Valsalva-associated orbital compartment syndrome in the setting of frontoethmoidal mucocele and orbital cellulitis.

Valsalva-associated orbital compartment syndrome in the setting of orbital cellulitis, mucocele, or subperiosteal abscess has not been previously reported. A previously healthy girl presented with orbital cellulitis complicated by a subperiosteal abscess and frontoethmoidal mucocele. On the day of her planned orbitotomy and endoscopic sinus surgery, she developed a Valsalva-associated retrobulbar hemorrhage and elevated intraocular pressure after crying during a blood glucose fingerstick. An urgent canthotomy and cantholysis in addition to the planned endoscopic sinus procedure was performed. She did well post-operatively with normal vision at follow-up. Based on these experiences, there should be a consideration to implement heightened vigilance to prevent or minimize Valsalva maneuvers in orbital cellulitis patients with subperiosteal abscesses or mucoceles extending into the orbit. While it remains unclear whether and to what degree these patients may be at an increased risk of developing retrobulbar hemorrhage leading to orbital compartment syndrome, we hope that this novel report aids in providing another consideration with the goal of preventing vision loss.

Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension.

OBJECTIVE: To estimate the association between mean arterial pressure during pregnancy and neonatal outcomes in participants with chronic hypertension using data from the CHAP (Chronic Hypertension and Pregnancy) trial. METHODS: A secondary analysis of the CHAP trial, an open-label, multicenter randomized trial of antihypertensive treatment in pregnancy, was conducted. The CHAP trial enrolled participants with mild chronic hypertension (blood pressure [BP] 140-159/90-104 mm Hg) and singleton pregnancies less than 23 weeks of gestation, randomizing them to active treatment (maintained on antihypertensive therapy with a goal BP below 140/90 mm Hg) or standard treatment (control; antihypertensives withheld unless BP reached 160 mm Hg systolic BP or higher or 105 mm Hg diastolic BP or higher). We used logistic regression to measure the strength of association between mean arterial pressure (average and highest across study visits) and to select neonatal outcomes. Unadjusted and adjusted odds ratios (per 1-unit increase in millimeters of mercury) of the primary neonatal composite outcome (bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, or intraventricular hemorrhage grade 3 or 4) and individual secondary outcomes (neonatal intensive care unit admission [NICU], low birth weight [LBW] below 2,500 g, and small for gestational age [SGA]) were calculated. RESULTS: A total of 2,284 participants were included: 1,155 active and 1,129 control. Adjusted models controlling for randomization group demonstrated that increasing average mean arterial pressure per millimeter of mercury was associated with an increase in each neonatal outcome examined except NEC, specifically neonatal composite (adjusted odds ratio [aOR] 1.12, 95% CI, 1.09-1.16), NICU admission (aOR 1.07, 95% CI, 1.06-1.08), LBW (aOR 1.12, 95% CI, 1.11-1.14), SGA below the fifth percentile (aOR 1.03, 95% CI, 1.01-1.06), and SGA below the 10th percentile (aOR 1.02, 95% CI, 1.01-1.04). Models using the highest mean arterial pressure as opposed to average mean arterial pressure also demonstrated consistent associations. CONCLUSION: Increasing mean arterial pressure was positively associated with most adverse neonatal outcomes except NEC. Given that the relationship between mean arterial pressure and adverse pregnancy outcomes may not be consistent at all mean arterial pressure levels, future work should attempt to further elucidate whether there is an absolute threshold or relative change in mean arterial pressure at which fetal benefits are optimized along with maternal benefits. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02299414.

Immunomodulation of salivary gland function due to cancer therapy.

Functional salivary glands (SG) are essential for maintaining oral health, and salivary dysfunction is a persistent major clinical challenge. Several cancer therapies also have off-target effects leading to SG dysfunction. Recent advances highlight the role of SG immune populations in homeostasis, dysfunction and gland regeneration. Here, we review what is known about SG immune populations during development and postnatal homeostasis. We summarize recent findings of immune cell involvement in SG dysfunction following cancer treatments such as irradiation (IR) for head and neck cancers, immune transplant leading to graft-versus-host-disease (GVHD) and immune checkpoint inhibitor (ICI) treatment. The role of immune cells in SG in both homeostasis and disease, is an emerging field of research that may provide important clues to organ dysfunction and lead to novel therapeutic targets.

Predominantly unilateral laryngomalacia in infants with unilateral vocal fold paralysis.

BACKGROUND: Neonatal unilateral vocal fold paralysis may arise iatrogenically, idiopathically, or in the context of an underlying neurologic disorder. Management is often supportive, focusing on diet modification to allow for safe oral feeding. We describe the clinical course of six infants with unilateral vocal fold paralysis who developed predominantly unilateral laryngomalacia ipsilateral to the affected vocal fold with associated severe respiratory symptoms and feeding difficulty. METHODS: Retrospective review of six infants with unilateral vocal fold paralysis and predominantly unilateral laryngomalacia. Charts were reviewed for etiology of vocal fold paralysis, presenting symptoms, operative details, postoperative course, and outcomes for breathing and swallowing. RESULTS: Etiology of vocal fold paralysis included cardiac surgery in four patients, intubation-related in one, and idiopathic in one. Presenting symptoms included increased work of breathing, stridor, feeding difficulty, respiratory failure requiring noninvasive respiratory support, and weak cry. All infants were on nasogastric tube feedings. Direct microlaryngoscopy with unilateral or predominantly unilateral (conservative contralateral aryepiglottic fold division) supraglottoplasty was performed. Stridor and work of breathing improved in all six patients within 1 week postoperatively. Oral feeding improved in three patients within 2 weeks. Three patients had persistent feeding impairment with improvement within one year. CONCLUSIONS: Predominantly unilateral laryngomalacia may arise in the context of unilateral vocal fold paralysis. Addressing the ipsilateral cuneiform collapse can improve breathing and feeding. This may be an under-described phenomenon and represents an additional reason to include the otolaryngologist early in the care of infants with suspected possible new unilateral vocal fold paralysis. Breathing and swallow can improve post-operatively, but feeding may remain limited by the vocal fold paralysis and any medical comorbidities. Ongoing follow-up and collaboration with speech-language pathology to optimize feeding are important.

Informing the Exposure Landscape: The Fate of Microplastics in a Large Pelagic In-Lake Mesocosm Experiment.

Understanding microplastic exposure and effects is critical to understanding risk. Here, we used large, in-lake closed-bottom mesocosms to investigate exposure and effects on pelagic freshwater ecosystems. This article provides details about the experimental design and results on the transport of microplastics and exposure to pelagic organisms. Our experiment included three polymers of microplastics (PE, PS, and PET) ranging in density and size. Nominal concentrations ranged from 0 to 29,240 microplastics per liter on a log scale. Mesocosms enclosed natural microbial, phytoplankton, and zooplankton communities and yellow perch (Perca flavescens). We quantified and characterized microplastics in the water column and in components of the food web (biofilm on the walls, zooplankton, and fish). The microplastics in the water stratified vertically according to size and density. After 10 weeks, about 1% of the microplastics added were in the water column, 0.4% attached to biofilm on the walls, 0.01% within zooplankton, and 0.0001% in fish. Visual observations suggest the remaining >98% were in a surface slick and on the bottom. Our study suggests organisms that feed at the surface and in the benthos are likely most at risk, and demonstrates the value of measuring exposure and transport to inform experimental designs and achieve target concentrations in different matrices within toxicity tests.

Buccal Versus Vaginal Misoprostol Combined with a Foley Catheter among Individuals with Obesity Undergoing Induction.

BACKGROUND: Combining pharmacologic agents with mechanical ripening achieves the shortest labor duration, yet there is no clear evidence on route of drug administration in obese individuals. The use of buccal misoprostol has shown greater patient acceptance but remains understudied. OBJECTIVE: Our objective was to evaluate the difference in time to delivery of buccal compared with vaginal misoprostol in combination with a Foley catheter (FC) for induction of labor (IOL) in the obese population. STUDY DESIGN: This was a secondary analysis of a randomized controlled trial comparing identical dosages (25 µg) of buccal and vaginal misoprostol in combination with a FC. The parent trial was an institutional review board-approved, randomized clinical trial conducted from June 2019 through January 2020. Labor management was standardized among participants. Women undergoing IOL at ≥37 weeks with a singleton gestation and cervical dilation ≤2 cm were included. Body mass index (BMI, kg/m2) was stratified. The primary outcome was time to delivery. RESULTS: A total of 215 participants were included. Demographic characteristics were similar between the three groups. Vaginal drug administration achieved a faster median time to delivery than the buccal route among patients with a body mass index greater than or equal to 30 kg/m2 (vaginal misoprostol-FC: 21.3 hours vs. buccal misoprostol-FC: 25.2 hours, p = 0.006). There was no difference in the cesarean delivery rate between the two groups. Furthermore, patients with a BMI greater than or equal to 30 kg/m2 receiving vaginal misoprostol delivered 1.2 times faster than women who received buccal misoprostol after censoring for cesarean delivery and adjusting for parity (hazard ratio: 1.2, 95% confidence interval: 1.1-1.7). There were no significant differences in maternal and neonatal outcomes. CONCLUSION: We found that vaginal misoprostol was superior to buccal misoprostol when combined with a FC among individuals with a BMI greater than or equal to 30 kg/m2. Vaginal misoprostol should be the preferred route of drug administration for term IOL in this population. KEY POINTS: · Vaginal misoprostol was superior to buccal route among patients with obesity.. · There was no difference in the cesarean delivery rate between the two groups.. · Vaginal misoprostol should be the preferred route of administration among patients with obesity..

Type II Thyroplasty with Bilateral Partial Cricothyroid Myectomy for Vocal Tic in Child with Cerebral Dysgenesis.

Vocal tics can occur in neuropsychiatric disorders and result in familial distress. Management is challenging, particularly in children with developmental delay. A 5-year-old with cerebral dysgenesis presented with a high amplitude, high-frequency vocal tic. Type II thyroplasty with bilateral cricothyroid muscle myectomy was performed after initial botulinum toxin trial. Amount, volume, and pitch of tics significantly decreased, without change in swallow. Benefits persisted at 1-year follow-up. This is the first description of combined type II thyroplasty with cricothyroid myectomy for high-frequency vocal tic. This can be done safely and provide sustained benefit for a rare, impactful voice disorder.

Tranexamic acid to reduce blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery-a randomized controlled trial.

BACKGROUND: Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Tranexamic acid has proven to be useful in treating hemorrhage from acute blood loss. However, its role in preventing blood loss in women at high risk of postpartum hemorrhage undergoing cesarean delivery is not well studied. OBJECTIVE: This study aimed to assess the role of tranexamic acid in reducing blood loss during elective and unscheduled cesarean deliveries in women at high risk of postpartum hemorrhage. STUDY DESIGN: This was a prospective, placebo-controlled, randomized controlled trial from March 2021 to February 2022 at the Karnatak Lingayat Education Society Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, India. Women at a high risk of postpartum hemorrhage undergoing cesarean delivery were recruited and randomized to receive either tranexamic acid or placebo (1:1) at least 10 minutes before skin incision. High-risk factors for postpartum hemorrhage included obesity, hypertension, multiparity, previous cesarean delivery, multiple pregnancy, abnormally implanted placenta, placenta previa, abruption, uterine leiomyomas, polyhydramnios, and fetal macrosomia. The primary outcome was blood loss, calculated by a formula using pre- and postoperative hematocrit levels. In addition, gravimetrically measured blood loss was measured and compared between the 2 groups. RESULTS: A total of 212 women met the inclusion criteria and were randomized (tranexamic acid [n=106] and placebo [n=106]). The mean blood loss estimates were 400.9 mL in the tranexamic acid group and 597.9 mL in the placebo group (P<.001). The mean gravimetrically measured blood loss estimates were 379.2 mL in the tranexamic acid group and 431.1 mL in the placebo group (P<.001). In addition, there was a significant difference in the fall in hemoglobin levels (1.04 vs 1.61 g/dL) and change in hematocrit levels (3.20% vs 4.95%) from the pre- to postoperative period between the 2 groups (P<.001). No difference in the need for additional uterotonics (P=.26) or the need for postoperative parental iron (P=.18) was noted. No woman was transfused in either group. CONCLUSION: High-risk women receiving tranexamic acid had significantly less blood loss than women receiving placebo during cesarean delivery.

A City-Wide Emissions Inventory of Plastic Pollution.

A global agreement on plastic should have quantitative reduction targets for the emissions of plastic pollution and regular measurements to track success. Here, we present a framework for measuring plastic emissions, akin to greenhouse gas emissions, and demonstrate its utility by calculating a baseline measurement for the City of Toronto in Ontario, Canada. We identify relevant sources of plastic pollution in the city, calculate emissions for each source by multiplying activity data by emission factors for each source, and sum the emissions to obtain the total annual emissions of plastic pollution generated. Using Monte Carlo simulations, we estimate that 3,531 to 3,852 tonnes (T) of plastic pollution were emitted from Toronto in 2020. Littering is the largest source overall (3,099 T), and artificial turf is the largest source of microplastic (237 T). Quantifying source emissions can inform the most effective mitigation strategies to achieve reduction targets. We recommend this framework be scaled up and replicated in cities, states, provinces, and countries around the world to inform global reduction targets and measure progress toward reducing plastic pollution.

A Multicompartment Assessment of Microplastic Contamination in Semi-remote Boreal Lakes.

Microplastic contamination is ubiquitous across the globe, even in remote locations. Still, the sources and pathways of microplastics to such locations are largely unknown. To investigate microplastic contamination in a semi-remote location, we measured microplastic concentrations in nine oligotrophic lakes within and around the International Institute for Sustainable Development-Experimental Lakes Area in northwestern Ontario, Canada. Our first objective was to establish ambient concentrations of microplastics in bottom sediments, surface water, and atmospheric deposition in semi-remote boreal lakes. Across all lakes, mean shallow and deep sediment microplastic concentrations, near-surface water microplastic concentrations from in situ filtering, and dry atmospheric microplastic deposition rates were 551 ± 354 particles kg-1, 177 ± 103 particles kg-1, 0.2 ± 0.3 particles L-1, and 0.4 ± 0.2 particles m-2 day-1, respectively. Our second objective was to investigate whether microplastic contamination of these lakes is driven by point sources including local runoff and direct anthropogenic inputs or nonpoint sources such as atmospheric deposition. Lakes were selected based on three levels of anthropogenic activity-low, medium, and high-though activity levels were minimal across all study lakes compared with highly populated areas. Whereas a positive correlation would indicate that point sources were a likely pathway, we observed no relationship between the level of anthropogenic activity and microplastic contamination of surface water. Moreover, the composition of microplastics in surface water and atmospheric deposition were similar, comprising mostly polyester and acrylic fibers. Together, these results suggest that atmospheric deposition may be the main pathway of microplastics to these remote boreal lakes. Environ Toxicol Chem 2024;43:999-1011. © 2024 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals LLC on behalf of SETAC.

Neurodevelopment of Children Whose Mothers Were Randomized to Low-Dose Aspirin During Pregnancy.

OBJECTIVE: Because low-dose aspirin is now commonly prescribed in pregnancy, we sought to assess the association between early antenatal exposure and child neurodevelopment. METHODS: We performed a noninferiority, masked, neurodevelopmental follow-up study of children between age 33 and 39 months whose mothers had been randomized to daily low-dose aspirin (81 mg) or placebo between 6 0/7 and 13 6/7 weeks of gestation through 37 weeks. Neurodevelopment was assessed with the Bayley-III (Bayley Scales of Infant and Toddler Development, 3rd Edition) and the ASQ-3 (Ages and Stages Questionnaire, 3rd Edition). The primary outcome was the Bayley-III cognitive composite score with a difference within 4 points demonstrating noninferiority. RESULTS: A total of 640 children (329 in the low-dose aspirin group, 311 in the placebo group) were evaluated between September 2021 and June 2022. The Bayley-III cognitive composite score was noninferior between the two groups (-1, adjusted mean -0.8, 95% CI, -2.2 to 0.60). Significant differences were not seen in the language composite score (difference 0.7, 95% CI, -0.8 to 2.1) or the motor composite score (difference -0.6, 95% CI, -2.5 to 1.2). The proportion of children who had any component of the Bayley-III score lower than 70 did not differ between the two groups. Similarly, the communication, gross motor, fine motor, problem-solving, and personal-social components of the ASQ-3 did not differ between groups. Maternal characteristics, delivery outcomes, breastfeeding rates, breastfeeding duration, and home environment as measured by the Family Care Indicators were similar. CONCLUSION: Antenatal low-dose aspirin exposure was not associated with altered neurodevelopmental outcomes at age 3 years. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04888377.

Long-Term Outcomes and Revision Rates in Laryngeal Reinnervation.

OBJECTIVES: Nonselective laryngeal reinnervation is an effective procedure to improve voice quality after unilateral vocal fold paralysis. Few studies have captured long-term outcome data, and the revision rate for this operation is currently unknown. The objective of this study is to describe the long-term outcomes and revision rates of unilateral, nonselective reinnervation in pediatric and adult patients. METHODS: Patients who underwent laryngeal reinnervation from 2000 to 2022 with a single surgeon were identified for inclusion. Patients who underwent bilateral, super selective, deinnervation and reinnervation, and/or concurrent arytenoid adduction procedures were excluded. Outcome measures included maximum phonation time [MPT], voice handicap index score [VHI], patient-reported percent normal voice, revision procedures, and complications. Data were compiled and analyzed using paired t-tests, repeated measures analysis of covariance, and binary logistic regression analysis. RESULTS: One hundred thirty-two patients underwent unilateral, nonselective ansa-recurrent laryngeal nerve [RLN] laryngeal reinnervation. Reinnervation significantly improved MPT and patient-reported percentage of normal voice and significantly decreased VHI. Eleven patients underwent revision procedures, corresponding to a revision rate of 8.3%. Additional procedures included medialization laryngoplasty [n = 3], medialization laryngoplasty with arytenoid adduction [n = 3] and injection augmentation greater than 1 year after reinnervation [n = 5]. The only factor associated with the need for additional surgery was time lapse from nerve injury to reinnervation. The overall complication rate was 6.8%; no patient required reintubation or tracheostomy. CONCLUSION: Unilateral, nonselective laryngeal reinnervation can provide reliable improvement in vocal symptoms after recurrent laryngeal nerve injury. The revision rate after laryngeal reinnervation is favorable and comparable to framework surgery. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:3187-3192, 2024.

Indications and Short-Term Outcomes for In-Office Therapeutic Superior Laryngeal Nerve Block.

OBJECTIVE: Superior laryngeal nerve (SLN) block consists of injection of steroid and anesthetic at the internal branch of the SLN entry site. Prior case series have demonstrated beneficial effects on neurogenic cough. SLN blocks have also recently shown benefit for paralaryngeal pain. We describe short-term outcomes for multiple symptoms of irritable larynx syndrome (ILS) including neurogenic cough, dysphonia related to laryngeal hypersensitivity, inducible laryngeal obstruction (ILO), paralaryngeal pain, and isolated globus. METHODS: Retrospective review from 2 institutions of patients undergoing a single SLN block for the indications listed. Variables include age, sex, indication(s), known vagus neuropathy, and patient-reported outcomes at short-term follow-up. RESULTS: A total of 209 patients were included (59 males, 150 females; age: 58 ± 13 years). Twenty-six patients (12%) had a history of a vagus nerve injury. Indications included neurogenic cough (n = 149), dysphonia related to laryngeal hypersensitivity (n = 66), paralaryngeal pain (n = 50), ILO (n = 23), and isolated globus (n = 3). Some patients had multiple indications. Significant improvements in patient-reported measures occurred after a single SLN block within 2 to 4 weeks for neurogenic cough (cough severity index; 25.2 ± 11.2 to 19.0 ± 12.8; P < .001), dysphonia (voice handicap index-10; 22.1 ± 12.2-18.0 ± 13.3; P = .005), and ILO (dyspnea index; 21.0 ± 14.9-14.7 ± 15.7; P = .017). Subjective pain improved in 23 of 39 patients with paralaryngeal pain. There was no observed improvement for isolated globus. Presence of known vagal neuropathy or therapy around the time of SLN block did not affect outcome. CONCLUSION: SLN block can be an effective component of treatment for a variety of ILS symptoms. Patients may experience some improvement after 1 injection. LAY SUMMARY: Symptoms of irritable larynx syndrome, such as neurogenic cough, paralaryngeal pain, inducible laryngeal obstruction, and dysphonia related to laryngeal hypersensitivity can be challenging to manage. In-office Superior Laryngeal Nerve blocks can serve as a quick, well tolerated, adjunctive treatment with positive short-term outcomes. LEVEL OF EVIDENCE: 4.

Uterine Weight and Perioperative Morbidity in Robotic-Assisted versus Conventional Laparoscopic Hysterectomy.

Background and Objectives: Minimally invasive approaches to benign hysterectomy are the current standard of care when feasible. Use of robotic-assisted laparoscopic hysterectomy (RA-LH) has been increasing; however, direct comparative data that accounts for uterine weight in conventional laparoscopic hysterectomy (CLH) and RA-LH is limited. We sought to examine the impact of uterine weight on immediate perioperative morbidity in CLH versus RA-LH. The primary outcome was a composite of complications including visceral injuries, conversions to abdominal procedures, and transfusions. Methods: A retrospective cohort study of patients who underwent a minimally invasive laparoscopic hysterectomy (CLH and RA-LH) in a single hospital system between January 1, 2014 and December 31, 2017 as identified by Current Procedural Terminology codes. The primary exposure was CLH or RA-LH. Uterine weight was categorized into four groups: <150 g, 150 to < 250 g, 250 to < 450 g, and ≥ 450 g. Results: A total of 1506 patients were included; 539 underwent CLH and 967 underwent RA-LH. Median uterine weight was higher in patients who underwent CLH (161.0 g) compared to RA-LH (147.0 g), P = .001. The odds of the composite of complications in CLH was 4.43 (2.84 - 6.92) higher than the odds of the composite in RA-LH. When stratified by the uterine weight, the odds of complications was significantly higher in CLH in the following categories: <150 g, 250 to < 450 g, and ≥ 450 g (OR: 4.41, 3.28, and 7.81, respectively). Conclusion: Surgical morbidity was lower in RA-LH across the spectrum of uterine weights compared to CLH. Patients may particularly benefit from RA-LH at higher uterine weights.

A Machine Learning Algorithm using Clinical and Demographic Data for All-Cause Preterm Birth Prediction.

OBJECTIVE: Preterm birth remains the predominant cause of perinatal mortality throughout the United States and the world, with well-documented racial and socioeconomic disparities. To develop and validate a predictive algorithm for all-cause preterm birth using clinical, demographic, and laboratory data using machine learning. STUDY DESIGN: We performed a cohort study of pregnant individuals delivering at a single institution using prospectively collected information on clinical conditions, patient demographics, laboratory data, and health care utilization. Our primary outcome was all-cause preterm birth before 37 weeks. The dataset was randomly divided into a derivation cohort (70%) and a separate validation cohort (30%). Predictor variables were selected amongst 33 that had been previously identified in the literature (directed machine learning). In the derivation cohort, both statistical (logistic regression) and machine learning (XG-Boost) models were used to derive the best fit (C-Statistic) and then validated using the validation cohort. We measured model discrimination with the C-Statistic and assessed the model performance and calibration of the model to determine whether the model provided clinical decision-making benefits. RESULTS: The cohort includes a total of 12,440 deliveries among 12,071 individuals. Preterm birth occurred in 2,037 births (16.4%). The derivation cohort consisted of 8,708 (70%) and the validation cohort consisted of 3,732 (30%). XG-Boost was chosen due to the robustness of the model and the ability to deal with missing data and collinearity between predictor variables. The top five predictor variables identified as drivers of preterm birth, by feature importance metric, were multiple gestation, number of emergency department visits in the year prior to the index pregnancy, initial unknown body mass index, gravidity, and prior preterm delivery. Test performance characteristics were similar between the two populations (derivation cohort area under the curve [AUC] = 0.70 vs. validation cohort AUC = 0.63). CONCLUSION: Clinical, demographic, and laboratory information can be useful to predict all-cause preterm birth with moderate precision. KEY POINTS: · Machine learning can be used to create models to predict preterm birth.. · In our model, all-cause preterm birth can be predicted with moderate precision.. · Clinical, demographic, and laboratory information can be useful to predict all-cause preterm birth..

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

IMPORTANCE: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.