ABSTRACT
BACKGROUND: Feeding difficulty is the most common cause of delayed hospital discharge and readmission of late preterm infants. Frequent and adequate feedings from birth are protective against dehydration, hypoglycemia, and jaundice. The National Perinatal Association's feeding guidelines provide the foundation for late preterm infant standards of care. Feeding at least every 3 hours promotes nutritional status and neurologic development. One feeding assessment every 12 hours during the hospital stay can ensure quality of infant feeding. PROBLEM: At a large urban hospital, medical record reviews were completed to evaluate nursing care practices consistent with the hospital's late preterm infant care standard policy. Feeding frequency and nurse assessment of feeding effectiveness were far below acceptable targets. A quality improvement team was formed to address inconsistency with expected practice. METHODS: The project included an investigation using the define, design, implement, and sustain method of quality improvement. Parent education, nurse education, and visual cues were developed to sustain enhanced nursing practice. RESULTS: Late preterm infants who received feedings at least every 3 hours increased from 2.5% (1 of 40) to 27% (11 of 40); (M = 0.275, SD = 0.446), p = 0.001. Documented breastfeeding assessments increased from 2% (5 of 264) to 8% (10 of 126), p = 0.001. Documented bottle-feeding assessments increased from 15% (39 of 264) to 31% (53 of 172), p < 0.001. Intervention time was cut short due to reprioritization of efforts in response to the COVID-19 pandemic. CONCLUSION: Interventions and implementation of this process improvement is easy to replicate through attainable and sustainable goals directed toward improved outcomes for late preterm infants.
Subject(s)
Breast Feeding , Feeding Methods/adverse effects , Health Knowledge, Attitudes, Practice , Infant Care/methods , Infant, Premature , Mothers/education , Nursing Care/standards , Quality Improvement , Female , Gestational Age , Hospitals , Humans , Infant, Newborn , PandemicsABSTRACT
BACKGROUND: Observational studies are often the only option to estimate effects of interventions during pregnancy. Causal inference from observational data can be conceptualized as an attempt to emulate a hypothetical pragmatic randomized trial: the target trial. OBJECTIVE: To provide a step-by-step description of how to use healthcare databases to estimate the effects of interventions initiated during pregnancy. As an example, we describe how to specify and emulate a target trial of COVID-19 vaccination during pregnancy, but the framework can be generally applied to point and sustained strategies involving both pharmacologic and non-pharmacologic interventions. METHODS: First, we specify the protocol of a target trial to evaluate the safety and effectiveness of vaccination during pregnancy. Second, we describe how to use observational data to emulate each component of the protocol of the target trial. We propose different target trials for different gestational periods because the outcomes of interest vary by gestational age at exposure. We identify challenges that affect (i) the target trial and thus its observational emulation (censoring and competing events), and (ii) mostly the observational emulation (confounding, immortal time, and measurement biases). CONCLUSION: Some biases may be unavoidable in observational emulations, but others are avoidable. For instance, immortal time bias can be avoided by aligning the start of follow-up with the gestational age at the time of the intervention, as we would do in the target trial. Explicitly emulating target trials at different gestational ages can help reduce bias and improve the interpretability of effect estimates for interventions during pregnancy.
Subject(s)
COVID-19 , Female , Humans , Pregnancy , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Databases, Factual , Gestational Age , Vaccination , Pragmatic Clinical Trials as Topic , Randomized Controlled Trials as TopicABSTRACT
The article analyzes the prevalence of coronavirus infection in newborns in the Republic of Kazakhstan from the pandemic outbreak till April 2022. The article provides the dynamics of the number of newborns with positive SARS-CoV-2 tests in the reporting period, describes the specifics of the course of coronavirus infection in newborns depending on the neonatal gestational age, and reports the immediate outcomes.
Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Pregnancy , Female , Infant, Newborn , Humans , SARS-CoV-2 , Pregnancy Complications, Infectious/epidemiology , Gestational Age , Disease ProgressionABSTRACT
Purpose: To evaluate breastfeeding outcomes in preterm infants born during the Covid-19 pandemic. Design: An observational cohort study of 33 infants born ≤34 weeks' gestation was conducted. Sample: The study sample consisted of 33 infants divided into 2 groups: infants born during the Covid-19 pandemic (Covid group, n = 11) and those born prior to the pandemic (pre-Covid group, n = 22). Main Outcome Variable: Breastfeeding at hospital discharge. Results: Fewer infants in the Covid group received breastfeeds at full oral feed (p = .015) and none breastfeeding at hospital discharge (p = .001). In addition, fewer infants in the Covid group received non nutritive sucking (p = .612) and more infants in the Covid group required milk supplementation (p = .032). Study results suggest that breastfeeding establishment at hospital discharge in preterm infants is significantly impacted by the Covid-19 pandemic. There is a critical need, in low-risk disease transmission areas, to enhance parental access and to increase in-hospital lactation supports to help safeguard breastfeeding outcomes in preterm infants.
Subject(s)
COVID-19 , Infant, Premature , Infant , Female , Infant, Newborn , Humans , Breast Feeding/methods , Pandemics , COVID-19/epidemiology , Gestational AgeABSTRACT
This was a retrospective cohort study of patients who delivered singleton, small-for-gestational-age (SGA) neonates between April and June 2019, before the coronavirus disease 2019 (COVID-19) pandemic (pre-COVID-19), and between April and July 2020, during the pandemic (COVID-19 epoch). The primary outcome was the rate of undetected antenatal fetal growth restriction (FGR) in the two periods. A total of 268 patients met inclusion criteria. Patients who delivered small-for-gestational-age neonates during the COVID-19 epoch were significantly more likely to have undetected FGR compared with those who delivered pre-COVID-19 (70.1% vs 58.1%, P =.04). Patients who delivered SGA neonates during the COVID-19 epoch had more telehealth visits but fewer in-person prenatal visits, recorded fundal height measurements, and growth ultrasonograms. As telemedicine continues to be incorporated into prenatal care, these data may lend further support toward self-assessment of fundal height or routine third-trimester growth ultrasonograms to identify fetal growth abnormalities.
Subject(s)
COVID-19 , Fetal Growth Retardation , Infant, Newborn , Pregnancy , Humans , Female , Fetal Growth Retardation/diagnostic imaging , Fetal Growth Retardation/epidemiology , Retrospective Studies , Pandemics , Ultrasonography, Prenatal , COVID-19/epidemiology , Infant, Small for Gestational Age , Gestational AgeABSTRACT
Resumen Objetivo: La pandemia de SARS-CoV-2 ha obligado a una reorganización de las visitas presenciales, y por ese motivo se han minimizado hasta el punto de reconsiderar la realización de la visita del tercer trimestre. Nuestro centro suprimió dicha visita obstétrica y obtuvo datos propios para comparar los resultados perinatales logrados con dicho manejo. Método: Se realizó un estudio de cohortes retrospectivo, en marzo de 2020, con una cohorte con visita presencial única en la semana 40 de gestación (122 gestantes) frente a una cohorte con seguimiento convencional con visita presencial en la semana 36 de gestación (162 gestantes). Se evaluaron la restricción del crecimiento fetal, la edad gestacional al nacimiento, el peso neonatal y las tasas de inducciones, partos eutócicos y cesáreas urgentes en trabajo de parto. Resultados: Se encontraron diferencias leves en la tasa de nuliparidad (p < 0,04), sin hallarlas en el resto de las variables maternas. No hubo diferencias entre las dos cohortes en los resultados neonatales. Conclusiones: No hay diferencias entre los resultados materno-fetales obtenidos en gestantes con seguimiento gestacional con restricción de la visita del tercer trimestre respecto del seguimiento tradicional, excepto en el diagnóstico de las alteraciones de la estática fetal al término de la gestación.
Abstract Objective: The SARS-CoV-2 pandemic has forced a reorganization of face-to-face visits, for this reason they have been minimized to the point of reconsidering the completion of the third trimester visit. Our center eliminated the performance of this obstetric visit and obtained its own data to compare the perinatal results obtained with such management. Method: A retrospective cohort study was carried out in March 2020, with a cohort with a single face-to-face visit at 40th week of gestation (122 pregnant women), versus a cohort with conventional follow-up with face-to-face visit at 36th week of gestation (162 pregnant women). The following were evaluated fetal growth restriction, gestational age at birth, neonatal weight, rate of inductions, of eutocic deliveries, and of urgent cesarean sections in labor. Results: Slight differences were found in the nulliparity rate (p < 0.04), without finding them in the rest of the maternal variables. There were no differences between the two cohorts in neonatal outcomes. Conclusions: There were no differences between the maternal-fetal results obtained in pregnant women with gestational follow-up with restriction of the third trimester visit compared to traditional follow-up, except in the diagnosis of alterations in fetal statics at the end of pregnancy.
Subject(s)
Humans , Female , Pregnancy , Pregnancy Trimester, Third , SARS-CoV-2 , Parity , Gestational Age , Fetal Growth RetardationABSTRACT
BACKGROUND: During pregnancy, certain viral infections are known to significantly affect fetal development. Data regarding the impact of COVID-19 viral infection in pregnancy, specifically in asymptomatic or mild cases, remains limited. This presents a challenge in providing prenatal counseling and antepartum surveillance in pregnancies complicated by COVID-19 infection. Placenta studies have demonstrated that vascular malperfusion patterns attributed to COVID-19 appear to depend on the timing of infection. Given these placental changes, we aim to evaluate the impact of COVID-19 on fetal growth in pregnant patients with asymptomatic or mild disease, stratified by trimester of infection. We hypothesize that COVID-19 infection, especially early in pregnancy, increases the risk of fetal growth restriction (FGR). STUDY DESIGN: This is a single institution, retrospective cohort study of patients ages 16-55 years old with a singleton delivery between December 10, 2020, and April 19, 2021 who had not received a COVID-19 vaccination prior to delivery. COVID-19 infection during pregnancy was defined as a positive SARS-CoV-2 RT-PCR test. FGR was defined as an estimated fetal weight less than the 10th percentile for gestational age or abdominal circumference less than the 10th percentile for gestational age. Maternal and fetal characteristics, including FGR, were compared between women with versus without COVID-19 infection during pregnancy. RESULTS: Among 1971 women with a singleton delivery, 208 (10.6 %) had a prior asymptomatic or mild COVID-19 infection during pregnancy. With the exception in the median prenatal BMI being significantly higher in the COVID-19 group (median, 27.5 vs 26.3, p = 0.04), there were no significant differences in demographics, baseline maternal comorbidities or gestational age between those with versus without COVID-19 infection during pregnancy, or in the proportion of their offspring with FGR (3.4 % (7/208) vs 4.8 % (84/1763), p = 0.36). When the 208 women were stratified by the timing of their COVID-19 infection, the proportion with an offspring with FGR was 8.7 % (2/23), 1.2 % (1/84), and 4.0 % (4/101), for those first diagnosed with COVID-19 during the 1st, 2nd, and 3rd trimesters, respectively (p = 0.72 Cochran-Armitage test for trend). CONCLUSION: Asymptomatic or mild COVID-19 infection in pregnancy, regardless of timing of infection, does not appear to be associated with FGR. Routine serial fetal growth assessment may not be warranted solely for history of COVID-19 infection.
Subject(s)
COVID-19 , Placenta , Pregnancy , Female , Humans , Adolescent , Young Adult , Adult , Middle Aged , Placenta/blood supply , Retrospective Studies , COVID-19 Vaccines , COVID-19/complications , COVID-19/diagnosis , SARS-CoV-2 , Fetal Development , Fetal Growth Retardation/etiology , Gestational AgeABSTRACT
OBJECTIVE: Identifying the time of SARS-CoV-2 viral infection relative to specific gestational weeks is critical for delineating the role of viral infection timing in adverse pregnancy outcomes. However, this task is difficult when it comes to Electronic Health Records (EHR). In combating the COVID-19 pandemic for maternal health, we sought to develop and validate a clinical information extraction algorithm to detect the time of clinical events relative to gestational weeks. MATERIALS AND METHODS: We used EHR from the National COVID Cohort Collaborative (N3C), in which the EHR are normalized by the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). We performed EHR phenotyping, resulting in 270,897 pregnant women (June 1st, 2018 to May 31st, 2021). We developed a rule-based algorithm and performed a multi-level evaluation to test content validity and clinical validity, and extreme length of gestation (<150 or >300). RESULTS: The algorithm identified 296,194 pregnancies (16,659 COVID-19, 174,744 without COVID-19) in 270,897 pregnant women. For inferring gestational age, 95% cases (n = 40) have moderate-high accuracy (Cohen's Kappa = 0.62); 100% cases (n = 40) have moderate-high granularity of temporal information (Cohen's Kappa = 1). For inferring delivery dates, the accuracy is 100% (Cohen's Kappa = 1). The accuracy of gestational age detection for the extreme length of gestation is 93.3% (Cohen's Kappa = 1). Mothers with COVID-19 showed higher prevalence in obesity or overweight (35.1% vs. 29.5%), diabetes (17.8% vs. 17.0%), chronic obstructive pulmonary disease (0.2% vs. 0.1%), respiratory distress syndrome or acute respiratory failure (1.8% vs. 0.2%). DISCUSSION: We explored the characteristics of pregnant women by different gestational weeks of SARS-CoV-2 infection with our algorithm. TED-PC is the first to infer the exact gestational week linked with every clinical event from EHR and detect the timing of SARS-CoV-2 infection in pregnant women. CONCLUSION: The algorithm shows excellent clinical validity in inferring gestational age and delivery dates, which supports multiple EHR cohorts on N3C studying the impact of COVID-19 on pregnancy.
Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Premature Birth , Female , Pregnancy , Humans , COVID-19/epidemiology , Pandemics , Pregnant Women , Gestational Age , SARS-CoV-2 , Electronic Health Records , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Pregnancy Outcome , Algorithms , Premature Birth/epidemiologyABSTRACT
OBJECTIVE: Many institutions implemented policy changes to protect patients and clinicians during the COVID-19 pandemic. This study examines how institutional policy changes and patient behaviors affected perinatal outcomes. We hypothesized that obstetric practice changes occurred and that these changes affected perinatal outcomes. METHODS: We conducted a retrospective cohort study of singleton pregnancies delivered at a single institution with low incidence of COVID-19. Deliveries occurring from December 15, 2019 through March 14, 2020 were designated as the pre-COVID-19 group. Those occurring from March 15, 2020, through June 15, 2020, were designated the COVID-19 group. The primary outcome is a perinatal composite defined as delivery ≥ 41 weeks, hypertensive disorder of pregnancy at term, unplanned Cesarean delivery, term neonatal intensive care unit admission, 42-day maternal readmission, and 7-day neonatal readmission. Additional maternal, neonatal, and delivery composites also were analyzed, and we evaluated all individual outcomes secondarily. RESULTS: Of 2,268 deliveries, 1,210 occurred during the COVID-19 period. Four of the 1,210 (0.3%) were diagnosed with COVID-19. Women during the COVID-19 period were more likely to present in spontaneous labor and less likely to undergo induction. Maternal and neonatal length of stay was also shorter. There was no difference in the perinatal composite between the 2 groups (36.3% vs 36.7% [OR 1.05; 95% CI, 0.86-1.21]). There was a significant increase in deliveries occurring at or after 41 weeks (4.7% vs 6.9% [OR 1.83; 95% CI, 1.00-3.34]). There was no difference in maternal, neonatal, and delivery composites or the outcomes assessed individually. CONCLUSIONS: We demonstrated significant changes in clinical practice secondary to policy changes and patient behaviors during the COVID-19 pandemic. As an institution that globally adopted ARRIVE (A Randomized Trial of Induction Versus Expectant Management) practices, we noted fewer inductions, more women presenting in labor and more women delivering at or after 41 weeks. We also noted a shorter length of hospital stay for the mother-baby dyad. Overall, these changes in clinical practice did not affect perinatal outcomes.
Subject(s)
COVID-19 , Labor, Induced , Infant, Newborn , Pregnancy , Female , Humans , COVID-19/epidemiology , Gestational Age , Retrospective Studies , Pandemics , Watchful WaitingABSTRACT
BACKGROUND: Studies of preterm delivery after COVID-19 are often subject to selection bias and do not distinguish between early vs. late infection in pregnancy, nor between spontaneous vs. medically indicated preterm delivery. This study aimed to estimate the risk of preterm birth (overall, spontaneous, and indicated) after COVID-19 during pregnancy, while considering different levels of disease severity and timing. METHODS: Pregnant and recently pregnant people who were tested for or clinically diagnosed with COVID-19 during pregnancy enrolled in an international internet-based cohort study between June 2020 and July 2021. We used several analytic approaches to minimize confounding and immortal time bias, including multivariable regression, time-to-delivery models, and a case-time-control design. RESULTS: Among 14,264 eligible participants from 70 countries who did not report a pregnancy loss before 20 gestational weeks, 5893 had completed their pregnancies and reported delivery information; others were censored at time of their last follow-up. Participants with symptomatic COVID-19 before 20 weeks' gestation had no increased risk of preterm delivery compared to those testing negative, with adjusted risks of 10.0% (95% CI 7.8, 12.0) vs. 9.8% (9.1, 10.5). Mild COVID-19 later in pregnancy was not clearly associated with preterm delivery. In contrast, severe COVID-19 after 20 weeks' gestation led to an increase in preterm delivery compared to milder disease. For example, the risk ratio for preterm delivery comparing severe to mild/moderate COVID-19 at 35 weeks was 2.8 (2.0, 4.0); corresponding risk ratios for indicated and spontaneous preterm delivery were 3.7 (2.0, 7.0) and 2.3 (1.2, 3.9), respectively. CONCLUSIONS: Severe COVID-19 late in pregnancy sharply increased the risk of preterm delivery compared to no COVID-19. This elevated risk was primarily due to an increase in medically indicated preterm deliveries, included preterm cesarean sections, although an increase in spontaneous preterm delivery was also observed. In contrast, mild or moderate COVID-19 conferred minimal risk, as did severe disease early in pregnancy.
Subject(s)
COVID-19 , Premature Birth , Female , Pregnancy , Infant, Newborn , Humans , Premature Birth/epidemiology , COVID-19/epidemiology , Cohort Studies , Gestational Age , Registries , Pregnancy Outcome/epidemiologyABSTRACT
OBJECTIVE: The effect of severe maternal infectious morbidity on fetal growth during the second half of pregnancy is under debate. Preliminary evidence suggests that such association may be plausible. The objectives of this study were to determine: 1) The association between severe maternal infectious morbidity and adverse pregnancy outcome; and 2) The effect of maternal infection during pregnancy on fetal growth. STUDY DESIGN: This retrospective population - based cohort study included 4771 women who gave birth at our medical center during the study period. Parturients were allocated into two groups: 1) patients with severe maternal infection during the second half of pregnancy (n = 368); and 2) control group comprised of normal pregnant women who were matched to the study group by maternal age, gravidity and parity (n = 4403). RESULTS: The severe maternal infection group included women with pneumonia (n = 198), pyelonephritis (n = 131), and viral pneumonitis (n = 39). In comparison to the normal patients group: 1) having had pneumonia during the second half of pregnancy was associated with increased rates of fetal growth restriction, placental abruption, fetal demise (P < 0.001, for all comparisons) and preeclampsia (P = 0.041); 2) Pyelonephritis during the second half of gestation was associated with higher rates of fetal growth restriction (P < 0.001), placental abruption (P = 0.006) and labor induction (P = 0.039). As a group, women with severe maternal infection had higher rates of small for gestational age neonates compared to normal parturients (P < 0.001). Among women with infections, only those who had pyelonephritis (P = 0.032) or pneumonia (P = 0.008), had a higher rate of small for gestational age neonates than those in the control group. After adjustment to confounding factors, maternal infection (OR = 1.42, 95% CI 1.085-1.85) and previous delivery of a small for gestational age neonate (OR = 2.54, 95% CI 2.02-3.19), were independent risk factors for the delivery of a small for gestational age neonate. CONCLUSION: Severe maternal infectious morbidity during the second half of pregnancy is an independent risk factor for the delivery of a small for gestational age neonate and is associated with adverse pregnancy outcomes. Both, pneumonia and pyelonephritis, during the second half of gestation affect fetal growth and are related to higher rates of small for gestational age neonates.
Subject(s)
Abruptio Placentae , Pyelonephritis , Cohort Studies , Female , Fetal Growth Retardation/epidemiology , Gestational Age , Humans , Infant, Newborn , Infant, Small for Gestational Age , Morbidity , Placenta , Pregnancy , Pregnancy Outcome , Retrospective Studies , Risk FactorsABSTRACT
Purpose: To evaluate the effectiveness and future implications of COVID-related risk stratification for managing retinopathy of prematurity (ROP). Methods: A prospective study was conducted at a tertiary eye care center from the beginning of the lockdown in India from 23 March 2020 till the end of the first phase of lockdown on 29 May 2020. We evaluated 200 prematurely born infants (< 34 weeks of gestational age) using the new safety guideline protocols for low-risk babies developed in conjunction with the Indian ROP Society for care during the COVID-19 pandemic. Low risk included babies born at more than 30 weeks of gestational age, post menstrual age 34 weeks or above at presentation, more than 1000 grams of birth weight, and stable systemically with good weight gain. Results: New guidelines were implemented in 106 (53%) infants who were low risk while 94 (47%) infants with high risk were followed up as per the old guidelines. Out of the 106 infants (212 eyes) managed by the new guidelines, good outcome (group 1) was seen in 102 (96.2%) infants. Twenty-seven of the 102 infants had some form of ROP and 5 of these infants needed treatment. None of the low-risk babies with no detachment at presentation managed by new guidelines required surgery later (group 2). Two (1.9%) infants came with retinal detachment at presentation and underwent successful surgery (group 3) and two infants (1.9%) were lost to follow up. Conclusion: New risk stratification during the COVID-19 pandemic was an efficient and safe strategy in managing low-risk ROP babies.
Subject(s)
COVID-19 , Retinopathy of Prematurity , Birth Weight , Cities , Communicable Disease Control , Gestational Age , Humans , Infant , Infant, Newborn , Infant, Premature , Pandemics , Prospective Studies , Retrospective Studies , Risk Assessment , Risk FactorsABSTRACT
BACKGROUND: Coronavirus disease 2019 (COVID-19) during pregnancy and early infancy can result in severe disease. Evaluating the effect of gestational age at the time of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination on maternal antibody levels and transplacental antibody transfer has important implications for maternal care and vaccination strategies. METHODS: Maternal and cord blood sera were collected from mother-newborn dyads (nâ =â 402), following term delivery after antenatal 2-dose SARS-CoV-2 BNT162b2 mRNA vaccination. SARS-CoV-2 spike protein (S) and receptor binding domain (RBD)-specific IgG levels were evaluated in the samples collected. RESULTS: Median anti-S and anti-RBD-specific IgG levels in maternal sera at the time of delivery were lowest following first-trimester vaccination (nâ =â 90; anti-S IgG: 76 AU/mL; anti-RBD-specific IgG: 478 AU/mL), intermediate in those vaccinated in the second trimester (nâ =â 124; anti-S IgG: 126 AU/mL; anti-RBD-specific IgG: 1263 AU/mL), and highest after third-trimester vaccination (nâ =â 188; anti-S IgG: 240 AU/mL; anti-RBD-specific IgG: 5855 AU/mL). Antibody levels in neonatal sera followed a similar pattern and were lowest following antenatal vaccination in the first trimester (anti-S IgG: 126 AU/mL; anti-RBD-specific IgG: 1140 AU/mL). In a subgroup of parturients vaccinated in the first trimester (nâ =â 30), a third booster dose was associated with significantly higher maternal and neonatal antibody levels. CONCLUSIONS: These results suggest a considerable antibody waning throughout pregnancy in those vaccinated at early gestation. The observed boosting effect of a third vaccine dose hints at its potential benefit in those who completed the 2-dose vaccine series at early pregnancy or before conception. The impact of antenatal immunization timing on SARS-CoV-2 transplacental antibody transfer may influence neonatal seroprotection.
Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Viral Vaccines , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , Female , Gestational Age , Humans , Immunoglobulin G , Infant, Newborn , Pregnancy , Pregnancy Complications, Infectious/prevention & control , RNA, Messenger , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , VaccinationABSTRACT
Preeclampsia and cardiovascular disease (CVD) share multiple features and risk factors. Circulating angiotensin-converting enzyme 2 (ACE2) is increased in CVD and mediates SARS-CoV-2 entry into host cells, causing COVID-19 infection. The role of ACE2 in preeclampsia pathophysiology is unknown. We hypothesized that circulating ACE2 is increased in mid-pregnancy in women later developing preeclampsia. We included 296 women later developing preeclampsia (cases) and 333 women with a continuous healthy pregnancy (controls). Circulating ACE2 was measured with an immunoassay based on proximity extension assay technology, with levels being expressed as relative quantification on a log2 scale. Median (interquartile range) ACE2 levels were higher in cases than in controls; 3.84 (3.50-4.24) vs. 3.72 (3.45-4.04), p = 0.002. Adjusted logistic regression models showed a 60% increased risk for later development of preeclampsia with one unit elevation of ACE2 (adjusted odds ratio (aOR) 1.60, 95% confidence intervals (CI) 1.17-2.18). Preterm preeclampsia (diagnosis before 37 gestational weeks, n = 97) seemed to have a stronger ACE2 association than term preeclampsia, n = 199 (aORs, 95% Cis 2.14, 1.15-3.96 and 1.52, 1.04-2.23, respectively). Circulating ACE2 is increased at mid-pregnancy in women later developing preeclampsia, particularly preterm preeclampsia. Thus, our finding indicates a partly shared pathophysiological pathway between preeclampsia and CVD.
Subject(s)
Angiotensin-Converting Enzyme 2/blood , Pre-Eclampsia/diagnosis , Adult , Body Mass Index , Cardiovascular Diseases/complications , Cardiovascular Diseases/pathology , Case-Control Studies , Female , Gestational Age , Hospitals, University , Humans , Logistic Models , Odds Ratio , Pre-Eclampsia/pathology , Pregnancy , Risk Factors , SwedenABSTRACT
We conducted a pilot diagnostic randomized clinical trial (RCT) to examine the feasibility, acceptability, and preliminary outcomes of adding bowel ultrasound (BUS) to the diagnostic evaluation for necrotizing enterocolitis (NEC). Infants ≤ 32 weeks' gestational age with NEC concern were randomized to undergo abdominal X-ray (AXR) or AXR + BUS. The primary outcome was study feasibility. Secondary outcomes included rates of NEC diagnosis and duration of treatment with bowel rest and antibiotics. A total of 56 infants were enrolled; 16 developed NEC concern and were randomized. Rates of recruitment (56/82 = 68%), retention (16/16 = 100%), and protocol compliance (126/127 = 99%) met pre-specified thresholds for feasibility. No significant differences in rates of NEC diagnosis were found between the two groups. Durations of bowel rest and antibiotic treatment were also similar. Conclusion: Our study supports the feasibility of conducting a definitive diagnostic RCT to establish safety and efficacy of BUS for NEC. Clinical trial registration: The study was registered at https://clinicaltrials.gov (NCT03963011). What is Known: ⢠Bowel ultrasound (BUS) is increasingly being utilized as an adjunct to abdominal radiographs in evaluating for necrotizing enterocolitis (NEC). ⢠The impact of BUS on patient outcomes is unknown. What is New: ⢠A diagnostic randomized controlled trial study design to determine safety and effectiveness of adding BUS to NEC evaluation is feasible and acceptable.
Subject(s)
Enterocolitis, Necrotizing , Infant, Newborn, Diseases , Enterocolitis, Necrotizing/diagnostic imaging , Enterocolitis, Necrotizing/drug therapy , Feasibility Studies , Gestational Age , Humans , Infant , Infant, Newborn , UltrasonographyABSTRACT
Evidence that music therapy stabilises vital parameters in preterm infants is growing, but the optimal setting for therapy is still under investigation. Our study aimed to quantify the effect of physical contact during live music therapy in preterm infants born < 32 weeks' gestational age (GA) on post-therapy vital sign values. Live music therapy was delivered twice-weekly until discharge from hospital to 40 stable infants < 32 weeks' GA. Baseline and post-therapy heart rate, respiratory rate, oxygen saturation and physical contact during each session were recorded. 159 sessions were performed with, and 444 sessions without, physical contact. Descriptive and multivariable regression analyses based on directed acyclic graphs were performed. The mean GA was 28.6 ± 2.6 weeks, and 26 (65%) infants were male. Mean absolute values for heart and respiratory rates lowered during music therapy regardless of physical contact. The mean post-therapy SaO2 was higher compared to baseline values regardless of physical contact (mean differences -8.6 beats/min; -13.3 breaths/min and +2.0%). There were no clinically relevant changes in vital sign responses between therapy sessions, with or without physical contact, or adjusted post-therapy values for any of the studied vital signs. Physical contact caused better baseline and post-therapy vital sign values but did not enhance the vital sign response to music therapy. Thus, the effect of music therapy on preterm infants' vital signs is independent of physical contact and parents' presence during music therapy in the neonatal intensive care unit.
Subject(s)
Music Therapy , Music , Female , Gestational Age , Humans , Infant , Infant, Newborn , Infant, Premature , Intensive Care Units, Neonatal , Male , Vital SignsABSTRACT
OBJECTIVE: To assess the risk of preterm birth, small for gestational age at birth, and stillbirth after covid-19 vaccination during pregnancy. DESIGN: Population based retrospective cohort study. SETTING: Ontario, Canada, 1 May to 31 December 2021. PARTICIPANTS: All liveborn and stillborn infants from pregnancies conceived at least 42 weeks before the end of the study period and with gestational age ≥20 weeks or birth weight ≥500 g. MAIN OUTCOME MEASURES: Using Cox regression, hazard ratios and 95% confidence intervals were estimated for preterm birth before 37 weeks (overall and spontaneous preterm birth), very preterm birth (<32 weeks), small for gestational age at birth (<10th centile), and stillbirth. Vaccination against covid-19 was treated as a time varying exposure in the outcome specific risk window, and propensity score weighting was used to adjust hazard ratios for potential confounding. RESULTS: Among 85 162 births, 43 099 (50.6%) occurred in individuals who received one dose or more of a covid-19 vaccine during pregnancy-42 979 (99.7%) received an mRNA vaccine. Vaccination during pregnancy was not associated with any increased risk of overall preterm birth (6.5% among vaccinated v 6.9% among unvaccinated; adjusted hazard ratio 1.02, 95% confidence interval 0.96 to 1.08), spontaneous preterm birth (3.7% v 4.4%; 0.96, 0.90 to 1.03), or very preterm birth (0.59% v 0.89%; 0.80, 0.67 to 0.95). No increase was found in risk of small for gestational age at birth (9.1% v 9.2%; 0.98, 0.93 to 1.03) or stillbirth (0.25% v 0.44%; 0.65, 0.51 to 0.84). Findings were similar by trimester of vaccination, mRNA vaccine product, and number of doses received during pregnancy. CONCLUSION: The findings suggest that vaccination against covid-19 during pregnancy is not associated with a higher risk of preterm birth, small for gestational age at birth, or stillbirth.
Subject(s)
COVID-19 Vaccines , COVID-19 , Premature Birth , Stillbirth , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cohort Studies , Female , Fetal Growth Retardation , Gestational Age , Humans , Infant , Infant, Newborn , Infant, Small for Gestational Age , Ontario/epidemiology , Pregnancy , Pregnancy Outcome/epidemiology , Premature Birth/epidemiology , Premature Birth/etiology , Retrospective Studies , Stillbirth/epidemiology , Vaccination , Vaccines, Synthetic , mRNA VaccinesABSTRACT
OBJECTIVE: Pregnancy involves dynamic changes in the maternal immune system, thus potentially affecting women's response to infection. The aim of this study was to investigate whether gestational age at the time of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is associated with mortality and morbidity related to coronavirus disease 2019 (COVID-19) in hospitalized pregnant women. METHODS: This was a cohort study of pregnant women with confirmed SARS-CoV-2 infection at any gestational age (categorized into trimesters) who were hospitalized in Brazil from February 2020 to November 2021. Sociodemographic and epidemiological characteristics, signs and symptoms, comorbidities, interventions, vaccination status and type of healthcare establishment were obtained from a nationwide database. Multivariate logistic and Cox regression analyses were used to identify independent risk factors for in-hospital COVID-19-related mortality and morbidity (defined as time from hospital admission to recovery). RESULTS: A total of 7461 SARS-CoV-2-infected pregnant women were included in the study (9.3%, 28.4% and 62.3% in the first, second and third trimesters, respectively). After adjustment for sociodemographic, epidemiological and clinical characteristics, and intervention-related variables, gestational age at infection was found not to be associated with COVID-19-related mortality and morbidity. Women admitted to establishments with an obstetric center, compared to hospitals without, were 38% less likely to die from SARS-CoV-2 infection (adjusted odds ratio, 0.62; 95% CI, 0.48-0.80), while patients who received private not-for-profit healthcare had a 13% shorter time to recovery (adjusted hazard ratio, 1.13; 95% CI, 1.07-1.20) compared to those who received public healthcare. CONCLUSIONS: Despite a higher percentage of women being admitted in the third trimester, we found no association between gestational age and COVID-19 mortality and morbidity. The previously reported increase in morbidity and mortality in the third trimester in pregnant women with COVID-19 may be attributable to other gestational-age-affected variables for which adjustment was made in our study. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.