Society for Maternal-Fetal Medicine Special Statement: A critique of postpartum readmission rate as a quality metric.

Hospital readmission is considered a core measure of quality in healthcare. Readmission soon after hospital discharge can result from suboptimal care during the index hospitalization or from inadequate systems for postdischarge care. For many conditions, readmission is associated with a high rate of serious morbidity and potentially avoidable costs. In obstetrics, for postpartum care specifically, hospitals and payers can easily track the rate of maternal readmission after childbirth and may seek to incentivize obstetricians, maternal-fetal medicine specialists, or provider groups to reduce the rate of readmission. However, this practice has not been shown to improve outcomes or reduce harm. There are major concerns with incentivizing providers to reduce postpartum readmissions, including the lack of a standardized metric, a baseline rate of 1% to 2% that is too low to accurately discriminate between random variation and controllable factors, the need for risk adjustment that greatly complicates rate calculations, the potential for bias depending on the duration of the follow-up interval, the potential for the "gaming" of the metric, the lack of evidence that obstetrical providers can influence the rate, and the potential for unintended harm in the vulnerable postpartum population. Until these problems are adequately addressed, maternal readmission rate after a childbirth hospitalization currently has limited utility as a metric for quality or performance improvement or as a factor to adjust provider reimbursement.

Adherence to Definitions of Labor Arrest Influence on Primary Cesarean Delivery Rate.

OBJECTIVE: The cesarean delivery rate in the United States is 31.9%. One of the leading indications for primary cesarean delivery is labor arrest. A modern understanding of the labor curve supports more time prior to the diagnosis of labor arrest. We conducted this study to examine the impact of adherence to the modern criteria for labor arrest and failed induction on rates of primary cesarean delivery and to identify predictors of meeting these criteria. STUDY DESIGN: We analyzed rates of primary cesarean deliveries overall and primary cesarean deliveries occurring due to arrest of dilation, arrest of descent, and failed induction among the 17,877 live births at a large academic center from 2010 through 2013. Multiple logistic regression modeling identified predictors of meeting the new criteria for these indications based on guidelines published by the 2012 National Institute of Child Health and Human Development. RESULTS: The primary cesarean delivery rate decreased from 23.5 to 21.1% (p = 0.026) from 2010 to 2013. Primary cesarean delivery rate for labor arrest and failed induction decreased from 8.5 to 6.7% (p = 0.005). The percentage of primary cesarean deliveries meeting the 2012 criteria for labor arrest increased from 18.8 to 34.9% (p = 0.002), and the rate of primary cesarean deliveries due to arrest of dilation decreased from 5.1 to 3.4% (p < 0.0005). The percentage of cases meeting the 2012 criteria for arrest of descent increased from 57.8 to 71.0% (p < 0.007), while primary cesarean delivery rate due to arrest of descent remained relatively unchanged, 3.1 to 2.6% (p = 0.330). CONCLUSION: A decrease in the primary cesarean rate was attributable to a decrease in cesarean for arrest of dilation in the setting of a significant increase in meeting the 2012 criteria for arrest of dilation. At the end of the study period, 65.2% of cesareans still did not meet the criteria for arrest of dilation. Greater rates of adherence to these guidelines may yield further reductions in the cesarean rate. KEY POINTS: · Primary cesarean delivery for labor arrest was decreased.. · Meeting criteria for labor arrest increased.. · A hospitalist provider increased odds of meeting criteria..

Society for Maternal-Fetal Medicine Consult Series #53: Intrahepatic cholestasis of pregnancy: Replaces Consult #13, April 2011.

Intrahepatic cholestasis of pregnancy is a hepatic disorder characterized by pruritus and an elevation in serum bile acid levels. Although intrahepatic cholestasis of pregnancy poses little risk for women, this condition carries a significant risk for the fetus, including complications such as preterm delivery, meconium-stained amniotic fluid, and stillbirth. The purpose of this Consult is to review the current literature on intrahepatic cholestasis of pregnancy and provide recommendations based on the available evidence. The recommendations by the Society for Maternal-Fetal Medicine are as follows: (1) we recommend measurement of serum bile acid and liver transaminase levels in patients with suspected intrahepatic cholestasis of pregnancy (GRADE 1B); (2) we recommend that ursodeoxycholic acid be used as the first-line agent for the treatment of maternal symptoms of intrahepatic cholestasis of pregnancy (GRADE 1A); (3) we suggest that patients with a diagnosis of intrahepatic cholestasis of pregnancy begin antenatal fetal surveillance at a gestational age when delivery would be performed in response to abnormal fetal testing results or at the time of diagnosis if the diagnosis is made later in gestation (GRADE 2C); (4) we recommend that patients with total bile acid levels of ≥100 µmol/L be offered delivery at 36 0/7 weeks of gestation, given that the risk of stillbirth increases substantially around this gestational age (GRADE 1B); (5) we recommend delivery between 36 0/7 and 39 0/7 weeks of gestation for patients with intrahepatic cholestasis of pregnancy and total bile acid levels of <100 µmol/L (GRADE 1C); (6) we recommend administration of antenatal corticosteroids for fetal lung maturity for patients delivering before 37 0/7 weeks of gestation if not previously administered (GRADE 1A); (7) we recommend against preterm delivery at <37 weeks of gestation in patients with a clinical diagnosis of intrahepatic cholestasis of pregnancy without laboratory confirmation of elevated bile acid levels (GRADE 1B).

Society for Maternal-Fetal Medicine Consult Series #54: Assessing the risk of maternal morbidity and mortality.

The rates of maternal morbidity and mortality in the United States demand a comprehensive approach to assessing pregnancy-related risks. Numerous medical and nonmedical factors contribute to maternal morbidity and mortality. Reducing the number of women who experience pregnancy morbidity requires identifying which women are at greatest risk and initiating appropriate interventions early in the reproductive life course. The purpose of this Consult is to educate all healthcare practitioners about factors contributing to a high-risk pregnancy, strategies to assess maternal health risks due to pregnancy, and the importance of risk assessment across the reproductive spectrum in reducing maternal morbidity and mortality.

Hospital variation in utilization and success of trial of labor after a prior cesarean.

BACKGROUND: Trial of labor after cesarean delivery is an effective and safe option for women without contraindications. OBJECTIVES: The objective of the study was to examine hospital variation in utilization and success of trial of labor after cesarean delivery and identify associated institutional characteristics and patient outcomes. STUDY DESIGN: Using linked maternal and newborn hospital discharge records and birth certificate data in 2010-2012 from the state of California, we identified 146,185 term singleton mothers with 1 prior cesarean delivery and no congenital anomalies or clear contraindications for trial of labor at 249 hospitals. Risk-standardized utilization and success rates of trial of labor after cesarean delivery were estimated for each hospital after accounting for differences in patient case mix. Risk for severe maternal and newborn morbidities, as well as maternal and newborn length of stay, were compared between hospitals with high utilization and high success rates of trial of labor after cesarean delivery and other hospitals. Bivariate analysis was also conducted to examine the association of various institutional characteristics with hospitals' utilization and success rates of trial of labor after cesarean delivery. RESULTS: In the overall sample, 12.5% of women delivered vaginally. After adjusting for patient clinical risk factors, utilization and success rates of trial of labor after cesarean delivery varied considerably across hospitals, with a median of 35.2% (10th to 90th percentile range: 10.2-67.1%) and 40.5% (10th to 90th percentile range: 8.5-81.1%), respectively. Risk-standardized utilization and success rates of trial of labor after cesarean delivery demonstrated an inverted U-shaped relationship such that low or excessively high use of trial of labor after cesarean delivery was associated with lower success rate. Compared with other births, those delivered at hospitals with above-the-median utilization and success rates of trial of labor after cesarean delivery had a higher risk for uterine rupture (adjusted risk ratio, 2.74, P < .001), severe newborn respiratory complications (adjusted risk ratio, 1.46, P < .001), and severe newborn neurological complications/trauma (adjusted risk ratio, 2.48, P < .001), but they had a lower risk for severe newborn infection (adjusted risk ratio, 0.80, P = .003) and overall severe unexpected newborn complications (adjusted risk ratio, 0.86, P < .001) as well as shorter length of stays (adjusted mean ratio, 0.948 for mothers and 0.924 for newborns, P < .001 for both). Teaching status, system affiliation, larger volume, higher neonatal care capacity, anesthesia availability, higher proportion of midwife-attended births, and lower proportion of Medicaid or uninsured patients were positively associated with both utilization and success of trial of labor after cesarean delivery. However, rural location and higher local malpractice insurance premium were negatively associated with the utilization of trial of labor after cesarean delivery, whereas for-profit ownership was associated with lower success rate. CONCLUSION: Utilization and success rates of trial of labor after cesarean delivery varied considerably across hospitals. Strategies to promote vaginal birth should be tailored to hospital needs and characteristics (eg, increase availability of trial of labor after cesarean delivery at hospitals with low utilization rates while being more selective at hospitals with high utilization rates, and targeted support for lower capacity hospitals).

Optimal maternal and neonatal outcomes and associated hospital characteristics.

BACKGROUND: This study aims to examine hospital variation in both maternal and neonatal morbidities and identify institutional characteristics associated with hospital performance in a combined measure of maternal and neonatal outcomes. METHODS: Using the California Linked Birth File containing data from birth certificate and hospital discharge records, we identified 1 322 713 term births delivered at 248 hospitals during 2010-2012. For each hospital, a risk-standardized rate of severe maternal morbidities and a risk-standardized rate of severe newborn morbidities were calculated after adjusting for patient clinical risk factors. Hospitals were ranked based on combined information on their maternal and newborn morbidity rates. RESULTS: Risk-standardized severe maternal and severe newborn morbidity rates varied substantially across hospitals (10th to 90th percentile range = 67.5-148.2 and 141.8-508.0 per 10 000 term births, respectively), although there was no significant association between the two (P = 0.15). Government hospitals (non-Federal) were more likely than other hospitals to be in worse rank quartiles (P value for trend = 0.004), whereas larger volume was associated with better rank among hospitals in the first three quartiles (P = 0.004). The most prevalent morbidities that differed progressively across hospital rank quartiles were severe hemorrhage, disseminated intravascular coagulation, and heart failure during procedure/surgery for mothers, and severe infection, respiratory complication, and shock/resuscitation for neonates. CONCLUSIONS: Hospitals with low maternal morbidity rates may not have low neonatal morbidity rates and vice versa, highlighting the importance of assessing joint maternal-newborn outcomes in order to fully characterize a hospital's obstetrical performance. Hospitals with smaller volume and government ownership tend to have less desirable outcomes and warrant additional attention in future quality improvement efforts.

Establishing and Maintaining a Quality and Safety Program on Labor and Delivery.

There is no single framework for a successful obstetric patient safety program. However, there are ample resources for the important components needed to create a patient safety program. All labor and delivery units should formulate their own quality and safety program that is individualized to the patients and staff that they serve. Here we will lay out the infrastructure as has been supported by the literature and reinforced in our experience.

Limiting the Exposure of Select Fetuses to Intrauterine Infection/Inflammation Improves Short-Term Neonatal Outcomes in Preterm Premature Rupture of Membranes.

BACKGROUND: To improve neonatal outcomes in pregnancies at heightened risk for early-onset neonatal sepsis (EONS), there is a need to identify fetuses that benefit from expectant management as opposed to early delivery. Detectable haptoglobin and haptoglobin-related protein (Hp&HpRP switch-on status) in cord blood has been proposed as a biomarker of antenatal exposure to intra-amniotic infection and/or inflammation (IAI), an important determinant of EONS. SUBJECTS AND METHODS: We analyzed 185 singleton newborns delivered secondary to preterm premature rupture of membranes (PPROM). In 123 cases, amniocentesis was performed to exclude amniotic fluid (AF) infection. Delivery was indicated for 61 cases with confirmed infection. Women without AF infection (n = 62) and those without amniocentesis (n = 62) were managed expectantly. Interleukin 6 and Hp&HpRP switch-on status were evaluated by ELISA and Western blot. Newborns were followed prospectively for short-term outcomes until hospital discharge or death. RESULTS: Newborns exposed antenatally to IAI had an increased risk of adverse neonatal outcome [OR: 3.0 (95% CI: 1.15-7.59)]. Increasing gestational age [OR: 0.61 (95% CI: 0.52-0.70)] and management with amniocentesis [OR: 0.37 (95% CI: 0.14-0.95)] lowered the newborn's risk of developing adverse outcomes. DISCUSSION: In the setting of PPROM and IAI, early delivery benefits a select subgroup of fetuses that have not yet progressed to Hp&HpRP switch-on status.

Frequency and Importance of Incomplete Screening Fetal Anatomic Sonography in Pregnancy.

OBJECTIVES: To determine (1) how often routine screening fetal anatomic sonography fails to completely visualize fetal anatomy; (2) the proportion of women with incomplete ultrasound examinations who are recommended for repeat screening and then undergo repeat sonography; and (3) how often abnormal fetal anatomy is detected on repeat sonography. METHODS: We conducted a retrospective cohort study at a high-volume academic obstetric ultrasound center. Participants were 16,300 women at 17 through 21 weeks' gestation with a singleton pregnancy presenting for screening anatomic sonography between January 2009 and December 2013. Main outcome measures were (1) incomplete visualization of anatomy at initial screening sonography; (2) among women with incomplete but otherwise normal initial screening ultrasound examinations, recommendation for and performance of repeat sonography; and (3) among women undergoing repeat sonography, discovery of abnormal fetal anatomy within anatomic components that were previously incompletely visualized. RESULTS: The mean maternal age ± SD was 30.8 ± 6.3 years, and the mean gestational age was 18.8 ± 1.0 weeks. Among 16,300 initial screening ultrasound examinations, 2157 (13.2%) had incomplete visualization of fetal anatomy. Of those women eligible for follow-up, 91.5% were recommended for repeat screening, of whom 92.8% had a subsequent examination. Of 1560 repeat screening ultrasound examinations, 8 (0.5%) showed an abnormality in the components of anatomy that were previously visualized incompletely. CONCLUSIONS: In this large single-center study, incomplete visualization was common in screening fetal anatomic ultrasound examinations. Recommendations for repeat imaging were nearly universal, but abnormal fetal anatomy was infrequently discovered on repeat screening.

A comprehensive obstetric patient safety program reduces liability claims and payments.

Begun in 2003, the Yale-New Haven Hospital comprehensive obstetric safety program consisted of measures to standardize care, improve teamwork and communication, and optimize oversight and quality review. Prior publications have demonstrated improvements in adverse outcomes and safety culture associated with this program. In this analysis, we aimed to assess the impact of this program on liability claims and payments at a single institution. We reviewed liability claims at a single, tertiary-care, teaching hospital for two 5-year periods (1998-2002 and 2003-2007), before and after implementing the safety program. Connecticut statute of limitations for professional malpractice is 36 months from injury. Claims/events were classified by event-year and payments were adjusted for inflation. We analyzed data for trends as well as differences between periods before and after implementation. Forty-four claims were filed during the 10-year study period. Annual cases per 1000 deliveries decreased significantly over the study period (P < .01). Claims (30 vs 14) and payments ($50.7 million vs $2.9 million) decreased in the 5-years after program inception. Compared with before program inception, median annual claims dropped from 1.31 to 0.64 (P = .02), and median annual payments per 1000 deliveries decreased from $1,141,638 to $63,470 (P < .01). Even estimating the monetary awards for the 2 remaining open cases using the median payments for the surrounding 5 years, a reduction in the median monetary amount per case resulting in payment to the claimant was also statistically significant ($632,262 vs $216,815, P = .046). In contrast, the Connecticut insurance market experienced a stable number of claims and markedly increased cost per claim during the same period. We conclude that an obstetric safety initiative can improve liability claims exposure and reduce liability payments.

Adherence to Labor Arrest and Failed Induction of Labor Guidelines: The Impact of a Quality-Improvement Educational Intervention.

Background/Objective: To evaluate adherence to labor arrest and failed induction of labor (IOL) criteria in nulliparous, term, singleton, and vertex (NTSV) cesarean deliveries at an academic medical center and to measure the impact of a quality-improvement educational initiative that focused on obstetric provider education of modern labor arrest and failed IOL criteria. Methods: This is a retrospective cohort study using electronic health record (EHR) data with a pre- (1 September 2018-30 September 2019) and post-intervention (1 October 2019-31 March 2020) study design of all NTSV cesarean deliveries for labor arrest or failed IOL performed at an academic medical center in the northeastern United States. The quality-improvement educational intervention consisted of the distribution of educational pocket cards outlining modern labor arrest and failed IOL criteria to obstetric providers. Outcomes included adherence to labor arrest and failed IOL criteria pre- and post-intervention with secondary outcomes evaluating adherence by provider type (Maternal-Fetal Medicine (MFM) or generalist obstetrician). Descriptive and bivariate statistics were used in the analysis. Results: Pre-intervention, 272 NTSV cesarean deliveries were performed for labor arrest or failed IOL versus 92 post-intervention. Adherence improved post-intervention amongst failed IOL (OR 6.5, CI 1.8-23.8), first-stage arrest (OR 4.5, CI 2.2-10.8) and second-stage arrest (OR 3.7, CI 1.5-9.4). When comparing provider type, MFM physicians were more likely to be adherent to labor arrest and failed IOL criteria compared to generalist obstetricians pre-intervention (OR 3.1, CI 1.7-5.5); however, post-intervention, there was no longer a difference in adherence (OR 3.3, CI 0.9-12.3). Conclusions: Adherence to labor arrest criteria was suboptimal in the pre-intervention period; however, a targeted quality-improvement educational intervention improved adherence rates to labor arrest and failed IOL criteria among obstetric providers.

Post-Acute Sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Infection During Pregnancy.

OBJECTIVE: To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors. METHODS: In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC. RESULTS: Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9-10.9%) measured at a median of 10.3 months (interquartile range 6.1-21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12-2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79-3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05-2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00-3.44) were associated with increased prevalence of PASC. CONCLUSION: The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05172024.

Antihypertensives in Pregnancy.

Hypertensive disorders of pregnancy (HDP) can result in significant maternal morbidity and even mortality. Available data suggest that many antihypertensives can be safely used in pregnant patients, albeit with close supervision of parameters like fetal growth and amniotic fluid volume. This article summarizes current guidelines on the diagnosis and treatment of hypertension in pregnancy and provides an in-depth guide to the available safety and efficacy data for antihypertensives during pregnancy and postpartum.

Choice Architecture to Assist Clinicians with Appropriate COVID-19 Test Ordering.

BACKGROUND: Despite improving supplies, SARS-CoV-2 nucleic acid amplification tests remain limited during surges and more so given concerns around COVID-19/influenza co-occurrence. Matching clinical guidelines to available supplies ensures resources remain available to meet clinical needs. We report a change in clinician practice after an electronic health record (EHR) order redesign to impact emergency department (ED) testing patterns. METHODS: We included all ED visits between December 1, 2021 and January 18, 2022 across a hospital system to assess the impact of EHR order changes on provider behavior 3 weeks before and after the change. The EHR order redesign included embedded symptom-based order guidance. Primary outcomes were the proportion of COVID-19 + flu/respiratory syncytial virus (RSV) testing performed on symptomatic, admitted, and discharged patients, and the proportion of COVID-19 + flu testing on symptomatic, discharged patients. RESULTS: A total of 52 215 ED visits were included. For symptomatic, discharged patients, COVID-19 + flu/RSV testing decreased from 11.4 to 5.8 tests per 100 symptomatic visits, and the rate of COVID-19 + flu testing increased from 7.4 to 19.1 before and after the intervention, respectively. The rate of COVID-19 + flu/RSV testing increased from 5.7 to 13.1 tests per 100 symptomatic visits for symptomatic patients admitted to the hospital. All changes were significant (P < 0.0001). CONCLUSIONS: A simple EHR order redesign was associated with increased adherence to institutional guidelines for SARS-CoV-2 and influenza testing amidst supply chain limitations necessitating optimal allocation of scarce testing resources. With continually shifting resource availability, clinician education is not sufficient. Rather, system-based interventions embedded within exiting workflows can better align resources and serve testing needs of the community.

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

Importance: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER- Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. Methods: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. Discussion: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. Registration: NCT05172024.

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

IMPORTANCE: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

Antenatal lamivudine to reduce perinatal hepatitis B transmission: a cost-effectiveness analysis.

OBJECTIVES: This study aimed to determine whether administration of lamivudine to pregnant women with chronic hepatitis B in the third trimester is a cost-effective strategy in preventing perinatal transmission. STUDY DESIGN: We developed a decision analysis model to compare the cost-effectiveness of 2 management strategies for chronic hepatitis B in pregnancy: (1) expectant management or (2) lamivudine administration in the third trimester. We assumed that lamivudine reduced perinatal transmission by 62%. RESULTS: Our Markov model demonstrated that lamivudine administration is the dominant strategy. For every 1000 infected pregnant women treated with lamivudine, $337,000 is saved and 314 quality-adjusted life-years are gained. For every 1000 pregnancies with maternal hepatitis B, lamivudine prevents 21 cases of hepatocellular carcinoma and 5 liver transplants in the offspring. The model remained robust in sensitivity analysis. CONCLUSION: Antenatal lamivudine administration to pregnant patients with hepatitis B is cost-effective, and frequently cost-saving, under a wide range of circumstances.