Lasix for the prevention of de novo postpartum hypertension: A randomized placebo-controlled trial (LAPP Trial).

BACKGROUND: Birthing people with de novo postpartum hypertensive disorders remain among the highest risk for severe maternal morbidity. Randomized controlled trials demonstrate a benefit to oral loop-diuretics in decreasing postpartum hypertensive morbidity in patients with an antenatal diagnosis of preeclampsia. It is not known whether this same therapy benefits patients at risk for new-onset postpartum hypertension OBJECTIVE: To evaluate whether oral furosemide can reduce risk for de novo postpartum hypertension (dnPPHTN) among high-risk birthing people by reducing post-delivery blood pressure. STUDY DESIGN: From October 2021 to April 2022, we conducted a randomized triple-masked placebo-controlled clinical trial of individuals at high risk for dnPPHTN at a single university-based tertiary care medical center. A total of 82 postpartum patients with no antenatal diagnosis of chronic hypertension or a hypertensive disorder of pregnancy who were at high-risk for the development of dnPPHTN based on a pre-specified risk factor algorithm were enrolled after childbirth. The participants were randomly assigned in a 1:1 ratio to a five-day course of oral furosemide 20 mg daily or identical-appearing placebo starting within eight hours of delivery. Participants were followed for 6 weeks postpartum using Bluetooth-enabled remote blood pressure monitoring and electronic surveys. The primary outcome was the difference in mean arterial pressure (MAP) averaged over the 24 hours prior to discharge or the 24 hours prior to antihypertensive therapy initiation. The study was powered to detect a 5 mmHg difference in mean MAP (standard deviation 6.4 mmHg) with 90% power at an alpha of 0.05, requiring a sample size of 41 per group. Secondary outcomes included the rate of dnPPHTN, readmission data, other measures of hypertensive and maternal morbidity, breastfeeding data, and drug-related neonatal outcomes. RESULTS: The primary outcome was assessed in 80 of the 82 participants. Baseline characteristics were similar between groups. There was no significant difference in mean MAP 24 hours prior to discharge (or antihypertensive initiation) in the furosemide group (88.9 ± 7.4 mmHg) compared to the placebo group (86.8 ± 7.1 mmHg; absolute difference 2.1 mmHg, 95% CI -1.2 to 5.3). Of the 79 participants for whom secondary outcomes were assessed, 10% (n=8) developed dnPPHTN and 9% (n=7) were initiated on antihypertensive therapy. Rates were not significantly different between groups. CONCLUSIONS: De novo postpartum hypertension is a common phenomenon among at-risk patients, warranting close monitoring for severe hypertension and other maternal morbidity. There is insufficient evidence to suggest that furosemide reduces mean MAP in the 24 hours prior to discharge from the delivery hospitalization (or antihypertensive medication initiation) compared to placebo.

Innovating Evaluation and Treatment of Intrapartum Fevers: Where Do We Go from Here?

As intrapartum fevers are not always infectious in origin, determining whether antibiotics are indicated is challenging. We previously sought to create a point-of-care calculator using clinical data available at the time of an intrapartum fever to identify the subset of women who require antibiotic treatment to avoid maternal and neonatal morbidity. Despite the use of a comprehensive dataset from our institutions, we were unable to propose a valid and highly predictive model. In this commentary, we discuss why our model failed, as well as future research directions to identify and treat true intraamniotic infection. Developing a risk-stratification model is paramount to minimizing maternal and neonatal exposure to unnecessary antibiotics while allowing for early identification of women and babies at risk for infectious morbidity. KEY POINTS: · Determining whether antibiotics are indicated in intrapartum fever is challenging.. · Developing a risk-stratification model for febrile laboring women is critical to decreasing harm.. · A point-of-care calculator based on clinical and biomarker data is the necessary approach..

Longitudinal Risk Adjustment for Maternal End-Organ Injury and Death.

OBJECTIVE: To determine whether adjusting for healthcare utilization and comorbidity diagnosed in the year before delivery improves the prediction of adverse maternal outcomes. METHODS: The Truven Health MarketScan database was used to determine whether healthcare utilization and comorbidity diagnosed in the year before pregnancy improved prediction of acute organ injury or death during the delivery hospitalization through 30 days postpartum in this retrospective cohort study. In an initial model, we analyzed the risk for adverse outcomes controlling for underlying comorbidity, obesity, and demographic risk factors present during pregnancy. Subsequent models included diagnoses from the year before pregnancy as well as whether patients had emergency department encounters, inpatient hospitalizations, or received medications from a pharmacy. We compared risk estimates and whether prediction of acute organ injury or death improved with data from the year before pregnancy. Unadjusted and adjusted log-linear regression models were performed to demonstrate the association between exposures and outcomes with unadjusted (RR) and adjusted risk ratios (aRR) with 95% CIs as measures of effects. Logistic regression was performed to calculate the c-statistic of the adjusted models. Separate analyses were performed for patients with Medicaid and commercial insurance. An analysis of Medicaid patients by maternal race and ethnicity was performed to determine if diagnoses and utilization before pregnancy accounted for maternal disparities. RESULTS: A total of 740,002 patients were analyzed in this study. In unadjusted analyses of patients with commercial insurance, ≥2 compared to 0 emergency department encounters (RR = 1.82, 95% CI = 1.61, 2.07), ≥2 compared to 0 inpatient hospitalizations (RR = 4.43, 95% CI = 3.20, 6.13), and receipt of medications from ≥5 prescription groups compared to no prescriptions (RR = 1.97, 95% CI = 1.74, 2.24) were all associated with increased risk for acute organ injury or death. Higher underlying comorbidity and obesity were also associated with increased risk. These risks were attenuated in adjusted analyses but retained significance. Risk estimates were similar for patients with Medicaid insurance with the exception of receipt of medications from ≥5 prescription groups which was non-significant in adjusted analyses (aRR = 1.12, 95% CI = 0.90, 1.40). C-statistics from logistic regression models were similar for models with and without pre-pregnancy data. When race was added to the adjusted models, risk among black women in the adjusted models did not differ significantly from the unadjusted estimate. CONCLUSION: ED encounters and inpatient admissions the year before pregnancy were associated with increased risk of adverse maternal outcomes. However, adding these risk factors to adjusted models did not meaningfully improve the amount of variance accounted for. Further research is indicated to determine to what degree longitudinal care quality is associated with maternal risk.

Services and payer mix of Black-serving hospitals and related severe maternal morbidity.

BACKGROUND: Black-serving hospitals are associated with increased maternal risk. However, prior administrative data research on maternal disparities has generally included limited hospital factors. More detailed evaluation of hospital factors related to obstetric outcomes may be important in understanding disparities. OBJECTIVE: To examine detailed characteristics of Black-serving hospitals and how these characteristics are associated with risk for severe maternal morbidity (SMM). METHODS: This serial cross-sectional study linked the 2010-2011 Nationwide Inpatient Sample and the 2013 American Hospital Association Annual Survey Databases. Delivery hospitalizations occurring to women 15-54 years of age were identified. The proportions of non-Hispanic Black patients within a hospital was categorized into quartiles, and hospital factors such as specialized medical, surgical and safety-net services as well as payer mix were compared across these quartiles. A series of models was performed evaluating risk for SMM with Black-serving hospital quartile as the primary exposure. Log linear regression models with a Poisson distribution (and robust variance) were performed with unadjusted and adjusted risk ratios (aRR) with 95% confidence intervals (CIs) as measures of effect. RESULTS: Overall 965,202 deliveries from 430 hospitals met inclusion criteria and were included in the analysis. By quartile, non-Hispanic Black patients accounted for 1.3%, 5.4%, 13.4%, and 33.8% of patients. Many services were significantly less common in the lowest compared to the highest Black-serving hospital quartile including cardiac intensive care (48.9% versus 74.5%), neonatal intensive care (28.9% versus 64.9%), pediatric intensive care (20.0% versus 45.7%), pediatric cardiology (29.6% versus 44.7%), and HIV/AIDS services (36.3% versus 71.3%) (p≤0.01 for all). Indigent care clinics, crisis prevention, and enabling services (p≤0.01 for all) were more common at Black-serving hospitals as was Medicaid payer. Following adjustments for detailed hospital factors, the lowest Black serving hospital quartile carried the lowest risk for SMM. However, SMM risks were similar across the 2nd (aRR 1.31, 95% CI 1.08, 1.59), 3rd (aRR 1.27, 95% 1.05, 1.55), and 4th (aRR 1.29, 95% CI 1.07, 1.55) quartiles. CONCLUSION: Black-serving hospitals were more likely to provide a range of specialized medical, surgical, and safety-net services and to have a higher Medicaid burden. Payer mix and unmeasured confounding may account for some of the maternal risk associated with Black-serving hospitals.

Addressing mental health in patients and providers during the COVID-19 pandemic.

The pandemic, and the associated changes to pregnancy and postpartum experiences, can lead to profound psychological reactions including panic, hyperarousal, sleep disturbance, anxiety, depression, and traumatic stress disorders. Providers face compassion fatigue and shared trauma. In this article, we describe the mental health outcomes known to date in regard to the novel coronavirus disease 2019 pandemic for obstetric patients and their providers as well as therapeutic approaches, including our novel embedded mental health service, to address these mental health needs.

Building an obstetric intensive care unit during the COVID-19 pandemic at a tertiary hospital and selected maternal-fetal and delivery considerations.

During the novel Coronavirus Disease 2019 pandemic, New York City became an international epicenter for this highly infectious respiratory virus. In anticipation of the unfortunate reality of community spread and high disease burden, the Anesthesia and Obstetrics and Gynecology departments at NewYork-Presbyterian / Columbia University Irving Medical Center, an academic hospital system in Manhattan, created an Obstetric Intensive Care Unit on Labor and Delivery to defray volume from the hospital's preexisting intensive care units. Its purpose was threefold: (1) to accommodate the anticipated influx of critically ill pregnant and postpartum patients due to novel coronavirus, (2) to care for critically ill obstetric patients who would previously have been transferred to a non-obstetric intensive care unit, and (3) to continue caring for our usual census of pregnant and postpartum patients, who are novel Coronavirus negative and require a higher level of care. In this chapter, we share key operational details for the conversion of a non-intensive care space into an obstetric intensive care unit, with an emphasis on the infrastructure, personnel and workflow, as well as the goals for maternal and fetal monitoring.

Telehealth Uptake into Prenatal Care and Provider Attitudes during the COVID-19 Pandemic in New York City: A Quantitative and Qualitative Analysis.

OBJECTIVE: This study aimed to (1) determine to what degree prenatal care was able to be transitioned to telehealth at prenatal practices associated with two affiliated hospitals in New York City during the novel coronavirus disease 2019 (COVID-19) pandemic and (2) describe providers' experience with this transition. STUDY DESIGN: Trends in whether prenatal care visits were conducted in-person or via telehealth were analyzed by week for a 5-week period from March 9 to April 12 at Columbia University Irving Medical Center (CUIMC)-affiliated prenatal practices in New York City during the COVID-19 pandemic. Visits were analyzed for maternal-fetal medicine (MFM) and general obstetrical faculty practices, as well as a clinic system serving patients with public insurance. The proportion of visits that were telehealth was analyzed by visit type by week. A survey and semistructured interviews of providers were conducted evaluating resources and obstacles in the uptake of telehealth. RESULTS: During the study period, there were 4,248 visits, of which approximately one-third were performed by telehealth (n = 1,352, 31.8%). By the fifth week, 56.1% of generalist visits, 61.5% of MFM visits, and 41.5% of clinic visits were performed via telehealth. A total of 36 providers completed the survey and 11 were interviewed. Accessing technology and performing visits, documentation, and follow-up using the telehealth electronic medical record were all viewed favorably by providers. In transitioning to telehealth, operational challenges were more significant for health clinics than for MFM and generalist faculty practices with patients receiving public insurance experiencing greater difficulties and barriers to care. Additional resources on the patient and operational level were required to optimize attendance at in-person and video visits for clinic patients. CONCLUSION: Telehealth was rapidly implemented in the setting of the COVID-19 pandemic and was viewed favorably by providers. Limited barriers to care were observed for practices serving patients with commercial insurance. However, to optimize access for patients with Medicaid, additional patient-level and operational supports were required. KEY POINTS: · Telehealth uptake differed based on insurance.. · Medicaid patients may require increased assistance for telehealth.. · Quick adoption of telehealth is feasible..

Telehealth for High-Risk Pregnancies in the Setting of the COVID-19 Pandemic.

As New York City became an international epicenter of the novel coronavirus disease 2019 (COVID-19) pandemic, telehealth was rapidly integrated into prenatal care at Columbia University Irving Medical Center, an academic hospital system in Manhattan. Goals of implementation were to consolidate in-person prenatal screening, surveillance, and examinations into fewer in-person visits while maintaining patient access to ongoing antenatal care and subspecialty consultations via telehealth virtual visits. The rationale for this change was to minimize patient travel and thus risk for COVID-19 exposure. Because a large portion of obstetric patients had underlying medical or fetal conditions placing them at increased risk for adverse outcomes, prenatal care telehealth regimens were tailored for increased surveillance and/or counseling. Based on the incorporation of telehealth into prenatal care for high-risk patients, specific recommendations are made for the following conditions, clinical scenarios, and services: (1) hypertensive disorders of pregnancy including preeclampsia, gestational hypertension, and chronic hypertension; (2) pregestational and gestational diabetes mellitus; (3) maternal cardiovascular disease; (4) maternal neurologic conditions; (5) history of preterm birth and poor obstetrical history including prior stillbirth; (6) fetal conditions such as intrauterine growth restriction, congenital anomalies, and multiple gestations including monochorionic placentation; (7) genetic counseling; (8) mental health services; (9) obstetric anesthesia consultations; and (10) postpartum care. While telehealth virtual visits do not fully replace in-person encounters during prenatal care, they do offer a means of reducing potential patient and provider exposure to COVID-19 while providing consolidated in-person testing and services. KEY POINTS: · Telehealth for prenatal care is feasible.. · Telehealth may reduce coronavirus exposure during prenatal care.. · Telehealth should be tailored for high risk prenatal patients..

Association Between Vulvovaginal Discomfort and Activity of Inflammatory Bowel Diseases.

BACKGROUND & AIMS: Inflammatory bowel diseases (IBD) affect 200-400 people per 100,000 in the United States, about half of whom are women. We aimed to define the prevalence of vulvovaginal symptoms and association with IBD activity in a large cohort of women. METHODS: Women more than 18 years old with IBD (1250) completed an online survey querying the presence and severity of vulvar or vaginal itch, burn, or irritation, vaginal discharge or dryness, and vulvovaginal pain. The survey collected information on demographic features and IBD activity (categorized using the Manitoba index). Women with and without symptoms were compared using bivariate analyses. Logistic regression evaluated associations between IBD severity and vulvovaginal symptoms, adjusted for diagnosis, menopause, smoking, depression, and use of medications to treat IBD. RESULTS: A total of 512 (41%) women reported at least 1 moderate-severe vulvovaginal symptom. All vulvovaginal symptoms except vaginal dryness were more common in women with active IBD. In a multivariate model controlled for menopause, smoking, t-score from the PROMIS depression instrument, and use of IBD medications, women with constant or frequent active IBD, based on Manitoba index scores, had increased odds for moderate-severe vulvovaginal symptoms (odds ratio, 1.68; 95% CI, 1.22-2.32) compared to women in remission. Vulvovaginal discomfort frequently or always decreased interest in sex (n=336; 28%) or ability to have sex (n=207; 16%). CONCLUSIONS: In an online survey of 1250 women, we found that women with more active IBD have increased prevalence of vulvovaginal discomfort, compared to women in remission. These symptoms affect sexual health.

Microbiology and Antibiotic Resistance in Peripartum Bacteremia.

OBJECTIVE: To examine the microbiology and associated antibiotic resistance patterns among febrile peripartum women with positive blood cultures. METHODS: We conducted a retrospective cohort study in which we reviewed all bacteremia cases between 2009 and 2016 that occurred between 7 days before and 30 days after delivery. Institutional guidelines include obtaining blood cultures and promptly initiating intravenous antibiotics for all obstetric patients with fever of 100.4°F or higher. We describe antibiotic resistance patterns for the most frequently isolated organisms and perform univariate analyses regarding maternal and neonatal outcomes based on type of bacteremia. RESULTS: Among 56,835 deliveries, 3,797 (6.7%) obstetric patients had blood cultures drawn and 120 (3.2%) had documented bacteremia. The most commonly cultured organisms were Escherichia coli (17.5%, n=21), Bacteroides species (10.8%, n=13), Enterococcus species (10.8%, n=13), group B streptococci (10.8%, n=13), and group A streptococci (5.0%, n=6). E coli had high rates of resistance to ampicillin (n=17, 81.0%) and extended spectrum beta lactams (n=10, 47.6%). Gram-positive bacteremia was noted in 65/120 patients (54.2%), gram-negative bacteremia in 39/120 (32.5%), and anaerobic bacteremia in 16/120 (13.3%) (P=.02). Neonatal bacteremia was identified in 8/120 cases (6.7%), of which 7/8 (87.5%) were attributable to gram-negative bacteria and 1/8 (12.5%) were attributable to gram-positive bacteremia (P=.004). There were no differences in neonatal death or maternal intensive care unit admission. CONCLUSION: Peripartum bacteremia is uncommon, with the most frequently isolated organism being E coli. The evolution of antibiotic resistance patterns in E coli at our institution may be of clinical significance in determining antibiotic choice for peripartum fever.

Diagnostic Validity of the Proposed Eunice Kennedy Shriver National Institute of Child Health and Human Development Criteria for Intrauterine Inflammation or Infection.

OBJECTIVE: To investigate the test characteristics of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) criteria for intrauterine inflammation or infection or both (triple I) and rates of adverse outcomes in a cohort of febrile intrapartum women. METHODS: This retrospective cohort study included women at 24 weeks of gestation or greater from June 2015 to September 2017 at a single tertiary hospital with a temperature 100.4°F or greater (38.0°C) during labor or within 1 hour postpartum, all of whom had blood culture data. Women with a fetal demise, expectantly managed preterm prelabor rupture of membranes, or nonobstetric infections were excluded. Documented fever was defined as a single temperature 102.2°F or greater (39.0°C) or a temperature 100.4°F or greater (38.0°C) but less than 102.2°F (39.0°C) on two measurements 45 minutes apart. We defined two analysis groups: 1) suspected triple I, defined as women with documented fever with clinical signs of infection; and 2) isolated maternal fever, defined as women with at least one temperature 100.4°F or greater (38.0°C) who did not meet criteria for suspected triple I. We assessed test characteristics of suspected triple I to predict 1) confirmed triple I, defined as suspected triple I with placental pathology diagnostic of infection; and 2) adverse clinical infectious outcome, defined as a composite of maternal and neonatal adverse infectious outcomes. We also calculated the incidence of adverse clinical infectious outcomes for both groups. RESULTS: Three hundred thirty-nine women were analyzed: 212 with suspected triple I and 127 with isolated maternal fever. Baseline demographic and obstetric characteristics were similar between groups. The incidence of adverse clinical infectious outcomes was 11.8% among women with suspected triple I and 9.5% among women with isolated maternal fever (P=.50). The sensitivity and specificity of suspected triple I for confirmed triple I were 71.4% (95% CI 61.4-80.1%) and 40.5% (95% CI 33.6-47.8%), respectively, and for an adverse clinical infectious outcome were 67.6% (95% CI 50.2-82.0%) and 38.1% (95% CI 32.6-43.8%), respectively. CONCLUSION: Applying the NICHD criteria to guide clinical diagnosis and management of intrauterine infection or inflammation may overlook an important proportion of laboring febrile women at risk for adverse infectious outcomes.

Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether a liposomal bupivacaine incisional block decreases postoperative pain and represents an opioid-minimizing strategy after scheduled cesarean delivery. METHODS: In a single-blind, randomized controlled trial among opioid-naive women undergoing cesarean delivery, liposomal bupivacaine or placebo was infiltrated into the fascia and skin at the surgical site, before fascial closure. Using an 11-point numeric rating scale, the primary outcome was pain score with movement at 48 hours postoperatively. A sample size of 40 women per group was needed to detect a 1.5-point reduction in pain score in the intervention group. Pain scores and opioid consumption, in oral morphine milligram equivalents, at 48 hours postoperatively were summarized as medians (interquartile range) and compared using the Wilcoxon rank-sum test. RESULTS: Between March and September 2017, 249 women were screened, 103 women enrolled, and 80 women were randomized. One woman in the liposomal bupivacaine group was excluded after randomization as a result of a vertical skin incision, leaving 39 patients in the liposomal bupivacaine group and 40 in the placebo group. Baseline characteristics between groups were similar. The median (interquartile range) pain score with movement at 48 hours postoperatively was 4 (2-5) in the liposomal bupivacaine group and 3.5 (2-5.5) in the placebo group (P=.72). The median (interquartile range) opioid use was 37.5 (7.5-60) morphine milligram equivalents in the liposomal bupivacaine group and 37.5 (15-75) morphine milligram equivalents in the placebo group during the first 48 hours postoperatively (P=.44). CONCLUSION: Compared with placebo, a liposomal bupivacaine incisional block at the time of cesarean delivery resulted in similar postoperative pain scores in the first 48 hours postoperatively. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02959996.

Mycoplasma genitalium: An Overlooked Sexually Transmitted Pathogen in Women?

Mycoplasma genitalium is a facultative anaerobic organism and a recognized cause of nongonococcal urethritis in men. In women, M. genitalium has been associated with cervicitis, endometritis, pelvic inflammatory disease (PID), infertility, susceptibility to human immunodeficiency virus (HIV), and adverse birth outcomes, indicating a consistent relationship with female genital tract pathology. The global prevalence of M. genitalium among symptomatic and asymptomatic sexually active women ranges between 1 and 6.4%. M. genitalium may play a role in pathogenesis as an independent sexually transmitted pathogen or by facilitating coinfection with another pathogen. The long-term reproductive consequences of M. genitalium infection in asymptomatic individuals need to be investigated further. Though screening for this pathogen is not currently recommended, it should be considered in high-risk populations. Recent guidelines from the Centers for Disease Control regarding first-line treatment for PID do not cover M. genitalium but recommend considering treatment in patients without improvement on standard PID regimens. Prospective studies on the prevalence, pathophysiology, and long-term reproductive consequences of M. genitalium infection in the general population are needed to determine if screening protocols are necessary. New treatment regimens need to be investigated due to increasing drug resistance.