Leah M. Savitsky

Objective: Optimal strategies for intrapartum glycemic control among patients with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) remain uncertain. In 2024, our labor and delivery unit implemented a subcutaneous (SC) insulin protocol to replace routine intravenous (IV) insulin initiation when glucose exceeded a treatment threshold. We hypothesized that this change would not worsen neonatal outcomes and would improve nursing (RN) satisfaction. Methods: We conducted a retrospective cohort quality improvement study of patients with GDM or T2DM who delivered at ≥36 weeks between March 2021 and December 2025. July 2024, when the protocol was introduced, was excluded as a washout period. The intervention included both a shift to SC insulin‐first management and standardization of intrapartum glycemic treatment to a target of ≤ 120 mg/dL. The primary outcome was a composite of neonatal hypoglycemia or neonatal intensive care unit (NICU) admission for hypoglycemia within 24 h of life. Secondary outcomes included IV insulin duration and RN satisfaction. Outcomes were compared before and after implementation. Poisson regression with an interrupted time series framework assessed pre‐implementation trends, immediate level changes, and post‐implementation trends in the primary composite outcome. Multivariable logistic regression evaluated associations between insulin modality and the primary outcome. Surveys were analyzed by Wilcoxon rank‐sum tests. Results: Of 1140 deliveries in the analytic cohort, the primary outcome occurred in 269 (23.6%). Rates were similar before and after protocol implementation (23.4% vs. 23.9%, p = 0.837). Interrupted time series analysis showed no significant pre‐implementation trend, but did demonstrate a significant immediate reduction in monthly event rates at implementation (incidence rate ratio [IRR], 0.20; 95% confidence interval [CI], 0.04–0.90), with no significant post‐implementation trend change (IRR, 1.03; 95% CI, 0.99–1.06). In adjusted analyses, insulin modality was not significantly associated with the primary outcome. RN satisfaction improved after implementation, with agreement or strong agreement increasing from 29.2% to 51.8% ( p = 0.032). Conclusion: Implementation of an SC insulin‐first intrapartum diabetes management protocol for patients with GDM and T2DM was not associated with increased neonatal hypoglycemia nor NICU admission for hypoglycemia. The protocol was associated with improved RN satisfaction. This approach may offer a pragmatic alternative to routine IV insulin initiation during labor.

OBJECTIVE: To evaluate the cost effectiveness of universal fetal echocardiogram for patients with pregestational diabetes mellitus by first-trimester hemoglobin A_1c (Hb A_1c) level. METHODS: We developed a cost-effectiveness model comparing two strategies of screening for critical fetal congenital heart disease among patients with diabetes: universal fetal echocardiogram and fetal echocardiogram only after abnormal findings on detailed anatomy ultrasonogram. We excluded ventricular septal defect, atrial septal defects, and bicuspid aortic valve from the definition of critical fetal congenital heart disease. Probabilities and costs were derived from the literature. We used individual models to evaluate different scenarios: first-trimester Hb A_1c lower than 6.5%, Hb A_1c 6.5–9.0%, and Hb A_1c higher than 9.0%. Primary outcomes included fetal death, neonatal death, and false-positive and false-negative results. A cost-effectiveness threshold was set at $100,000 per quality-adjusted life-year. Univariable sensitivity analyses were performed to investigate the drivers of the model. RESULTS: Universal fetal echocardiogram is not cost effective except for when first-trimester Hb A_1c level is higher than 9.0% (incremental cost-effectiveness ratio $638,100, $223,693, and $67,697 for Hb A_1c lower than 6.5%, 6.5–9.0%, and higher than 9.0%, respectively). The models are sensitive to changes in the probability of congenital heart disease at a given Hb A_1c level, as well as the cost of neonatal transfer to a higher level of care. Universal fetal echocardiogram became both cost saving and more effective when the probability of congenital heart disease reached 14.48% (15.4 times the baseline risk). In the Monte Carlo simulation, universal fetal echocardiogram is cost effective in 22.7%, 48.6%, and 62.3% of scenarios for each of the three models, respectively. CONCLUSION: For pregnant patients with first-trimester Hb A_1c levels lower than 6.5%, universal fetal echocardiogram was not cost effective, whereas, for those with first-trimester Hb A_1c levels higher than 9.0%, universal fetal echocardiogram was cost effective. For those with intermediate Hb A_1c levels, universal fetal echocardiogram was cost effective in about 50% of cases; therefore, clinical judgment based on individual patient values, willingness to pay to detect congenital heart disease, and resource availability needs to be considered.

Preterm birth (PTB) remains the leading cause of infant morbidity and mortality. Despite 50 years of research, therapeutic options are limited and many lack clear efficacy. Tocolytic agents are drugs that briefly delay PTB, typically to allow antenatal corticosteroid administration for accelerating fetal lung maturity or to transfer patients to high-level care facilities. Globally, there is an unmet need for better tocolytic agents, particularly in low- and middle-income countries. Although most tocolytics, such as betamimetics and indomethacin, suppress downstream mediators of the parturition pathway, newer therapeutics are being designed to selectively target inflammatory checkpoints with the goal of providing broader and more effective tocolysis. However, the relatively small market for new PTB therapeutics and formidable regulatory hurdles have led to minimal pharmaceutical interest and a stagnant drug pipeline. In this review, we present the current landscape of PTB therapeutics, assessing the history of drug development, mechanisms of action, adverse effects, and the updated literature on drug efficacy. We also review the regulatory hurdles and other obstacles impairing novel tocolytic development. Ultimately, we present possible steps to expedite drug development and meet the growing need for effective preterm birth therapeutics.

Objective The health care system has been struggling to find the optimal way to protect patients and staff from coronavirus disease 2019 (COVID-19). Our objective was to evaluate the impact of two strategies on transmission of COVID-19 to health care workers (HCW) on labor and delivery (L&D). Study Design We developed a decision analytic model comparing universal COVID-19 screening and universal PPE on L&D. Probabilities and costs were derived from the literature. We used individual models to evaluate different scenarios including spontaneous labor, induced labor, and planned cesarean delivery (CD). The primary outcome was the cost to prevent COVID-19 infection in one HCW. A cost-effectiveness threshold was set at $25,000 to prevent a single infection in an HCW. Results In the base case using a COVID-19 prevalence of 0.36% (the rate in the United States at the time), universal screening is the preferred strategy because while universal PPE is more effective at preventing COVID-19 transmission, it is also more costly, costing $4,175,229 and $3,413,251 to prevent one infection in the setting of spontaneous and induced labor, respectively. For planned CD, universal PPE is cost saving. The model is sensitive to variations in the prevalence of COVID-19 and the cost of PPE. Universal PPE becomes cost-effective at a COVID-19 prevalence of 34.3 and 29.5% and at a PPE cost of $512.62 and $463.20 for spontaneous and induced labor, respectively. At a higher cost-effectiveness threshold, the prevalence of COVID-19 can be lower for universal PPE to become cost-effective. Conclusion Universal COVID-19 screening is generally the preferred option. However, in locations with high COVID-19 prevalence or where the local societal cost of one HCW being unavailable is the highest such as in rural areas, universal PPE may be cost-effective and preferred. This model may help to provide guidance regarding allocation of resources on L&D during these current and future pandemics. Key Points

We found low prevalence of SARS-CoV-2 (2.7% [5/188]) among pregnant and postpartum patients with universal testing. Prevalence among symptomatic patients was similar under initial targeted screening (22.2% [4/18]) and universal approaches (19.1% [8/42]). Among 170 asymptomatic patients, 2 were positive or inconclusive, respectively; repeat testing at 24 hours was negative.

Objective We sought to identify factors associated with a successful trial of labor (TOL) following two cesarean deliveries (CDs) in a contemporary North American cohort. Study Design This is a retrospective cohort study of term, nonanomalous, singleton, vertex pregnancies attempting a vaginal birth after cesarean (VBAC) following a history of two previous CDs in the United States from 2012 to 2014. Maternal and intrapartum factors were analyzed using chi-square tests and multivariable logistic regression. Results A total of 22,762 women met the inclusion criteria and underwent TOL. Of these, 12,192 (53.6%) had a VBAC. Using multivariate logistic regression, previous vaginal delivery and delivery at 40 to 41 weeks' gestation were associated with VBAC; maternal age, education, Medicaid insurance, non-Caucasian race/ethnicity, weight (overweight or obese), and gestational weight gain above the Institute of Medicine guidelines (adjusted odds ratio: 0.88; 95% confidence interval: 0.81–0.95) were associated with CD. Induction of labor did not affect the VBAC rate. Conclusion For those desiring a TOL after two previous CDs, prospective studies are needed to assess interventions that limit gestational weight gain as well as the safety and optimal timing of an induction of labor. The decision to attempt a TOL should be guided by counseling regarding the risks, benefits, and chances of a successful TOL.

Background Oxytocin is one of the most frequently used medications in obstetrics. It is generally considered to be safe and effective for induction and augmentation of labor but has been implicated in uterine hyperstimulation and adverse fetal outcomes. The management of labor with oxytocin in response to changes in fetal status remains an area of debate. Objective This study sought to assess the cost-effectiveness of reducing or ceasing oxytocin administration in response to Category II fetal heart rate tracings. Study Design A decision-analytic model was built using TreeAge 2016 software (TreeAge Software Inc.) with probabilities, costs, and utilities derived from the literature. Primary outcomes included cerebral palsy (CP), neonatal mortality, and mode of delivery. Secondary outcomes included cost per quality-adjusted life year (QALY; cost-effectiveness threshold set at $100,000/QALY), admission to the neonatal intensive care unit (NICU), and low 5-minute Apgar score (<7). Sensitivity analyses were performed to determine the robustness of our baseline assumptions. Results In a theoretical cohort of 900,000 women (estimated number of women undergoing induction at term in the United States), decreasing or stopping oxytocin in response to Category II tracings prevented 12,510 NICU admissions, 4,410 low Apgar scores, 204 neonatal deaths, and 126 cases of CP. However, there were 81,900 more cesarean deliveries. The strategy cost $356 million more, but was cost-effective with an ICER of $9,881.5 per QALY. Sensitivity analysis revealed that the intervention would be cost-effective up to a cesarean rate of 54%. Conclusion Decreasing or stopping oxytocin in response to Category II fetal heart rate tracings is cost-effective. This intervention increases the rate of cesarean deliveries but reduces neonatal morbidity and mortality. Further work on this guideline should be performed to ascertain how the approach using different aspects of the Category II tracing to guide care might lead to similar improved outcomes without increasing the cesarean delivery rate. Decreasing oxytocin in response to Category II tracings is cost-effective over a wide range of assumptions. This study was presented as a poster presentation at the Society for Maternal Fetal Medicine Pregnancy Meeting 2017, Las Vegas, Nevada (Abstract #430).