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.

Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension.

OBJECTIVE: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. METHODS: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding. RESULTS: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine. CONCLUSION: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02299414.

Optimal Timing of Delivery for Pregnant Individuals With Mild Chronic Hypertension.

OBJECTIVE: To investigate the optimal gestational age to deliver pregnant people with chronic hypertension to improve perinatal outcomes. METHODS: We conducted a planned secondary analysis of a randomized controlled trial of chronic hypertension treatment to different blood pressure goals. Participants with term, singleton gestations were included. Those with fetal anomalies and those with a diagnosis of preeclampsia before 37 weeks of gestation were excluded. The primary maternal composite outcome included death, serious morbidity (heart failure, stroke, encephalopathy, myocardial infarction, pulmonary edema, intensive care unit admission, intubation, renal failure), preeclampsia with severe features, hemorrhage requiring blood transfusion, or abruption. The primary neonatal outcome included fetal or neonatal death, respiratory support beyond oxygen mask, Apgar score less than 3 at 5 minutes, neonatal seizures, or suspected sepsis. Secondary outcomes included intrapartum cesarean birth, length of stay, neonatal intensive care unit admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn, and hypoglycemia. Those with a planned delivery were compared with those expectantly managed at each gestational week. Adjusted odds ratios (aORs) with 95% CIs are reported. RESULTS: We included 1,417 participants with mild chronic hypertension; 305 (21.5%) with a new diagnosis in pregnancy and 1,112 (78.5%) with known preexisting hypertension. Groups differed by body mass index (BMI) and preexisting diabetes. In adjusted models, there was no association between planned delivery and the primary maternal or neonatal composite outcome in any gestational age week compared with expectant management. Planned delivery at 37 weeks of gestation was associated with RDS (7.9% vs 3.0%, aOR 2.70, 95% CI, 1.40-5.22), and planned delivery at 37 and 38 weeks was associated with neonatal hypoglycemia (19.4% vs 10.7%, aOR 1.97, 95% CI, 1.27-3.08 in week 37; 14.4% vs 7.7%, aOR 1.82, 95% CI, 1.06-3.10 in week 38). CONCLUSION: Planned delivery in the early-term period compared with expectant management was not associated with a reduction in adverse maternal outcomes. However, it was associated with increased odds of some neonatal complications. Delivery timing for individuals with mild chronic hypertension should weigh maternal and neonatal outcomes in each gestational week but may be optimized by delivery at 39 weeks.

Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension.

OBJECTIVE: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial. METHODS: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated. RESULTS: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations. CONCLUSION: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT02299414.

Postpartum blood pressure control and the rate of readmission.

BACKGROUND: Postpartum hypertension is a major contributor to the rising maternal mortality rates in the United States, with nearly half of maternal deaths occurring after delivery. Previous studies have found evidence that the maximum blood pressure reading during labor and delivery admission can predict readmission; however, the optimal blood pressure to reduce the need for readmissions and additional medical treatment in the postpartum period is not known. OBJECTIVE: This study aimed to investigate the relationship between postpartum blood pressure control at discharge and readmission within the first 6 weeks after delivery. STUDY DESIGN: Data were obtained from Cosmos, an electronic health record-based, Health Insurance Portability and Accountability Act-defined limited dataset that includes more than 1.4 million birth encounters. All birthing parents with blood pressure data after delivery were included. Demographic information, medications, and readmissions were queried from the dataset. Patients were grouped into categories based on blood pressure readings in the 24 hours before discharge (≥160/110, ≥150/100, ≥140/90, ≥130/80, ≥120/80, and <120/80 mm Hg). The readmission rates across these groups were compared. Planned subanalyses included stratification by the use of antihypertensive medications and a sensitivity analysis using the highest blood pressure during admission. Covariates included maternal age, preexisting diabetes mellitus or lupus erythematosus, and body mass index. RESULTS: The analysis included 1,265,766 total birth encounters, 391,781 (30.9%) in the referent group (120/80 mm Hg), 392,592 (31.0%) in the group with <120/80 mm Hg, 249,414 (19.7%) in the group with ≥130/80 mm Hg, 16,125 (1.3%) in the group with ≥140/90 mm Hg, 50,659 (4.0%) in the group with ≥150/100 mm Hg, and 20,196 (1.6%) in the group with ≥160/110 mm Hg. In the first 6 weeks after delivery, readmission rates increased with higher blood pressure readings. More than 5% of postpartum patients with the highest blood pressure readings (≥160/110 mm Hg) were readmitted. These patients were almost 3 times more likely to be readmitted than patients whose highest blood pressure reading fell into the referent group (120/80 mm Hg) (odds ratio [OR], 2.90; 95% confidence interval, 2.69-3.12). Patients with blood pressures of >150/100 mm Hg (odds ratio, 2.72; 95% confidence interval, 2.58-2.87), >140/90 mm Hg (odds ratio, 2.03; 95% confidence interval, 1.95-2.11), and >130/80 mm Hg (odds ratio, 1.43; 95% confidence interval, 1.37-1.49) all had higher odds of readmission, whereas patients with a blood pressure of <120/80 mm Hg had a lower odds of readmission (odds ratio, 0.78; 95% confidence interval, 0.75-0.81). Patients who had higher blood pressures during admission but had improved control in the 24 hours before discharge had lower rates of readmission than those whose blood pressures remained elevated. In all blood pressure categories, patients who received an antihypertensive prescription had higher rates of readmission. CONCLUSION: In this large, national dataset, blood pressure control at discharge and readmission in the postpartum period were significantly correlated. Our data should inform postpartum hypertension treatment goals and the role of remote monitoring programs in improving maternal safety.

Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids: The ALPS Follow-Up Study.

Importance: The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids. Objective: To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes. Design, Setting, and Participants: Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022. Exposure: Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart. Main Outcome and Measures: The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up. Results: Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups. Conclusion and Relevance: In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.

Desirability of outcome ranking for obstetrical trials: illustration and application to the ARRIVE trial.

BACKGROUND: In randomized trials, 1 primary outcome is typically chosen to evaluate the consequences of an intervention, whereas other important outcomes are relegated to secondary outcomes. This issue is amplified for many obstetrical trials in which an intervention may have consequences for both the pregnant person and the child. In contrast, desirability of outcome ranking, a paradigm shift for the design and analysis of clinical trials based on patient-centric evaluation, allows multiple outcomes-including from >1 individual-to be considered concurrently. OBJECTIVE: This study aimed to describe desirability of outcome ranking methodology tailored to obstetrical trials and to apply the methodology to maternal-perinatal paired (dyadic) outcomes in which both individuals may be affected by an intervention but may experience discordant outcomes (eg, an obstetrical intervention may improve perinatal but worsen maternal outcomes). STUDY DESIGN: This secondary analysis applies the desirability of outcome ranking methodology to data from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network ARRIVE trial. The original analysis found no substantial difference in the primary (perinatal composite) outcome, but a decreased risk of the secondary outcome of cesarean delivery with elective induction at 39 weeks. In the present desirability-of-outcome-ranking analysis, dyadic outcomes ranging from spontaneous vaginal delivery without severe neonatal complication (most desirable) to cesarean delivery with perinatal death (least desirable) were classified into 8 categories ranked by overall desirability by experienced investigators. Distributions of the desirability of outcome ranking were compared by estimating the probability of having a more desirable dyadic outcome with elective induction at 39 weeks of gestation than with expectant management. To account for various perspectives on these outcomes, a complementary analysis, called the partial credit strategy, was used to grade outcomes on a 100-point scale and estimate the difference in overall treatment scores between groups using a t test. RESULTS: All 6096 participants from the trial were included. The probability of a better dyadic outcome for a randomly selected patient who was randomized to elective induction was 53% (95% confidence interval, 51-54), implying that elective induction led to a better overall outcome for the dyad when taking multiple outcomes into account concurrently. Furthermore, the desirability-of-outcome-ranking probability of averting cesarean delivery with elective induction was 52% (95% confidence interval, 51-53), which was not at the expense of an operative vaginal delivery or a poorer outcome for the perinate (ie, survival with a severe neonatal complication or perinatal death). Randomization to elective induction was also advantageous in most of the partial credit score scenarios. CONCLUSION: Desirability-of-outcome-ranking methodology is a useful tool for obstetrical trials because it provides a concurrent view of the effect of an intervention on multiple dyadic outcomes, potentially allowing for better translation of data for decision-making and person-centered care.

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.

Postpartum contraceptive choice and fulfillment in patients with opioid use disorder.

OBJECTIVE: We examined the differences in postpartum contraception between patients with and without opioid use disorder (OUD). STUDY DESIGN: We conducted a retrospective, single-institution, cohort analysis assessing differences in desired method of postpartum contraception and plan fulfillment. RESULTS: Patients with OUD comprised 200/8654 (2.3%) of our study cohort. After 2:1 matching, method desired (matched odds ratio [mOR] 0.86, 95% confidence interval [CI] 0.60-1.23 for highly vs. moderately effective) and receipt (mOR 0.77, 95% CI 0.53-1.12) of desired method were comparable between groups. CONCLUSION: Patients with and without OUD were similar in their choice and fulfillment of postpartum contraception.

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.

The Ohio Maternal Safety Quality Improvement Project: initial results of a statewide perinatal hypertension quality improvement initiative implemented during the COVID-19 pandemic.

BACKGROUND: Hypertensive disorders of pregnancy are a leading cause of severe maternal morbidity and mortality, and studies have shown that more than 60% of cases are preventable. As part of a statewide quality Maternal Safety Quality Improvement Project, we adapted the Alliance for Innovation on Maternal Health Severe Hypertension in Pregnancy bundle in a consortium of maternity hospitals in Ohio to improve care processes and outcomes for patients with a severe hypertensive event during pregnancy or the postpartum period. OBJECTIVE: This study aimed to report the first year of data from this Maternal Safety Quality Improvement Project, including an assessment of the process measures by hospital level of maternal care designation, and provide perspective on the unique challenges of implementing a large-scale Maternal Safety Quality Improvement Project during a global pandemic. STUDY DESIGN: This Maternal Safety Quality Improvement Project engaged Ohio level 1 to 4 maternity hospitals and provided multimodal quality improvement support. Participating hospitals submitted monthly patient-level data, which included all cases of new-onset sustained severe hypertension. The primary process measure was the proportion of birthing people in Ohio with sustained severe hypertension who received treatment with appropriate acute antihypertensive therapy within 60 minutes. The secondary process measures included receipt of a follow-up appointment after hospital discharge within 72 hours (if discharged on medication) or 10 days (if discharged without medication), a blood pressure cuff on hospital discharge, and education about urgent maternal warning signs. Data for primary and secondary process measures were plotted on a biweekly basis, and statistical process control methods were used to identify special cause variation over time. Data were stratified by various demographic variables, including race or ethnicity, insurance status, and maternal level of care. To assess the effect of the COVID-19 pandemic on this Maternal Safety Quality Improvement Project, process measure data were compared with COVID-19 case volume in Ohio across the study epoch. RESULTS: A total of 29 hospitals participated in the project from July 2020 to September 2021. Data were collected on 4948 hypertensive events representing 4678 unique patients. In aggregate, the primary process measure (timely and appropriate treatment) demonstrated a 19.3% increase (from a baseline of 56.5% to 67.4%; P<.001). The secondary process measures demonstrated significant increases ranging from 26.1% to 166.8% (all P<.001). Both non-Hispanic Black and White pregnant or postpartum people demonstrated shifts and sustained improvements in the treatment of severe hypertension, which did not differ by race across the study period. Process measure improvements were achieved and sustained across peaks in the COVID-19 pandemic. CONCLUSION: This Ohio Maternal Safety Quality Improvement Project demonstrated meaningful changes in project process measures in the identification and treatment of severe hypertension in pregnancy and the postpartum period. Process measures improvements were achieved across all hospital levels of maternal care, and differences were not observed by race or ethnicity. Our findings suggest that a robust and comprehensive quality improvement initiative with appropriate support and resources can achieve meaningful gains in the setting of a global pandemic.

Body composition in term neonates of mothers with hypertensive disorders of pregnancy.

BACKGROUND: Neonates of gravidas with hypertensive disorders of pregnancy (HDP) are at increased lifelong risk of cardiometabolic complications. Neonatal adiposity measured by body composition (BC) is a better surrogate of nutritional status than birth weight. Data comparing BC in term neonates of hypertensive and normotensive pregnant patients is lacking. Our objective was to compare body composition in both groups of neonates. METHODS: This was a retrospective cohort study from March 2018 to June 2019 at our tertiary institution where term neonatal BC are routinely measured. Neonates of patients with HDP and matched controls were included. Skin fold thickness (SFT) and percent body fat (PBF) were calculated using a validated anthropometric formula and compared using Mann-Whitney U and chi-square tests. RESULTS: One hundred and forty-two neonates of patients with HDP were compared to 150 controls. Demographic characteristics were similar except for higher pre-pregnancy BMI (29.7 ± 8.4 vs 26.75 ± 7.1, p = <0.01) in the HDP group. SFT was not significantly different (4.6 vs 4.4 mm, p = 0.09) but PBF was higher in the hypertensive group (13.15 vs 11.72, p = 0.01). CONCLUSIONS: PBF is higher in neonates of mothers with HDP, which may contribute to an increased risk of cardiometabolic complications later in life. IMPACT: Birth weight percentiles do not explain the predisposition to cardiovascular complications in offspring of hypertensive mothers. Body composition estimation may provide an explanation for this increased risk. Percent body fat is higher in term neonates of mothers with hypertensive disorders of pregnancy than neonates of normotensive mothers. Body composition is different in term neonates of mothers with hypertensive disorders of pregnancy.

Missed anti-D immune globulin administration to postpartum patients in 2 health systems: an unrecognized patient safety risk.

BACKGROUND: Maternal-fetal Rh-alloimmunization is a rare but potentially fatal event, most often caused by maternal exposure to D-antigen-presenting Rh-positive erythrocytes at the time of delivery. Prophylaxis with anti-D immune globulin is highly effective with a low side-effect profile and results in a dramatically decreased risk of alloimmunization. Postpartum anti-D immune globulin prophylaxis is recommended by national societies to reduce Rh-alloimmunization. We hypothesized that a small number of postpartum patients do not receive prophylaxis as indicated.  . OBJECTIVE: We investigated patients in 2 separate health systems that did not receive indicated prophylaxis and devised a suite of Electronic Health Record interventions to prevent future errors. STUDY DESIGN: We reviewed charts retrospectively from Electronic Health Record data of 2 urban academic health systems, the MetroHealth System and Oregon Health & Science University. We identified all Rh-negative postpartum patients and their infants delivering from 2014 to 2019. The primary outcome was the proportion of postpartum patients not receiving indicated anti-D immune globulin prophylaxis. Once cases of missed anti-D immune globulin prophylaxis were identified, we reviewed individual charts to determine the relevant clinical circumstances and potential causes for error. RESULTS: Of 29,801 deliveries over 5 years (15,444 at MetroHealth System and 14,357 at Oregon Health & Science University), there were 3087 Rh-negative postpartum patients, of whom 7 were alloimmunized and ineligible for prophylaxis. Anti-D immune globulin was indicated for 2162 (70.0%) women as they delivered an Rh-positive infant. A total of 37 indicated patients did not receive postpartum anti-D immune globulin. Twenty patients were offered prophylaxis and declined. We missed a total of 17 opportunities, thus our institutions appropriately offered indicated anti-D prophylaxis to 99.2% of patients over a period of 5 years. Of the 17 true misses, anti-D immune globulin was ordered for some patients, whereas others did not have an anti-D immune globulin order placed. A toolkit in the Electronic Health Record consisting of decision-support hard stops, automated documentation, and longitudinal reporting was implemented at the MetroHealth System in the year after its inception. The Toolkit identified and helped prevent 4 potential misses, resulting in a 100% anti-D prophylaxis rate at the MetroHealth System. CONCLUSION: Given the serious nature of Rh-alloimmunization, we believe missed prophylaxis should be a never event. Through examination of our current processes, we identified areas of improvement and developed a Postpartum Anti-D Immune Globulin Prophylaxis Electronic Health Record Toolkit, which showed improvement in administration rates. Such a toolkit has the potential to identify patients appropriately and avoid missed anti-D immune globulin prophylaxis events.

Society for Maternal-Fetal Medicine Special Statement: Quality metric for timely postpartum follow-up after severe hypertension.

Hypertensive disorders of pregnancy are a leading cause of maternal morbidity and mortality. Because postpartum exacerbation of severe hypertension is common, the American College of Obstetricians and Gynecologists recommends that patients with severe hypertension during the childbirth hospitalization be seen within 72 hours after discharge. In this statement, the Society for Maternal-Fetal Medicine proposes a uniform metric reflecting the rate of timely postpartum follow-up of patients with severe hypertension. The metric is designed to be measured using automated calculations based on billing codes derived from claims data. The metric can be used in quality improvement projects to increase the rate of timely follow-up in patients with severe hypertension during the childbirth hospitalization. Suggested steps for implementing such a project are outlined.

Society for Maternal-Fetal Medicine Special Statement: Best-practice recommendations for ultrasound network connectivity.

Prenatal ultrasound is an indispensable tool used by obstetrical care providers to assist in the everyday care of their pregnant patients. Alongside advancements in imaging, the electronic systems that support this technology have become more advanced. However, it is currently difficult for these individual systems to communicate with each other "out of the box." There is also minimal standardization of the type and format of data transmitted within these systems. Clinicians and system vendors must work collaboratively to create clinical and technical standards to serve as the foundation for increased interoperability among the various systems within each institutional network. Therefore, the Society for Maternal-Fetal Medicine Clinical Informatics Committee established an Ultrasound Electronic Health Record Subcommittee to facilitate collaboration between clinicians, including maternal-fetal medicine subspecialists, and ultrasound network component vendors. Based on the work of this subcommittee, the purpose of this document is to provide: (1) a basic understanding of ultrasound network architecture and capabilities, and (2) best-practice recommendations for electronic health record order design, obstetrical clinical data standards, and billing and coding practices.

Comparing Two Testing Strategies: Universal versus Symptomatic SARS-CoV-2 Testing in Obstetric Patients.

OBJECTIVE: To compare universal severe acute respiratory syndrome coronvirus-2 (SARS-CoV-2) testing to symptomatic testing at two large academic centers. STUDY DESIGN: We performed a retrospective cohort study comparing the approach to testing at two academic centers in Northeast Ohio. The study period started with the inception of symptomatic testing for SARS-CoV-2 at both institutions in March 2020. Women younger than 18 years were excluded. The primary outcome was the SARS-CoV-2 positivity rate in symptomatic pregnant patients at both institutions. Our coprimary outcome was the additional positivity rate obtained from universal testing at the University Hospitals. The secondary outcome of interest was the percentage of SARS-CoV-2 screen positive mothers with screen positive neonates. Data were analyzed using Mann-Whitney U test for continuous variables with chi-square and Fisher's exact tests for proportions. RESULTS: During the study period, 144 pregnant women with symptoms of coronavirus disease 2019 (COVID-19) were tested at MetroHealth of which 27 resulted as positive for SARS-CoV-2 (18.7% positivity rate). University Hospitals tested 392 pregnant women with symptoms of COVID-19 of which 67 resulted as positive for SARS-CoV-2 (positivity rate 17.0%). In the universal testing program at University Hospitals, an additional 2,870 tests were performed on asymptomatic pregnant women of which 30 were positive for SARS-CoV-2 (1.0% positivity rate).There were no SARS-CoV-2 positive infants in our cohort, and all cases of maternal critical illness occurred in symptomatic patients. CONCLUSION: Universal and symptomatic testing approaches demonstrated similar clinical performance within a single geographic region in obstetric patients. KEY POINTS: · There is a lack of data to recommend an optimal approach to SARS-CoV-2 testing in obstetric patients.. · Universal testing detected few additional cases of SARS-CoV-2.. · Maternal and neonatal outcomes were unaffected by testing strategy..

Evaluation of multidisciplinary shoulder dystocia simulation training on knowledge, performance, and documentation.

BACKGROUND: Research has shown the utility of simulations involving individuals, yet little data exist on whether communication and documentation are impacted by the integration of all team members into a scenario. In 2018, the obstetrics department at this tertiary hospital began a multidisciplinary team-training simulation for shoulder dystocia. An educational portion was included, teaching a new practice where the provider announces delivery events (head, shoulder, body) to be marked on the delivery record, a standardized approach was introduced, and a pre- and post-simulation test was administered. OBJECTIVE: In this study, we sought to evaluate the lasting impact of this team-based tool on the outcomes and documentation of shoulder dystocia cases, specifically the recording of the exact shoulder dystocia duration in seconds. Secondary outcomes included evaluation of the documentation of shoulder dystocia maneuvers and a pre- and post-simulation knowledge test. Included in this test were questions from the validated survey, the Safety Attitudes Questionnaire, a tool focused on evaluating team dynamics and communication. It was hypothesized that this simulation would improve communication as shown by sustained improvement in documentation, competence in shoulder dystocia care, and confidence among members of the team as shown by improved scores on the Safety Attitudes Questionnaire. STUDY DESIGN: This was a retrospective cohort study of shoulder dystocia cases from 2017 and 2019 at a safety-net tertiary care hospital, 1 full year before and after the implementation of a multidisciplinary shoulder dystocia simulation in 2018. Delivery outcomes were compared, documentation of delivery event times was recorded and analyzed, and the delivery note was evaluated using the American College of Obstetricians and Gynecologists guidelines for shoulder dystocia. The surveys from participants were assessed for postsimulation improvement. Categorical variables were analyzed using chi-square tests and continuous variables were compared using Student t tests. Because shoulder dystocia duration is a nonparametric variable, this was compared using a Kruskal-Wallis test. RESULTS: There were 28 cases in the 2017 cohort and 25 in the 2019 cohort. In the 2017 cohort, 25% of delivery documentation (7 of 25) included the exact shoulder dystocia duration, which increased to 96% (24 of 25) in the 2019 cohort (P<.001). There was no significant impact on the shoulder dystocia duration (P=.163). On average, 2.7 maneuvers were required in the 2017 cohort, which increased to 3.4 maneuvers used in the 2019 cohort, showing a significant increase in the use of shoulder dystocia maneuvers (P=.030). The posttests showed no impact on shoulder dystocia background knowledge (P=.142) or knowledge of risk factors (P=.171) but did show an increased understanding of the definition and performance of shoulder dystocia maneuvers (P=.008). The Safety Attitudes Questionnaire revealed that simulation participants would feel safe being treated by their colleagues with a score of 4.7/5. On the paired responses after the simulation, nurses reported feeling that their input was more highly valued (P=.045), and participants of all disciplines felt they received adequate feedback on their performances (P=.041). CONCLUSION: A multidisciplinary simulation on shoulder dystocia led to sustained improvement in documentation and shoulder dystocia maneuvers used, suggesting increased comfort with advanced maneuvers. Future studies should evaluate whether multidisciplinary simulations, mimicking the normal delivery team, may lead to other sustained improvements in maternal care.