differences in survey responses between rural and urban pharmacists. We used multivariable logistic regression to estimate the association between rural practice and prescribing hormonal contraception., Results: Our sampling frame consisted of 822 licensed pharmacists. We received 256 responses, for a response rate of 31.1%. We found that rural pharmacists were as likely as their urban counterparts to prescribe hormonal contraception (adjusted odds ratio 1.22 [95% CI 0.56-2.68], P = 0.50). Five main barriers included a need for additional training, reimbursement for services, liability concerns, corporate policies, and shortage of staff. No difference in barriers were identified by rural location or staff role., Conclusion: Pharmacy access has the potential to improve access to contraception across New Mexico, including underserved rural areas., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Children at high risk for sudden cardiac death (SCD) (>6% over 5 years) receive an implantable cardioverter-defibrillator (ICD), but no guidelines are available for those at lower risk. For children at intermediate risk for SCD (4%-6% over 5 years), the utility and cost-effectiveness of in-home automated external defibrillators (AEDs) are unclear., Objective: The purpose of this study was to assess the cost-effectiveness of in-home AED for children at intermediate risk for SCD., Methods: Using hypertrophic cardiomyopathy (HCM) as the proxy disease, a theoretical cohort of 1550 ten-year-old children with HCM was followed for 69 years. Baseline annual risk of SCD was 0.8%. Outcomes were SCD, severe neurologic morbidity (SNM), cost, and quality-adjusted life-years (QALYs). Model inputs were derived from the literature, with a willingness-to-pay threshold of $100,000 per QALY., Results: Among children at intermediate risk for SCD, in-home AED resulted in 31 fewer cases of SCD but 3 more cases of SNM. There were 319 QALYs gained. Although costs were higher by $28 million, the incremental cost-effectiveness ratio was $86,458, which is below the willingness-to-pay threshold., Conclusion: For children at intermediate risk for SCD and HCM, in-home AED is cost-effective, resulting in fewer deaths and increased QALYS for a cost below the willingness-to-pay threshold. These findings highlight the economic benefits of in-home AED use in this population., (Copyright © 2020. Published by Elsevier Inc.)

Objective: Antenatal corticosteroids given prior to preterm deliveries reduce the risk of adverse neonatal outcomes. However, steroid administration in the setting of a viral respiratory infection can worsen maternal outcomes. Therefore, the decision to administer corticosteroids must balance the neonatal benefits with the potential harm to the mother if she is infected with the novel coronavirus disease 2019 (COVID-19). This study aimed to determine the gestational ages for which administering antenatal corticosteroids to women at high risk of preterm labor with concurrent COVID-19 infection results in improved combined maternal and infant outcomes., Study Design: A decision-analytic model using TreeAge (2020) software was constructed for a theoretical cohort of hospitalized women with COVID-19 in the United States. All model inputs were derived from the literature. Outcomes included maternal intensive care unit (ICU) admission and death, along with infant outcomes of death, respiratory distress syndrome, intraventricular hemorrhage, and neurodevelopmental delay. Quality-adjusted life years (QALYs) were assessed from the maternal and infant perspectives. Sensitivity analyses were performed to determine if the results were robust over a range of assumptions., Results: In our theoretical cohort of 10,000 women delivering between 24 and 33 weeks of gestation with COVID-19, corticosteroid administration resulted in 2,200 women admitted to the ICU and 110 maternal deaths. No antenatal corticosteroid use resulted in 1,500 ICU admissions and 75 maternal deaths. Overall, we found that corticosteroid administration resulted in higher combined QALYs up to 31 weeks of gestation in all hospitalized patients, and up to 29 weeks of gestation in ICU patients., Conclusion: Administration of antenatal corticosteroids at less than 32 weeks of gestation for hospitalized patients and less than 30 weeks of gestation for patients admitted to the ICU resulted in higher combined maternal and infant outcomes compared with expectant management for women at high risk of preterm birth with COVID-19 infection. These results can guide clinicians in their counseling and management of these pregnant women., Key Points: · Antenatal steroids reduce adverse neonatal outcomes.. · Steroids worsen maternal outcomes in COVID-19.. · Steroids given < 32 weeks result in improved outcomes.., Competing Interests: None declared., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: To evaluate the cost-effectiveness and health outcomes related to continuous support from a layperson during a woman's first two births in a theoretical population., Design: Cost-effectiveness analysis., Participants: A theoretical cohort of 1.2 million women based on an approximation of annual low-risk, nulliparous, term, singleton births in the United States with the assumption that these women have second births. This reflects the average number of births per woman in the United States., Methods: We designed a cost-effectiveness model to compare outcomes in women with continuous support from relatives, friends, or community members with minimal to no training (excluding trained doulas) during labor and birth compared with outcomes for women with no continuous support. Outcomes included mode of birth, uterine rupture, hysterectomy, maternal death, cost, and quality-adjusted life years (QALYs). We derived probabilities from the literature and set a cost-effectiveness threshold at $100,000/QALY., Results: In this theoretical model, continuous support by a layperson during the first birth resulted in fewer cesarean births, decreased costs, and increased QALYs for the first and subsequent births. Women with support from laypersons had 71,090 fewer cesarean births, 35 fewer uterine ruptures, 9 fewer hysterectomies, and 16 fewer maternal deaths, which saved $364 million with 2,673 increased QALYs. Sensitivity analyses showed that continuous support in the first birth was cost-effective even when varying the estimate of lost wages of the support person up to $708., Conclusion: Continuous labor support from a layperson leads to fewer cesarean births, improved outcomes, decreased costs, and increased QALYs. This highlights the need to increase women's access to continuous layperson support during labor and birth uninhibited by financial and institutional barriers., (Copyright © 2019. Published by Elsevier Inc.)

Introduction: Multiple studies have demonstrated the benefits of intrapartum doula care, including lower risk for cesarean birth and shortened labor time for nulliparous women. However, analyses investigating the cost-effectiveness of doula care are limited. This study evaluated the potential cost-effectiveness of professional doula support during a woman's first birth in a theoretical population of US women, with all women having a second birth without doula care., Methods: A cost-effectiveness model was designed to compare outcomes in women with a professional doula versus no doula labor support. A theoretical cohort of 1.6 million women, the approximate number of annual low-risk, nulliparous, term, singleton births in the United States, was used. Outcomes included mode of birth, maternal death, uterine rupture, cesarean hysterectomy, costs, and quality-adjusted life years (QALYs). Probability estimates used in the model were derived from the literature, and a cost-effectiveness threshold was set at $100,000 per QALY. Sensitivity analyses were used to investigate the robustness of the results., Results: In this theoretical model, professional doula care during the first birth resulted in fewer cesarean births and improved QALYs. Additionally, doula support resulted in 202,538 fewer cesarean births, 46 fewer maternal deaths secondary to fewer cesarean births, 99 fewer uterine ruptures, and 26 fewer hysterectomies, with an additional cost of $185 million and 7617 increased QALYs for the first and subsequent births. Sensitivity analyses demonstrated a professional doula was potentially cost-saving up to $884 and cost-effective up to $1360 per doula., Discussion: Professional doula care during a woman's first birth may lead to improved outcomes and increased QALYs during her first and second births. Given the limitations of this analysis, the cost-effectiveness estimate is likely conservative, further supporting broader integration of professional doulas into the US maternity care system and highlighting the need for higher doula care reimbursement., (© 2019 by the American College of Nurse-Midwives.)