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A vaccination against respiratory syncytial virus (RSV) was approved by the U.S. Food and Drug Administration recently and is now recommended during pregnancy at 32–36 weeks of gestation for patients who will deliver during RSV season if the infant is not anticipated to receive nirsevimab. Respiratory syncytial virus (RSV) is a significant cause of infant morbidity and mortality worldwide with peak hospitalization rates for RSV-mediated illnesses between 2 and 3 months of life. Until very recently, prevention strategies for RSV involved primarily passive immunization of neonates at high risk with monoclonal antibodies and promotion of breastfeeding. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices now recommends passive immunization of all neonates with monoclonal antibodies during RSV season, and the American Association of Pediatrics has endorsed this practice. The U.S. Food and Drug Administration (FDA) recently approved a vaccination for RSV in pregnancy. The CDC's Advisory Committee on Immunization Practices has recently recommended RSV vaccination for all pregnant patients between 32 and 36 weeks of gestation who are anticipated to deliver during RSV season if they are not planning nirsevimab for their infants. This recommendation has been endorsed by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. In this clinical perspective, we review the scientific evidence, potential concerns, challenges, and future considerations for RSV vaccination in pregnancy. [ABSTRACT FROM AUTHOR]

The novel coronavirus disease 2019 (COVID-19) is a growing pandemic that is impacting daily life across the globe. Though disease is often mild, in high-risk populations, severe disease often leads to intubation, intensive care admission (ICU) admission, and in many cases death. The implications for pregnancy remain largely unknown. Early data suggest that COVID-19 may not pose increased risk in the pregnant population. Vertical transmission has not been confirmed. Because no treatment, no vaccine and no herd immunity exist, social distancing is the best mechanism available to protect patients and health care workers from infection. This review will discuss what is known about the virus as it relates to pregnancy and then consider management considerations based on these data. Key Points COVID-19 severity in pregnancy is unclear. Social distancing is the best protective mechanism. No clear evidence of vertical transmission exists. Mother/baby separation avoids transmission. [ABSTRACT FROM AUTHOR]

Background: Recent data in nonpregnant individuals suggest a protective effect of influenza vaccination against SARS‐CoV‐2 infection and its severity. Objectives: Our primary objective was to evaluate whether influenza vaccination was associated with COVID‐19 severity and pregnancy and neonatal outcomes among those infected with SARS‐CoV‐2. The secondary objective was to examine the association between influenza vaccination and SARS‐CoV‐2 infection. Study Design: Secondary analysis of a multicenter retrospective cohort of pregnant people who tested positive for SARS‐CoV‐2 between March and August 2020, and a cohort of random deliveries during the same time period. The associations between 2019 influenza vaccination and the primary outcome of moderate‐to‐critical COVID‐19 as well as maternal and perinatal outcomes were examined among all people who tested positive for SARS‐CoV‐2 between March and August 2020. The association between 2019 influenza vaccination and having a positive SARS‐CoV‐2 test was examined among a cohort of individuals who delivered on randomly selected dates between March and August 2020. Univariable and multivariable analyses were performed. Results: Of 2325 people who tested positive for SARS‐CoV‐2, 1068 (45.9%) were vaccinated against influenza in 2019. Those who received the influenza vaccine were older, leaner, more likely to have private insurance, and identify as White or Hispanic. They were less likely to smoke tobacco and identify as Black. Overall, 419 (18.0%) had moderate, 193 (8.3%) severe, and 52 (2.2%) critical COVID‐19. There was no association between influenza vaccination and moderate‐to‐critical COVID‐19 (29.2% vs. 28.0%, adjusted OR 1.10, 95% CI 0.90–1.34) or adverse maternal and perinatal outcomes among those who tested positive. Of 8152 people who delivered in 2020, 4658 (57.1%) received the influenza vaccine. Prior vaccination was not associated with a difference in the odds of SARS‐CoV‐2 infection (3.8% vs. 4.2%, adjusted OR 0.94, 95% CI 0.74–1.19). Conclusion: Prior influenza vaccination was not associated with decreased severity of COVID‐19 or lower odds of SARS‐CoV‐2 infection in pregnancy. [ABSTRACT FROM AUTHOR]

Objective: To estimate the effects of a brief prenatal behavioral intervention on risk behaviors for maternal cytomegalovirus (CMV) infection.Methods: Women were screened with CMV serology during prenatal care before 20 weeks of gestation and followed for at least 10 weeks. Women without serologic evidence of primary CMV infection were approached. Participants were apprised of serostatus and then randomized 2:1 to either a brief behavioral intervention during their prenatal care visit or to standard care (a brochure). The 7- to 10-minute in-office intervention included a video and hygiene education using motivational interviewing. Participants were then given a reminder calendar to take home and weekly text message reminders. The primary outcome was change in behavioral compliance score on a scale of 0-100. Secondary outcomes included process evaluation and domains of behavior change. A sample size of 180 participants was planned to compare the behavioral compliance score change of at least 15% between intervention and control groups with 80% power and 2.5% two-sided α.Results: From April 2013 to October 2014, 197 women were randomized. One hundred eighty-seven (96%) had outcome data available. Mean gestational age at screening and randomization was 9 4/7 and 13 6/7 weeks of gestation, respectively. Primary outcome assessment occurred at a mean of 28 4/7 weeks of gestation. Baseline behavioral compliance scores increased modestly in the intervention group (mean: 7-point increase from 80.7 to 87.7, 95% CI 2.4-5.9) compared with the comparison group (mean: 4-point increase from 79.7 to 84.1, 95% CI 5.9-8.4; mean difference in change score: 3.0, 95% CI, 0.8-5.2; P=.007). Those in the intervention group reported change in risk perception related to perceived severity and susceptibility, self-efficacy, and perceived norms (P<.05 for all).Conclusion: A brief behavioral intervention delivered in the prenatal care setting was modestly effective at changing behaviors related to CMV infection risk.Clinical Trial Registration: ClinicalTrials.gov, NCT01819519. [ABSTRACT FROM AUTHOR]

Key Content: Cytomegalovirus (CMV) is the most common cause of congenital viral infections; 75–90% of infections are asymptomatic at birth but 10–25% of infants will develop neurological sequelae.Diagnosis of primary maternal CMV in pregnancy should be based on seroconversion in pregnancy (de novo appearance of virus‐specific immunoglobulin G [IgG] in the serum of pregnant women who were previously seronegative) or on detection of specific immunoglobulin M (IgM) and IgG antibodies in association with low IgG avidity.Primary maternal infection is associated with a 30–40% risk of intrauterine transmission and fetal infection, with 20–25% of those infected developing sequelae postnatally.Prenatal diagnosis of fetal CMV is imperfect and based on amniocentesis performed at least 7 weeks after presumed maternal infection and after 21 weeks of gestation.The presence of radiologic findings by ultrasound in combination with CMV DNA viral load in amniotic fluid may have prognostic significance for risk of neurologic sequelae. Learning objectives: To understand the prevalence, diagnosis and implications of CMV infection in pregnancy.To explore the management options in a pregnancy affected by congenital CMV. Ethical issues: Should routine screening for CMV be recommended in pregnancy?How should termination counselling be conducted following prenatal confirmation of fetal infection with amniocentesis? [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to examine whether there is an association between insulin resistance and subsequent development of puerperal infection by measuring insulin resistance in the mid-trimester using the homeostasis model assessment (HOMA:IR). Methods Secondary analysis of low-risk nulliparas enrolled in a multicenter pre-eclampsia prevention trial. HOMA:IR was measured on fasting plasma glucose and insulin concentrations among low-risk nulliparas between 22 and 26 weeks' gestation. Median HOMA:IR was compared between women who did and did not develop puerperal infection using Wilcoxon rank sum test. Logistic regression was used to control for potential confounders. Results Of 1,180 women with fasting glucose and insulin available, 121 (10.3%) had a puerperal infection. Median HOMA:IR was higher among those with subsequent puerperal infection (4.3 [interquartile, IQR: 2.2-20.5] vs. 2.6 [IQR: 1.5-6.7], p < 0.0001). After controlling for potentially confounding variables HOMA:IR was only marginally associated with an increased risk of development of puerperal infection, adjusted odds ratio: 1.01 (95% confidence interval: 1.00-1.02; p = 0.04) per unit increase. Elevated HOMA:IR performed poorly as a predictor of puerperal infection, with a positive predictive value of 15% and a negative predictive value of 92%. Conclusion Though associated with an increased risk of puerperal infection, insulin resistance, measured by HOMA:IR, is not a clinically useful predictor of puerperal infection. [ABSTRACT FROM AUTHOR]

The article presents the discussion on CMV hyperimmune globulin being associated with a lower incidence of congenital CMV infection than no treatment.

Objective This study aimed to test the hypothesis that being pregnant and delivering during the coronavirus disease 2019 (COVID-19) pandemic was associated with changes in gestational weight gain (GWG) or frequency of small- (SGA) or large-for-gestational-age (LGA) neonates. Study Design Secondary analysis of a multicenter observational cohort comparing pregnant people who delivered during the COVID-19 pandemic (June–December 2020) to people who delivered prior to the pandemic (March–December 2019). Those with multiple gestations, fetuses with major congenital anomalies, implausible GWG values, unavailable body mass index (BMI), or who were severe acute respiratory syndrome coronavirus-2-positive were excluded. The primary outcome was frequency of optimal recommended GWG based on prepregnancy BMI. Neonatal outcomes included birth weight, ponderal index, and frequency of SGA, LGA, and small head circumference for live births. Multivariable regression analysis was used to assess associations between exposure to the pandemic and outcomes. Results A total of 10,717 pregnant people were included in our analysis. A total of 4,225 pregnant people were exposed to the pandemic and 6,492 pregnant people delivered prior to the COVID-19 pandemic. Pregnant people exposed to the pandemic were older and more likely to have gestational diabetes. The frequency of appropriate GWG was 28.0% during the pandemic and 27.6% before the pandemic (adjusted odds ratio [aOR]: 1.02, 95% confidence interval [CI]: 0.93–1.11). Excessive GWG was more likely (54.9 vs. 53.1%; aOR: 1.08, 95% CI: 1.001–1.17), and inadequate GWG was less likely during the pandemic (17.0 vs. 19.3%; aOR: 0.86, 95% CI: 0.77–0.95). The frequency of SGA was 5.4% during the pandemic and 6.1% before the pandemic (aOR: 0.90, 95% CI: 0.76–1.06), and the frequency of LGA was 16.0% during the pandemic versus 15.0% before the pandemic (aOR: 1.06, 95% CI: 0.95–1.18). Other neonatal outcomes including birth weight percentile (62.1 [35.8–83.2] vs. 60.2 [34.4–82.2]; adjusted mean difference (aMD) = 1.50, 95% CI: −0.28 to 3.29), ponderal index (2.6 g/cm 3 [2.4–2.8] in both groups; aMD = 0.01, 95% CI: 0.00–0.02), and small head circumference for livebirths (<10th percentile [8.2 vs. 8.1%; aOR: 1.03, 95% CI: 0.89–1.19], <3rd percentile [3.5 vs. 3.1%; aOR: 1.16, 95% CI: 0.93–1.44]) were similar between groups as well. Conclusion Being pregnant and delivering during the COVID-19 pandemic was associated with a higher likelihood of excessive GWG and a lower likelihood of inadequate GWG. Key Points Delivering during the COVID-19 pandemic was associated with higher likelihood of excessive GWG. Delivering during the COVID-19 pandemic was associated with lower likelihood of inadequate GWG. COVID-19 pandemic was not associated with changes in frequency of SGA or LGA. [ABSTRACT FROM AUTHOR]

Objective This study aimed to develop a prediction model that estimates the probability that a pregnant person who has had asymptomatic or mild coronavirus disease 2019 (COVID-19) prior to delivery admission will progress in severity to moderate, severe, or critical COVID-19. Study Design This was a secondary analysis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients who delivered from March through December 2020 at hospitals across the United States. Those eligible for this analysis presented for delivery with a current or previous asymptomatic or mild SARS-CoV-2 infection. The primary outcome was moderate, severe, or critical COVID-19 during the delivery admission through 42 days postpartum. The prediction model was developed and internally validated using stratified cross-validation with stepwise backward elimination, incorporating only variables that were known on the day of hospital admission. Results Of the 2,818 patients included, 26 (0.9%; 95% confidence interval [CI], 0.6–1.3%) developed moderate–severe–critical COVID-19 during the study period. Variables in the prediction model were gestational age at delivery admission (adjusted odds ratio [aOR], 1.15; 95% CI, 1.08–1.22 per 1-week decrease), a hypertensive disorder in a prior pregnancy (aOR 3.05; 95% CI, 1.25–7.46), and systolic blood pressure at admission (aOR, 1.04; 95% CI, 1.02–1.05 per mm Hg increase). This model yielded an area under the receiver operating characteristic curve of 0.82 (95% CI, 0.72–0.91). Conclusion Among individuals presenting for delivery who had asymptomatic–mild COVID-19, gestational age at delivery admission, a hypertensive disorder in a prior pregnancy, and systolic blood pressure at admission were predictive of delivering with moderate, severe, or critical COVID-19. This prediction model may be a useful tool to optimize resources for SARS-CoV-2-infected pregnant individuals admitted for delivery. Key Points Three factors were associated with delivery with more severe COVID-19. The developed model yielded an area under the receiver operating characteristic curve of 0.82 and model fit was good. The model may be useful tool for SARS-CoV-2 infected pregnancies admitted for delivery. [ABSTRACT FROM AUTHOR]

Objective: We aimed to evaluate whether delivering during the early the coronavirus disease 2019 (COVID-19) pandemic was associated with increased risk of maternal death or serious morbidity from common obstetric complications compared with a historical control period.Methods: This was a multicenter retrospective cohort study with manual medical-record abstraction performed by centrally trained and certified research personnel at 17 U.S. hospitals. Individuals who gave birth on randomly selected dates in 2019 (before the pandemic) and 2020 (during the pandemic) were compared. Hospital, health care system, and community risk-mitigation strategies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in response to the early COVID-19 pandemic are described. The primary outcome was a composite of maternal death or serious morbidity from common obstetric complications, including hypertensive disorders of pregnancy (eclampsia, end organ dysfunction, or need for acute antihypertensive therapy), postpartum hemorrhage (operative intervention or receipt of 4 or more units blood products), and infections other than SARS-CoV-2 (sepsis, pelvic abscess, prolonged intravenous antibiotics, bacteremia, deep surgical site infection). The major secondary outcome was cesarean birth.Results: Overall, 12,133 patients giving birth during and 9,709 before the pandemic were included. Hospital, health care system, and community SARS-CoV-2 mitigation strategies were employed at all sites for a portion of 2020, with a peak in modifications from March to June 2020. Of patients delivering during the pandemic, 3% had a positive SARS-CoV-2 test result during pregnancy through 42 days postpartum. Giving birth during the pandemic was not associated with a change in the frequency of the primary composite outcome (9.3% vs 8.9%, adjusted relative risk [aRR] 1.02, 95% CI 0.93-1.11) or cesarean birth (32.4% vs 31.3%, aRR 1.02, 95% CI 0.97-1.07). No maternal deaths were observed.Conclusion: Despite substantial hospital, health care, and community modifications, giving birth during the early COVID-19 pandemic was not associated with higher rates of serious maternal morbidity from common obstetric complications.Clinical Trials Registration: ClinicalTrials.gov, NCT04519502. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.Methods: We conducted a secondary analysis of a multicenter randomized placebo-controlled trial of CMV hyperimmune globulin to prevent congenital infection. Women were eligible if they had primary CMV infection, defined as detectable plasma CMV-specific immunoglobulin (Ig)M and CMV-specific IgG with avidity less than 50% before 24 weeks of gestation or IgG seroconversion before 28 weeks, and were carrying a singleton fetus without ultrasonographic findings suggestive of CMV infection. Antibody assays were performed in a single reference laboratory. Congenital infection was defined as CMV detection in amniotic fluid, neonatal urine or saliva, or postmortem tissue. Using backward elimination, we developed logit models for prediction of congenital infection using factors known at randomization. The performance of the model was assessed using leave-one-out cross-validation (a method of internal validation).Results: Of 399 women enrolled in the trial, 344 (86%) had informative data for this analysis. Congenital infection occurred in 68 pregnancies (20%). The best performing model included government-assisted insurance, IgM index 4.5 or higher, IgG avidity less than 32%, and whether CMV was detectable by polymerase chain reaction in maternal plasma at the time of randomization. Cross-validation showed an average area under the curve of 0.76 (95% CI 0.70-0.82), indicating moderate discriminatory ability. More parsimonious one-, two-, and three-factor models performed significantly less well than the four-factor model. Examples of prediction with the four-factor model: for a woman with government-assisted insurance, avidity less than 32%, IgM index 4.5 or higher, and detectable plasma CMV, probability of congenital infection was 0.69 (95% CI 0.53-0.82); for a woman with private insurance, avidity 32% or greater, IgM index less than 4.5, and undetectable plasma CMV, probability of infection was 0.03 (95% CI 0.02-0.07).Conclusion: We developed models to predict congenital CMV infection in the presence of primary maternal CMV infection and absence of ultrasonographic findings suggestive of congenital infection. These models may be useful for patient counseling and decision making. [ABSTRACT FROM AUTHOR]

Importance: It remains unknown whether SARS-CoV-2 infection specifically increases the risk of serious obstetric morbidity.Objective: To evaluate the association of SARS-CoV-2 infection with serious maternal morbidity or mortality from common obstetric complications.Design, Setting, and Participants: Retrospective cohort study of 14 104 pregnant and postpartum patients delivered between March 1, 2020, and December 31, 2020 (with final follow-up to February 11, 2021), at 17 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Gestational Research Assessments of COVID-19 (GRAVID) Study. All patients with SARS-CoV-2 were included and compared with those without a positive SARS-CoV-2 test result who delivered on randomly selected dates over the same period.Exposures: SARS-CoV-2 infection was based on a positive nucleic acid or antigen test result. Secondary analyses further stratified those with SARS-CoV-2 infection by disease severity.Main Outcomes and Measures: The primary outcome was a composite of maternal death or serious morbidity related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2. The main secondary outcome was cesarean birth.Results: Of the 14 104 included patients (mean age, 29.7 years), 2352 patients had SARS-CoV-2 infection and 11 752 did not have a positive SARS-CoV-2 test result. Compared with those without a positive SARS-CoV-2 test result, SARS-CoV-2 infection was significantly associated with the primary outcome (13.4% vs 9.2%; difference, 4.2% [95% CI, 2.8%-5.6%]; adjusted relative risk [aRR], 1.41 [95% CI, 1.23-1.61]). All 5 maternal deaths were in the SARS-CoV-2 group. SARS-CoV-2 infection was not significantly associated with cesarean birth (34.7% vs 32.4%; aRR, 1.05 [95% CI, 0.99-1.11]). Compared with those without a positive SARS-CoV-2 test result, moderate or higher COVID-19 severity (n = 586) was significantly associated with the primary outcome (26.1% vs 9.2%; difference, 16.9% [95% CI, 13.3%-20.4%]; aRR, 2.06 [95% CI, 1.73-2.46]) and the major secondary outcome of cesarean birth (45.4% vs 32.4%; difference, 12.8% [95% CI, 8.7%-16.8%]; aRR, 1.17 [95% CI, 1.07-1.28]), but mild or asymptomatic infection (n = 1766) was not significantly associated with the primary outcome (9.2% vs 9.2%; difference, 0% [95% CI, -1.4% to 1.4%]; aRR, 1.11 [95% CI, 0.94-1.32]) or cesarean birth (31.2% vs 32.4%; difference, -1.4% [95% CI, -3.6% to 0.8%]; aRR, 1.00 [95% CI, 0.93-1.07]).Conclusions and Relevance: Among pregnant and postpartum individuals at 17 US hospitals, SARS-CoV-2 infection was associated with an increased risk for a composite outcome of maternal mortality or serious morbidity from obstetric complications. [ABSTRACT FROM AUTHOR]

• Theme 1) participants reported a lack of awareness of pregnancy-related warning signs. • Theme 2) presenting symptoms participants experienced were not typical of expected warning signs. • Theme 3) participant concerns were met with dismissal leading to delays in diagnosis. • Theme 4) participants experienced long-term sequelae from maternal sepsis. Prior studies have shown that maternal deaths due to sepsis occur due to delays in recognition, treatment, and escalation of care through medical chart reviews. This study was conducted to obtain the patient perspective for near-miss and maternal mortality cases due to sepsis. To identify quality improvement opportunities for improving maternal sepsis through patient and support person experiences. Twenty semi-structured interviews and three follow-up focus groups with patients who experienced critical illness from maternal sepsis in the United States and their support persons (when available) were conducted from May 23, 2022, through October 14, 2022. In this qualitative study, data were analyzed using inductive thematic analysis. In this qualitative study of patients with maternal sepsis and their support persons, four main quality improvement themes were identified. The themes were the following: (1) participants reported a lack of awareness of pregnancy-related warning signs and symptoms of when to seek care, (2) many of the presenting symptoms participants experienced were not typical of expected warning signs of maternal sepsis, such as severe pain, overwhelming tiredness, and lack of fever (3) participant concerns were met with dismissal leading to delays in diagnosis, (4) participants experienced long-term sequelae but had difficulty receiving screening and referrals for treatment. The findings of this study suggest that standardized patient education about the warning signs of maternal sepsis and provider education about the presentation of maternal sepsis, improved listening to patients, and follow-up for sequalae of sepsis are needed. [ABSTRACT FROM AUTHOR]

Lower mean arterial pressure was associated with improved neonatal outcomes among individuals with 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. [ABSTRACT FROM AUTHOR]

Both labetalol and nifedipine reduce pregnancy risks, with no increased risk of small for gestational age in patients with 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. [ABSTRACT FROM AUTHOR]

Objective: To describe coronavirus disease 2019 (COVID-19) severity in pregnant patients and evaluate the association between disease severity and perinatal outcomes.Methods: We conducted an observational cohort study of all pregnant patients with a singleton gestation and a positive test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who delivered at 1 of 33 U.S. hospitals in 14 states from March 1 to July 31, 2020. Disease severity was classified by National Institutes of Health criteria. Maternal, fetal, and neonatal outcomes were abstracted by centrally trained and certified perinatal research staff. We evaluated trends in maternal characteristics and outcomes across COVID-19 severity classes and associations between severity and outcomes by multivariable modeling.Results: A total of 1,219 patients were included: 47% asymptomatic, 27% mild, 14% moderate, 8% severe, 4% critical. Overall, 53% were Hispanic; there was no trend in race-ethnicity distribution by disease severity. Those with more severe illness had older mean age, higher median body mass index, and pre-existing medical comorbidities. Four maternal deaths (0.3%) were attributed to COVID-19. Frequency of perinatal death or a positive neonatal SARS-CoV-2 test result did not differ by severity. Adverse perinatal outcomes were more frequent among patients with more severe illness, including 6% (95% CI 2-11%) incidence of venous thromboembolism among those with severe-critical illness compared with 0.2% in mild-moderate and 0% in asymptomatic (P<.001 for trend across severity). In adjusted analyses, severe-critical COVID-19 was associated with increased risk of cesarean birth (59.6% vs 34.0%, adjusted relative risk [aRR] 1.57, 95% CI 1.30-1.90), hypertensive disorders of pregnancy (40.4% vs 18.8%, aRR 1.61, 95% CI 1.18-2.20), and preterm birth (41.8% vs 11.9%, aRR 3.53, 95% CI 2.42-5.14) compared with asymptomatic patients. Mild-moderate COVID-19 was not associated with adverse perinatal outcomes compared with asymptomatic patients.Conclusion: Compared with pregnant patients with SARS-CoV-2 infection without symptoms, those with severe-critical COVID-19, but not those with mild-moderate COVID-19, were at increased risk of perinatal complications. [ABSTRACT FROM AUTHOR]

Among people with hepatitis C virus infection, those with viremia during pregnancy are less likely to initiate breastfeeding than those with an undetectable viral load. OBJECTIVE: To characterize breastfeeding behaviors and identify factors associated with breastfeeding initiation among people with hepatitis C virus (HCV) infection. METHODS: We conducted a secondary analysis of a multicenter observational cohort of pregnant people with singleton gestations and HCV seropositivity. This analysis includes individuals with data on breastfeeding initiation and excludes those with human immunodeficiency virus (HIV) co-infection. The primary outcome was self-reported initiation of breastfeeding or provision of expressed breast milk. Secondary outcomes included duration of breastfeeding. Demographic and obstetric characteristics were compared between those who initiated breastfeeding and those who did not to identify associated factors. Univariable and multivariable analyses were performed. RESULTS: Overall, 579 individuals (75.0% of participants in the parent study) were included. Of those, 362 (62.5%) initiated breastfeeding or provided breast milk to their infants, with a median duration of breastfeeding of 1.4 months (interquartile range 0.5–6.0). People with HCV viremia , defined as a detectable viral load at any point during pregnancy, were less likely to initiate breastfeeding than those who had an undetectable viral load (59.4 vs 71.9%, adjusted odds ratio [aOR] 0.61, 95% CI, 0.41–0.92). People with private insurance were more likely to initiate breastfeeding compared with those with public insurance or no insurance (80.0 vs 60.1%; aOR 2.43, 95% CI, 1.31–4.50). CONCLUSION: Although HCV seropositivity is not a contraindication to breastfeeding regardless of viral load, rates of breastfeeding initiation were lower among people with HCV viremia than among those with an undetectable viral load. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01959321. [ABSTRACT FROM AUTHOR]

Pregnancy-adjusted sepsis screening criteria were most accurate in identifying sepsis for nondelivery admissions after 20 weeks of gestation and before 3 days postpartum. OBJECTIVE: To evaluate the performance characteristics of existing screening tools for the prediction of sepsis during antepartum and postpartum readmissions. METHODS: This was a case–control study using electronic health record data obtained between 2016 and 2021 from 67 hospitals for antepartum sepsis admissions and 71 hospitals for postpartum readmissions up to 42 days. Patients in the sepsis case group were matched in a 1:4 ratio to a comparison cohort of patients without sepsis admitted antepartum or postpartum. The following screening criteria were evaluated: the CMQCC (California Maternal Quality Care Collaborative) initial sepsis screen, the non–pregnancy-adjusted SIRS (Systemic Inflammatory Response Syndrome), the MEWC (Maternal Early Warning Criteria), UKOSS (United Kingdom Obstetric Surveillance System) obstetric SIRS, and the MEWT (Maternal Early Warning Trigger Tool). Time periods were divided into early pregnancy (less than 20 weeks of gestation), more than 20 weeks of gestation, early postpartum (less than 3 days postpartum), and late postpartum through 42 days. False-positive screening rates, C-statistics, sensitivity, and specificity were reported for each overall screening tool and each individual criterion. RESULTS: We identified 525 patients with sepsis during an antepartum hospitalization and 728 patients with sepsis during a postpartum readmission. For early pregnancy and more than 3 days postpartum, non–pregnancy-adjusted SIRS had the highest C-statistics (0.78 and 0.83, respectively). For more than 20 weeks of gestation and less than 3 days postpartum, the pregnancy-adjusted sepsis screening tools (CMQCC and UKOSS) had the highest C-statistics (0.87–0.94). The MEWC maintained the highest sensitivity rates during all time periods (81.9–94.4%) but also had the highest false-positive rates (30.4–63.9%). The pregnancy-adjusted sepsis screening tools (CMQCC, UKOSS) had the lowest false-positive rates in all time periods (3.9–10.1%). All tools had the lowest C-statistics in the periods of less than 20 weeks of gestation and more than 3 days postpartum. CONCLUSION: For admissions early in pregnancy and more than 3 days postpartum, non–pregnancy-adjusted sepsis screening tools performed better than pregnancy-adjusted tools. From 20 weeks of gestation through up to 3 days postpartum, using a pregnancy-adjusted sepsis screening tool increased sensitivity and minimized false-positive rates. The overall false-positive rate remained high. [ABSTRACT FROM AUTHOR]

During delivery admissions, the California Maternal Quality Care Collaborative and United Kingdom Obstetric Surveillance System pregnancy-adjusted sepsis screening tools have the lowest false-positive rates while maintaining greater than 90% sensitivity rates. OBJECTIVE: To evaluate the screening performance characteristics of existing tools for the diagnosis of sepsis during delivery admissions. METHODS: This was a case–control study using electronic health record data, including vital signs and laboratory results, for all delivery admissions of patients with sepsis from 59 nationally distributed hospitals. Patients with sepsis were matched by gestational age at delivery in a 1:4 ratio with patients without sepsis to create a comparison group. Patients with chorioamnionitis and sepsis were compared with a complete cohort of patients with chorioamnionitis without sepsis. Multiple screening criteria for sepsis were evaluated: the CMQCC (California Maternal Quality Care Collaborative), SIRS (Systemic Inflammatory Response Syndrome), the MEWC (the Maternal Early Warning Criteria), UKOSS (United Kingdom Obstetric Surveillance System), and the MEWT (Maternal Early Warning Trigger Tool). Sensitivity, false-positive rates, and C-statistics were reported for each screening tool. Analyses were stratified into cohort 1, which excluded patients with chorioamnionitis–endometritis, and cohort 2, which included those patients. RESULTS: Delivery admissions at 59 hospitals were extracted for patients with sepsis. Cohort 1 comprised 647 patients with sepsis, including 228 with end-organ injury, matched with a control group of 2,588 patients without sepsis. Cohort 2 comprised 14,591 patients with chorioamnionitis–endometritis, of whom 1,049 had sepsis and 238 had end-organ injury. In cohort 1, the CMQCC and the UKOSS pregnancy-adjusted criteria had the lowest false-positive rates (6.9% and 9.6%, respectively) and the highest C-statistics (0.92 and 0.91, respectively). Although other screening criteria, such as SIRS and the MEWC, had similar sensitivities, it was at the cost of much higher false-positive rates (21.3% and 38.3%, respectively). In cohort 2, including all patients with chorioamnionitis–endometritis, the highest C-statistics were again for the CMQCC (0.67) and UKOSS (0.64). All screening tools had high false-positive rates, but the false-positive rates for the CMQCC and UKOSS were substantially lower than those for SIRS and the MEWC. CONCLUSION: During delivery admissions, the CMQCC and UKOSS pregnancy-adjusted screening criteria have the lowest false-positive results while maintaining greater than 90% sensitivity rates. Performance of all screening tools was degraded in the setting of chorioamnionitis–endometritis. [ABSTRACT FROM AUTHOR]

Objective  To develop a model to predict cesarean-associated red blood cell transfusion. Study Design  Secondary analysis of all cesarean deliveries in the Maternal-Fetal Medicine Units Network Cesarean Registry. Using a split-sample technique, the derivation group was used to identify associated factors and build predictive models, and the validation group was used to estimate classification errors and determine test characteristics. Using factors available at the time of cesarean, we developed a multivariable logistic regression prediction model. Results  A total of 59,468 women were split evenly and randomly into the derivation and validation groups. The overall rate of transfusion was 2.7%. The area under the receiver operating characteristic curve for the derivation and validation groups were 0.82 (95% confidence interval [CI]: 0.80–0.84) and 0.84 (95% CI: 0.82–0.85), respectively (p  = 0.16). The strongest predictors of transfusion were placenta previa (odds ratio [OR]: 7.06, 95% CI: 5.19–9.61) and eclampsia/Hemolysis Elevated Liver Enzymes Low Platelets syndrome (OR: 5.67, 95% CI: 3.77–8.51). In the validation group, the model had a sensitivity, specificity, positive, and negative predictive values of 55.8, 91.5, 16.2, and 98.6%, respectively. Overall, 90.5% of patients were correctly classified. Conclusion  A regression model incorporating variables available at the time of cesarean accurately predicts the need for intra- or postoperative transfusion. [ABSTRACT FROM AUTHOR]

HIV-exposed but uninfected (HEU) infants are at an increased risk of many infectious diseases that can contribute to the high mortality seen among HEU children. Maternal immunisation could be a promising strategy to reduce infections in HEU infants. However, very little research has explored the effect of HIV on the immunogenicity and effectiveness of vaccines given during pregnancy. We review the available evidence on maternal immunisation among women living with HIV (WLWH) for all vaccines recommended, considered, or being investigated for routine or risk-based use during pregnancy. Of the 11 vaccines included, only three have been investigated in WLWH. Available evidence suggests that maternal HIV infection limits the immunogenicity of several vaccines, leaving HEU infants more susceptible to infection during their first few months of life. Whether maternal immunisation reduces the infectious morbidity and mortality associated with infectious diseases in HEU children remains unknown. We conclude the Review by identifying future research priorities. [ABSTRACT FROM AUTHOR]

Objective Pyelonephritis is the most common nonobstetric cause for hospitalization during pregnancy. The maternal and obstetric complications associated with antepartum pyelonephritis are well described. However, it is not clear whether these risks extend into the postpartum period. The primary objective of this study was to describe the morbidity associated with postpartum pyelonephritis, by comparing the morbidity associated with pyelonephritis in the postpartum period to morbidity seen during pregnancy or delivery. Study Design A retrospective cohort study was performed using the Nationwide Readmissions Database (NRD), an all-payor sample of discharges from approximately 60% of U.S. hospitalizations. Discharges between October 2015 and December 2018 were included. Maternity-associated hospitalizations, diagnosis of pyelonephritis, comorbid conditions, and incidence of severe maternal morbidity were identified using International Classification of Disease-10th Revision (ICD-10) diagnosis and procedure codes. Bivariate statistics, weighted to account for the complex survey methods in the NRD, were used to evaluate the association between antepartum, delivery, and postpartum hospital stays associated with pyelonephritis and maternal morbidity. Weighted regression models were used to evaluate the association between admission timing and maternal outcomes. Results A total of 32,850 pyelonephritis admissions were identified, corresponding to a national estimate of 61,837 admissions. Of these, 1,465 (2.4%) were postpartum, 55,056 (89.0%) were antepartum, and 5,317 (8.6%) involved a delivery stay. Rates of severe maternal morbidity were higher in the postpartum group than the antepartum or delivery hospitalization groups (59.5 vs. 12.9 and 15.8%, respectively, p < 0.001); when compared with antepartum hospitalizations, the adjusted relative risk for composite severe maternal morbidity for postpartum hospitalizations was 4.68 (95% confidence interval [CI]: 4.33, 5.05). Most of this difference was driven by rates of sepsis (53.2 vs. 11.0 vs. 10.9%). Conclusion Though relatively uncommon, postpartum hospitalizations for pyelonephritis are associated with higher rates of severe maternal morbidity, driven by differential rates of sepsis, than are antepartum or delivery-associated hospitalizations. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the association between maternal blood pressure (BP) below 130/80 mm Hg compared with 130–139/80–89 mm Hg and pregnancy outcomes. METHODS: We conducted a planned secondary analysis of CHAP (Chronic Hypertension and Pregnancy), an open label, multicenter, randomized controlled trial. Participants with mean BP below 140/90 mm Hg were grouped as below 130/80 mm Hg compared with 130–139/80–89 mm Hg by averaging postrandomization clinic BP throughout pregnancy. The primary composite outcome was preeclampsia with severe features, indicated preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The secondary outcome was small for gestational age (SGA). RESULTS: Of 2,408 patients in CHAP, 2,096 met study criteria; 1,328 had mean BP 130–139/80–89 mm Hg and 768 had mean BP below 130/80 mm Hg. Participants with mean BP below 130/80 mm Hg were more likely to be older, on antihypertensive medication, in the active treatment arm, and to have lower BP at enrollment. Mean clinic BP below 130/80 mm Hg was associated with lower frequency of the primary outcome (16.0% vs 35.8%, adjusted relative risk 0.45; 95% CI 0.38–0.54) as well as lower risk of severe preeclampsia and indicated birth before 35 weeks of gestation. There was no association with SGA. CONCLUSION: In pregnant patients with mild chronic hypertension, mean BP below 130/80 mm Hg was associated with improved pregnancy outcomes without increased risk of SGA. [ABSTRACT FROM AUTHOR]

Objective: Hepatitis C virus and intrahepatic cholestasis of pregnancy (ICP) are well-known independent risk factors for adverse outcomes in pregnancy. In addition, it is well-established that there is an association between Hepatitis C and ICP. This study's objective was to describe the impact of having both Hepatitis C and ICP on maternal and obstetric outcomes compared to patients having either Hepatitis C or ICP. Methods: We conducted a retrospective cohort study of the Nationwide Readmissions Database, an all-payor sample of discharges from approximately 60% of US hospitalizations. Deliveries at 24–42+ weeks between 10/2015 and 12/2020 were included. Diagnosis of Hepatitis C and ICP, and outcomes related to severe maternal morbidity were identified using International Classification of Disease-10 codes. Patients were categorized based on Hepatitis C and ICP status. Weighted logistic and negative binomial regression analyses were used to evaluate the association between Hepatitis C and ICP status and outcomes, adjusting for patient and hospital characteristics. The primary outcome was any severe maternal morbidity; secondary outcomes included acute respiratory distress syndrome, acute kidney injury, sepsis, gestational diabetes, cesarean delivery, preterm birth, and hospital length of stay. We modeled interaction terms between ICP and Hepatitis C to assess whether there was a greater or lesser effect from having both conditions on outcomes than we would expect from additive combination of the individual components (i.e., synergy or antagonism). Results: A total of 10,040,850 deliveries between 24–42+ weeks were identified. Of these, 45,368 had Hepatitis C only; 84,582 had ICP only; and 1,967 had both Hepatitis C and ICP. Patients with both Hepatitis C and ICP had 1.5-fold higher odds of developing severe maternal morbidity compared to having neither. There was an also an increased odds of severe maternal morbidity in patients with both Hepatitis C and ICP compared to patients with only Hepatitis C or ICP. Having both was also associated with higher odds of preterm birth and length of stay compared to having only Hepatitis C, only ICP, or neither (preterm birth: aOR 5.09, 95% CI 4.87–5.33 vs. neither; length of stay: 46% mean increase, 95% CI 35–58% vs. neither). Associations were additive—no significant interactions between hepatitis C and cholestasis were found on rates of severe maternal morbidity, acute respiratory distress syndrome, acute kidney injury, sepsis, cesarean section, or preterm birth (all p>0.05), and was minimal for gestational diabetes and length of stay. Conclusion: Hepatitis C and ICP are independent, additive risk factors for adverse maternal and obstetric outcomes. Despite physiologic plausibility, no evidence of a synergistic effect of these two diagnoses on outcomes was noted. These data may be useful in counseling patients regarding their increased risk of adverse outcomes when ICP presents in association with Hepatitis C versus ICP alone. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To estimate the rate of perinatal transmission of hepatitis C virus (HCV) infection, to identify risk factors for perinatal transmission of HCV infection, and to determine the viremic threshold for perinatal transmission. METHODS: This was a prospective, multicenter, observational study of pregnant individuals at less than 24 weeks of gestation screened for HCV infection from 2012 to 2018 in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Individuals found to be HCV antibody--positive were followed throughout pregnancy. Children were followed for evidence of perinatal transmission at 2-6 months (HCV RNA testing) and at 18-24 months (HCV RNA and antibody testing) of life. The primary outcome was perinatal transmission, defined as positive test results at either follow-up time point. RESULTS: A total of 109,379 individuals were screened for HCV infection. Of the 1,224 participants who screened positive, 772 (63.1%) enrolled and 432 of those 772 (56.0%) had data available to assess primary outcome. The overall rate of perinatal transmission was 6.0% (26/432, 95% CI 4.0-8.7%). All children with HCV infection were born to individuals with demonstrable viremia. In viremic participants (n5314), the perinatal transmission rate was 8.0% (95% CI 5.2-11.5%). Risk factors for perinatal transmission included HCV RNA greater than 106 international units/mL (adjusted odds ratio [aOR] 8.22, 95% CI 3.16-21.4) and vaginal bleeding reported at any time before delivery (aOR 3.26, 95% CI 1.32-8.03). A viremic threshold for perinatal transmission could not be established. CONCLUSION: Perinatal transmission of HCV infection was limited to viremic individuals. High viral loads and antepartum bleeding were associated with perinatal transmission. [ABSTRACT FROM AUTHOR]

Sepsis in obstetric care is one of the leading causes of maternal death in the United States, with Black, Asian/ Pacific Islander, and American Indian/Alaska Native obstetric patients experiencing sepsis at disproportionately higher rates. State maternal mortality review committees have determined that deaths are preventable much of the time and are caused by delays in recognition, treatment, and escalation of care. The "Sepsis in Obstetric Care" patient safety bundle provides guidance for health care teams to develop coordinated, multidisciplinary care for pregnant and postpartum people by preventing infection and recognizing and treating infection early to prevent progression to sepsis. This is one of several core patient safety bundles developed by AIM (the Alliance for Innovation on Maternal Health) to provide condition- or event-specific clinical practices that should be implemented in all appropriate care settings. As with other bundles developed by AIM, the "Sepsis in Obstetric Care" patient safety bundle is organized into five domains: Readiness, Recognition and Prevention, Response, Reporting and Systems Learning, and Respectful, Equitable, and Supportive Care. The Respectful, Equitable, and Supportive Care domain provides essential best practices to support respectful, equitable, and supportive care to all patients. Further health equity considerations are integrated into the elements of each domain. [ABSTRACT FROM AUTHOR]

The onset of the coronavirus disease 2019 (COVID-19) pandemic was not associated with a change in the rate of preterm birth, regardless of socioeconomic status. OBJECTIVE: To evaluate whether preterm birth rates changed in relation to the onset of the coronavirus disease 2019 (COVID-19) pandemic and whether any change depended on socioeconomic status. METHODS: This is an observational cohort study of pregnant individuals with a singleton gestation who delivered in the years 2019 and 2020 at 1 of 16 U.S. hospitals of the Maternal-Fetal Medicine Units Network. The frequency of preterm birth for those who delivered before the onset of the COVID-19 pandemic (ie, in 2019) was compared with that of those who delivered after its onset (ie, in 2020). Interaction analyses were performed for people of different individual- and community-level socioeconomic characteristics (ie, race and ethnicity, insurance status, Social Vulnerability Index (SVI) of a person's residence). RESULTS: During 2019 and 2020, 18,526 individuals met inclusion criteria. The chance of preterm birth before the COVID-19 pandemic was similar to that after the onset of the pandemic (11.7% vs 12.5%, adjusted relative risk 0.94, 95% CI 0.86–1.03). In interaction analyses, race and ethnicity, insurance status, and the SVI did not modify the association between the epoch and the chance of preterm birth before 37 weeks of gestation (all interaction P >.05). CONCLUSION: There was no statistically significant difference in preterm birth rates in relation to the COVID-19 pandemic onset. This lack of association was largely independent of socioeconomic indicators such as race and ethnicity, insurance status, or SVI of the residential community in which an individual lived. [ABSTRACT FROM AUTHOR]

Background The purpose of this study was to estimate prevalence of asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among patients admitted to obstetric inpatient units throughout the United States as detected by universal screening. We sought to describe the relationship between obstetric inpatient asymptomatic infection rates and publicly available surrounding community infection rates. Methods A cross-sectional study in which medical centers reported rates of positive SARS-CoV-2 testing in asymptomatic pregnant and immediate postpartum patients over a 1–3-month time span in 2020. Publicly reported SARS-CoV-2 case rates from the relevant county and state for each center were collected from the COVID Act Now dashboard and the COVID Tracking Project for correlation analysis. Results Data were collected from 9 health centers, encompassing 18 hospitals. Participating health centers were located in Alabama, California, Illinois, Louisiana, New Jersey, North Carolina, Pennsylvania, Rhode Island, Utah, and Washington State. Each hospital had an active policy for universal SARS-CoV-2 testing on obstetric inpatient units. A total of 10 147 SARS-CoV-2 tests were administered, of which 124 were positive (1.2%). Positivity rates varied by site, ranging from 0–3.2%. While SARS-CoV-2 infection rates were lower in asymptomatic obstetric inpatient groups than the surrounding communities, there was a positive correlation between positivity rates in obstetric inpatient units and their surrounding county (P =.003, r =.782) and state (P =.007, r =.708). Conclusions Given the correlation between community and obstetric inpatient rates, the necessity of SARS-CoV-2–related healthcare resource utilization in obstetric inpatient units may be best informed by surrounding community infection rates. [ABSTRACT FROM AUTHOR]

Background: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.Methods: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth.Results: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99).Conclusions: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.). [ABSTRACT FROM AUTHOR]

The proposed changes to obstetrics and gynecology fellowship start dates have unintended consequences that introduce inequity in the fellowship-training process. [ABSTRACT FROM AUTHOR]

This study sought to assess the impact of COVID-19 on placental vasculature in the context of maternal symptomatology – comparing asymptomatic to symptomatic pregnant patients – and disease severity – comparing pregnant patients with mild, moderate, severe, and critical COVID-19 infection. PCR-confirmed COVID-19 positive pregnant patients in a single health system who delivered between 3/2020-5/2021 included. All patients had positive COVID test and delivered during the study period. Primary outcome was incidence of any vascular malperfusion on placental pathology. Secondary outcomes were FVM and MVM on placental pathology. Placental pathology compared between symptomatic (sCOVID) and asymptomatic (aCOVID) patients. Secondary analysis of symptomatic patients, comparing placental pathology between mild disease(mCOVID) and worse disease(moderate, severe, or critical-defined by 2020 NIH guidelines) (dCOVID), also performed. Of 112 patients, 53 (47%) had symptoms. Twenty-seven (24.1%) patients had evidence of vascular malperfusion; 26 (23.2%) had MVM. When comparing aCOVID and sCOVID patients, no difference in rate of vascular malperfusion identified, nor any differences in rates of FVM or MVM. Among sCOVID patients (n = 53), 39 (74%) had mCOVID and 14 (26%) had dCOVID (moderate n = 4, severe n = 9, critical n = 1). Patients with dCOVID had earlier median delivery GA (37.4wks vs 39.2wks, p =.03). No difference in latency from diagnosis to delivery seen between mCOVID and dCOVID groups (4.4 vs 3.0wks, p =.96). Twelve (30.8%) patients had vascular malperfusion on pathology, all had mCOVID (p =.02). Eleven (28.2%) mCOVID patients had MVM; no dCOVID patients had evidence of vascular malperfusion (p =.03). No difference in FVM was found between cohorts. Symptomatic COVID-19 infection did not impact placental vasculature differently than asymptomatic infection, even when stratifying by trimester of infection. Among pregnant patients with symptomatic COVID-19, mild disease was associated with placental vascular changes on the maternal side while severe disease was not. Further studies are needed to understand the implications of these findings. [ABSTRACT FROM AUTHOR]

Objective: To investigate the association between maternal obesity as measured by prepregnancy body mass index (BMI) and group B streptococcus (GBS) colonization. Methods: We conducted a secondary analysis from the Consortium on Safe Labor Study (CSL) in the United States cohort study (2002–2008). Pregnant women with deliveries at ≥37 weeks of gestation who attempted labor were included (115,070 assessed deliveries). The association between maternal prepregnancy BMI, categorized as normal weight or below (<25 kg/m2), overweight (25 to <30 kg/m2), class I obesity (30 to <35 kg/m2), class II obesity (35 to <40 kg/m2), and class III obesity (≥40 kg/m2), and GBS colonization was modeled using logistic regression with generalized estimating equations. Models adjusted for maternal age, parity, race, pregestational diabetes, insurance status, study site/region, and year of delivery. Results: The overall prevalence of GBS colonization was 20.5% (23,625/115,070), which increased with rising maternal BMI, normal weight 19.3% (13,543/70,098), overweight 20.8% (5,353/25,733), class I obesity 23.0% (2,596/11,275), class II obesity 26.1% (1,270/4,850), and class III obesity 27.7% (863/3,114). In multivariable analysis, increasing maternal obesity severity was associated with higher odds of GBS colonization, namely overweight (adjusted odds ratio [AOR]: 1.09, 95% confidence interval [CI]: 1.05–1.13), class I obesity (AOR: 1.20, 95% CI: 1.15–1.26), class II obesity (AOR: 1.42, 95% CI: 1.33–1.51), and class III obesity (AOR: 1.50; 95% CI: 1.38–1.62) compared with normal weight. In secondary analyses, these associations persisted when stratified by maternal race. Conclusions: In a national U.S. sample, increasing maternal obesity severity as assessed by prepregnancy BMI was associated with a higher likelihood of maternal GBS colonization during pregnancy. [ABSTRACT FROM AUTHOR]

Objective: To describe the prevalence of hepatitis C virus (HCV) antibody, evaluate current risk factors associated with HCV antibody positivity, and identify novel composite risk factors for identification of groups most likely to demonstrate HCV antibody seropositivity in an obstetric population from 2012 to 2015.Methods: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network initiated an observational study of mother-to-child transmission of HCV in 2012 that included offering HCV antibody screening to their entire obstetric population. Women presenting for prenatal care before 23 weeks of gestation without a known multifetal gestation were eligible. For each woman who was HCV antibody-positive, two women at similar gestational age who were HCV antibody-negative were identified and included for comparison. Risk factors were evaluated by patient interview and chart review. Women in the case group were identified to have a signal-to-cutoff value of at least 5 on the Abbott ARCHITECT platform. RNA status was evaluated for women in the case group.Results: Of 106,842 women screened for the HCV antibody, 254 had positive results. The HCV antibody seroprevalence rate was 2.4 cases per 1,000 women (95% CI 2.1-2.7). One hundred thirty-one women in the case group and 251 women in the control group were included in the case-control analysis. Factors associated with HCV antibody positivity included injection drug use (adjusted odds ratio [aOR] 22.9, 95% CI 8.2-64.0), blood transfusion (aOR 3.7, 95% CI 1.3-10.4), having a partner with HCV (aOR 6.3, 95% CI 1.8-22.6), more than three lifetime sexual partners (aOR 5.3, 95% CI 1.4-19.8), and smoking (aOR 2.4, 95% CI 1.2-4.6). A composite of any of these potential risk factors provided the highest sensitivity for detecting HCV antibody (75/82 cases, 91%).Conclusion: In this cohort, the seroprevalence of HCV antibody was low, and the current risk factors for HCV screening were not identified. These findings may be useful in defining new strategies for identifying mothers with the HCV antibody and the neonates susceptible to maternal transmission of HCV.Clinical Trial Registration: ClinicalTrials.gov, NCT01959321. [ABSTRACT FROM AUTHOR]

Our objective was to identify metabolites associated with fetal growth restriction (FGR) by examining early and late pregnancy differences in non-targeted urinary metabolites among FGR cases and non-FGR controls. An exploratory case-control study within LIFECODES birth cohort was performed. FGR cases (N = 30), defined as birthweight below the 10th percentile, were matched with controls (N = 30) based on maternal age, race, pre-pregnancy body mass index, and gestational age at delivery. Gas chromatography/electron-ionization mass spectrometry was performed on urine samples collected at 10 and 26 weeks of gestation. Differences in urinary metabolite levels in cases and controls at each time point and between the two time points were calculated and then changes compared across pregnancy. 137 unique urinary metabolites were annotated, and several identified that were higher in cases compared to controls. For example, urinary concentrations of benzoic acid were higher in cases compared to controls at both study visits (3.01-fold higher in cases at visit 1, p < 0.01; 3.10-fold higher in cases at visit 3, p = 0.05). However, these findings from our exploratory analysis were not robust to false-discovery-rate adjustment. In conclusion, using a high-resolution, non-targeted approach, we found specific urinary organic acids differed over pregnancy by FGR case status. [ABSTRACT FROM AUTHOR]

Background  Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-α-hydroxyprogesterone caproate or "17P") to placebo has been published, and this trial was stopped early due to a large treatment benefit. Objective  This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation. Study Design  This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB (clinicaltrials.gov : NCT 01004029). Women were enrolled at 93 clinical centers (41 in the United States and 52 outside the United States) between 16 0/7 to 20 6/7 weeks in a 2:1 ratio, to receive either weekly intramuscular (IM) injections of 250 mg of 17-OHPC or an inert oil placebo; treatment was continued until delivery or 36 weeks. Co-primary outcomes were PTB < 35 weeks and a neonatal morbidity composite index. The composite included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, or proven sepsis. A planned sample size of 1,707 patients was estimated to provide 98% power to detect a 30% reduction in PTB < 35 weeks (30% to 21%) and 90% power to detect a 35% reduction in neonatal composite index (17%–11%) using a two-sided type-I error of 5%. Finally, this sample size would also provide 82.8% power to rule out a doubling in the risk of fetal/early infant death assuming a 4% fetal/early infant death rate. Analysis was performed according to the intention-to-treat principle. Results  Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had >1 prior SPTB, 7% smoked cigarettes, and 89% were married/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and <2% had cervical shortening <25 mm. There were no significant differences in the frequency of PTB < 35 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk = 0.95 [95% confidence interval (CI): 0.71–1.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk = 1.12 [95% CI: 0.68–1.61]). There were also no differences in frequency of fetal/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk = 0.87 [95% CI: 0.4–1.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States (n  = 391; 23% of all patients), although the rate of PTB < 35 weeks was higher than the overall study population, there were no statistically significant differences between groups (15.6% vs. 17.6%; relative risk = 0.88 [95% CI: 0.55, 1.40]. Conclusion  In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death. [ABSTRACT FROM AUTHOR]

Cytomegalovirus (CMV) is the most common congenital infection and infectious cause of fetal anomaly and neurologic injury. However, treatment strategies for congenital CMV (cCMV) infection during pregnancy remain elusive. We report a case of hydrops fetalis secondary to cCMV infection with minimal sequelae after maternal and subsequent neonatal treatment with valganciclovir. [ABSTRACT FROM AUTHOR]

Objective: To assess treatment outcomes associated with an obstetric hypertensive emergency quality improvement intervention instituted in a tertiary care women's emergency department.Methods: We conducted a cohort study of pregnant (20 weeks of gestation or greater) and postpartum (6 weeks of gestation or less) women treated for hypertensive emergency (systolic blood pressure [BP] 160 mm Hg or greater, diastolic 110 mm Hg or greater, or both) before and after a quality improvement intervention. A multidisciplinary task force revised clinical guidelines and nursing policy, updated electronic order sets, and provided staff education and clinical management aids. Data were collected by electronic chart review. The primary outcome was achieving goal BP (systolic 150 mm Hg or less and diastolic 100 mm Hg or less) within an hour of initial therapy. Secondary outcomes included time from first severe BP to 1) first antihypertensive treatment and 2) goal BP.Results: There were no significant differences in baseline characteristics in the preintervention (n=173; September 2014 to September 2015) and postintervention (n=173; December 2015 to November 2016) groups, including gestational age, days postpartum, maternal age, race-ethnicity, or comorbidities. We found no significant difference in primary outcome frequency: 41% achieved goal BP within 60 minutes preintervention vs 47% postintervention (P=.28). Median time from first severe BP to first treatment was unchanged (30 minutes preintervention vs 29 minutes postintervention, P=.058); however, median time from first severe BP to goal BP decreased significantly (122 vs 95 minutes, P=.04). Confirmation of hypertensive emergency within 15 minutes (recommended) was only achieved in approximately 20% of women in either group. More women initially received intravenous antihypertensive treatment after the intervention (52% preintervention vs 80% postintervention, P<.001).Conclusion: A quality improvement initiative was not associated with more women achieving BP control within an hour of obstetric hypertensive emergency treatment, but was associated with decreased time to achieve control. This suggests improved clinical practice after the intervention. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate whether the predicted chance of success is associated with the choice to undergo trial of labor after cesarean (TOLAC). STUDY DESIGN: Retrospective cohort study of women with a single prior nonelective cesarean delivering a term singleton in 2012 at a tertiary care hospital. A vaginal birth after cesarean (VBAC) score (likelihood of success) was estimated for each patient. The primary outcome was percentage of women choosing TOLAC among women with favorable (> 70% likelihood) and unfavorable VBAC scores. Other factors such as desired sterilization, provider type, and spontaneous labor were included in the analysis. RESULTS: In 2012, 434 women were eligible: 73 with VBAC score >70%, and 361 with score ≤70%. Of those with score >70%, 63% chose TOLAC, compared with 21% with score ≤70% (p < 0.01). In a multivariable analysis, spontaneous labor onset was highly associated with choosing TOLAC: adjusted odds ratio 26.7 (95% confidence interval 13.86-51.29). The choice of TOLAC was also positively associated with resident provider and desired fertility. CONCLUSION: Almost four in ten women with a history of nonelective primary cesarean and a very high predicted likelihood of VBAC choose elective repeat cesarean. Spontaneous labor was strongly associated with the choice to undergo TOLAC. [ABSTRACT FROM AUTHOR]

Objective: To prospectively validate the Sepsis in Obstetrics Score, a pregnancy-specific sepsis scoring system, to identify risk for intensive care unit (ICU) admission for sepsis in pregnancy.Methods: This is a prospective validation study of the Sepsis in Obstetrics Score. The primary outcome was admission to the ICU for sepsis. Secondary outcomes included admission to a telemetry unit and time to administration of antibiotic therapy. We evaluated test characteristics of a predetermined score of 6 or greater.Results: Between March 2012 and May 2015, 1,250 pregnant or postpartum women presented to the emergency department and met systemic inflammatory response syndrome criteria. Of those, 425 (34%) had a clinical suspicion or diagnosis of an infection, 14 of whom (3.3%) were admitted to the ICU. The Sepsis in Obstetrics Score had an area under the curve of 0.85 (95% CI 0.76-0.95) for prediction of ICU admission for sepsis. This is within the prespecified 15% margin of the area under the curve of 0.97 found in the derivation cohort. A score of 6 or greater had a sensitivity of 64%, specificity of 88%, positive predictive value of 15%, and negative predictive value of 98.6%. Women with a score 6 or greater were more likely to be admitted to the ICU (15% compared with 1.4%, P<.01), admitted to a telemetry unit (37.3% compared with 7.2%, P<.01), and have antibiotic therapy initiated (90% compared with 72.9%, P<.01), initiated more quickly (3.2 compared with 3.7 hours, P=.03), although not within 1 hour (5.6 compared with 3.4%, P=.44).Conclusion: The Sepsis in Obstetrics Score is a validated pregnancy-specific score to identify risk of ICU admission for sepsis with the threshold score of 6 having a negative predictive value of 98.6%. Adherence to antibiotic administration guidelines is poor. [ABSTRACT FROM AUTHOR]

Background. Cytomegalovirus (CMV) is the most common infectious cause of fetal malformations and childhood hearing loss. CMV is more common among socially disadvantaged groups, and it clusters geographically in poor communities. We conducted a geospatial analysis of chronic and primary CMV infection among pregnant women around Durham, NC. Methods. We performed a geospatial analysis of subjects from an ongoing study of CMV infection among pregnant women using geographic information systems and spatial statistics. Subjects were categorized on the basis of results of their CMV immunoglobulin G avidity testing as seronegative, seropositive, or primary infection. We used generalized additive models to analyze the spatial distributions of individuals who fell into each category and to control for confounders such as race and age. We used a generalized estimating equation to correlate community-level variables with CMV status. Results. Of 3527 pregnant women aged 15 to 59 years, 93.4% were either white or black. CMV seropositivity was significantly more common among non-Hispanic white subjects than among minority subjects (odds ratio, 3.76 [95% confidence interval, 3.25-4.34]). We identified a cluster in which women had elevated odds of CMV seropositivity in the urban neighborhoods of Durham. Cases of primary CMV infection were more common in areas with higher-than-average CMV seroprevalence. Neighborhood median family income was associated inversely with the prevalence of chronic CMV. Conclusions. We found a high prevalence of CMV seropositivity in urban low-income neighborhoods among pregnant women, particularly among racial and ethnic minorities. Seronegative pregnant women from these communities might be at heightened risk for primary CMV infection. [ABSTRACT FROM AUTHOR]

The optimal antibiotic prophylaxis dosing regimen of cefazolin for cesarean delivery (CD) in overweight and obese women is unknown. This study was done to compare the duration that cefazolin concentrations remain above the minimum inhibitory concentration (MIC) in adipose tissue (AT). Serum and AT concentrations from 3 previous studies in CD patients were comodeled using the nonparametric adaptive grid algorithm in Pmetrics. AT concentrations for 5000 overweight and obese patients receiving 1-, 2-, and 3-g cefazolin regimens were simulated to calculate the probability that free drug concentrations remained above an MIC of 2 μg/mL at 1, 1.5, and 2 hours after administration. Sixty-seven patients (mean body mass index 38.7 kg/m2; range 25.5-55.8 kg/m2) provided data. A 2-compartment model with 1 of the compartments representing AT fit the data best. Final model parameters were clearance 7.38 ± 5.34 L/h, volume of central compartment 11.8±9.36 L, and AT volume of distribution 80.12 ± 55.47 L. The mean±SD (median) penetration ratio of cefazolin into AT was 0.81 ± 2.06 (0.62). At 1.5 and 2 hours, 1-, 2-, and 3-g regimens achieved AT concentrations above the MIC in 71.2%, 92.4%, and 94.7%, and 55.7%, 86.8%, and 91.7%, respectively, of simulated patients. Cefazolin achieved good penetration into AT. Because CD duration is commonly less than 1.5 hours, a 2-g dose has a high probability of providing AT concentrations above the target pathogens' MIC for overweight and obese females. A second dose may be considered for longer surgeries. [ABSTRACT FROM AUTHOR]

Objective: To evaluate use (both appropriate and inappropriate) of rescue corticosteroids before and after the implementation of a guideline for their use.Methods: We conducted a retrospective cohort study using a pharmacy log to identify women who received an initial course of antenatal corticosteroids in the year before (2008) and in the 4 years (2009-2012) after implementation of the guideline. The charts were then reviewed to determine eligibility and assess receipt of rescue corticosteroids according to the guideline. Our primary study outcome was a temporal change in the percentage of appropriate rescue corticosteroid administration.Results: Of 2,528 women who received a first course of corticosteroids, 142 (5.6%) were eligible for a rescue course, of whom 103 (73%) received it. The rate of appropriate administration increased from 18.2% (95% confidence interval [CI] 5-40%) in 2008 to 65.4% (95% CI 44-83%) in 2009, 93.5% (95% CI 79-99%) in 2010, 96.1% (95% CI 80-99%) in 2011, and 75.7% (95% CI 59-88%) in 2012 (P for test of trend <.001). Only 25 of these 103 eligible women (24.3%) delivered within 2-7 days of receipt of the rescue course. The rate of inappropriate administration among women who were not eligible for a rescue course (n=2,381) also rose from 0.4% (95% CI 0.04-1.4%) in 2008 to 1.9% (95% CI 0.9-3.5%) in 2009, 1.8% (95% CI 0.8-3.6%) in 2010, 2.4% (95% CI 1.2-4.3%) in 2011, and 2.2% (95% CI 1.1-4.0%) in 2012 (P for test of trend=.03). Among all recipients of rescue corticosteroids, 28% (41/144) were ineligible according to the guideline.Conclusion: Implementation of an institutional guideline for rescue corticosteroids was associated with a high rate of use among eligible women. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-effectiveness of universal group B streptococci (GBS) screening in women with a singleton pregnancy planning a repeat cesarean delivery.Methods: We conducted a decision analysis from a health care perspective to compare the cost-effectiveness of GBS screening for women planning a repeat cesarean delivery. With universal screening, all GBS-positive women who labored before a scheduled cesarean delivery received antibiotic prophylaxis. With no screening, women who presented in labor received antibiotics based on risk-based criteria. Neonates born to women colonized with GBS were at risk for early-onset GBS disease, disability, and death. We assumed a GBS prevalence of 25%, that 26.6% of women labored between 35 weeks of gestation and their scheduled time for cesarean delivery, and that 3.3% who planned a repeat cesarean delivery instead delivered vaginally. The primary outcome was cost per neonatal quality-adjusted life-year gained, with a cost-effectiveness threshold of $100,000 per quality-adjusted life-year. Neonatal quality of life was assessed using five health states (healthy, mild, moderate, or severe disability, and death) with a life expectancy of 79 years for healthy neonates. One-way sensitivity and Monte Carlo analyses were used to evaluate the results.Results: In the base case, universal GBS screening in women planning a repeat cesarean delivery was not cost-effective compared with no screening, costing $114,445 per neonatal quality-adjusted life-year gained. The cost to prevent an adverse outcome from GBS exceeded $400,000. If greater than 28% of women were GBS-positive, greater than 29% labored before their scheduled delivery, or greater than 10% delivered vaginally, universal screening became cost effective.Conclusion: Universal GBS screening in women with a singleton pregnancy planning a repeat cesarean delivery may not be cost-effective in all populations. However, in populations with a high GBS prevalence, women at high risk of laboring before their scheduled cesarean delivery, or women who may ultimately opt for a vaginal delivery, GBS screening may be cost effective. [ABSTRACT FROM AUTHOR]

Objective: To estimate the proportion of group B streptococci (GBS)-colonized women with a reported penicillin allergy without anaphylaxis receiving appropriate intrapartum antibiotic prophylaxis.Methods: We performed a retrospective cohort study of GBS-colonized, penicillin-allergic women delivering at term receiving intrapartum antibiotic prophylaxis during labor. Scheduled cesarean deliveries were excluded. The primary outcome was the proportion of women who received appropriate antibiotic coverage, defined as penicillin or cefazolin. Secondary outcomes included neonatal outcomes such as Apgar score, blood draws, antibiotic use, length of hospital stay, and composite morbidity.Results: Of 165 women reporting a penicillin allergy without anaphylaxis, 73 (44.2%) received an appropriate antibiotic and 92 (55.8%) received an inappropriate antibiotic. Of those receiving an inappropriate antibiotic, 56 (60.9%) were given clindamycin, 1 (1.1%) erythromycin, and 35 (38.0%) vancomycin. Women reporting rash as a penicillin reaction were more likely to receive cefazolin than another antibiotic (44 [60.3%] compared with 24 [26.1%], respectively; P<.001), whereas women whose reaction was not documented were less likely to receive cefazolin (18 [24.7%] compared with 63 [68.5%], respectively; P<.001). Among neonates whose mothers received appropriate compared with inappropriate antibiotics, there were no differences in Apgar score, number of blood draws, antibiotic use, length of hospital stay, or composite morbidity.Conclusion: More than half of women allergic to penicillin without anaphylaxis received an antibiotic other than penicillin or cefazolin as prophylaxis, indicating poor adherence to national guidelines. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost to prevent one case of congenital syphilis or fetal or neonatal death with universal third-trimester syphilis rescreening in the United States and to estimate the incidence of syphilis seroconversion at which rescreening becomes cost-effective.Methods: We created a decision model comparing universal third-trimester syphilis rescreening in women who screened negative in the first trimester with no rescreening. The assumed base case incidence of seroconversion was 0.012%. The primary outcome was the cost to prevent one case of congenital syphilis. Secondary outcomes included the cost to prevent one fetal or neonatal death and the number needed to rescreen to prevent one adverse outcome. A strategy was considered cost-effective if it cost less than $285,000 to prevent one case of congenital syphilis (the estimated long-term care cost).Results: Under our assumptions, universal third-trimester rescreening would cost an additional $419,842 for each case of congenital syphilis prevented and $3,621,144 and $6,052,534, respectively, for each fetal and neonatal death prevented. Rescreening 4,000,000 women would prevent 60 cases of congenital syphilis and seven fetal and four neonatal deaths. Prevention of one case of congenital syphilis would require 65,790 women be rescreened. Seroconversion incidence of 0.017% would make third-trimester rescreening cost-effective.Conclusion: Universal third-trimester syphilis rescreening requires a large number of women be rescreened at a high health care cost to prevent one adverse outcome from maternal syphilis. Seroconversion incidence must be 19-fold higher than the national average of primary and secondary syphilis in women for universal third-trimester rescreening to be cost-effective. [ABSTRACT FROM AUTHOR]