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Lower respiratory tract infections are frequently treated with antibiotics, despite a viral cause in many cases. It remains unknown whether low procalcitonin concentrations can identify patients with lower respiratory tract infection who are unlikely to benefit from antibiotics. We aimed to compare the efficacy and safety of azithromycin versus placebo to treat lower respiratory tract infections in patients with low procalcitonin.We conducted a randomised, placebo-controlled, double-blind, non-inferiority trial at five health centres in the USA. Adults aged 18 years or older with clinically suspected non-pneumonia lower respiratory tract infection and symptom duration from 24 h to 28 days were eligible for enrolment. Participants with a procalcitonin concentration of 0·25 ng/mL or less were randomly assigned (1:1), in blocks of four with stratification by site, to receive over-encapsulated oral azithromycin 250 mg or matching placebo (two capsules on day 1 followed by one capsule daily for 4 days). Participants, non-study clinical providers, investigators, and study coordinators were masked to treatment allocation. The primary outcome was efficacy of azithromycin versus placebo in terms of clinical improvement at day 5 in the intention-to-treat population. The non-inferiority margin was -12·5%. Solicited adverse events (abdominal pain, vomiting, diarrhoea, allergic reaction, or yeast infections) were recorded as a secondary outcome. This trial is registered with ClinicalTrials.gov, NCT03341273.Between Dec 8, 2017, and March 9, 2020, 691 patients were assessed for eligibility and 499 were enrolled and randomly assigned to receive azithromycin (n=249) or placebo (n=250). Clinical improvement at day 5 was observed in 148 (63%, 95% CI 54 to 71) of 238 participants with full data in the placebo group and 155 (69%, 61 to 77) of 227 participants with full data in the azithromycin group in the intention-to-treat analysis (between-group difference -6%, 95% CI -15 to 2). The 95% CI for the difference did not meet the non-inferiority margin. Solicited adverse events and the severity of solicited adverse events were not significantly different between groups at day 5, except for increased abdominal pain associated with azithromycin (47 [23%, 95% CI 18 to 29] of 204 participants) compared with placebo (35 [16%, 12 to 21] of 221; between-group difference -7% [95% CI -15 to 0]; p=0·066).Placebo was not non-inferior to azithromycin in terms of clinical improvement at day 5 in adults with lower respiratory tract infection and a low procalcitonin concentration. After accounting for both the rates of clinical improvement and solicited adverse events at day 5, it is unclear whether antibiotics are indicated for patients with lower respiratory tract infection and a low procalcitonin concentration.National Institute of Allergy and Infectious Diseases, bioMérieux.

Objective: The primary aim of this study was to examine USPSTF guideline concordant LDA counseling and factors associated with counseling in nulliparous birthing individuals. Study Design: We conducted a retrospective cohort study of nulliparous birthing individuals who delivered between January 1, 2019, and June 30, 2020, and received prenatal care at the Duke High Risk Obstetrical Clinics (HROB). All nulliparous patients over 18 years old who established or transferred care to HROB by 16 weeks, 6 days were included in the analysis. We excluded patients with more than two previous first-trimester pregnancy losses, multiple gestation, a known contraindication to LDA, initiation of LDA prior to their prenatal care or documented medical history of coagulation disorder. Bivariate associations between demographic/medical characteristics and our primary outcome, receipt of counseling (Yes/No), were assessed using two-sample t-tests for continuous variables and Chi-square or Fisher’s exact test for categorical variables. Factors significantly associated with the primary outcome (p < 0.05) were entered into the multivariable logistic regression model. Results: Among 391 birthing individuals included in the final analysis cohort, 51.7% of eligible patients received guideline consistent LDA counseling. Factors associated with increased odds of LDA counseling were advanced maternal age (adjusted odds ratio [aOR]:1.05, 95% confidence interval [CI]:1.01-1.09), Black race compared to White race (aOR:1.75, 95%CI: 1.03-2.98), chronic hypertension (aOR: 4.17, 95%CI: 1.82-9.55), and obesity (aOR:5.02, 95%CI: 3.12-8.08). Conclusions: Approximately half of all nulliparous birthing individuals had appropriately documented LDA counseling. The USPSTF guidelines on LDA for preeclampsia risk reduction are complex, which may lead to ineffective provider adherence. Efforts to simplify guidelines and improve LDA counseling are vital to ensuring this low-cost, evidence-based preeclampsia prevention is used in a consistent and equitable manner.

Objective This study aims to explore vaccination acceptance among individuals with a history of preterm birth between March and June during the pre-COVID (2019), early-COVID (2020), and late-COVID (2021) periods. Study Design This is a cross-sectional, retrospective cohort study of pregnant individuals with a history of preterm birth ( Results Among 293 pregnancies, influenza vaccination rate was highest in early-COVID (p Conclusion In this study on high-risk pregnant individuals, the majority of our cohort remained unvaccinated against COVID-19 into the late-COVID period. Additionally, their influenza vaccination rates were greater than the national average in early-COVID and substantially lower than the national average in late-COVID. This shift in influenza vaccination acceptance may have been sparked by COVID-19 vaccine distribution beginning in January 2021 leading to overall vaccination hesitancy. Standardized guidelines and counseling concerning prenatal safety in recommended immunizations may serve as important tools of reassurance and health promotion. Key Points

BACKGROUND: Piperacillin/tazobactam is one of the most frequently used antimicrobials in older adults. INTRODUCTION: Using an opportunistic study design we evaluated the pharmacokinetics (PK) of piperacillin/tazobactam as a probe drug to evaluate changes in antibacterial drug exposure and dosing requirements, including in older adults. METHODS: A total of 121 adult patients were included. The population PK models that best characterized the observed plasma concentrations of piperacillin and tazobactam were one-compartment structural models with zero-order input and linear elimination. RESULTS: Among all potential covariates, estimated creatinine clearance had the most substantial impact on the elimination clearance for both piperacillin and tazobactam. After accounting for renal function and body size, there was no remaining impact of frailty on the PK of piperacillin and tazobactam. Monte Carlo simulations indicated that renal function had a greater impact on the therapeutic target attainment than age, although these covariates were highly correlated. Frailty, using the Canadian Study of Health and Aging Clinical Frailty Scale, was assessed in 60 patients who were ≥65 years of age. CONCLUSION: The simulations suggested that adults ≤50 years of age infected with organisms with higher minimum inhibitory concentrations (MICs) may benefit from continuous piperacillin/tazobactam infusions (12 g/day of piperacillin component) or extended infusions of 4 g every 8 hours. However, for a target of 50% fT>MIC, dosing based on renal function is generally preferable to dosing by age, and simulations suggested that patients with creatinine clearance ≥120 mL/min may benefit from infusions of 4 g every 8 hours for organisms with higher MICs.

OBJECTIVE To evaluate race and ethnicity differences in cesarean birth and maternal morbidity in low-risk nulliparous people at term. METHODS We conducted a secondary analysis of a randomized trial of expectant management compared with induction of labor in low-risk nulliparous people at term. The primary outcome was cesarean birth. Secondary outcome was maternal morbidity, defined as: transfusion of 4 or more units of red blood cells, any transfusion of other products, postpartum infection, intensive care unit admission, hysterectomy, venous thromboembolism, or maternal death. Multivariable modified Poisson regression was used to evaluate associations between race and ethnicity, cesarean birth, and maternal morbidity. Indication for cesarean birth was assessed using multivariable multinomial logistic regression. A mediation model was used to estimate the portion of maternal morbidity attributable to cesarean birth by race and ethnicity. RESULTS Of 5,759 included participants, 1,158 (20.1%) underwent cesarean birth; 1,404 (24.3%) identified as non-Hispanic Black, 1,670 (29.0%) as Hispanic, and 2,685 (46.6%) as non-Hispanic White. Adjusted models showed increased relative risk of cesarean birth among non-Hispanic Black (adjusted relative risk [aRR] 1.21, 95% CI 1.03-1.42) and Hispanic (aRR 1.26, 95% CI 1.08-1.46) people compared with non-Hispanic White people. Maternal morbidity affected 132 (2.3%) individuals, and was increased among non-Hispanic Black (aRR 2.05, 95% CI 1.21-3.47) and Hispanic (aRR 1.92, 95% CI 1.17-3.14) people compared with non-Hispanic White people. Cesarean birth accounted for an estimated 15.8% (95% CI 2.1-48.7%) and 16.5% (95% CI 4.0-44.0%) of excess maternal morbidity among non-Hispanic Black and Hispanic people, respectively. CONCLUSION Non-Hispanic Black and Hispanic nulliparous people who are low-risk at term undergo cesarean birth more frequently than low-risk non-Hispanic White nulliparous people. This difference accounts for a modest portion of excess maternal morbidity.

BACKGROUND: Primary cytomegalovirus (CMV) infection during pregnancy carries a risk of congenital infection and possible severe sequelae. There is no established intervention for preventing congenital CMV infection. METHODS: In this multicenter, double-blind trial, pregnant women with primary CMV infection diagnosed before 24 weeks’ gestation were randomly assigned to receive a monthly infusion of CMV hyperimmune globulin (at a dose of 100 mg per kilogram of body weight) or matching placebo until delivery. The primary outcome was a composite of congenital CMV infection or fetal or neonatal death if CMV testing of the fetus or neonate was not performed. RESULTS: From 2012 to 2018, a total of 206,082 pregnant women were screened for primary CMV infection before 23 weeks of gestation; of the 712 participants (0.35%) who tested positive, 399 (56%) underwent randomization. The trial was stopped early for futility. Data on the primary outcome were available for 394 participants; a primary outcome event occurred in the fetus or neonate of 46 of 203 women (22.7%) in the group that received hyperimmune globulin and of 37 of 191 women (19.4%) in the placebo group (relative risk, 1.17; 95% confidence interval [CI], 0.80 to 1.72; P = 0.42). Death occurred in 4.9% of fetuses or neonates in the hyperimmune globulin group and in 2.6% in the placebo group (relative risk, 1.88; 95% CI, 0.66 to 5.41), preterm birth occurred in 12.2% and 8.3%, respectively (relative risk, 1.47; 95% CI, 0.81 to 2.67), and birth weight below the 5th percentile occurred in 10.3% and 5.4% (relative risk, 1.92; 95% CI, 0.92 to 3.99). One participant in the hyperimmune globulin group had a severe allergic reaction to the first infusion. Participants who received hyperimmune globulin had a higher incidence of headaches and shaking chills while receiving infusions than participants who received placebo. CONCLUSIONS: Among pregnant women, administration of CMV hyperimmune globulin starting before 24 weeks’ gestation did not result in a lower incidence of a composite of congenital CMV infection or perinatal death than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences; ClinicalTrials.gov number, NCT01376778.)

Objective The objective of this study is to evaluate whether there is an association between in-utero exposure to nicotine and subsequent hearing dysfunction. Patients and Methods Secondary analysis of a multicenter randomized trial to prevent congenital cytomegalovirus (CMV) infection among gravidas with primary CMV infection was conducted. Monthly intravenous immunoglobulin hyperimmune globulin therapy did not influence the rate of congenital CMV. Dyads with missing urine, fetal or neonatal demise, infants diagnosed with a major congenital anomaly, congenital CMV infection, or with evidence of middle ear dysfunction were excluded. The primary outcome was neonatal hearing impairment in one or more ears defined as abnormal distortion product otoacoustic emissions (DPOAEs; 1 to 8 kHz) that were measured within 42 days of birth. DPOAEs were interpreted using optimized frequency-specific level criteria. Cotinine was measured via enzyme-linked immunosorbent assay kits in maternal urine collected at enrollment and in the third trimester (mean gestational age 16.0 and 36.7 weeks, respectively). Blinded personnel ran samples in duplicates. Maternal urine cotinine >5 ng/mL at either time point was defined as in-utero exposure to nicotine. Multivariable logistic regression included variables associated with the primary outcome and with the exposure (p Results Of 399 enrolled patients in the original trial, 150 were included in this analysis, of whom 46 (31%) were exposed to nicotine. The primary outcome occurred in 18 (12%) newborns and was higher in nicotine-exposed infants compared with those nonexposed (15.2 vs. 10.6%, odds ratio [OR] 1.52, 95% confidence interval [CI] 0.55–4.20), but the difference was not significantly different (adjusted odds ratio [aOR] = 1.0, 95% CI 0.30–3.31). This association was similar when exposure was stratified as heavy (>100 ng/mL, aOR 0.72, 95% CI 0.15–3.51) or mild (5–100 ng/mL, aOR 1.28, 95% CI 0.33–4.95). There was no association between nicotine exposure and frequency-specific DPOAE amplitude. Conclusion In a cohort of parturients with primary CMV infection, nicotine exposure was not associated with offspring hearing dysfunction assessed with DPOAEs. Key Points

Background Influenza A/H5N8 viruses infect poultry and wild birds in many countries. In 2021, the first human A/H5N8 cases were reported. Methods We conducted a phase I, cohort-randomized, double-blind, controlled trial of inactivated influenza A/H5N8 vaccine (clade 2.3.4.4c) administered with or without adjuvant. Cohort 1 subjects received either two doses of AS03-adjuvanted vaccine containing 3.75 μg or 15 μg hemagglutinin (HA); two doses of 15 μg HA unadjuvanted vaccine; or one dose of AS03-adjuvanted vaccine (3.75 μg or 15 μg HA), followed by one dose of non-adjuvanted vaccine (same HA content). Cohort 2 subjects received two doses of MF59-adjuvanted vaccine containing 3.75 μg or 15 μg HA, or 15 μg HA of non-adjuvanted vaccine. Subjects were followed for 13 months for safety and immunogenicity. Results We enrolled 386 adult subjects in good health. Solicited adverse events were generally mild and more common among subjects who received adjuvanted vaccines. Antibody responses (hemagglutination inhibition or microneutralization assays) were highest in the two-dose AS03 group, followed by the one-dose AS03 group, the MF59 groups, and the non-adjuvanted groups. Antibody levels returned to baseline 12 months after the second vaccination in all groups except the 15 μg AS03-adjuvanted group. Cross-reactive antibodies to clade 2.3.4.4b strains isolated from recent human cases were demonstrated in a subset of both 15 μg adjuvanted groups. Conclusions Two doses of influenza A/H5N8 vaccine were well-tolerated. Immunogenicity improved with receipt of two doses of adjuvanted vaccine and higher antigen content. (Funded by the National Institute of Allergy and Infectious Diseases

Objective In the antenatal late preterm steroids (ALPS) trial betamethasone significantly decreased short-term neonatal respiratory morbidity but increased the risk of neonatal hypoglycemia, diagnosed only categorically ( Study Design Secondary analysis of infants from ALPS, a multicenter trial randomizing women at risk for late preterm delivery to betamethasone or placebo. This study was a reabstraction of all available charts from the parent trial, all of which were requested. Unreviewed charts included those lost to follow-up or from sites not participating in the reabstraction. Duration of hypoglycemia ( Results Of 2,831 randomized, 2,609 (92.2%) were included. There were 387 (29.3%) and 223 (17.3%) with hypoglycemia in the betamethasone and placebo groups, respectively (relative risk [RR]: 1.69, 95% confidence interval [CI]: 1.46–1.96). Hypoglycemia generally occurred in the first 24 hours in both groups: 374/385 (97.1%) in the betamethasone group and 214/222 (96.4%) in the placebo group (p = 0.63). Of 387 neonates with hypoglycemia in the betamethasone group, 132 (34.1%) received treatment, while 73/223 (32.7%) received treatment in placebo group (p = 0.73). The lowest recorded blood sugar was similar between groups. Most hypoglycemia resolved by 24 hours in both (93.0 vs. 89.3% in the betamethasone and placebo groups, respectively, p = 0.18). Among infants with hypoglycemia in the first 24 hours, the time to resolution was shorter in the betamethasone group (2.80 [interquartile range: 2.03–7.03) vs. 3.74 (interquartile range: 2.15–15.08) hours; p = 0.002]. Persistence for >72 hours was rare and similar in both groups, nine (2.4%, betamethasone) and four (1.9%, placebo, p = 0.18). Conclusion In this cohort, hypoglycemia was transient and most received no treatment, with a quicker resolution in the betamethasone group. Prolonged hypoglycemia was uncommon irrespective of steroid exposure. Key Points

Vaccine hesitancy is a persistent but under-prioritized issue in North Carolina. Plans are needed for systematic data collection on vaccine hesitancy trends, enhancing access to trusted sources of information, strengthening policies encouraging vaccinations, and reducing missed vaccination opportunities to inform a multifaceted strategy for reducing vaccine hesitancy in North Carolina.

OBJECTIVE To compare risks of maternal and perinatal outcomes by completed week of gestation from 39 weeks in low-risk nulliparous patients undergoing expectant management. METHODS We conducted a secondary analysis of a multicenter randomized trial of elective induction of labor at 39 weeks of gestation compared with expectant management in low-risk nulliparous patients. Participants with nonanomalous neonates, who were randomized to and underwent expectant management and attained 39 0/7 weeks of gestation, were included. Delivery gestation was categorized by completed week: 39 0/7-39 6/7 (39 weeks), 40 0/7-40 6/7 (40 weeks), and 41 0/7-42 2/7 (41-42 weeks) (none delivered after 42 2/7). The coprimary outcomes were cesarean delivery and a perinatal composite (death, respiratory support, 5-minute Apgar score 3 or less, hypoxic ischemic encephalopathy, seizure, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support). Other outcomes included a maternal composite (blood transfusion, surgical intervention for postpartum hemorrhage, or intensive care unit admission), hypertensive disorders of pregnancy, peripartum infection, and neonatal intermediate or intensive care unit admission. For multivariable analysis, P

Background Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. Methods The reported data span 21 March to 16 June 2020 for hospitalized pregnant women with polymerase chain reaction–confirmed severe acute respiratory syndrome coronavirus 2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200 mg on day 1, followed by 100 mg for days 2–10, given intravenously). Results Nineteen of 86 women delivered before their first dose and were reclassified as immediate “postpartum” (median postpartum day 1 [range, 0–3]). At baseline, 40% of pregnant women (median gestational age, 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (AEs) (16%). Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were grade 1 or 2. There was 1 maternal death attributed to underlying disease and no neonatal deaths. Conclusions Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate-use remdesivir, recovery rates were high, with a low rate of serious AEs., Among 86 pregnant and postpartum women with severe coronavirus disease 2019 who received compassionate-use remdesivir, recovery rates from serious infection were high with a low rate of serious adverse events.

Objective Inactivated influenza virus vaccines (IIVs) are recommended for all pregnant women in the United States. We conducted a prospective, randomized, double blind study of three licensed seasonal trivalent IIVs (IIV3s) to assess their safety and immunogenicity in pregnant women and determine the level and persistence of passively transferred maternal antibody in infants. Study design 139 pregnant women ages 18–39 years and 14–33 weeks’ gestation, and 44 non-pregnant women, were randomized 1:1:1 to receive a single intramuscular dose of one of three licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®) prior to the 2010–2011 influenza season. Reactogenicity, adverse events (AEs) and pregnancy outcomes were documented. Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays were collected prior to and 28 and 180 days after immunization. Maternal sera and cord blood were collected at the time of delivery and sera were obtained from 44 infants at 6 weeks of age. Results Pregnant and non-pregnant women experienced similar frequency of injection site (92% and 86%, respectively) and systemic (95% and 87%, respectively) reactions, the majority of which were mild. There were no vaccine-associated maternal or infant serious AEs. Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women. The ratios of cord blood (infant) to maternal HAI antibody titers at delivery ranged between 1.1 and 1.7 for each of the vaccine antigens. Influenza antibody concentrations in infants were 70–40% of the birth titer by 6 weeks of age. Conclusions The three IIV3s were well tolerated in pregnant women. Antibody responses were comparable in pregnant and non-pregnant women, and after second or third trimester vaccination. Transplacental transfer of maternal antibodies to the infant was efficient. However, antibody titers decline rapidly in the first 6 weeks of life.

OBJECTIVE: This study explores OB/GYN providers’ knowledge about published health and healthcare disparities in women’s reproductive health. METHOD: We collected demographic and health disparities knowledge information from OB/GYN providers who were members of ACOG District IV using an online survey (n=483). We examined differences across groups using statistical tests and regression analyses in a structural equation modeling approach. RESULTS: Receiving disparities education was positively associated with higher self-reported disparities knowledge and disparities quiz performance (p

Administration of vaccines during pregnancy provides maternal protection against infectious diseases. This protection is extended to their infants during the first months of life, as pathogen-specific antibodies formed in response to maternal vaccination are transferred across the placenta to the fetus. Notably, Tdap (tetanus-diphtheria-acellular pertussis) vaccination booster is routinely administered to pregnant women both to prevent neonatal tetanus and to ensure that infants have protective levels of pertussis antibodies until they are able to establish their own vaccine-induced levels. Whether infant protection through maternal immunization is merely due to an increase in maternal antibody levels or whether maternal immunization enhances the transfer of vaccine-specific antibodies is unclear. Moreover, the potential impact of prenatal vaccinations on the transplacental transfer of other antibodies, such as antibodies raised as a result of infections or other vaccines administered prior to pregnancy, has not been studied. The goal of this study was to define the impact of maternal vaccination on IgG transplacental transfer efficiency. We analyzed antigen-specific antibody populations and IgG subclass distribution in maternal and cord blood samples from 58 mother-infant pairs. All women received the seasonal inactivated influenza vaccine during pregnancy and 25 women received the Tdap vaccine during the second or third trimester of gestation. Prenatal Tdap vaccination did not impact the efficiency of IgG transplacental transfer; however, it was associated with higher maternal and infant vaccine-elicited Tdap-specific antibody levels, and with a higher proportion of infants with protective levels of antibodies, especially against diphtheria. There was also no difference in the IgG transplacental transfer rate of antibodies against non-Tdap vaccines between the two groups of women. Our results confirm previous reports demonstrating the benefits of prenatal Tdap immunization and indicate that this strategy does not impede the transplacental transfer of other antibodies that are also important for infant protection.

The Project Baseline Health Study (PBHS) was launched to map human health through a comprehensive understanding of both the health of an individual and how it relates to the broader population. The study will contribute to the creation of a biomedical information system that accounts for the highly complex interplay of biological, behavioral, environmental, and social systems. The PBHS is a prospective, multicenter, longitudinal cohort study that aims to enroll thousands of participants with diverse backgrounds who are representative of the entire health spectrum. Enrolled participants will be evaluated serially using clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, and other health-related measurements. An initial deeply phenotyped cohort will inform the development of a large, expanded virtual cohort. The PBHS will contribute to precision health and medicine by integrating state of the art testing, longitudinal monitoring and participant engagement, and by contributing to the development of an improved platform for data sharing and analysis.

Objective The aim of the study was to test the hypothesis that 5% monolaurin vaginal gel, a naturally occurring monoglyceride shown to have antimicrobial effects on vaginal pathogens without affecting Lactobacillus species, cures bacterial vaginosis (BV). Materials and methods This was a multicenter, double-blinded, randomized controlled trial comparing 5% monolaurin vaginal gel to vehicle placebo (glycol-based) gel administered twice daily for 3 days. Nonpregnant, nonbreastfeeding women between ages 18 and 50 years were recruited and BV confirmed. Primary outcome was clinical cure assessed by resolution of all 4 Amsel criteria. Secondary outcomes included safety and tolerability assessed by solicited urogenital adverse events. Exploratory outcomes included colony counts for vaginal microbes associated with healthy vaginal flora (Lactobacillus species) and the dysbiosis often associated with BV (Gardnerella species and Mobiluncus species). A 2:1 test article to placebo randomization scheme was planned. Results One hundred nine women participated with 73 randomized to the treatment arm and 36 to the placebo arm. There was no significant difference in clinical cure for BV (p = .42) with 17% of the monolaurin group and 25% of the placebo group achieving clinical cure. Lactobacilli species counts increased in the monolaurin group compared with placebo (1.0 × 10 vs -5.2 × 10). Two thirds of both groups reported solicited urogenital adverse events, but these were mild to moderate with no significant difference between groups (p = .24). Conclusions Monolaurin was no more clinically or microbiologically effective than placebo in curing BV. Future research should explore whether monolaurin may be used to increase Lactobacilli species.

Objective The aim of the study is to evaluate the association between amniotomy at various time points during labor induction and maternal and neonatal outcomes among term, nulliparous women. Study Design Secondary analysis of a randomized trial of term labor induction versus expectant management in low-risk, nulliparous women (2014–2017) was conducted. Women met inclusion criteria if they underwent induction ≥38 weeks' gestation using oxytocin with documented time and type of membrane rupture. Women with antepartum stillbirth or fetal anomaly were excluded. The primary outcome was cesarean delivery. Secondary outcomes included maternal and neonatal complications. Maternal and neonatal outcomes were compared among women with amniotomy versus women with intact membranes and no amniotomy at six 2-hour time intervals: before oxytocin initiation, 0 to Results Of 6,106 women in the parent trial, 2,854 (46.7%) women met inclusion criteria. Of these 2,340 (82.0%) underwent amniotomy, and majority of the women had amniotomy performed between 2 and 24 hours. Amniotomy at time intervals ≥2 hours and 3 days. Amniotomy was not associated with postpartum or neonatal complications. Conclusion Among a contemporary cohort of nulliparous women undergoing term labor induction, amniotomy was associated with either lower or similar odds of cesarean delivery and other adverse outcomes, compared with no amniotomy.

Navigating the research domain at an academic medical center can be challenging, even for seasoned investigators. To address this, Duke University launched two initiatives: (1) a research navigation “hotline” to provide brief assistance with a variety of research questions; and (2) researcher onboarding and consultation, a one-to-one tailored offering to ensure that researchers are equipped to navigate research resources and processes effectively. The services are provided by the myRESEARCHnavigators (MRN) team, funded by Duke’s CTSA. The diverse scientific backgrounds of the six team members align well with those of the research community, allowing for a good match between the researcher and MRN team member. The MRN team answers approximately 30 questions per month, and has provided consultations to almost 400 researchers. Both services receive high satisfaction ratings (4 or 5 stars [out of 5 stars] given to 90% of hotline answers, and 99% of researcher onboarding/consultation sessions). As of July 2019, the School of Medicine has determined that the consultations are critical to their mission and have made them a requirement for new research faculty. The team will continue marketing both services to encourage adoption.

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 (

To compare health care medical resource utilization in low-risk nulliparous pregnancies according to body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) categories.This is a secondary analysis of a multicenter randomized controlled trial of induction of labor between 39 0/7 39 and 4/7 weeks of gestation compared with expectant management in low-risk nulliparous pregnant people, defined as those without standard obstetric indications for delivery at 39 weeks. Body mass index at randomization was categorized into four groups (lower than 25, 25-29, 30-39, and 40 or higher). The primary outcome of this analysis was time spent in the labor and delivery department from admission to delivery. Secondary outcomes included length of stay (LOS) postdelivery, total hospital LOS, and antepartum, intrapartum, and postpartum resource utilization, which were defined a priori. Multivariable generalized linear modeling and logistic regressions were performed, and 99% CIs were calculated.A total of 6,058 pregnant people were included in the analysis; 640 (10.6%) had BMIs of lower than 25, 2,222 (36.7%) had BMIs between 25 and 29, 2,577 (42.5%) had BMIs of 30-39, and 619 (10.2%) had BMIs of 40 or higher. Time spent in the labor and delivery department increased from 15.1±9.2 hours for people with BMIs of lower than 25 to 23.5±13.6 hours for people with BMIs of 40 or higher, and every 5-unit increase in BMI was associated with an average 9.8% increase in time spent in the labor and delivery department (adjusted estimate per 5-unit increase in BMI 1.10, 99% CI 1.08-1.11). Increasing BMI was not associated with an increase in antepartum resource utilization, except for blood tests and urinalysis. However, increasing BMI was associated with higher odds of intrapartum resource utilization, longer total hospital LOS, and postpartum resource utilization. For example, every 5-unit increase in BMI was associated with an increase of 26.1% in the odds of antibiotic administration, 57.6% in placement of intrauterine pressure catheter, 5.1% in total inpatient LOS, 31.0 in postpartum emergency department visit, and 23.9% in postpartum hospital admission.Among low-risk nulliparous people, higher BMI was associated with longer time from admission to delivery, total hospital LOS, and more frequent utilization of intrapartum and postpartum resources.ClinicalTrials.gov, NCT01990612.

To evaluate whether hypertensive disorders of pregnancy (HDP) among low-risk nulliparous women expectantly managed at or after 39 weeks of gestation are associated with adverse outcomes.Secondary analysis of a randomised trial.Multicentre, USA.Individuals in the expectantly managed group who delivered on or after 39 weeks.Multivariable analysis to estimate adjusted relative risks (aRR) for binomial outcomes, adjusted odds ratios (aOR) for multinomial outcomes and 95% CI.Composite adverse maternal outcome including placental abruption, pulmonary oedema, postpartum haemorrhage, postpartum infection, venous thromboembolism or intensive care unit admission. Secondary outcomes included a composite of perinatal death or severe neonatal complications, mode of delivery, small and large for gestational age and neonatal intermediate or intensive unit length of stay.Of the 3044 women randomised to expectant management in the original trial, 2718 (89.3%) were eligible for this analysis, of whom 373 (13.7%) developed HDP. Compared with participants who remained normotensive, those who developed HDP were more likely to experience the maternal composite (12% versus 6%, aRR 1.84, 95% CI 1.33-2.54) and caesarean delivery (29% versus 23%, aOR 1.32, 95% CI 1.01-1.71). Differences between the two groups were not significantly different for the adverse perinatal composite (7% versus 5%, aRR 1.38, 95% CI 0.92-2.07) or for other secondary outcomes.Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed HDP, and were more likely to experience adverse maternal outcomes compared with those who did not develop HDP.Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed hypertensive disorders of pregnancy, and were more likely to experience adverse maternal outcomes compared with those who did not develop hypertensive disorders.

Objective Non-Hispanic Black birthing individuals are at increased risk of preterm birth compared to other racial and ethnic groups. In our clinical setting, we offer a tailored package of recommendations to reduce the risk of preterm birth known as an individualized prematurity prevention plan (IP3). Patient-centered, community engaged interventions that address patient-perceived barriers to preterm birth prevention are urgently needed. Materials and methods We engaged a group of stakeholders to develop a mutli-level (patient-centered and community-involved) intervention that will increase adherence to an individualized prematurity prevention plan (IP3) by addressing barriers identified during our prior qualitative studies. Results The intervention includes trained doulas from a community-led, Black owned doula group. The doulas will moderate group prenatal social support sessions. In between the group sessions, participants will be encouraged to continue interacting with one another and the doulas using a private Facebook™ group page. We will pilot test the intervention in a cohort of pregnant, self-identified non-Hispanic Black patients with a history of prior preterm birth. Conclusion We present a novel, patient-centered, community engaged intervention to reduce preterm birth in high-risk non-Hispanic Black birthing individuals. If the intervention is feasible based on the pilot study findings, we anticipate conducting an appropriately powered study to determine whether the intervention achieves our goal of reducing preterm birth.

To develop and internally validate a noninvasive method for the prediction of congenital cytomegalovirus (CMV) infection after primary maternal CMV infection.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).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).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.

Objectives The US preterm birth rate varies dramatically by race and ethnicity yet the racial and ethnic representation within studies evaluating 17-hydroxprogesterone caproate (17-P) for preterm birth prevention is unknown. The objectives of our study were to 1) examine the racial and ethnic representation of participants in 17-P preterm birth prevention studies, 2) evaluate adherence to the NIH race and ethnicity reporting guidelines and 3) compare racial and ethnic representation in research studies to national preterm birth incidence. Methods We systematically reviewed US studies published between January 2000 and December 2019. Study participant’s race and ethnicity were reported using descriptive statistics then compared to US 2017//2018 preterm birth data using Pearson’s chi-square. Results Eighteen studies met the inclusion criteria, 17 studies reported race, 11 studies reported ethnicity, and yet none of the studies followed the NIH criteria. Compared to 2017/2018 US preterm births, the proportion of black/African American study participants was significantly higher whereas the proportions of all other race categories were lower. Conclusions More detailed reporting of race and ethnicity is needed in 17-P literature. Black women appear to be well represented while other racial and ethnic groups may be understudied.

This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals. This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (LD) stay. Multivariable analysis was used to adjust for patient characteristics. Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter LD stay (adjusted mean difference = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE. In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of LD stay was the shortest with concurrent Foley-oxytocin.· Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial..

Botulism is a rare, life-threatening paralytic disease caused by Clostridium botulinum neurotoxin (BoNT). Available treatments, including an equine antitoxin and human immune globulin, are given postexposure and challenging to produce and administer. NTM-1632 is an equimolar mixture of 3 human IgG monoclonal antibodies, B1, B2, and B3, targeting BoNT serotype B (BoNT/B). This first-in-human study assessed the safety, tolerability, pharmacokinetics (PK), and immunogenicity of NTM-1632. This double-blind, single-center, placebo-controlled dose escalation study randomized 3 cohorts of healthy volunteers to receive a single intravenous dose of NTM-1632 (0.033, 0.165, or 0.330 mg/kg) or saline placebo. Safety monitoring included physical examinations, clinical laboratory studies, and vital signs. Blood sampling was performed at prespecified time points for PK and immunogenicity analyses. Twenty-four subjects received study product (18 NTM-1632; 6 placebo), and no deaths or serious adverse events were reported. Adverse events in the NTM-1632 groups were generally mild and similar in frequency and severity to the placebo group, and no safety signal was identified. NTM-1632 has a favorable PK profile with a half-life of >20 days for the 0.330-mg/kg dose and an approximately linear relationship with respect to maximum concentration and area under the concentration-time curve (AUC0→t). NTM-1632 demonstrated low immunogenicity with only a few treatment-emergent antidrug antibody responses in the low and middle dosing groups and none at the highest dose. NTM-1632 is well tolerated at the administered doses. The favorable safety, PK, and immunogenicity profile of NTM-1632 supports further clinical development as a treatment for BoNT/B intoxication and postexposure prophylaxis. (This study has been registered at ClinicalTrials.gov under identifier NCT02779140.)

BackgroundA key mitigation strategy to the COVID-19 pandemic has been the development and roll-out of vaccines. However, pregnant and lactating people were not included in initial vaccine trials and this population is hesitant to receive the vaccine, despite contrary recommendations from the American College of Obstetrics and Gynecology and the Centers for Disease Control and Prevention. Understanding the reasons behind this hesitancy is vital to promote vaccine uptake.MethodsWe surveyed pregnant people in California from December 2020 to January 2021 (n=387) to describe cognitions and decision-making regarding COVID-19 vaccination. Using descriptive, regression-based analyses, we examined rates of planned uptake and reasoning among individuals who reported COVID-19 vaccine hesitancy.ResultsOverall, the pregnant Californians that we surveyed were aware of the COVID-19 vaccines. Of 387 participants, 43% reported planning to get the vaccine as soon as possible. The remaining 57% were hesitant: 27% responded that they would not receive the vaccine. Some demographic features did predict more COVID-19 vaccine hesitancy, particularly younger age (AOR=0.95, p=0.025) and living in a less urban context (AOR=0.80, p=0.041). Essential worker status also was associated with vaccine hesitancy. Having had, or intending to have, a flu vaccine was negatively associated with COVID-19 vaccine hesitancy (p&nbsp

Women with a history of a preterm birth (PTB) are at high risk for recurrence. Weekly 17-hydroxyprogestrone caproate (17-P) injections can reduce the risk of recurrence in women with prior spontaneous PTB. PTB occurs disproportionately in non-Hispanic black (NHB) women, and uptake and adherence to 17-P among NHB women are lower compared to women in other racial/ethnic groups. Evidence-based interventions to improve 17-P uptake and adherence that incorporate women's perceptions and preferences are needed. Our objective was to identify women's perspectives and preferences for interventions to promote uptake of and adherence to 17-P, particularly among NHB women. We conducted an exploratory sequential mixed methods study using focus group discussions (FGDs), a survey, and in-depth interviews (IDIs). We recruited women with a history of PTB who self-identified as NHB for the FGDs and IDIs. Survey participation was open to any woman with a history of PTB regardless of their race and ethnicity. Women could only participate in one of the three data collection activities. Transcripts from the qualitative focus groups and in-depth interviews were analyzed using applied thematic analysis. Descriptive statistics was used to analyze the quantitative survey. Eighty-two women participated in the study (FGDs [n = 7], surveys [n = 60], and IDIs [n = 15]). Suggested interventions were separated into two categories: (1) clinic-based interventions (i.e., interventions delivered during the clinical encounter) and (2) community-based interventions (i.e., interventions delivered outside of the clinical encounter). Clinic level interventions included improved clinic access and scheduling, same-day appointments, appointment reminders, making the clinic experience more comfortable for patients, and encouragement from providers. Interventions at the community level included increased 17-P awareness among support persons, employers, and community members and administration of 17-P outside the clinic setting. Our findings offer multiple potential interventions that could improve uptake of and adherence to 17-P for PTB prevention among NHB women. These proposed interventions have the potential to mitigate barriers to 17-P and narrow the disparity in PTB rates. Given the alarming and increasing rates of prematurity and PTB disparities, it is imperative to test, refine, and incorporate effective interventions into clinical practice. Our findings provide insights from patients that can help shape such interventions.

Objective This study aimed to evaluate the association between clinical and examination features at admission and late preterm birth. Study Design The present study is a secondary analysis of a randomized trial of singleton pregnancies at 340/7 to 365/7 weeks' gestation. We included women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term). We calculated a statistical cut-point optimizing the sensitivity and specificity of initial cervical dilation and effacement at predicting preterm birth and used multivariable regression to identify factors associated with late preterm delivery. Results A total of 431 out of 732 (59%) women delivered preterm. Cervical dilation ≥ 4 cm was 60% sensitive and 68% specific for late preterm birth. Cervical effacement ≥ 75% was 59% sensitive and 65% specific for late preterm birth. Earlier gestational age at randomization, nulliparity, and fetal malpresentation were associated with late preterm birth. The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68–0.75, and p-value Conclusion Four in 10 women in late-preterm labor subsequently delivered at term. Combination of examination and clinical features (including parity and gestational age) improved late-preterm birth prediction.

Introduction Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone. Methods We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3–5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day. Results Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%–12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction. Conclusions Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit. Implications A disseminable texting program helped some pregnant women quit smoking. Clinical Trial Registration number: NCT01995097.

Objective To examine the association between perioperative Beta (β))-lactam versus non-β-lactam antibiotics and cesarean delivery surgical site infection (SSI). Study Design Retrospective cohort of women undergoing cesarean delivery from January 1 to December 31, 2014. All women undergoing cesarean after 34 weeks with a postpartum visit were included. Prevalence of SSI was compared between women receiving β-lactam versus non-β-lactam antibiotics. Bivariate analyses were performed using Pearson's Chi-square, Fisher's exact, or Wilcoxon's rank-sum tests. Logistic regression models were fit controlling for possible confounders. Results Of the 929 women included, 826 (89%) received β-lactam prophylaxis and 103 (11%) received a non-β-lactam. Among the 893 women who reported a non-type I (low risk) allergy, 819 (92%) received β-lactam prophylaxis. SSI occurred in 7% of women who received β-lactam antibiotics versus 15% of women who received a non-β-lactam (p = 0.004). β-Lactam prophylaxis was associated with lower odds of SSI compared with non-β-lactam antibiotics (odds ratio [OR] = 0.43; 95% confidence interval [CI] = 0.22–0.83; p = 0.01) after controlling for chorioamnionitis in labor, postlabor cesarean, endometritis, tobacco use, and body mass index (BMI). Conclusion β-Lactam perioperative prophylaxis is associated with lower odds of a cesarean delivery surgical site infection compared with non-β-lactam antibiotics.

Objective Weekly 17-hydroxyprogesterone caproate (17OHP-C) from 16 to 36 weeks' gestation reduces the risk of recurrent spontaneous preterm birth (sPTB). Limited data suggest poor adherence to published guidelines. This study aimed to identify factors associated with 17OHP-C utilization. Study Design This retrospective cohort study included women with a singleton pregnancy who delivered within one academic health system between January 2014 and December 2015. Eligible women had a history of ≥1 singleton sPTB. Primary outcomes were counseling about, receipt of, and adherence to 17OHP-C therapy. Demographic and clinical predictors of the primary outcomes were determined using stepwise logistic regression. Results Of 410 eligible subjects, 69% (N = 284) were counseled about and 36% (N = 148) received 17OHP-C. Hispanic ethnicity, delay in prenatal care initiation, and a history of prior term births were associated with lower odds of 17OHP-C counseling. Each week delay in prenatal care initiation, Hispanic ethnicity, and each additional week's gestation of the earliest prior sPTB decreased the odds of receiving 17OHP-C. Maternal age and prior term births were associated with adherence. Conclusion Utilization of evidence-based 17OHP-C therapy remains suboptimal: cultural and access-to-care barriers for eligible women may impede efforts to decrease recurrent sPTB rates.

To reduce the risk of recurrence, women with a history of spontaneous preterm birth (PTB) are recommended to receive 17-hydroxyprogesterone caproate (17-P) injections starting by the 20th week of pregnancy. In women eligible for 17-P, we aimed to identify patient factors and geospatial locations associated with increased risk of presentation beyond 20 weeks gestation.We conducted a secondary analysis of a retrospective cohort study including all women meeting criteria for 17-P within a single academic medical center over a 2-year period. We compared early ( 20 6/7 weeks) with late ( 21 weeks) presenters via demographics, social history, and index pregnancy outcomes using standard and Bayesian statistical models. Geospatial mapping was performed to determine residential areas with high risk for late presentation.Geocoded address data was available for 351 women in whom the mean gestational age at first visit was 14.9 weeks, and 63 of whom were late presenters (17.9%). Younger maternal age, current smoking, and lack of health insurance were predictors of late presentation with greater than 95% probability. Hispanic ethnicity and black race were associated with higher odds of late presentation with 87 and 69% probability, respectively. The area with the latest gestational age at presentation was located within central Durham City and to the northeast.Our study identified patient-level risk factors and geographic locations associated with presentation beyond the recommend window for 17-P initiation. These findings suggest an urgent need for intervention to improve early prenatal care initiation and a target location where such interventions will be most impactful.

BACKGROUND In the Northern Hemisphere, influenza season typically starts in December and lasts through March. Pregnant people are at increased risk for influenza-related morbidity and mortality. Potentially, new viral strains or reduced provider suspicion leading to delayed diagnosis of late-season influenza could result in an increased risk of severe infection. OBJECTIVE This study aimed to assess the incidence and morbidity associated with late-season influenza in pregnancy, compared with influenza in other seasons. STUDY DESIGN This was a retrospective cohort study using the 2007–2018 National Inpatient Sample. Pregnant patients with discharge diagnosis codes consistent with influenza infection were compared on the basis of hospital admission quarter (quarter 1: October to December; quarter 2: January to March; quarter 3: April to June; quarter 4: July to September), with quarter 3 defined as “late-season.” The primary outcome was the severe maternal morbidity composite defined by the Centers for Disease Control and Prevention. The secondary outcomes included sepsis, shock, acute renal failure, acute heart failure, temporary tracheostomy, and invasive mechanical ventilation. Associations between outcomes and quarter of infection were adjusted for age, hospitalization type (antepartum, delivery, or postpartum), and comorbid conditions using relative risk regression, weighted to reflect the National Inpatient Sample design. RESULTS Of 7355 hospitalizations, corresponding to a weighted national estimate of 36,042, 2266 (30.8%) occurred in quarter 1, 4051 (55.0%) in quarter 2, 633 (8.6%) in quarter 3, and 405 (5.5%) in quarter 4. A nonsignificant trend toward higher rates of severe maternal morbidity was seen in the “late-season” compared with other quarters (13.9% [quarter 3] vs 10.5% [quarter 1] vs 12.1% [quarter 2] vs 13.6% [quarter 4]; P=.07). Moreover, sepsis was more common in patients with late-season influenza (8.0% [quarter 3] vs 4.8% [quarter 1] vs 5.8% [quarter 2] vs 5.9% [quarter 4]; P=.03). In the adjusted analyses, patients with late-season influenza had a 1.34 (95% confidence interval, 1.01–1.78) higher risk of severe maternal morbidity and 1.57 (95% confidence interval, 1.06–2.32) higher risk of sepsis than patients with influenza in quarter 1. CONCLUSION Influenza infection between April and June, that is, late-season influenza, is associated with a higher risk of severe maternal morbidity and sepsis in pregnant patients. Obstetrical providers must continue to have awareness and suspicion for influenza infection during these months.