Immediate vs on-demand maternal oral full feeding
BACKGROUND:Acute funisitis-the histologic diagnosis of inflammation within the umbilical cord-represents a fetal inflammatory response and has been associated with adverse neonatal outcomes. Little is known regarding the maternal and intrapartum risk factors associated with the development of acute funisitis among term deliveries complicated by intraamniotic infection. OBJECTIVE:This study aimed to identify the maternal and intrapartum risk factors associated with developing acute funisitis among term deliveries complicated by intraamniotic infection. STUDY DESIGN:After institutional review board approval, we conducted a retrospective cohort study of term deliveries affected by clinical intraamniotic infection at a single tertiary center between 2013 and 2017, with placental pathology consistent with histologic chorioamnionitis. The exclusion criteria included intrauterine fetal demise, missing delivery information or placental pathology, and documented congenital fetal abnormalities. Maternal sociodemographic, antepartum, and intrapartum factors were compared among patients with acute funisitis on pathology to those without acute funisitis using bivariate statistics. Regression models were developed to estimate the adjusted odds ratios. RESULTS:Of 123 patients meeting the inclusion criteria, 75 (61%) had acute funisitis on placental pathology. Compared with placental specimens without acute funisitis, acute funisitis was observed more frequently among patients with maternal BMI ≥30 kg/m2 (58.7% vs 39.6%, P=.04) and labor courses with increased rupture of membrane duration (17.3 vs 9.6 hours, P=.001). Use of fetal scalp electrode was observed less frequently in acute funisitis (5.3% vs 16.7%, P=.04) than cases without acute funisitis. In regression models, maternal BMI ≥30 kg/m2 (adjusted odds ratio, 2.67; 95% confidence interval, 1.21-5.90) and rupture of membrane >18 hours (adjusted odds ratio, 2.48; 95% confidence interval, 1.07-5.75) were significantly associated with acute funisitis. Fetal scalp electrode use (adjusted odds ratio, 0.18; 95% confidence interval, 0.04-0.71) was negatively associated with acute funisitis. CONCLUSION:In term deliveries with intraamniotic infection and histologic chorioamnionitis, maternal BMI ≥30 kg/m2, and rupture of membrane>18 hours were associated with acute funisitis on placental pathology. As insight into the clinical impact of acute funisitis grows, the ability to predict which pregnancies are at the greatest risk for its development may allow for a tailored approach to predicting neonatal risk for sepsis and related comorbidity.
BACKGROUND: Acute funisitis-the histologic diagnosis of inflammation within the umbilical cord-represents a fetal inflammatory response to infection. Although acute funisitis has been associated with an increased risk of adverse outcomes among preterm neonates, there are limited and conflicting data with term deliveries. OBJECTIVE: This study aimed to evaluate the association between acute funisitis and neonatal morbidity in neonates born at term to pregnant patients with a clinical diagnosis of intraamniotic infection. STUDY DESIGN: This was a retrospective cohort study of pregnant patients who had clinically diagnosed intraamniotic infection at term, delivered vaginally at a single tertiary institution from 2013 to 2019, and had histologic chorioamnionitis on placental pathology. Patients with intrauterine fetal demise or missing neonatal/placental pathology data were excluded. The primary outcome was a neonatal sepsis composite, defined as culture-positive bacteremia, neutropenia (absolute neutrophil count<3500/mu L), or immature-to-total neutrophil ratio>0.2. The secondary outcomes included composite neonatal morbidity, defined as neonatal intensive care unit admission, 5-minute Apgar score <7, bacteremia, endotracheal intubation or need for continuous positive airway pressure, intraventricular hemorrhage (grade 3 or 4), necrotizing enterocolitis (stage 3 or 4), umbilical artery pH<7.1, umbilical artery base excess>12, and neonatal mortality. The components of these composites, neonatal intensive care unit length of stay, and Kaiser early-onset sepsis score were also measured. Neonates with acute funisitis on pathology were compared with those without acute funisitis using bivariate statistics. Regression was used to estimate the relative risk of outcomes. RESULTS: Of 184 neonates with deliveries complicated by intraamniotic infection, acute funisitis was present in 109 (59%) placental specimens. Composite neonatal sepsis was significantly higher among neonates with acute funisitis (relative risk, 1.85; 95% confidence interval, 1.13-3.03) than in those without acute funisitis. As a marker for sepsis, acute funisitis has a sensitivity of 39.4%, negative predictive value of 47.2%, specificity of 78.7%, and positive predictive value of 72.9%. An immature-to-total neutrophil ratio>0.2 (relative risk, 1.83; 95% confidence interval, 1.09-3.08) was also significantly associated with acute funisitis. Neonatal morbidity composite, intraventricular hemorrhage, necrotizing enterocolitis, neonatal intensive care unit admission, higher Kaiser early-onset sepsis scores, and other examined outcomes were not statistically associated with acute funisitis. CONCLUSION: In term deliveries complicated by intraamniotic infection, acute funisitis was associated with increased neonatal sepsis. Current approaches for estimating neonatal sepsis risk are limited by their reliance on indirect maternal factors such as maximum maternal temperature and intrapartum antibiotic use. This study suggests that acute funisitis may serve as a marker that could be utilized to augment risk stratification at birth if a protocol for evaluating the umbilical cord in realtime were widely adopted.
Objective. We designed a multi-faceted intervention to increase the rate of outpatient goals of care (GOC) conversations in women with gynecologic cancers who are at high-risk of death. Methods and materials. A multidisciplinary team developed an educational program around GOC conversations at end-of-life and chose criteria to prospectively identify patients at high-risk of death who might benefit from timely GOC conversations: recurrent or metastatic endometrial, cervical or vulvar cancer or platinumresistant ovarian cancer. Gynecologic oncology provider consensus was built regarding the need to improve the quality and timing of GOC conversations. Eligible outpatients were prospectively identified and providers alerted pre-encounter; timely GOC documentation within 3 visits of high-risk identification was tracked. Our institution concurrently and subsequently tracked GOC documentation during the last 6 months of life among all established oncology patients. Results. Of 220 pilot period high-risk patients (96 pre- and 124 during pilot period 2017-2018), timely GOC discussion documentation increased from 30.2% to 88.7% (p < 0.001) and this increase was sustained over time. In the post-pilot period (2019-2020), among patients seen by oncologists during last 6 months of life, compared to other cancer types, gynecologic cancer patients had a higher rate of GOC documentation (81% versus 9%; p < 0.001), a lower rate of receiving chemotherapy during the last 14 days of life (2% vs 5%; p = 0.051), and no difference in end-of-life admissions (29% vs 31%; p = NS).
Importance Intra-amniotic infection (IAI) is a common condition with potentially devastating maternal and neonatal complications. However, there are incomplete data regarding the most effective antimicrobial treatment regimen for this condition. Objective This article aims to review the current evidence and recommendations for intrapartum and postpartum management of IAI. Evidence Acquisition Original research articles, review articles, and guidelines on IAI were reviewed. Results Numerous known risk factors for IAI exist, some of which are modifiable. Serious neonatal complications can result from exposure to IAI including increased risk of preterm birth and neonatal death. Possible maternal complications include increased risk of cesarean delivery, postpartum hemorrhage, and postpartum endometritis. Antibiotics are the mainstay of treatment for IAI for both mothers and neonates, although there is no consensus on which antimicrobial agents are best and the appropriate duration of therapy. Conclusions and Relevance Monitoring patients for signs of IAI, proper treatment, and communication of the diagnosis with the pediatric team are essential for preventing maternal and neonatal complications of IAI. More research is needed to determine the proper treatment regimens for both mothers diagnosed with IAI and their neonates. Target Audience Obstetricians and gynecologists, family physicians Learning Objectives After participating in this activity, the provider should be better able to assess the etiology, risk factors, and current guidelines for diagnosis of IAI; describe the maternal and neonatal complications of IAI; and outline the current recommendations for management of IAI in the intrapartum and postpartum periods.
Objective. To describe and evaluate the effects of implementation of a venous thromboembolism (VTE) prophylaxis quality improvement (QI) initiative on a gynecologic oncology service at a single institution. Methods. Prior to 2018, no consensus gynecologic oncology VTE prophylaxis protocol existed at the authors' academic institution. Published, evidence-based guidelines were reviewed to create a standardized VTE risk stratification algorithm. Interventions to improve perioperative heparin administration and sequential compression device (SCD) compliance as well as provider/patient education efforts were introduced in January 2018. Initial efforts included nursing and patient SCD education, internal dissemination of VTE prophylaxis guidelines, and creation of a VTE 'dashboard' to track performance. During a second phase, VTE prophylaxis guidelines were reviewed and further refined, non-compliant operative cases reviewed weekly, and guidelines incorporated into the electronic medical record. Performance was measured using Tableau data software (www.tableau. com) and by separately evaluating adherence to the developed guidelines in three retrospective cancer enriched surgical cohorts (2016-2017, 2018, 2019). Results. Compared to the baseline period, we observed a reduction in VTE rate during the 2018-2019 VTE QI implementation period from 2.1% (19/905) to 1.0% (20/2015, p = 0.02) among gynecologic oncology inpatients. In the retrospective cancer-enriched cohorts, adherence to evidence based guidelines improved: 31.0% in 2016-2017, 69.1% in 2018, and 82.4% in 2019 (p < 0.001). There were no significant differences in rates of peri-operative blood transfusion, surgical site infections, hematomas, or vaginal cuff dehiscences. Conclusions. Implementation of a robust VTE prophylaxis QI initiative has resulted in improved VTE prophylaxis guideline adherence and higher rates of pre-operative heparin administration. (c) 2021 Published by Elsevier Inc.
Objectives: To evaluate implementation of a venous thromboembolism (VTE) prophylaxis algorithm on adherence to evidence-based guidelines including the rate of administration of preoperative heparin and the overall VTE rate on the gynecologic-oncology service at a single institution. Methods: Prior to 2018, no consensus VTE prophylaxis protocol existed on the gynecologic oncology service at the authors’ academic institution. ACOG and Chest guidelines were used to modify a published gynecology VTE risk algorithm. Interventions to improve preoperative heparin administration included: ID badge algorithm attachments, placards in operating rooms, integration of algorithm into the H&P template and order set in the electronic medical record. Surgical, anesthesia, and nursing teams were contacted to investigate cases in which pre-operative heparin was indicated but not administered. In 2020, three retrospective cohorts of 100 patients each (2016-2017, 2018, and 2019) spanning the pre-, intra- and post-QI implementation periods were consecutively identified using cancer and radical surgery-specific CPT codes to evaluate performance in these highest risk cases; cohorts were filled to 100 using randomly selected additional gynecologic oncology cases. Perioperative heparin administration and VTE rates were evaluated. Proportions were compared using chi-square tests; continuous factors were compared using ANOVA or Kruskal-Wallis tests. Results: Conclusions: Implementation of an individualized perioperative VTE prophylaxis algorithm has resulted in improved adherence to evidence-based prophylaxis guidelines and improvement in rates of preoperative heparin administration; observed trends in VTE rates have not achieved significance. To evaluate implementation of a venous thromboembolism (VTE) prophylaxis algorithm on adherence to evidence-based guidelines including the rate of administration of preoperative heparin and the overall VTE rate on the gynecologic-oncology service at a single institution. Prior to 2018, no consensus VTE prophylaxis protocol existed on the gynecologic oncology service at the authors’ academic institution. ACOG and Chest guidelines were used to modify a published gynecology VTE risk algorithm. Interventions to improve preoperative heparin administration included: ID badge algorithm attachments, placards in operating rooms, integration of algorithm into the H&P template and order set in the electronic medical record. Surgical, anesthesia, and nursing teams were contacted to investigate cases in which pre-operative heparin was indicated but not administered. In 2020, three retrospective cohorts of 100 patients each (2016-2017, 2018, and 2019) spanning the pre-, intra- and post-QI implementation periods were consecutively identified using cancer and radical surgery-specific CPT codes to evaluate performance in these highest risk cases; cohorts were filled to 100 using randomly selected additional gynecologic oncology cases. Perioperative heparin administration and VTE rates were evaluated. Proportions were compared using chi-square tests; continuous factors were compared using ANOVA or Kruskal-Wallis tests. Implementation of an individualized perioperative VTE prophylaxis algorithm has resulted in improved adherence to evidence-based prophylaxis guidelines and improvement in rates of preoperative heparin administration; observed trends in VTE rates have not achieved significance.
PURPOSE:Two recent clinical trials have demonstrated that direct oral anticoagulants (DOACs) are effective as venous thromboembolism (VTE) prophylaxis in patients with moderate-to-high risk ambulatory cancer initiating chemotherapy. Patients with advanced ovarian cancer receiving neoadjuvant chemotherapy are at particularly increased risk of VTE. We performed a cost-effectiveness analysis from a health system perspective to determine if DOACs are a feasible prophylactic strategy in this population.METHODS:A simple decision tree was created from a health system perspective, comparing two strategies: prophylactic DOAC taken for 18 weeks during chemotherapy versus no VTE prophylaxis. Rates of VTE (7.3% DOAC v 13.6% no treatment), major bleeding (2.6% v 1.3%), and clinically relevant nonmajor bleeding (4.6% v 3.3%) were modeled. Cost estimates were obtained from wholesale drug costs, published studies, and Medicare reimbursement data. Probabilistic, one-way, and two-way sensitivity analyses were performed.RESULTS:In the base case model, DOAC prophylaxis is more costly and more effective than no therapy (incremental cost-effectiveness ratio = $256,218 in US dollars/quality-adjusted life year). In one-way sensitivity analyses, reducing the DOAC cost by 32% or raising the baseline VTE rate above 18% renders this strategy potentially cost-effective with an incremental cost-effectiveness ratio below $150,000 in US dollars/quality-adjusted life year.CONCLUSION:Further confirmation of the true baseline VTE rate among women initiating neoadjuvant chemotherapy for ovarian cancer will determine whether prophylactic dose DOAC is a value-based strategy. Less costly VTE prophylaxis options such as generic DOACs (once available) and aspirin also warrant investigation.
7074 Background: Venous thromboembolism (VTE) is a major cause of morbidity and mortality among cancer patients. The Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients (AVERT) randomized controlled trial concluded that apixaban is a safe and effective option for VTE prophylaxis in high-risk ambulatory cancer patients initiating a new chemotherapy regimen. We performed a cost-effectiveness analysis from a health system perspective to determine if apixaban is a feasible prophylactic strategy for this population. Methods: A decision model was created from a third party payer perspective with a time horizon of 6 months, based on the treatment arms of the AVERT trial: (1) apixaban 2.5 mg twice daily for 6 months during active chemotherapy versus (2) placebo. Rates of VTE (4.2% apixaban vs 10.2% placebo), major bleeding (3.5% vs 1.8%) and clinically relevant nonmajor bleeding (CRNMB) (7.3% vs 5.5%) were modeled from the results of the AVERT trial. Cost estimates for treatments and events were obtained from wholesale drug costs, previously published studies and Medicare reimbursement data, and adjusted for inflation to 2018 dollars. Quality adjusted life years were calculated based on previously published utility values for the health states of advanced cancer, DVT, PE, and major bleeding events. An exploratory analysis was performed comparing prophylactic aspirin to no prophylaxis assuming a VTE rate of 7.2%, major bleeding rate of 3.5%, and CRNMB rate of 7.3%, based on the conservative assumptions that while aspirin may not be as effective at preventing VTE, the rate of clinically significant bleeding events would be similar or greater than that of apixaban. Results: In the base case model, apixaban is more costly and more effective than placebo (ICER = $5,013,190/QALY), and the cost per VTE prevented in the apixaban arm is $33,000. In one-way sensitivity analysis, if the cost of apixaban were reduced by 40% from $3,197 to $1,250 for a 6 month course, this could potentially be a cost-effective prophylaxis strategy with an ICER less than $100,000/QALY. In the alternative analysis, aspirin dominates placebo as it is both more effective and less expensive, and remains cost-effective even when the rate of clinically recognized bleeding with aspirin exceeds 15%. Conclusions: Further investigation into less costly prophylactic options such as generic direct oral anticoagulants (once available) and aspirin is warranted prior to broader implementation of a VTE prophylaxis strategy in this population.
1515 Background: Next generation sequencing (NGS) testing of tumor tissue or blood is performed to identify ‘actionable’ mutations that might guide patient care. NGS testing might incidentally identify germline mutations associated with cancer syndromes. No distinction is made between germline and somatic alterations on NGS reports, thus confirmatory germline testing is required. In this quality improvement (QI) initiative, we evaluated the frequency of referrals to genetic counseling (GC) for patients with potentially heritable germline mutations identified through NGS testing. Methods: We generated a list of high-risk mutations (HRMs) which merit GC referral based on NCCN guidelines. NGS test results for 3,400 consecutive patients with solid tumor malignancies were reviewed by the molecular tumor board from 1/2014-9/2019 and were screened for pathogenic HRMs. Basic demographic, oncologic, and GC data were retrospectively abstracted for each patient. The outcomes of interest were the frequency of HRMs identified through NGS testing, the proportion of patients subsequently referred to GC, and the proportion of patients ultimately diagnosed with a hereditary cancer syndrome. Results: 472 individual patients (14%) had NGS testing with one or more HRM identified; 465 patients were evaluable which corresponded to 519 HRMs that were included in the analysis (Table). Malignancies included were gastrointestinal 199 (42.8%), lung 83 (17.8%), genitourinary/renal 56 (12.0%), breast 49 (10.5%), gynecologic 35 (7.5%), and other 43 (9.2%). 75 (16.1%) patients had germline testing prior to NGS testing. Of those patients without prior germline genetic testing, 62 (15.9%) were referred to GC, and 19 (4.9%) patients were diagnosed with a hereditary cancer syndrome. Conclusions: Tumor NGS testing identifies HRMs that may represent an undiagnosed heritable germline mutation. Providers ordering NGS tests should review results for HRMs, refer to GC when appropriate, and offer confirmatory germline testing for patients and their families. [Table: see text]