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BACKGROUND: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear. METHODS: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed. RESULTS: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups. CONCLUSIONS: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).
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Antifibrinolíticos , Cesárea , Hemorragia Pós-Parto , Ácido Tranexâmico , Criança , Feminino , Humanos , Gravidez , Antifibrinolíticos/efeitos adversos , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica/mortalidade , Perda Sanguínea Cirúrgica/prevenção & controle , Hemoglobinas/análise , Morte Materna , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/uso terapêutico , Hemorragia Pós-Parto/sangue , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/mortalidade , Hemorragia Pós-Parto/prevenção & controle , Cesárea/efeitos adversos , Transfusão de Sangue , QuimioprevençãoRESUMO
BACKGROUND: Pre-eclampsia with severe features (severe PreE) is associated with heart dysfunction, yet the impact beyond pregnancy, including its association with cardiomyopathic genetic polymorphisms, remains poorly understood. OBJECTIVE: We aimed to characterize the temporal impact of severe PreE on heart function through the 4th trimester in women with and without deleterious cardiomyopathic genetic variants. METHODS: Pregnant women were enrolled to undergo transthoracic echocardiography (TTE) in late pregnancy and 3 months postpartum. In women with severe PreE a targeted approach to identify pathogenic cardiomyopathic genetic polymorphisms was undertaken, and heart function was compared in carriers and noncarriers. RESULTS: Pregnant women (32 ± 4 years old, severe PreE = 14, control = 8) were enrolled between 2019 - 2021. Women with severe PreE displayed attenuated myocardial relaxation (mitral e' = 11.0 ± 2.2 vs 13.2 ± 2.3 cm/sec, P < .05) in late pregnancy, and on in-silico analysis, deleterious cardiomyopathic variants were found in 58%. At 103 ± 33 days postpartum, control women showed stability in myocardial relaxation (Mitral e' Entry: 13.2 ± 2.3 vs Postpartum: 13.9 ± 1.7cm/sec, P = .464), and genetic negative severe PreE women (G-) demonstrated recovery of diastolic function to control level (Mitral e' Entry: 11.0 ± 3.0 vs Postpartum 13.7 ± 2.8cm/sec, P < .001), unlike their genetic positive (G+) counterparts (Mitral e' Entry: 10.5 ± 1.7 vs Postpartum 10.8 ± 2.4cm/sec, P = .853). CONCLUSIONS: Postpartum recovery of heart function after severe PreE is attenuated in women with deleterious cardiomyopathic genetic polymorphisms.
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Pré-Eclâmpsia , Humanos , Gravidez , Feminino , Adulto , Ecocardiografia , Volume SistólicoRESUMO
INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. METHODS: A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. RESULTS: A total of 214 women were randomized to Device (n = 113) or Control (n = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group (p = 0.040; two-tailed Fisher's test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. CONCLUSIONS: The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.
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OBJECTIVE: Prediction of blood transfusion during delivery admission allows for clinical preparedness and risk mitigation. Although prediction models have been developed and adopted into practice, their external validation is limited. We aimed to evaluate the performance of three blood transfusion prediction models in a U.S. cohort of individuals undergoing cesarean delivery. STUDY DESIGN: This was a secondary analysis of a multicenter randomized trial of tranexamic acid for prevention of hemorrhage at time of cesarean delivery. Three models were considered: a categorical risk tool (California Maternal Quality Care Collaborative [CMQCC]) and two regression models (Ahmadzia et al and Albright et al). The primary outcome was intrapartum or postpartum red blood cell transfusion. The CMQCC algorithm was applied to the cohort with frequency of risk category (low, medium, high) and associated transfusion rates reported. For the regression models, the area under the receiver-operating curve (AUC) was calculated and a calibration curve plotted to evaluate each model's capacity to predict receipt of transfusion. The regression model outputs were statistically compared. RESULTS: Of 10,785 analyzed individuals, 3.9% received a red blood cell transfusion during delivery admission. The CMQCC risk tool categorized 1,970 (18.3%) individuals as low risk, 5,259 (48.8%) as medium risk, and 3,556 (33.0%) as high risk with corresponding transfusion rates of 2.1% (95% confidence interval [CI]: 1.5-2.9%), 2.2% (95% CI: 1.8-2.6%), and 7.5% (95% CI: 6.6-8.4%), respectively. The AUC for prediction of blood transfusion using the Ahmadzia and Albright models was 0.78 (95% CI: 0.76-0.81) and 0.79 (95% CI: 0.77-0.82), respectively (p = 0.38 for difference). Calibration curves demonstrated overall agreement between the predicted probability and observed likelihood of blood transfusion. CONCLUSION: Three models were externally validated for prediction of blood transfusion during cesarean delivery admission in this U.S. COHORT: Overall, performance was moderate; model selection should be based on ease of application until a specific model with superior predictive ability is developed. KEY POINTS: · A total of 3.9% of individuals received a blood transfusion during cesarean delivery admission.. · Three models used in clinical practice are externally valid for blood transfusion prediction.. · Institutional model selection should be based on ease of application until further research identifies the optimal approach..
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Transfusão de Sangue , Cesárea , Adulto , Feminino , Humanos , Gravidez , Algoritmos , Antifibrinolíticos/uso terapêutico , Área Sob a Curva , Transfusão de Sangue/estatística & dados numéricos , Transfusão de Eritrócitos , Hemorragia Pós-Parto/terapia , Medição de Risco/métodos , Curva ROC , Ácido Tranexâmico/uso terapêutico , Estados UnidosRESUMO
Background: Discovery of modifiable factors influencing subjective withdrawal experience might advance opioid use disorder (OUD) research and precision treatment. This study explores one factor - withdrawal catastrophizing - a negative cognitive and emotional orientation toward withdrawal characterized by excessive fear, worry or inability to divert attention from withdrawal symptoms.Objectives: We define a novel concept - withdrawal catastrophizing - and present an initial evaluation of the Withdrawal Catastrophizing Scale (WCS).Methods: Prospective observational study (n = 122, 48.7% women). Factor structure (exploratory factor analysis) and internal consistency (Cronbach's α) were assessed. Predictive validity was tested via correlation between WCS and next-day subjective opiate withdrawal scale (SOWS) severity. The clinical salience of WCS was evaluated by correlation between WCS and withdrawal-motivated behaviors including risk taking, OUD maintenance, OUD treatment delay, history of leaving the hospital against medical advice and buprenorphine-precipitated withdrawal.Results: WCS was found to have a two-factor structure (distortion and despair), strong internal consistency (α = .901), and predictive validity - Greater withdrawal catastrophizing was associated with next-day SOWS (rs (99) = 0.237, p = .017). Withdrawal catastrophizing was also correlated with risk-taking behavior to relieve withdrawal (rs (119) = 0.357, p < .001); withdrawal-motivated OUD treatment avoidance (rs (119) = 0.421, p < .001), history of leaving the hospital against medical advice (rs (119) = 0.373, p < .001) and buprenorphine-precipitated withdrawal (rs (119) = 0.369, p < .001).Conclusion: This study provides first evidence of withdrawal catastrophizing as a clinically important phenomenon with implications for the future study and treatment of OUD.
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Importance: The Antenatal Late Preterm Steroids (ALPS) trial changed clinical practice in the United States by finding that antenatal betamethasone at 34 to 36 weeks decreased short-term neonatal respiratory morbidity. However, the trial also found increased risk of neonatal hypoglycemia after betamethasone. This follow-up study focused on long-term neurodevelopmental outcomes after late preterm steroids. Objective: To evaluate whether administration of late preterm (34-36 completed weeks) corticosteroids affected childhood neurodevelopmental outcomes. Design, Setting, and Participants: Prospective follow-up study of children aged 6 years or older whose birthing parent had enrolled in the multicenter randomized clinical trial, conducted at 13 centers that participated in the Maternal-Fetal Medicine Units (MFMU) Network cycle from 2011-2016. Follow-up was from 2017-2022. Exposure: Twelve milligrams of intramuscular betamethasone administered twice 24 hours apart. Main Outcome and Measures: The primary outcome of this follow-up study was a General Conceptual Ability score less than 85 (-1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores. Multivariable analyses adjusted for prespecified variables known to be associated with the primary outcome. Sensitivity analyses used inverse probability weighting and also modeled the outcome for those lost to follow-up. Results: Of 2831 children, 1026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years). Maternal, neonatal, and childhood characteristics were similar between groups except that neonatal hypoglycemia was more common in the betamethasone group. There were no differences in the primary outcome, a general conceptual ability score less than 85, which occurred in 82 (17.1%) of the betamethasone vs 87 (18.5%) of the placebo group (adjusted relative risk, 0.94; 95% CI, 0.73-1.22). No differences in secondary outcomes were observed. Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up also found no differences between groups. Conclusion and Relevance: In this follow-up study of a randomized clinical trial, administration of antenatal corticosteroids to persons at risk of late preterm delivery, originally shown to improve short-term neonatal respiratory outcomes but with an increased rate of hypoglycemia, was not associated with adverse childhood neurodevelopmental outcomes at age 6 years or older.
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Betametasona , Glucocorticoides , Transtornos do Neurodesenvolvimento , Efeitos Tardios da Exposição Pré-Natal , Criança , Feminino , Humanos , Recém-Nascido , Masculino , Gravidez , Betametasona/administração & dosagem , Betametasona/efeitos adversos , Betametasona/uso terapêutico , Desenvolvimento Infantil/efeitos dos fármacos , Seguimentos , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Glucocorticoides/uso terapêutico , Recém-Nascido Prematuro , Transtornos do Neurodesenvolvimento/induzido quimicamente , Transtornos do Neurodesenvolvimento/epidemiologia , Nascimento Prematuro/prevenção & controle , Cuidado Pré-Natal , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , Estudos ProspectivosRESUMO
Postpartum hemorrhage is a common and potentially life-threatening obstetric complication, with successful management relying heavily on early identification of hemorrhage and prompt intervention. This article will review the management of postpartum hemorrhage, including initial steps, exam-specific interventions, medical therapy, minimally invasive, and surgical interventions.
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Hemorragia Pós-Parto , Gravidez , Feminino , Humanos , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/terapia , Hemorragia Pós-Parto/etiologiaRESUMO
Coagulation disorders are rare causes of postpartum hemorrhage. Disturbances in coagulation should be suspected in patients with a family history of coagulopathy, those with a personal history of heavy menstrual bleeding, and those with persistent bleeding despite correction of other causes. The coagulopathic conditions discussed include disseminated intravascular coagulation, platelet disorders, and disturbances of coagulation factors. These should not be overlooked in the evaluation of obstetric hemorrhage, as diagnosis and appropriate treatment may prevent severe maternal morbidity and mortality.
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Transtornos da Coagulação Sanguínea , Coagulação Intravascular Disseminada , Hemorragia Pós-Parto , Gravidez , Feminino , Humanos , Hemorragia Pós-Parto/diagnóstico , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/terapia , Transtornos da Coagulação Sanguínea/complicações , Transtornos da Coagulação Sanguínea/diagnóstico , Transtornos da Coagulação Sanguínea/terapia , Coagulação Intravascular Disseminada/diagnóstico , Coagulação Intravascular Disseminada/etiologia , Coagulação Intravascular Disseminada/terapiaRESUMO
PURPOSE: Hepatitis C virus (HCV) is increasingly prevalent in pregnancy and among people with substance use disorders (SUD). Highly effective treatments are now available for chronic HCV. Qualifying for HCV treatment often requires preauthorization and several clinical criteria, including laboratory assessment of liver function and other infectious diseases and liver imaging to assess for fibrosis. Linkage to care (LTC) models have been shown to assist with obtaining the necessary clinical information (laboratory assessment/liver imaging) and improving HCV treatment rates in non-pregnant individuals. DESCRIPTION: Beginning in December 2020, a specialized LTC team identified patients with HCV viremia who were interested in postpartum treatment. The LTC team assisted patients with completing the necessary clinical criteria (laboratory assessment and liver imaging) for HCV treatment. Patients were then linked to infectious disease specialists who prescribed treatment to patients via telemedicine. Most patients identified with HCV were enrolled in our institution's co-located obstetric and SUD program, which provides continued care until 1 year postpartum. ASSESSMENT: In 2019, an internal review identified that none of the 26 pregnant patients with HCV viremia in our co-located obstetric and SUD program were prescribed direct-acting antiviral (DAA) treatment within 12 months postpartum. Between December 2020 and July 2022, our HCV LTC team identified 34 patients with HCV who were eligible for treatment. Of these patients, 55% (19/34) obtained all necessary laboratory and liver imaging requirements and 79% (15/19) were prescribed DAA treatment after a telehealth visit with an infectious disease specialist. All fifteen patients who were prescribed treatment participated in the co-located obstetric and SUD program. The largest barrier to obtaining treatment was completing the necessary laboratory and liver imaging requirements for prescribing DAA. Only one patient who did not receive care in our co-located obstetric and SUD program had completed the necessary laboratory and liver imaging requirements to proceed with treatment but did not follow up with the infectious disease specialist for DAA treatment. CONCLUSION: Our HCV LTC program was successful in treating postpartum patients for HCV if they participated in the co-located obstetric and SUD program at our institution. Creating a partnership with an infectious disease specialist and utilizing telemedicine were beneficial strategies to connect patients to treatment for HCV during the postpartum period.
Hepatitis C virus (HCV) is increasingly prevalent in the pregnant population and among individuals with SUD. Highly effective HCV treatments are available postpartum, however LTC is underutilized during prenatal and postpartum care. A LTC model involving a co-located obstetric and SUD program, partnership with a referral department, and telemedicine was effective at improving HCV treatment rates at our institution.
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Hepatite C Crônica , Hepatite C , Transtornos Relacionados ao Uso de Substâncias , Feminino , Humanos , Antivirais/uso terapêutico , Hepacivirus , Hepatite C Crônica/tratamento farmacológico , Viremia/tratamento farmacológico , Hepatite C/diagnóstico , Hepatite C/tratamento farmacológico , Hepatite C/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/terapiaRESUMO
OBJECTIVE: Individual patient-level measures of adverse social determinants of health are associated with neonatal opioid withdrawal syndrome (NOWS), but the relative impact of community-level adverse social determinants of health remains to be defined. We examined the association between community-level social vulnerability and NOWS among pregnant individuals receiving buprenorphine for opioid use disorder. STUDY DESIGN: We conducted a secondary analysis of an established cohort of pregnant individuals and their infants participating in a multidisciplinary prenatal/addiction care program from 2013 to 2021. Addresses were geocoded using ArcGIS and linked at the census tract to the Centers for Disease Control and Prevention 2018 Social Vulnerability Index (SVI), incorporating 15 census variables. The primary exposure was the SVI as a composite measure of community-level social vulnerability, and secondarily, individual scores for four thematic domains (socioeconomic status, household composition and disability, minority status and language, and housing type and transportation). The primary outcome was a clinical diagnosis of NOWS defined as withdrawal requiring pharmacological treatment following buprenorphine exposure. RESULTS: Among 703 pregnant individuals receiving buprenorphine, 39.8% (280/703) of infants were diagnosed with NOWS. Among our patinets, those who were nulliparous, had post-traumatic stress disorder, a term birth (≥ 37 weeks) and had a male infant were more likely to have an infant diagnosed with NOWS. Individuals with and without an infant diagnosed with NOWS had similarly high community-level social vulnerability per composite SVI scores (mean [standard deviation]: 0.6 [0.4-0.7] vs. 0.6 [0.4-0.7], p = 0.2]. In adjusted analyses, SVI, as a composite measure as well as the four domains, was not associated with NOWS diagnosis. CONCLUSION: Among pregnant persons receiving buprenorphine enrolled in a multidisciplinary prenatal and addition care program, while individual risk factors that measure adverse social determinants of health were associated with an NOWS diagnosis in the infant, community-level social vulnerability as measured by the SVI was not associated with the outcome. KEY POINTS: · Community-level SVI was not associated with neonatal opioid use disorder.. · Certain individual risk factors were identified as being associated with NOWS.. · Homogeneity of composite SVI scores may have led to lack of significant findings..
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In modern obstetric practice, providers will encounter patients for whom opioid use in pregnancy is reasonable or even necessary. A "one-size-fits-all" approach to the counseling and management of such patients is misguided. Understanding indications for ongoing opioid use in pregnancy is essential to patient-centered care. Specifically, recognition of the nuanced differences between opioid dependence and opioid use disorder is crucial for appropriate diagnosis, screening for common concurrent conditions, adequately counseling about individualized maternal and perinatal risks, and accurate documentation of diagnoses and medical decision-making. In this paper, we explore the current typical scenarios in which opioid use in pregnancy may be encountered, ongoing opioid prescribing should be considered, and provide a guide for the obstetric provider to navigate the antepartum, intrapartum, and postpartum periods. KEY POINTS: · Opioid use in pregnant and postpartum individuals is not rare.. · Obstetric providers may elect to assume opioid prescribing.. · Obstetric providers are positioned to optimize outcomes for the mother-infant dyad..
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Transtornos Relacionados ao Uso de Opioides , Complicações na Gravidez , Gravidez , Feminino , Humanos , Analgésicos Opioides/uso terapêutico , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/tratamento farmacológico , Complicações na Gravidez/psicologia , Padrões de Prática Médica , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Período Pós-PartoRESUMO
Managing pregnant individuals with acute respiratory disease secondary to COVID-19 has been a challenge. Most professional societies including the Society for Maternal-Fetal Medicine recommend keeping O2 saturation at ≥95% in pregnant individuals. Reaching this target has been increasingly difficult in some patients, especially during the latest wave of infections attributed to the delta variant of SARS-CoV-2. In the absence of adequate supporting data, and in the setting of a reassuring fetal status, we propose that maternal O2 saturation should be maintained between 92% and 96% for admitted patients with acute respiratory failure who require supplemental O2. This may prevent unnecessary invasive interventions that might not hold maternal or fetal benefit, specifically at very preterm gestational ages.
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COVID-19 , Complicações Infecciosas na Gravidez , Síndrome do Desconforto Respiratório , Feminino , Humanos , Recém-Nascido , Saturação de Oxigênio , Gravidez , Complicações Infecciosas na Gravidez/terapia , SARS-CoV-2RESUMO
OBJECTIVE: To examine the association between initial COVID-19 vaccine hesitancy and subsequent vaccination among pregnant and postpartum individuals. DESIGN: Prospective cohort. SETTING: A Midwestern tertiary-care academic medical center. Individuals completed a baseline vaccine hesitancy assessment from 22 March 2021 to 2 April 2021, with subsequent ascertainment of vaccination status at 3-6 months follow-up. METHODS: We used multivariable Poisson regression to estimate the relative risk of vaccination by baseline vaccine hesitancy status, and then characteristics associated with vaccination. MAIN OUTCOME MEASURES: Self-report of COVID-19 vaccination, and secondarily, consideration of COVID-19 vaccination among those not vaccinated. RESULTS: Of 456 individuals (93% pregnant, 7% postpartum) initially surveyed, 290 individuals (64%; 23% pregnant, 77% postpartum) provided subsequent vaccination status (median = 17 weeks). Of these 290 individuals, 40% (116/290) reported COVID-19 vaccine hesitancy upon enrolment, of whom 52% reported subsequent vaccination at follow-up. Few individuals transitioned during the study period from vaccine hesitant to vaccinated (10%); in comparison, 80% of those who were not vaccine hesitant were vaccinated at follow-up (aRR 0.19, 95% CI 0.11-0.33). Among those who remained unvaccinated at follow-up, 38% who were vaccine hesitant at baseline were considering vaccination, compared with 71% who were not vaccine hesitant (aRR 0.48, 95% CI 0.33-0.67). Individuals who were older, parous, employed and of higher educational attainment were more likely to be vaccinated, and those who identified as non-Hispanic black, were Medicaid beneficiaries, and were still pregnant at follow-up were less likely to be vaccinated. CONCLUSIONS: COVID-19 vaccine hesitancy persisted over time in the peripartum period, and few individuals who reported hesitancy at baseline were later vaccinated. Interventions that address vaccine hesitancy in pregnancy are needed.
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COVID-19 , Anormalidades Urogenitais , Vacinas , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Estudos Transversais , Feminino , Humanos , Pais , Período Pós-Parto , Gravidez , Estudos Prospectivos , Vacinação , Hesitação VacinalRESUMO
OBJECTIVE: To assess the frequency and associated characteristics of COVID-19 vaccine hesitancy among pregnant and postpartum individuals. DESIGN: Cross-sectional study. SETTING: Prenatal care at a single academic tertiary care centre. POPULATION: Pregnant and postpartum individuals enrolled in prenatal care at a single academic tertiary care centre from 22 March 2021 to 2 April 2021, concurrent with state guidelines recommending COVID-19 vaccination in pregnancy. METHODS: We used logistic regression to identify characteristics associated with COVID-19 vaccine hesitancy, and adjusted for: age, parity, race, trimester of pregnancy, and chronic comorbidities. MAIN OUTCOME MEASURES: COVID-19 vaccine hesitancy, defined as uncertainty or refusal of the vaccine, despite the availability of vaccine services, in accordance with the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on vaccine hesitancy. RESULTS: Of the 485 individuals screened and approached, 456 (94%) enrolled and completed the survey (435/456, 95% pregnant). The frequency of COVID-19 vaccine hesitancy was 46% (95% CI 41%-51%). Sociodemographic characteristics, including non-Hispanic Black race, younger age, lower education, public health insurance receipt, parity >1, and reported substance use, were associated with a higher odds of COVID-19 vaccine hesitancy, but not clinical risk conditions. Individuals who had a family or friend vaccinated for COVID-19, prior or planned vaccination for tetanus, diphtheria and acellular pertussis (Tdap) and/or influenza, and who perceived that vaccination benefited the baby were less likely to express COVID-19 vaccine hesitancy. CONCLUSIONS: COVID-19 vaccine hesitancy was frequent among pregnant and postpartum individuals. Those who may face barriers to accessing healthcare services were more likely to report vaccine hesitancy. These results can inform interventions to increase COVID-19 vaccine uptake in pregnancy. TWEETABLE ABSTRACT: COVID-19 vaccination hesitancy is frequent among pregnant and postpartum individuals, and those who face barriers to accessing healthcare services are more likely to report COVID-19 vaccine hesitancy.
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COVID-19 , Vacinas contra Difteria, Tétano e Coqueluche Acelular , Coqueluche , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/uso terapêutico , Estudos Transversais , Feminino , Humanos , Período Pós-Parto , Gravidez , Vacinação , Hesitação Vacinal , Coqueluche/prevenção & controleRESUMO
OBJECTIVES: To assess the association between aspirin and glycemic control in diabetic, pregnant patients, and the risk for aspirin resistance in those with poor glycemic control across gestation taking low-dose aspirin (LDA) for pre-eclampsia (PEC) prevention. STUDY DESIGN: We performed a secondary analysis of samples collected during the Maternal-Fetal Medicine Units trial of LDA for PEC prevention. A subset of insulin-controlled diabetic patient samples on placebo or 60 mg aspirin daily were evaluated. Glycosylated hemoglobin was measured at randomization, mid-second trimester, and third trimester time points. Thromboxane B2 (TXB2) measurements were previously assessed as part of the original study. Primary outcome was the effect of LDA on glycosylated hemoglobin levels compared with placebo across gestation. RESULTS: Levels of glycosylated hemoglobin increased across gestation in the placebo group (2,067.7 [interquartile range, IQR: 1,624.6-2,713.5 µg/mL] vs. 2,461.9 [1,767.0-3,209.9 µg/mL] vs. 3,244.3 [2,691.5-4,187.0 µg/mL]; p < 0.01) compared with no difference in levels of glycosylated hemoglobin across gestation in the LDA group (2,186.4 [IQR: 1,462.3-3,097.7 µg/mL] vs. 2,337.1 [1,327.7-5,932.6 µg/mL] vs. 2,532.9 [1,804.9-5,511.8 µg/mL]; p = 0.78). Higher levels of glycosylated hemoglobin were associated with increased TXB2 levels prior to randomization (r = 0.67, p < 0.05). Incomplete TXB2 was higher in pregnancies with increasing levels of glycosylated hemoglobin compared with those with decreasing levels of glycosylated hemoglobin across gestation (69.2 vs. 18.1%, p = 0.02). CONCLUSION: LDA exposure may be beneficial to glycemic control in this patient population. Additionally, poor glycemic control is associated with a higher level of TXB2 in diabetic pregnant patients on LDA. Higher doses of aspirin may be required in these patients to prevent development of PEC. KEY POINTS: · Low-dose aspirin may improve glycemic control.. · Poor glycemic control increases risk for aspirin resistance.. · Higher doses of aspirin may be required for pre-eclampsia prevention..
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Pré-Eclâmpsia , Aspirina/uso terapêutico , Feminino , Hemoglobinas Glicadas , Controle Glicêmico , Humanos , Pré-Eclâmpsia/epidemiologia , Pré-Eclâmpsia/prevenção & controle , GravidezRESUMO
INTRODUCTION: Rotational thromboelastometry (ROTEM) is a point-of-care viscoelastic test used in trauma for goal-directed transfusion. However, there are limited data on baseline ROTEM parameters in the U.S. obstetric population. Obtaining baseline parameters is a first step in implementing a goal-directed massive transfusion protocol in obstetric hemorrhage. OBJECTIVE: Our study aimed to establish pre- and postdelivery baseline parameters in a high-risk obstetric population and determine their association with postpartum hemorrhage (PPH). STUDY DESIGN: Prospective observational study of patients ≥34 weeks' gestation, at high risk of PPH, admitted for delivery. INTEM, EXTEM, FIBTEM, and APTEM assays were performed at the time of admission to labor and delivery and then 2 hours after delivery. Primary outcome was pre- and postdelivery ROTEM parameters among women without PPH. A sample size of 60 women was needed for >90% power to detect at least 50% correlation between pre- and postdelivery assuming a loss of 10% of participants to follow-up. RESULTS: Of 60 women in the study, 10 (17%) had PPH. Baseline characteristics were not different between those with or without PPH. Pre- and postdelivery ROTEM parameters were not significantly different except for APTEM. None of the patients who had PPH, compared with 4 (10%) of those who did not, had shortened clotting time and higher maximum clot firmness in postdelivery APTEM compared with EXTEM, a pattern suggestive of hyperfibrinolysis (p = 0.4). CONCLUSIONS: In this study, we describe baseline ROTEM parameters in women at high risk of PPH. The majority of patients did not have a ROTEM pattern that is suggestive of hyperfibrinolysis, for which tranexamic acid is thought to be beneficial. Based on our findings, previously established obstetric transfusion thresholds for goal-directed massive transfusion protocols are likely valid for the majority of the obstetric population regardless of the presence of comorbidities or pregnancy complications. KEY POINTS: · ROTEM parameters do not vary significantly before and after delivery.. · Most patients did not have a hyperfibrinolysis pattern, for which tranexamic acid is thought to be beneficial.. · Previous goal-directed obstetric transfusion thresholds are likely valid in most populations..
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OBJECTIVE: Peripartum cardiomyopathy (PPCM) affects 1:1,000 U.S. pregnancies, and while many recover from the disease, the risk of recurrence in subsequent pregnancy (SSP) is high. This study aims to evaluate the utility of left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) to predict the risk of recurrence of PPCM in SSP. STUDY DESIGN: We retrospectively evaluated outcomes in women with a history of PPCM and SSP at a large-volume cardioobstetrics program (2008-2019). RESULTS: There were 18 women who had incident PPCM and pursued SSP. Of 24 pregnancies in these women, 8 (33%) were complicated by the development of recurrent PPCM. LVEF ≥ 52% or GLS ≤ -16 was associated with a low risk of recurrent PPCM. CONCLUSION: Approximately one-third of women with PPCM developed recurrent PPCM in SSP. LVEF and GLS on prepregnancy echocardiography may predict the risk of recurrence. Additional studies evaluating risk for recurrence are required to better understand which women are the safest to consider SSP. KEY POINTS: · Peripartum cardiomyopathy affects 1:1000 US pregnancies.. · Approximately one third of women with a history of peripartum cardiomyopathy developed recurrent disease in a subsequent pregnancy.. · A left ventricular ejection fraction ≥52% or global longitudinal strain ≤-16 on echocardiogram is associated with a low risk of recurrence..
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Cardiomiopatias , Medição de Risco/métodos , Volume Sistólico , Disfunção Ventricular Esquerda/fisiopatologia , Adulto , Cardiomiopatias/diagnóstico por imagem , Cardiomiopatias/fisiopatologia , Feminino , Humanos , Período Periparto , Valor Preditivo dos Testes , Gravidez , Complicações Cardiovasculares na Gravidez/diagnóstico por imagem , Complicações Cardiovasculares na Gravidez/fisiopatologia , Prognóstico , Curva ROC , Recidiva , Estudos RetrospectivosRESUMO
OBJECTIVE: We aimed to assess the relationship between obstetric history and incidence of short cervical length (CL) at <24 weeks gestational age (GA) in women with a prior spontaneous preterm birth (PTB). STUDY DESIGN: Women with a singleton gestation and a history of spontaneous PTB on progesterone who received prenatal care at a single center from 2011 to 2016 were included. Those who did not undergo screening or had a history-indicated cerclage were excluded. The associations between short CL (<25 mm) before 24 weeks and obstetrical factors including: number of prior PTBs, history of term birth, and GA of earliest spontaneous PTB were estimated through modified Poisson regression, adjusting for confounding factors. Multiple pregnancies for the same woman were accounted for through robust sandwich standard error estimation. RESULTS: Among 773 pregnancies, 29% (n = 224) had a CL <25 mm before 24 weeks. The number of prior PTBs was not associated with short CL, but a prior full-term delivery conferred a lower risk of short CL (absolute risk reduction or aRR 0.79, 95% CI 0.63-1.00). Earliest GA of prior spontaneous PTB was associated with short CL. The strongest association was observed in women with a prior PTB at 160/7 to 236/7weeks (aRR 1.98, 95% CI: 1.46-2.70), compared with those with deliveries at 340/7 to 366/7 weeks. Yet, even women whose earliest PTB was 340/7 to 366/7 weeks remained at risk for a short CL, as 21% had a CL <25 mm. The number of prior PTBs did not modify the effect of GA of the earliest prior PTB (interaction test: p = 0.70). CONCLUSION: GA of earliest spontaneous PTB, but not the number of prior PTBs, is associated with short CL. Nevertheless, women with a history of later PTBs remain at sufficiently high risk of having a short CL at <24 weeks gestation that we cannot recommend modifications to existing CL screening guidelines in this group of women. KEY POINTS: · Prior 16 to 236/7 weeks birth is a key risk factor for CL <25 mm.. · One in five women with prior late PTB had a short CL.. · Number of PTBs is a less important risk factor..
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Colo do Útero , Nascimento Prematuro , Medida do Comprimento Cervical , Colo do Útero/diagnóstico por imagem , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Gravidez , Nascimento Prematuro/epidemiologia , Medição de RiscoRESUMO
OBJECTIVE: Administration of antenatal corticosteroids (ANCS) is recommended for individuals expected to deliver between 24 and 34 weeks of gestation. Properly timed administration of ANCS achieves maximal benefit. However, more than 50% of individuals receive ANCS outside the recommended window. This study aimed to examine maternal and hospital factors associated with suboptimal receipt of ANCS among individuals who deliver between 24 and 34 weeks of gestation. STUDY DESIGN: Secondary analysis of the Assessment of Perinatal Excellence (APEX), an observational study of births to 115,502 individuals at 25 hospitals in the United States from March 2008 to February 2011, was conducted. Data from 3,123 individuals who gave birth to a nonanomalous live-born infant between 240/7 to 340/7 weeks of gestation, had prenatal records available at delivery, and data available on the timing of ANCS use were included in this analysis. Eligible individuals' ANCS status was categorized as optimal (full course completed >24 hours after ANCS but not >7 days before birth) or suboptimal (none, too late, or too early). Maternal and hospital-level variables were compared using optimal as the referent group. Hierarchical multinomial logistic regression models, with site as a random effect, were used to identify maternal and hospital-level characteristics associated with optimal ANCS use. RESULTS: Overall, 83.6% (2,612/3,123) of eligible individuals received any treatment: 1,216 (38.9%) optimal and 1,907 (61.1%) suboptimal. Within suboptimal group, 495 (15.9%) received ANCS too late, 901 (28.9%) too early, and 511 (16.4%) did not receive any ANCS. Optimal ANCS varied depending on indication for hospital admission (p < 0.001). Individuals who were admitted with intent to deliver were less likely to receive optimal ANCS while individuals admitted for hypertensive diseases of pregnancy were most likely to receive optimal ANCS (10 vs. 35%). The median gestational age of individuals who received optimal ANCS was 31.0 weeks. Adjusting for hospital factors, hospitals with electronic medical records and who receive transfers have fewer eligible individuals who did not receive ANCS. ANCS administration and timing varied substantially by hospital, optimal frequencies ranged from 9.1 to 51.3%, and none frequencies from 6.1 to 61.8%. When evaluating variation by hospital site, models with maternal and hospital factors did not explain any of the variation in ANCS use. CONCLUSION: Optimal ANCS use varied by maternal and hospital factors and by hospital site, indicating opportunities for improvement. KEY POINTS: · Majority of individuals who deliver between 24 and 34 weeks of gestation do not receive properly timed antenatal corticosteroids.. · Optimal use of antenatal corticosteroids varies by maternal and hospital factors and hospital site.. · Significant variation in hospital sites regarding optimally timed administration of antenatal corticosteroids indicates opportunities for improvement..
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OBJECTIVE: This study aimed to compare neonatal outcomes for delivery at 36 weeks compared with 37 weeks in women with prior classical cesarean delivery (CCD). STUDY DESIGN: This was a secondary analysis of the prospective observational cohort of the Eunice Kennedy National Institute for Child and Human Development's Maternal-Fetal Medicine Unit Network Cesarean Registry. Data on cases of repeat cesarean delivery (RCD) in the setting of a prior CCD were abstracted and used for analysis. This study compared outcomes of women who delivered at 360/7 to 366/7 versus 370/7 to 376/7 weeks. The primary outcome was a composite of adverse neonatal outcomes that included neonatal intensive care unit (NICU) admission, respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), hypoglycemia, mechanical ventilation, sepsis, length of stay ≥5 days, and neonatal death. A composite of maternal outcomes that included uterine rupture, blood transfusion, general anesthesia, cesarean hysterectomy, venous thromboembolism, maternal sepsis, intensive care unit admission, and surgical complications was also evaluated. RESULTS: There were 436 patients included in the analysis. Women who delivered at 36 weeks (n = 176) were compared those who delivered at 37 weeks (n = 260). There were no differences in baseline characteristics. Delivery at 37 weeks was associated with a reduction in composite neonatal morbidity (24 vs. 34%, adjusted odds ratio [aOR] = 0.61 [0.31-0.94]), including a decrease in NICU admission rates (20 vs. 29%, aOR = 0.63 [0.40-0.99]), hospitalization ≥5 days (13 vs. 24%, aOR = 0.48 [0.29-0.8]), and RDS or TTN (9 vs. 19%, aOR = 0.43 [0.24-0.77]). There was no difference in adverse maternal outcomes (7 vs. 7%, aOR = 0.98 [0.46-2.09]). CONCLUSION: Delivery at 37 weeks for women with a history of prior CCD is associated with a decrease in adverse neonatal outcomes, compared with delivery at 36 weeks. KEY POINTS: · Classical cesarean section may have increased risk of uterine rupture in future pregnancies.. · This study compares outcomes of delivery at 370/7 to 376/7 versus 360/7 to 366/7 weeks.. · Delivery at 370/7 to 376/7 weeks was associated with decreased neonatal morbidity..