Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial.

Importance: The American College of Obstetricians and Gynecologists recommends a delay in umbilical cord clamping in term neonates for at least 30 to 60 seconds after birth. Most literature supporting this practice is from low-risk vaginal deliveries. There are no published data specific to cesarean delivery. Objective: To compare maternal blood loss with immediate cord clamping vs delayed cord clamping in scheduled cesarean deliveries at term (≥37 weeks). Design, Setting, and Participants: Randomized clinical trial performed at 2 hospitals within a tertiary academic medical center in New York City from October 2017 to February 2018 (follow-up completed March 15, 2018). A total of 113 women undergoing scheduled cesarean delivery of term singleton gestations were included. Interventions: In the immediate cord clamping group (n = 56), cord clamping was within 15 seconds after birth. In the delayed cord clamping group (n = 57), cord clamping was at 60 seconds after birth. Main Outcomes and Measures: The primary outcome was change in maternal hemoglobin level from preoperative to postoperative day 1, which was used as a proxy for maternal blood loss. Secondary outcomes included neonatal hemoglobin level at 24 to 72 hours of life. Results: All of the 113 women who were randomized (mean [SD] age, 32.6 [5.2] years) completed the trial. The mean preoperative hemoglobin level was 12.0 g/dL in the delayed and 11.6 g/dL in the immediate cord clamping group. The mean postoperative day 1 hemoglobin level was 10.1 g/dL in the delayed group and 9.8 g/dL in the immediate group. There was no significant difference in the primary outcome, with a mean hemoglobin change of -1.90 g/dL (95% CI, -2.14 to -1.66) and -1.78 g/dL (95% CI, -2.03 to -1.54) in the delayed and immediate cord clamping groups, respectively (mean difference, 0.12 g/dL [95% CI, -0.22 to 0.46]; P = .49). Of 19 prespecified secondary outcomes analyzed, 15 showed no significant difference. The mean neonatal hemoglobin level, available for 90 neonates (79.6%), was significantly higher with delayed (18.1 g/dL [95% CI, 17.4 to 18.8]) compared with immediate (16.4 g/dL [95% CI, 15.9 to 17.0]) cord clamping (mean difference, 1.67 g/dL [95% CI, 0.75 to 2.59]; P < .001). There was 1 unplanned hysterectomy in each group. Conclusions and Relevance: Among women undergoing scheduled cesarean delivery of term singleton pregnancies, delayed umbilical cord clamping, compared with immediate cord clamping, resulted in no significant difference in the change in maternal hemoglobin level at postoperative day 1. Trial Registration: ClinicalTrials.gov Identifier: NCT03150641.

Observation versus excision of lobular neoplasia on core needle biopsy of the breast.

PURPOSE: Controversy surrounds management of lobular neoplasia (LN), [atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS)], diagnosed on core needle biopsy (CNB). Retrospective series of pure ALH and LCIS reported "upgrade" rate to DCIS or invasive cancer in 0-40%. Few reports document radiologic/pathologic correlation to exclude cases of discordance that are the likely source of most upgrades, and there is minimal data on outcomes with follow-up imaging and clinical surveillance. METHODS: Cases of LN alone on CNB (2001-2014) were reviewed. CNB yielding LN with other pathologic findings for which surgery was indicated were excluded. All patients had either surgical excision or clinical follow-up with breast imaging. All cases included were subject to radiologic-pathologic correlation after biopsy. RESULTS: 178 cases were identified out of 62213 (0.3%). 115 (65%) patients underwent surgery, and 54 (30%) patients had surveillance for > 12 months (mean = 55 months). Of the patients who underwent surgical excision, 13/115 (11%) were malignant. Eight of these 13 found malignancy at excision when CNB results were considered discordant (5 DCIS, and 3 invasive lobular carcinoma), with the remainder, 5/115 (4%), having a true pathologic upgrade: 3 DCIS, and 2 microinvasive lobular carcinoma. Among 54 patients not having excision, 12/54 (22%) underwent subsequent CNB with only 1 carcinoma found at the initial biopsy site. CONCLUSIONS: Surgical excision of LN yields a low upgrade rate when careful consideration is given to radiologic/pathologic correlation to exclude cases of discordance. Observation with interval breast imaging is a reasonable alternative for most cases.

Postpartum Hemorrhage Trends and Outcomes in the United States, 2000-2019.

OBJECTIVE: To analyze temporal trends in and risk factors for postpartum hemorrhage and to analyze the association of risk factors with postpartum hemorrhage-related interventions such as blood transfusion and peripartum hysterectomy. METHODS: This repeated cross-sectional study analyzed delivery hospitalizations from 2000 to 2019 in the National (Nationwide) Inpatient Sample. Trends analyses were conducted using joinpoint regression to estimate the average annual percent change (AAPC) with 95% CIs. Unadjusted and adjusted survey-weighted logistic regression models were performed to evaluate the relationship between postpartum hemorrhage risk factors and likelihood of 1) postpartum hemorrhage, 2) postpartum hemorrhage that requires blood transfusion, and 3) peripartum hysterectomy in the setting of postpartum hemorrhage, with unadjusted odds ratios and adjusted odds ratios with 95% CIs as measures of association. RESULTS: Of an estimated 76.7 million delivery hospitalizations, 2.3 million (3.0%) were complicated by postpartum hemorrhage. From 2000 to 2019, the rate of postpartum hemorrhage increased from 2.7% to 4.3% (AAPC 2.6%, 94% CI 1.7-3.5%). Over the study period, the proportion of deliveries to individuals with at least one postpartum hemorrhage risk factor increased from 18.6% to 26.9% (AAPC 1.9%, 95% CI 1.7-2.0%). Among deliveries complicated by postpartum hemorrhage, blood transfusions increased from 5.4% to 16.7% from 2000 to 2011 and then decreased from 16.7% to 12.6% from 2011 to 2019. Peripartum hysterectomy among hospitalized individuals with postpartum hemorrhage increased from 1.4% to 2.4% from 2000 to 2009, did not change significantly from 2009 to 2016, and then decreased significantly from 2.1% to 0.9% from 2016 to 2019 (AAPC -27.0%, 95% CI -35.2% to -17.6%). Risk factors associated with postpartum hemorrhage and transfusion and hysterectomy in the setting of postpartum hemorrhage included prior cesarean delivery with previa or placenta accreta, placenta previa without prior cesarean delivery, and antepartum hemorrhage or placental abruption. CONCLUSION: Postpartum hemorrhage and related risk factors increased over a 20-year period. Despite the increased postpartum hemorrhage rates, blood transfusions, and hysterectomy rates decreased in recent years.

Deliveries Among Patients With Maternal Hepatitis C Virus Infection in the United States, 2000-2019.

OBJECTIVE: To assess clinical characteristics, trends, and outcomes associated with the diagnosis of hepatitis C virus (HCV) infection during pregnancy. METHODS: This cross-sectional study analyzed delivery hospitalizations using the National Inpatient Sample. Temporal trends in both diagnosis of HCV infection and clinical characteristics associated with HCV infection were analyzed using joinpoint regression to estimate the average annual percent change (AAPC) with 95% CIs. Survey-adjusted logistic regression models were fit to assess the association among HCV infection and preterm delivery, cesarean delivery, and severe maternal morbidity (SMM), adjusting for clinical, medical, and hospital factors with adjusted odds ratios (aORs) as the measure of association. RESULTS: An estimated 76.7 million delivery hospitalizations were included, in which 182,904 (0.24%) delivering individuals had a diagnosis of HCV infection. The prevalence of HCV infection diagnosed in pregnancy increased nearly 10-fold over the study period, from 0.05% in 2000 to 0.49% in 2019, representing an AAPC of 12.5% (95% CI 10.4-14.8%). The prevalence of clinical characteristics associated with HCV infection also increased over the study period, including opioid use disorder (from 10 cases/10,000 birth hospitalizations to 71 cases/10,000 birth hospitalizations), nonopioid substance use disorder (from 71 cases/10,000 birth hospitalizations to 217 cases/10,000 birth hospitalizations), mental health conditions (from 219 cases/10,000 birth hospitalizations to 1,117 cases/10,000), and tobacco use (from 61 cases/10,000 birth hospitalizations to 842 cases/10,000). The rate of deliveries among patients with two or more clinical characteristics associated with HCV infection increased from 26 cases per 10,000 birth hospitalizations to 377 cases per 10,000 delivery hospitalizations (AAPC 13.4%, 95% CI 12.1-14.8%). In adjusted analyses, HCV infection was associated with increased risk for SMM (aOR 1.78, 95% CI 1.61-1.96), preterm birth (aOR 1.88, 95% CI 1.8-1.95), and cesarean delivery (aOR 1.27, 95% CI 1.23-1.31). CONCLUSION: Diagnosis of HCV infection is increasingly common in the obstetric population, which may reflect an increase in screening or a true increase in prevalence. The increase in HCV infection diagnoses occurred in the setting of many baseline clinical characteristics that are associated with HCV infection becoming more common.

Risk for and disparities in critical care during delivery hospitalizations.

BACKGROUND: Need for critical care during delivery hospitalizations may be an important maternal outcome measure, but it is not well characterized. OBJECTIVE: This study aimed to characterize the risks and disparities in critical care diagnoses and interventions during delivery hospitalizations. STUDY DESIGN: This serial cross-sectional study used the 2000-2014 National Inpatient Sample. Here, the primary outcome was a composite of critical care interventions and diagnoses, including mechanical ventilation and intubation, central monitoring, septicemia, coma, acute cerebrovascular disease, extracorporeal membrane oxygenation, Swan-Ganz catheter monitoring, cardiac rhythm conversion, and respiratory failure. Temporal trends, risk of death, and the proportion of deaths with a critical care composite diagnosis were determined. Unadjusted and adjusted log-linear regression models were fit with a critical care composite as the outcome, adjusting for demographic, clinical, and hospital factors. To evaluate the role of critical care interventions in disparities, analyses were stratified by maternal race and ethnicity. RESULTS: Of 45.8 million deliveries identified, 0.21% had a critical care procedure or diagnosis during the delivery hospitalization. Overall, 75.8% of maternal deaths had an associated diagnosis from a critical care composite. The critical composite increased from 17.9 to 30.3 per 10,000 deliveries from 2000 to 2014 with an average annual percentage change of 3.4% (95% confidence interval, 1.3-5.5). Mechanical ventilation and intubation (21.5% of cases) and respiratory failure (54.8% of cases) were the most common diagnoses present in the composite. Although non-Hispanic black women were at 32.4% higher risk than non-Hispanic white women to die in the setting of a critical care diagnosis (2.2% vs 1.7%; P<.01), they were 162% more likely to have a critical care diagnosis (risk ratio, 2.62; 95% confidence interval, 2.58-2.66). Of clinical factors, primary cesarean delivery (adjusted relative risk, 7.54; 95% confidence interval, 7.43-7.65), postpartum hemorrhage (adjusted relative risk, 5.11; 95% confidence interval, 5.02-5.19), and chronic kidney disease (adjusted relative risk, 4.06; 95% confidence interval, 3.89-4.23) were associated with the highest adjusted risk of a critical care composite. CONCLUSION: Three-quarters of maternal deaths were associated with a critical care diagnosis or procedure. The rate of critical care during delivery hospitalizations increased over the study period. Maternal mortality disparities may result from risks of conditions that require critical care rather than the care received once a critical care condition has developed.

Influenza Complicating Delivery Hospitalization and Its Association With Severe Maternal Morbidity in the United States, 2000-2018.

OBJECTIVE: To characterize trends of an influenza diagnosis at delivery hospitalization and its association with severe maternal morbidity. METHODS: We conducted a repeated cross-sectional analysis of delivery hospitalizations using the Nationwide Inpatient Sample from 2000 to 2018. We assessed the association between an influenza diagnosis at delivery hospitalization and severe maternal morbidity excluding transfusion per Centers for Disease Control and Prevention criteria. Secondary outcomes included maternal death and morbidity measures associated with influenza (mechanical intubation and ventilation, sepsis and shock, and acute respiratory distress syndrome [ARDS]) and obstetric complications (preterm birth and hypertensive disorders of pregnancy). We assessed trends of severe maternal morbidity by annual influenza season and the association between influenza and severe maternal morbidity using multivariable log-linear regression, adjusting for demographic, clinical, and hospital characteristics. RESULTS: Of 74.7 million delivery hospitalizations, 23 per 10,000 were complicated by an influenza diagnosis. The rate of severe maternal morbidity was higher with an influenza diagnosis compared with those without influenza (86-410 cases vs 53-70 cases/10,000 delivery hospitalizations). Women with an influenza diagnosis at delivery hospitalization were at an increased risk of severe maternal morbidity compared with those without influenza (2.3 vs 0.7%; adjusted risk ratio 2.24, 95% CI 2.17-2.31). This association held for maternal death, mechanical intubation, sepsis and shock, and ARDS-as well as obstetric complications, including preterm birth and hypertensive disorders of pregnancy. CONCLUSION: Pregnant women with influenza are at increased risk of severe maternal morbidity, as well as influenza-related maternal and obstetric complications. These results emphasize the importance of primary prevention and recognition of influenza infection during pregnancy to reduce downstream maternal morbidity and mortality.

Associations of influenza, chronic comorbid conditions, and severe maternal morbidity among pregnant women in the United States with influenza at delivery hospitalization, 2000-2015.

BACKGROUND: Chronic comorbid conditions increase the risk of influenza-related morbidity. Whether this holds for pregnant women who are at a high risk of complications from influenza remains to be determined. OBJECTIVE: This study aimed to determine whether chronic comorbid conditions are associated with an increased risk of severe maternal morbidity among pregnant women with an influenza diagnosis at delivery hospitalization. STUDY DESIGN: We performed a cross-sectional analysis of delivery hospitalizations complicated by an influenza diagnosis using the National Inpatient Sample from 2000 to 2015. We assessed 4 prevalent chronic comorbid conditions associated with increased influenza complications outside of pregnancy, obstructive lung disease (asthma and chronic obstructive pulmonary disease), chronic hypertension, obesity, and pregestational diabetes mellitus, overall and individually. The primary outcome was severe maternal morbidity, excluding transfusion as defined by the Centers for Disease Control and Prevention, and the secondary outcomes were specific severe maternal morbidity measures that were recognized as influenza-related complications, acute respiratory distress syndrome, mechanical intubation and ventilation, and sepsis and shock. Multivariable survey-weighted log-linear models were used, adjusting for patient, hospital, and clinical characteristics. RESULTS: Of 62.7 million delivery hospitalizations, 144,572 (0.2%) were complicated by an influenza diagnosis at delivery hospitalization (23 cases of influenza per 10,000 delivery hospitalizations) and 36,054 (24.9%) with ≥1 chronic comorbid conditions, of which 77.4% included obstructive lung disease. Pregnant women with an influenza diagnosis at delivery hospitalization with chronic comorbid conditions had a slightly higher risk of severe maternal morbidity than those without (2.6% vs 1.7%; adjusted risk ratio, 1.11; 95% confidence interval, 1.03-1.21) and acute respiratory distress syndrome (0.9% vs 0.5%; adjusted risk ratio, 1.42; 95% confidence interval, 1.23-1.64) and mechanical intubation and ventilation (0.2% vs 0.1%; adjusted risk ratio, 1.92; 95% confidence interval, 1.37-2.69) but a lower risk of sepsis and shock (0.2% vs 0.3%; adjusted risk ratio, 0.57; 95% confidence interval, 0.45-0.73). Regarding specific conditions, obstructive lung disease was associated with an increased risk of severe maternal morbidity (adjusted risk ratio, 1.21; 95% confidence interval, 1.11-1.32) and acute respiratory distress syndrome (adjusted risk ratio, 1.54; 95% confidence interval, 1.32-1.79) and mechanical intubation and ventilation (adjusted risk ratio, 2.80; 95% confidence interval, 2.00-3.91). Chronic hypertension was associated with an increased risk of acute respiratory distress syndrome (adjusted risk ratio, 1.70; 95% confidence interval, 1.16-2.49) but a lower risk of sepsis and shock (adjusted risk ratio, 0.34; 95% confidence interval, 0.13-0.85). Obesity was associated with a lower risk of severe maternal morbidity (adjusted risk ratio, 0.84; 95% confidence interval, 0.74-0.97). Pregestational diabetes mellitus was not associated with severe maternal morbidity. CONCLUSION: Among women with a diagnosis of influenza at delivery hospitalization, chronic comorbid conditions may increase the risk of severe maternal morbidity and particularly outcomes related to influenza. These results can inform efforts to increase influenza vaccination for all pregnant women, in particular those with chronic comorbidities.

Outcomes of Neonates Born to Mothers With Severe Acute Respiratory Syndrome Coronavirus 2 Infection at a Large Medical Center in New York City.

Importance: Limited data on vertical and perinatal transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and health outcomes of neonates born to mothers with symptomatic or asymptomatic coronavirus disease 2019 (COVID-19) are available. Studies are needed to inform evidence-based infection prevention and control (IP&C) policies. Objective: To describe the outcomes of neonates born to mothers with perinatal SARS-CoV-2 infection and the IP&C practices associated with these outcomes. Design, Setting, and Participants: This retrospective cohort analysis reviewed the medical records for maternal and newborn data for all 101 neonates born to 100 mothers positive for or with suspected SARS-CoV-2 infection from March 13 to April 24, 2020. Testing for SARS-CoV-2 was performed using Cobas (Roche Diagnostics) or Xpert Xpress (Cepheid) assays. Newborns were admitted to well-baby nurseries (WBNs) (82 infants) and neonatal intensive care units (NICUs) (19 infants) in 2 affiliate hospitals at a large academic medical center in New York, New York. Newborns from the WBNs roomed-in with their mothers, who were required to wear masks. Direct breastfeeding after appropriate hygiene was encouraged. Exposures: Perinatal exposure to maternal asymptomatic/mild vs severe/critical COVID-19. Main Outcomes and Measures: The primary outcome was newborn SARS-CoV-2 testing results. Maternal COVID-19 status was classified as asymptomatic/mildly symptomatic vs severe/critical. Newborn characteristics and clinical courses were compared across maternal COVID-19 severity. Results: In total, 141 tests were obtained from 101 newborns (54 girls [53.5%]) on 0 to 25 days of life (DOL-0 to DOL-25) (median, DOL-1; interquartile range [IQR], DOL-1 to DOL-3). Two newborns had indeterminate test results, indicative of low viral load (2.0%; 95% CI, 0.2%-7.0%); 1 newborn never underwent retesting but remained well on follow-up, and the other had negative results on retesting. Maternal severe/critical COVID-19 was associated with newborns born approximately 1 week earlier (median gestational age, 37.9 [IQR, 37.1-38.4] vs 39.1 [IQR, 38.3-40.2] weeks; P = .02) and at increased risk of requiring phototherapy (3 of 10 [30.0%] vs 6 of 91 [7.0%]; P = .04) compared with newborns of mothers with asymptomatic/mild COVID-19. Fifty-five newborns were followed up in a new COVID-19 Newborn Follow-up Clinic at DOL-3 to DOL-10 and remained well. Twenty of these newborns plus 3 newborns followed up elsewhere had 32 nonroutine encounters documented at DOL-3 to DOL-25, and none had evidence of SARS-CoV-2 infection, including 6 with negative retesting results. Conclusions and Relevance: No clinical evidence of vertical transmission was identified in 101 newborns of mothers positive for or with suspected SARS-CoV-2 infection, despite most newborns rooming-in and direct breastfeeding practices.

Utility of surveillance MRI in women with a personal history of breast cancer.

PURPOSE: To determine the utility and rate of biopsy in women with a positive history of breast cancer screened with MRI. METHODS: Retrospective review of 491 breast MRI screening examinations in women with a personal history of breast cancer. RESULTS: In total, 107 biopsies were performed, an average of 0.09 biopsies per person year. The positive predictive value for biopsies prompted by MRI findings was 0.24 (95% C.I. 0.10-0.38). Eight of the nine subsequent cancers were initially identified on screening MRI alone. CONCLUSION: Surveillance MRI in breast cancer survivors may increase detection of subsequent cancers while increasing rate of biopsy.