Clinical Trials That Have Changed Clinical Practice and Care of Pregnant People With HIV.

Over the last 4 decades, significant advances in the care of HIV during pregnancy have successfully reduced, and nearly eliminated, the risk of perinatal HIV transmission. The baseline risk of transmission without intervention (25% to 30%) is now <1% to 2% in the United States with contemporary antepartum, intrapartum, and postnatal interventions. In this review, we discuss 3 landmark clinical trials that substantially altered obstetric practice for pregnant individuals with HIV and contributed to this extraordinary achievement: 1) the Pediatric AIDS Clinical Trials Group 076 Trial determined that antepartum and intrapartum administration of antiretroviral drug zidovudine to the pregnant individual, and postnatally to the newborn, could reduce the risk of perinatal transmission by approximately two-thirds; 2) the European Mode of Delivery Collaboration Trial demonstrated performance of a prelabor cesarean birth before rupture of membranes among pregnant people with viremia reduced the risk of perinatal transmission compared with vaginal birth; and 3) the International Maternal Pediatric Adolescent AIDS Clinical Trials Network 2010 Trial identified that dolutegravir-containing, compared with efavirenz-containing, antiretroviral regimens during pregnancy achieved a significantly higher rate of viral suppression at delivery with shorter time to viral suppression, with fewer adverse pregnancy outcomes. Collectively, these trials not only advanced obstetric practice but also advanced scientific understanding of the timing, mechanisms, and determinants of perinatal HIV transmission. For each trial, we will describe key aspects of the study protocol and outcomes, insights gleaned about the dynamics of perinatal transmission, how each study changed clinical practice, and relevant updates to current practice since the trial's publication.

Maternal and Neonatal Morbidities by Race in College-Educated Women.

Objective Non-Hispanic black and Hispanic women experience significantly higher adverse maternal and neonatal outcomes compared with non-Hispanic white women. The purpose of this study is to explore whether disparities in obstetric outcomes exist by race among women who are college-educated. Study Design This is a retrospective cohort study from a multicenter observational cohort of women undergoing cesarean delivery. Women were defined as "college-educated" if they reported completion of a 4-year college degree. Race/ethnicity was categorized as non-Hispanic white, non-Hispanic black, Hispanic, Asian, Native American, or unknown. The primary outcome was a composite of maternal morbidity, and a composite of neonatal morbidity was evaluated as a secondary outcome. A multivariable logistic regression model was then utilized to assess associations of race with the primary and secondary outcomes. Results A total of 2,540 women were included in the study. After adjusting for potential confounding variables, maternal morbidity was found to be significantly higher for college-educated non-Hispanic black women compared with non-Hispanic white women (odds ratio [OR] 1.77, 95% confidence interval [CI] 1.12-2.80). The incidence of neonatal morbidity was significantly higher for non-Hispanic black (OR 1.91, 95% CI 1.31-2.79) and Hispanic (OR 3.34, 95% CI 2.23-5.01) women. Conclusion In this cohort, the odds of cesarean-related maternal and neonatal morbidities were significantly higher for college-educated non-Hispanic black women, compared with their non-Hispanic white counterparts. This demonstrates that even among women with higher level education, racial and ethnic disparities persist in obstetric outcomes.

Latency Period after Preterm Premature Rupture of Membranes: Singletons versus Twins.

OBJECTIVE: Several studies have evaluated the differences in duration of latency and clinical outcomes between singleton and twin pregnancies after preterm premature rupture of membranes (PPROM); however, these data are limited to single-institution analyses and based on small sample sizes. The aim of this study was to assess differences in latency and clinical outcomes in singletons versus twin gestations affected by PPROM in a large, diverse cohort of women. STUDY DESIGN: This is a secondary analysis of a multicenter trial of magnesium for neuroprotection in women at high risk of preterm birth. Our study included women with PPROM ≥ 24 weeks with singleton and twin gestations. We compared singleton versus twin gestation and our primary outcome was duration of latency after PPROM. Secondary outcomes included selected perinatal and neonatal outcomes including long-term neurodevelopmental outcomes. We fit a linear regression model to assess independent risk factors for latency duration. RESULTS: Our study included 1,753 women, 1,602 singleton gestations (91%) and 151 twin gestations (9%). The median latency period was significantly shorter in twins (4 [interquartile range, IQR: 1-10] vs. 7 [IQR: 3-16] days, p < 0.001) and gestational age at delivery was significantly earlier (29.3 vs. 30.1 weeks, p = 0.001). Twins were more likely to develop neonatal sepsis (20.1 vs. 13.4%, p = 0.004), but rates of chorioamnionitis and abruption did not differ. Twins were more likely to suffer from adverse short-term neonatal outcomes, had higher rates of neonatal demise (7.9 vs. 3.8%, p = 0.002), and had higher rates of cerebral palsy (7.3 vs. 3.7, p = 0.005). When adjusting for confounders, twin gestation remained an independent risk factor for shorter latency (p < 0.001). CONCLUSION: Twin gestations affected by PPROM had shorter latency, earlier delivery, and higher rates of short- and long-term morbidity. Despite having longer latency, singleton gestations did not have higher rates of complications associated with expectant management. KEY POINTS: · Twins affected by PPROM had shorter latency duration and earlier gestational at delivery.. · Twins with PPROM had higher rates of both short- and long-term perinatal morbidity.. · Rates of chorioamnionitis and abruption did not differ between twins and singletons with PPROM..

Disparities in obstetric morbidity by maternal level of education.

BACKGROUND: Maternal race and socioeconomic status are predictors of obstetric morbidity and mortality in the U.S. A better understanding of the role that maternal education plays in these disparities could enable and target better interventions to improve obstetric outcomes. OBJECTIVE: This study aims to assess the impact of the level of education on morbidity. STUDY DESIGN: We conducted a retrospective nested cohort study from a multicenter observational cohort of women undergoing cesarean delivery. Nulliparous women with live, non-anomalous singleton gestations who underwent primary cesarean section and had education status recorded were included. Education level was categorized as none, elementary, high school, some college, and a college degree. The primary outcome was a composite of maternal cesarean complications including hysterectomy, uterine atony, blood transfusion, surgical injury, arterial ligation, infection, wound complication, and ileus. A composite of neonatal morbidity was evaluated as a secondary outcome. We then created a multivariable logistic regression model adjusting for selected demographic and obstetric variables that may influence the likelihood of the primary outcome. RESULTS: 10,344 women met inclusion criteria with a 20.3% incidence of the primary outcome. After adjusting for potential confounding variables including race and medical co-morbidities, the incidence of maternal cesarean complications was found to be higher for women with only elementary (OR 1.34, 95% CI 1.01-1.78) and high school (OR 1.24, 95% CI 1.03-1.48) education, compared to women with a college degree. There was also higher neonatal morbidity among women with high school (OR 1.39, 95% CI 1.20-1.62) and some college (OR 1.23, 95% CI 1.04-1.46) education, compared to women with a college degree. CONCLUSION: These findings suggest that efforts to alleviate adverse outcomes in obstetrics should target patient counseling and health literacy as differences in educational background are closely associated with disparities in maternal and neonatal morbidity.

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..

Symptoms and Critical Illness Among Obstetric Patients With Coronavirus Disease 2019 (COVID-19) Infection.

OBJECTIVE: To characterize symptoms and disease severity among pregnant women with coronavirus disease 2019 (COVID-19) infection, along with laboratory findings, imaging, and clinical outcomes. METHODS: Pregnant women with COVID-19 infection were identified at two affiliated hospitals in New York City from March 13 to April 19, 2020, for this case series study. Women were diagnosed with COVID-19 infection based on either universal testing on admission or testing because of COVID-19-related symptoms. Disease was classified as either 1) asymptomatic or mild or 2) moderate or severe based on dyspnea, tachypnea, or hypoxia. Clinical and demographic risk factors for moderate or severe disease were analyzed and calculated as odds ratios (ORs) with 95% CIs. Laboratory findings and associated symptoms were compared between those with mild or asymptomatic and moderate or severe disease. The clinical courses and associated complications of women hospitalized with moderate and severe disease are described. RESULTS: Of 158 pregnant women with COVID-19 infection, 124 (78%) had mild or asymptomatic disease and 34 (22%) had moderate or severe disease. Of 15 hospitalized women with moderate or severe disease, 10 received respiratory support with supplemental oxygen and one required intubation. Women with moderate or severe disease had a higher likelihood of having an underlying medical comorbidity (50% vs 27%, OR 2.76, 95% CI 1.26-6.02). Asthma was more common among those with moderate or severe disease (24% vs 8%, OR 3.51, 95% CI 1.26-9.75). Women with moderate or severe disease were significantly more likely to have leukopenia and elevated aspartate transaminase and ferritin. Women with moderate or severe disease were at significantly higher risk for cough and chest pain and pressure. Nine women received ICU or step-down-level care, including four for 9 days or longer. Two women underwent preterm delivery because their clinical status deteriorated. CONCLUSION: One in five pregnant women who contracted COVID-19 infection developed moderate or severe disease, including a small proportion with prolonged critical illness who received ICU or step-down-level care.

Safety of robotic-assisted gynecologic surgery and early hospital discharge in elderly patients.

BACKGROUND: A minimally invasive surgical approach has proven to decrease peri- and postoperative complications and shorten duration of hospital stay; however, there are limited data evaluating the safety of robotic-assisted surgery and early hospital discharge in the elderly population. Because age is a well-known, independent risk factor for perioperative morbidity and gynecologists treat many elderly patients, this is an important area of study. OBJECTIVE: The objective of the study was to evaluate discharge timing and surgical outcomes in elderly compared with younger patients undergoing robotic-assisted gynecologic surgery. STUDY DESIGN: This was a retrospective cohort study of all patients who underwent robotic-assisted gynecologic surgery at a high-volume, single institution from January 2013 through May 2016. Demographic information, discharge timing, and peri- and postoperative outcomes were compared for patients <65 years with those ≥65 years using univariate and multivariate analyses. RESULTS: There were 2757 patients included, with 2521 <65 years and 236 ≥65 years. Median age of the younger group was 42 years, while the median age of the elderly group was 69 years. Elderly patients had a higher body mass index (kilograms per square meter) (28 vs 26, P < .001) and higher American Society of Anesthesia classification (P < .001). Elderly were more likely to have malignancy as the indication for surgery (68% vs 11%, P < .001) and to undergo hysterectomy (81% vs 38%, P < .001) or surgery with lymph node dissection (44.5% vs 7.1%, P < .001). Elderly patients had a higher incidence of intraoperative complications (9% vs 4.6%, P = .002) and longer median hospital stay (17 vs 7 hours, P < .001) compared with younger patients. Same-day discharge was more common in younger patients (76% vs 45%, P < .001), and elderly patients were more likely to have admissions lasting >23 hours (13% vs 3%, P < .001) on univariate and multivariate analysis. Analysis of postoperative outcomes included 2023 patients with available postoperative data (80% of total population) (1794 <65 years, 229 ≥ 65 years). There were no differences between elderly and younger patients in overall postoperative complications, reoperations, intensive care unit admissions, emergency room visits, or hospital readmission within 6 weeks of surgery. CONCLUSION: Despite having more preoperative risk factors and more surgically complex procedures, elderly patients undergoing robotic-assisted gynecologic surgery had similar postoperative complication rates, and almost half of elderly patients were safely discharged the day of surgery. Our data suggest that robotic-assisted gynecologic surgery and early hospital discharge are safe in elderly patients.