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The Impact of a Protocol on Equitable Labor and Delivery Substance Use Screening: A Retrospective Cohort Study. 公平劳动和分娩物质使用筛查协议的影响:一项回顾性队列研究。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-29 DOI: 10.1055/a-2764-3361
Jennifer J M Cate, Siera Lunn, Adwoa Baffoe-Bonnie, Ronan Sugrue, Pennilee West, Tracy Truong, Alaattin Erkanli, Jennifer Gilner, Brenna Hughes, Sarahn Wheeler
<p><p>The Society for Maternal-Fetal Medicine (SMFM), the American College of Obstetricians and Gynecologists (ACOG), and the American Society of Addiction Medicine (ASAM) jointly recommend universal substance use screening in pregnancy with a validated tool. Biologic testing with urine drug screening (UDS) is not recommended unless testing would change medical management. Despite recommendations, racial and socioeconomic differences in substance use screening and biological testing exist. We evaluated the impact of an obstetric substance use screening protocol on validated screening, UDS indication documentation, pre-UDS patient assent, and UDS disparities across race, ethnicity, and payor.This retrospective cohort study used electronic health record data before (July 1, 2020-June 9, 2021) and after (June 10, 2021-May 31, 2022) implementation of an obstetric substance use screening protocol at a tertiary care center. Documented, validated screening, UDS indication, and patient assent were assessed among UDS encounters pre- and postintervention. Association of race, ethnicity, and payor with UDS was assessed using generalized estimating equations models pre- and postintervention. Categorical variables were compared using chi-square and Fisher's exact tests.UDS occurred less frequently postintervention than preintervention (1.9% [124/6,412 encounters] vs. 7.8% [441/5,658 encounters], <i>p</i> < 0.001). Adjusting for payor, Black individuals had higher odds of UDS (adjusted odds ratio [aOR] = 2.11, 95% confidence interval [CI]: 1.64-2.70) than White individuals preintervention; however, there were no differences (aOR = 1.23, 95% CI: 0.81-1.87) postintervention. Privately insured individuals had lower odds of UDS preintervention (OR = 0.23, 95% CI: 0.18-0.30) and postintervention (OR = 0.08, 95% CI: 0.04-0.15) than government-insured individuals. Among those with UDS, none (0/441) underwent validated screening preintervention versus 36.3% (45/124) postintervention. Documented UDS indication occurred in 27.9% (123/441) preintervention versus 55.7% (69/124) postintervention (<i>p</i> < 0.001). Documented assent occurred in 0.5% (2/441) of encounters preintervention versus 47.6% (59/124) postintervention (<i>p</i> < 0.001).Implementation of an obstetric substance use screening protocol was associated with decreasing UDS and increasing validated screening, documented UDS indication, and patient assent. Racial disparities in UDS were reduced postintervention; however, suboptimal screening remained, with persistent disparities by payor. · Substance use screening in pregnancy with a validated tool is performed suboptimally.. · There are known disparities in biologic testing for substance use by race and socioeconomic status.. · We evaluated an obstetric substance use screening protocol pre- and postintervention.. · The protocol was associated with validated tool use, patient assent, and screening documentation.. · Racial disparities in substance use screen
母胎医学学会(SMFM)、美国妇产科医师学会(ACOG)和美国成瘾医学学会(ASAM)联合推荐在怀孕期间使用一种有效的工具进行普遍的物质使用筛查。除非检测会改变医疗管理,否则不建议采用尿液药物筛查(UDS)进行生物检测。尽管有这些建议,但在药物使用筛查和生物测试方面存在种族和社会经济差异。我们评估了产科药物使用筛查方案对有效筛查、UDS指征文件、UDS前患者同意以及UDS在种族、民族和付款人之间的差异的影响。这项回顾性队列研究使用了三级保健中心实施产科药物使用筛查方案之前(2020年7月1日至2021年6月9日)和之后(2021年6月10日至2022年5月31日)的电子健康记录数据。在干预前和干预后的UDS就诊中评估记录的、有效的筛查、UDS适应症和患者同意。在干预前和干预后使用广义估计方程模型评估种族、民族和付款人与UDS的关系。分类变量比较采用卡方检验和Fisher精确检验。干预后UDS的发生率低于干预前(1.9%[124/ 6412例]vs. 7.8%[441/ 5658例],p p p
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引用次数: 0
Management of Infants Born to Pregnant Women with Reactive Syphilis Serology: Resource Saving from Using the Current Centers for Disease Control Guidelines. 梅毒反应性血清学孕妇所生婴儿的管理-使用当前疾病控制中心指南节省资源。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-23 DOI: 10.1055/a-2768-2636
Patricia L F Lofiego, Alena Tse-Chang, Jennifer Gratrix, Petra Smyczek, Joan L Robinson, Manoj Kumar

There has been a marked increase in the number of infants admitted to neonatal intensive care units (NICUs) in Canada for treatment of congenital syphilis. We studied the impact on resource utilization from using the Centers for Disease Control (CDC) guidelines that allow use of a single-dose intramuscular benzathine penicillin G (BPG), as compared with 10-day course of intravenous penicillin G (PG), in infants considered at low risk for congenital syphilis.This was a retrospective cohort study enrolling infants born to mothers with reactive syphilis serology and admitted for management to two Level 2 NICUs in Edmonton, Alberta, Canada, over a 2-year period. Data were extracted for key NICU resources that are used in managing these infants. We then estimated the resources that would be utilized if the entire cohort was managed per the current CDC guidelines.Forty-nine infants met the study criteria of which 42 were treated with 10-day course of PG. Of these 42 infants, 21 (50%) met the CDC criteria for a single dose of BPG. The use of the CDC criteria to manage this cohort could have avoided 244 hospital days, 128 central line days, 168 antibiotic days related to congenital syphilis treatment, 23 long bones X-rays, and 17 lumbar punctures, for an estimated savings of CDC $ 263,000 to the provincial health system.Using the current CDC guidelines, half of the infants exposed to maternal syphilis and treated with a 10-day course of PG in our cohort could have been managed with a single dose of BPG, resulting in a significant saving of health care resources and in hospital costs. · Cases of congenital syphilis have risen sharply in parts of Canada.. · Frequent admissions of such cases in the Canadian NICUs have aggravated bed capacity challenges.. · Applying the current CDC guidelines could reduce the NICU length of stay, the use of central lines, and other invasive procedures in this population..

背景:在加拿大,新生儿重症监护病房(NICUs)治疗先天性梅毒的婴儿数量显著增加。我们研究了使用疾病控制中心(CDC)指南对资源利用的影响,该指南允许在先天性梅毒低风险的婴儿中使用单剂量肌肉注射苄星青霉素G (BPG),与10天静脉注射青霉素G (PG)进行比较。方法:这是一项回顾性队列研究,纳入了加拿大埃德蒙顿两家2级新生儿重症监护病房治疗的梅毒血清学反应性母亲所生的婴儿。提取用于管理这些婴儿的关键NICU资源的数据。然后,我们估计如果整个队列按照当前的CDC指南进行管理,将使用的资源。结果:49名婴儿符合研究标准,其中42名接受了10天疗程的PG治疗。在这42名婴儿中,21名(50%)符合单剂量BPG的CDC标准。使用CDC标准来管理这一队列可以避免244个住院日,128个中央静脉管日,168个与先天性梅毒治疗相关的抗生素日,23个长骨x光片和17个腰椎穿刺,估计为省卫生系统节省了263,000加元。结论:使用目前的CDC指南,在我们的队列中,暴露于母体梅毒并接受10天PG疗程的婴儿中,有一半可以使用单剂量BPG进行管理,从而显着节省医疗资源和医院费用。
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引用次数: 0
Maternal Reticulocyte Hemoglobin as a Predictor of Neonatal Iron Deficiency and Anemia. 母体网织红细胞血红蛋白作为新生儿缺铁和贫血的预测因子。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-23 DOI: 10.1055/a-2768-2580
Cassandra E Pekar, Gayle D Haischer-Rollo, Alexandra P Hansen, James K Aden, Thornton S Mu

Anemia in pregnancy affects 30 to 40% of women globally, with iron deficiency (ID) accounting for half of the cases. In the United States, iron-deficiency anemia (IDA) prevalence during pregnancy is approximately 5%. ID and IDA negatively affect the maternal-fetal dyad. Reticulocyte hemoglobin equivalent (RET-He) estimates functional iron stores without additional blood sampling. Monitoring RET-He in pregnant women and neonates may facilitate earlier interventions with iron supplementation. The aim is to evaluate RET-He's utility in identifying pregnant women and neonates at risk for ID and IDA.This prospective, observational study followed pregnant women with anemia. RET-He and hemoglobin (HgB) values were measured during the first and third trimesters and at delivery (umbilical cord blood). Exclusions included preterm birth, monochorionic twin gestations, and conditions complicating cord blood collection.One hundred and seventy-seven dyads were included in the study. Maternal mean HgB was 12.2 ± 1.1 and 10.8 ± 1.2 g/dL, with RET-He values of 32.7 ± 3.2 and 30.5 ± 3.6 pg in the first and third trimesters, respectively. Neonatal mean cord HgB was 15.0 ± 1.6 g/dL with RET-He of 32.9 ± 2.6 pg. Thirteen percent (n = 23) of newborns were anemic (cord HgB < 13.5 g/dL), and 7% (n = 13) of the newborns were iron-deficient (RET-He < 29 pg). Only two of these iron-deficient infants were also anemic. Maternal HgB and RET-He values were not associated with neonatal anemia. Sensitivity and specificity of maternal RET-He for predicting neonatal anemia were not helpful, but improved when predicting neonatal ID, especially in the third trimester. RET-He indicating ID in pregnant women was associated with anemia during their pregnancy.Maternal RET-He does not predict neonatal anemia but may aid in earlier maternal ID diagnoses. Most infants are born with normal HgB and RET-He values. RET-He may be useful for monitoring women with IDA during their pregnancies. · Maternal reticulocyte hemoglobin does not predict neonatal anemia.. · Maternal reticulocyte hemoglobin may aid in diagnosing neonatal ID without anemia.. · Reticulocyte hemoglobin may be used to monitor ID among pregnant women with anemia..

目的:妊娠期贫血影响全球30-40%的妇女,其中缺铁(ID)占一半。在美国,缺铁性贫血(IDA)在怀孕期间的患病率约为5%。ID和IDA对母胎双体有负向影响。网织红细胞血红蛋白当量(RET-He)无需额外的血液采样估计功能性铁储量。监测孕妇和新生儿的RET-He可促进早期补铁干预。目的是评估RET-He在识别有ID和IDA风险的孕妇和新生儿中的效用。研究设计:这项前瞻性观察性研究随访了患有贫血的孕妇。在妊娠第1、3个月和分娩时(脐带血)测定RET-He和血红蛋白(HgB)值。排除包括早产、单绒毛膜双胎妊娠和脐带血采集并发症。结果:共纳入177对。产妇平均HgB为12.2±1.1 g/dL和10.8±1.2 g/dL, RET-He分别为32.7±3.2 pg和30.5±3.6 pg。新生儿平均脐带HgB为15.0±1.6 g/dL, RET-He为32.9±2.6 pg。13% (n=23)的新生儿贫血(脐带HgB)。结论:产妇RET-He不能预测新生儿贫血,但可能有助于早期产妇ID诊断。大多数婴儿出生时HgB和RET-He值正常。RET-He可能对妊娠期IDA患者的监测有用。
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引用次数: 0
Enhancing Maternal Health Surveillance in the United States Through Natural Language Processing. 通过自然语言处理加强美国孕产妇健康监测。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-19 DOI: 10.1055/a-2764-2341
Rebecca Horgan, Tetsuya Kawakita, George Saade

Maternal health outcomes are essential indicators of overall health care quality and societal well-being. However, in the United States, the maternal health surveillance is often inaccurate, restricting the clinical utility of the data gathered. The limits imposed by these inaccuracies restrict timely policy responses and hinder effective innovations, despite the increasing availability of electronic health records. This paper explores the potential use of natural language processing in improving maternal health surveillance. By combining rule-based linguistic processing with machine learning, natural language processing can transform narrative text into structured, analyzable data, allowing it to be used for predictive purposes, as well as the development of real-time public health surveillance systems. · Maternal health surveillance is often inaccurate, restricting the clinical utility of the data.. · Natural language processing can extract key insights from unstructured clinical notes.. · Artificial intelligence-driven surveillance in obstetrics may improve data accuracy and timeliness.. · Ethical use of natural language processing needs to ensure privacy, bias control, and validation..

产妇保健结果是总体保健质量和社会福祉的重要指标。然而,在美国,产妇健康监测往往不准确,限制了所收集数据的临床应用。尽管电子健康记录的可用性越来越高,但这些不准确造成的限制限制了及时的政策反应并阻碍了有效的创新。本文探讨了自然语言处理在改善孕产妇健康监测中的潜在应用。通过将基于规则的语言处理与机器学习相结合,自然语言处理可以将叙事文本转换为结构化的、可分析的数据,使其能够用于预测目的,以及开发实时公共卫生监测系统。
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引用次数: 0
Centralized Telemetry Enables Continuous Monitoring to Predict Clinical Deterioration in Infants Hospitalized with Bronchiolitis. 集中遥测技术可以持续监测毛细支气管炎患儿的临床恶化情况。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-18 DOI: 10.1055/a-2761-1697
Felipe González Martínez, Cristina Núñez Carretero, Laura García Fernández, Blanca Toledo Del Castillo, María Isabel González Sánchez, Ana María Angulo Chacón, Rosa Rodríguez Fernández

Bronchiolitis is the leading cause of hospitalization in infants, and early detection of clinical deterioration remains a major challenge in pediatric wards. The objective is to analyze continuous longitudinal telemetry data (heart rate [HR] and oxygen saturation [SpO2]) in infants hospitalized with bronchiolitis, and to evaluate whether this monitoring allows early prediction of the need for high-flow nasal cannula (HFNC) therapy or pediatric intensive care unit (PICU) admission.Retrospective, observational study in infants admitted for bronchiolitis (October 2021-January 2022). Clinical, epidemiological, and longitudinal data were collected using minute-by-minute HR and SpO2 during the first 24 hours of admission using Vital Sync (Medtronic). A mixed model (restricted maximum likelihood; REML) was constructed to model the longitudinal HR and SpO2 data.About 79 patients with 113,760 longitudinal HR and SpO2 data were included. A total of 16.5% required HFNC, and 9% were admitted to PICU. A higher HR was observed in the first hours of admission in those patients who required PICU (163 ± 5 vs. 146 ± 4 bpm; p < 0.01) and in those who required HFNC (158  ± 6 vs. 144 ± 5 bpm; p < 0.01). In the mixed model (REML), we found differences in HR (p < 0.01) between groups (PICU yes/no and HFNC yes/no) and over time (p < 0.01). The mixed model allowed prediction of the mean HR of patients admitted to PICU (162 bpm) and those requiring HFNC (159 bpm).Continuous monitoring of HR in infants hospitalized for bronchiolitis in pediatric wards may be a useful tool to help anticipate clinical deterioration. · Longitudinal continuous telemetry in infants with bronchiolitis may be a useful tool.. · Centralized telemetry monitoring may be promising in pediatric wards outside intensive care units.. · HR monitoring may be useful for the need for admission to the PICU..

毛细支气管炎是婴儿住院的主要原因,早期发现临床恶化仍然是儿科病房的主要挑战。目的是分析毛细支气管炎住院婴儿的连续纵向遥测数据(心率[HR]和血氧饱和度[SpO2]),并评估这种监测是否可以早期预测是否需要高流量鼻插管(HFNC)治疗或儿科重症监护病房(PICU)入院。对因毛细支气管炎入院的婴儿进行回顾性观察研究(2021年10月- 2022年1月)。使用Vital Sync (Medtronic)收集入院前24小时内每分钟的HR和SpO2的临床、流行病学和纵向数据。构建了一个混合模型(限制最大似然;REML)来模拟纵向HR和SpO2数据。共纳入79例患者,纵HR和SpO2数据为113,760。16.5%的患者需要HFNC, 9%的患者入住PICU。需要PICU的患者入院前1小时HR较高(163±5 vs 146±4 bpm; p p p p
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引用次数: 0
Cannabis Use and Intimate Partner Violence During Pregnancy Are Associated with Poorer Postpartum Mental Health. 怀孕期间使用大麻和亲密伴侣暴力与产后心理健康状况较差有关。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-18 DOI: 10.1055/a-2761-1601
Matthew J Marvin, Alexandra L Ballinger, Sara F Stein, Jewelian N Fairchild, G Anne Bogat, Joseph S Lonstein, Amy K Nuttall, Maria Muzik, Alytia A Levendosky

Intimate partner violence (IPV) victimization during pregnancy is a pervasive public health problem that is associated with mental health difficulties and increased rates of substance use, including cannabis. Despite being contraindicated by medical professionals, cannabis use during pregnancy is on the rise. Preliminary research among the general population suggests that cannabis use is associated with later mental health difficulties. While pregnancy IPV is associated with poorer postpartum mental health, less is known about the effects of pregnancy cannabis use on postpartum mental health. This study aims to investigate the combined effects of IPV victimization and cannabis use during pregnancy on postpartum mental health.In this study, 257 women were assessed at three points during pregnancy to measure IPV victimization and cannabis use. Then, at 6 months postpartum, women's posttraumatic stress disorder (PTSD), depression, and anxiety symptoms were assessed.Linear regression analyses revealed that pregnancy IPV victimization was significantly associated with elevated postpartum PTSD (β = 0.21, p = 0.005), depression (β = 0.17, p = 0.022), and anxiety symptoms (β = 0.21, p = 0.008). Pregnancy cannabis use was associated with elevated postpartum PTSD (β = 0.25, p < 0.001) and depression (β = 0.25, p < 0.001) symptoms. The interaction between pregnancy IPV and cannabis use was not significantly associated with postpartum mental health symptoms.Results suggest that cannabis use during pregnancy, as well as IPV victimization, are independent risk factors for specific postpartum mental health problems. Suggestions for nurses and other medical providers on how to best screen for and counsel pregnant women on cannabis use are discussed. · IPV during pregnancy is associated with elevated postpartum PTSD, depression, and anxiety symptoms.. · Cannabis use during pregnancy is associated with elevated postpartum PTSD and depression symptoms.. · IPV and cannabis use during pregnancy are independent risk factors for postpartum mental health difficulties.. · Medical professionals should screen for and discuss IPV and cannabis use with pregnant women..

怀孕期间遭受亲密伴侣暴力侵害是一个普遍存在的公共卫生问题,与精神健康困难和包括大麻在内的药物使用率增加有关。尽管医学专业人员禁止使用大麻,但怀孕期间使用大麻的人数仍在上升。在一般人群中进行的初步研究表明,大麻的使用与后来的精神健康问题有关。虽然孕期IPV与产后心理健康状况较差有关,但对孕期使用大麻对产后心理健康的影响知之甚少。本研究旨在探讨怀孕期间IPV受害和大麻使用对产后心理健康的综合影响。在这项研究中,257名妇女在怀孕期间的三个时间点接受了评估,以衡量IPV受害情况和大麻使用情况。然后,在产后6个月,对女性的创伤后应激障碍(PTSD)、抑郁和焦虑症状进行评估。线性回归分析显示,孕期IPV受害与产后PTSD (β = 0.21, p = 0.005)、抑郁(β = 0.17, p = 0.022)、焦虑症状(β = 0.21, p = 0.008)升高显著相关。妊娠期大麻使用与产后PTSD升高相关(β = 0.25, p
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引用次数: 0
Postpartum Hemorrhagic Morbidities with Livebirth versus Stillbirth. 活产与死产的产后出血发病率。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-15 DOI: 10.1055/a-2764-2296
Fabrizio Zullo, Rachel L Wiley, Ipsita Ghose, Giuseppe Rizzo, Antonella Giancotti, Hector Mendez-Figueroa, Daniele Di Mascio, Suneet P Chauhan

ACOG publications on stillbirth or postpartum hemorrhage (PPH) do not consider stillbirth as a risk factor for postpartum hemorrhagic morbidity. This study aimed to ascertain the likelihood of composite maternal hemorrhagic outcome (CMHO) among individuals who delivered vaginally with livebirth versus a stillbirth.This was a retrospective cohort study of all parturients greater than 20 weeks gestation who delivered vaginally at a single level IV site within 24 months. Demographic differences and baseline PPH risks were analyzed. CMHO included any of the following: estimated blood loss ≥1,000 mL, use of uterotonics (beyond prophylactic oxytocin), Bakri balloon, surgical management of PPH, blood transfusion, hysterectomy, venous thromboembolism (VTE), admission to the intensive care unit (ICU), or maternal death. Statistical analysis included chi-squared, Kruskal-Wallis, and Poisson regression with robust error variance for risk ratios, adjusting for gestational age (GA), bleeding on admission, chorioamnionitis, and prior uterine surgery.Of 8,623 consecutive vaginal births ≥20 weeks gestation, 89 (1.9%) were stillbirths. Maternal age, marital status, GA at delivery, and PPH risk stratification at admission differed significantly. Bleeding at admission (p < 0.001), prior uterine surgery (p < 0.001), magnesium sulfate use (p = 0.006), chorioamnionitis (p < 0.001), platelet count <100 (p = 0.001), platelet count <50 (p < 0.001), and retained products of conception (p < 0.001) were different in the two groups. CMHO was significantly higher with a stillbirth delivery (32.6 vs. 16.8%; aRR: 1.56, 95% CI: 1.01-2.46). After adjustment, the components of the CMHO that differed significantly were estimated blood loss ≥1,000 mL and ICU admission. Tamponade, surgical intervention, VTE, hysterectomy, and maternal death did not differ between the two groups.Pregnancies with stillbirth, compared with livebirth, had an increased risk of hemorrhagic related morbidity. In addition to being useful in shared decision-making, our results can be nidus for intervention trials to decrease the hemorrhagic morbidity associated with stillbirth. · The risk of CMHO was significantly higher in the stillbirth group even after adjustment for potential confounders (32.6% vs. 16.8%).. · Stillbirth was associated with a significantly higher risk of blood loss of ≥1,000 mL.. · Stillbirth was also associated with higher likelihood of uterotonic use, transfusion, and admission to ICU..

ACOG关于死产或产后出血(PPH)的出版物不认为死产是产后出血发病率的危险因素。目的:确定复合产妇出血结局(CMHO)的可能性在个体阴道分娩活产与死产。研究设计:这是一项回顾性队列研究,研究对象为24个月内在单一IV级部位阴道分娩的所有妊娠大于20周的产妇。分析人口统计学差异和基线PPH风险。CMHO包括以下任何一项:估计失血量bbb1000ml,使用子宫强张剂(不包括预防性催产素),Bakri球囊,产后出血的手术处理,输血,子宫切除术,静脉血栓栓塞(VTE),入住重症监护病房(ICU)或产妇死亡。统计分析采用卡方回归、Kruskal-Wallis回归和泊松回归,校正胎龄(GA)、入院时出血、绒毛膜羊膜炎和既往子宫手术。结果:8623例连续阴道分娩中,89例(1.9%)为死产。产妇年龄、婚姻状况、分娩时胎龄(GA)、入院时PPH风险分层差异显著。入院时出血(p 1000mL)和ICU入院时出血。填塞、手术干预、静脉血栓栓塞、子宫切除术和产妇死亡在两组之间没有差异。死产妊娠与活产妊娠相比,出血相关疾病的风险增加。除了在共同决策中有用外,我们的结果可以作为干预试验的焦点,以减少死产相关的出血性发病率。
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引用次数: 0
Design of a Phase 3, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG and Prednisone in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia. Nipocalimab或IVIG和强的松治疗有胎儿和新生儿同种免疫性血小板减少风险的妊娠的3期、多中心、随机、开放标签研究设计
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-12 DOI: 10.1055/a-2753-9323
James Bussel, Barbara Stegmann, Pamela Baker, Abbie Oey, Yanxin Jiang, Rebecca Zaha, Hillary Van Valkenburgh, Babajide Keshinro

Nipocalimab, a neonatal Fc receptor blocker, showed evidence of efficacy and safety in preventing or delaying fetal anemia in a phase 2 study of early-onset severe hemolytic disease of the fetus and newborn, demonstrating potential for treatment of other maternal immunoglobulin G alloantibody-mediated fetal diseases. The phase 3 FREESIA-3 study aims to evaluate the efficacy and safety of nipocalimab or intravenous immunoglobulin (IVIG) with prednisone in pregnancies with a previous occurrence of fetal and neonatal alloimmune thrombocytopenia (FNAIT) with or without intracranial hemorrhage or severe fetal/neonatal bleeding (high- or standard-risk, respectively).FREESIA-3 is a phase 3, open-label, randomized, multicenter study in pregnant individuals at risk for FNAIT. Participants are randomized 4:1 to receive either weekly 45 mg/kg intravenous nipocalimab or weekly IVIG with prednisone starting at 13 to 18 weeks of gestational age (standard-risk) or 12 weeks of gestational age (high-risk) until delivery. During treatment, pregnant participants will receive ultrasound monitoring every 2 weeks for fetal bleeding, growth, and development. Postnatal follow-up is 24 weeks for maternal participants and 104 weeks for neonates/infants.The primary endpoint is an adverse outcome of death or adjudicated severe bleeding in utero up to 1 week postbirth, or platelet count at birth of < 30 × 109/L in a fetus/neonate. Secondary endpoints include fetal/neonatal death, neonatal platelet count at birth, nadir neonatal platelet count over 1 week postbirth, neonate requiring platelet transfusion(s), adjudicated fetal and neonatal bleeding up to 1 week postbirth, neonate receiving IVIG for thrombocytopenia, safety in maternal participants and neonates/infants, and immunogenicity of nipocalimab. Exploratory endpoints include patient- and caregiver-reported outcome assessments and nipocalimab pharmacokinetics and pharmacodynamics.FREESIA-3, an open-label, multicenter, randomized, phase 3 study, will evaluate the efficacy and safety of nipocalimab in both standard- and high-risk pregnancies for FNAIT. · FNAIT is a transplacental alloantibody-driven disease.. · Nipocalimab blocks IgG recycling, lowering IgG levels.. · Nipocalimab blocks IgG placental transfer to the fetus.. · Nipocalimab reduced adverse outcomes in EOS-HDFN.. · FREESIA-3 studies nipocalimab efficacy/safety in FNAIT..

目的:Nipocalimab是一种新生儿Fc受体阻滞剂,在一项针对胎儿和新生儿早发性严重溶血性疾病的2期研究中显示出预防或延缓胎儿贫血的有效性和安全性,显示出治疗其他母体免疫球蛋白G异体抗体介导的胎儿疾病的潜力。3期FREESIA-3研究旨在评估尼波卡利单抗或静脉注射免疫球蛋白(IVIG)联合强的松治疗既往发生过胎儿和新生儿同种免疫性血小板减少症(FNAIT)并伴有或不伴有颅内出血或严重胎儿/新生儿出血(分别为高风险或标准风险)的妊娠的疗效和安全性。研究设计:FREESIA-3是一项3期、开放标签、随机、多中心研究,研究对象是有FNAIT风险的孕妇。参与者按4:1随机分配,从13-18孕周(标准风险)或12孕周(高风险)开始接受每周一次45mg /kg静脉注射尼波卡利单抗或每周一次强的松IVIG,直到分娩。在治疗期间,孕妇将每2周接受超声监测胎儿出血、生长和发育情况。产妇随访24周,新生儿/婴儿随访104周。结果:主要终点是出生后1周内死亡或宫内严重出血,或胎儿/新生儿出生时血小板计数为9/L的不良结局。次要终点包括胎儿/新生儿死亡、新生儿出生时血小板计数、出生后1周内新生儿血小板计数最低、需要输血小板的新生儿、出生后1周内胎儿和新生儿出血、因血小板减少而接受IVIG的新生儿、孕妇和新生儿/婴儿的安全性以及尼波卡利单抗的免疫原性。探索性终点包括患者和护理人员报告的结果评估和尼波卡利单抗药代动力学和药效学。结论:FREESIA-3是一项开放标签、多中心、随机、3期研究,将评估nipocalimab在FNAIT的标准风险和高危妊娠中的疗效和安全性。
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引用次数: 0
Servo-Controlled versus Manual Cooling for Therapeutic Hypothermia in Neonatal Hypoxic-Ischemic Encephalopathy: A Retrospective Comparative Study. 伺服控制与手动冷却治疗新生儿缺氧缺血性脑病的低温:回顾性比较研究。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-05 DOI: 10.1055/a-2752-8853
Maurício Magalhães, Danieli M K Leandro, Silvia S de Azevedo, Juliana Q Teixeira, Hannah A Hiratzuka, Marcelo J Mimica, Gabriel F T Variane

This study aimed to compare temperature control during therapeutic hypothermia (TH) in neonates with moderate or severe hypoxic-ischemic encephalopathy (HIE) using manual cooling (MC) or a servo-controlled (SC) system.Retrospective cohort study including neonates with ≥ 35 weeks' gestation with moderate or severe HIE who were treated with TH between 2018 and 2020, using MC with ice packs or a SC system. Temperature curves and clinical outcomes were compared between the two methods of cooling. Data were summarized using descriptive statistics. Groups were compared with appropriate parametric or nonparametric tests. Temperature stability and rewarming variability were evaluated, and secondary outcomes were analyzed using risk ratios with 95% confidence intervals and logistic regression adjusted for encephalopathy severity.During the study period, 56 neonates with moderate or severe HIE were cooled, 31 (55.4%) with MC and 25 (44.6%) with a SC system. Baseline characteristics and time to target temperature were similar. SC achieved more stable hypothermia, with less variability (p = 0.014) and reduced time outside the therapeutic range (2.7 vs. 8.1%, p = 0.005). Extreme temperature deviations occurred only in the MC group. Rewarming rates were comparable, although variability was greater with MC. Clinical outcomes showed lower risk of hypotension (RR: 0.647, 95% CI: 0.409-1.02; p = 0.044), inotrope use (RR: 0.647, 95% CI: 0.409-1.02; p = 0.044), and abnormal magnetic resonance imaging (MRI) findings (12.0 vs. 46.2%; RR: 0.26, 95% CI: 0.08-0.81; p = 0.013) in the SC group. After adjusting for clinical encephalopathy severity, SC remained independently protective against abnormal MRI (aOR: 0.19; 95% CI: 0.04-0.865; p = 0.03) and hypotension (aOR: 0.27; 95% CI: 0.08-0.95; p = 0.04). Mortality occurred only in the MC group.While both methods were effective, the SC system offered more stable temperature control and may reduce complications during and after TH. · Temperature stability is critical for the effectiveness of TH.. · SC cooling provided more stable temperature control than MC.. · SC cooling and MC were feasible in a neonatal intensive care unit setting.. · SC cooling may reduce neurological complications during and after TH..

本研究旨在比较使用手动冷却(MC)或伺服控制(SC)系统对中度或重度缺氧缺血性脑病(HIE)新生儿治疗性低温(TH)期间的温度控制。回顾性队列研究包括2018年至2020年期间接受TH治疗的妊娠≥35周的中度或重度HIE新生儿,使用冰敷或SC系统。比较两种降温方法的温度曲线和临床效果。数据采用描述性统计进行汇总。通过适当的参数或非参数检验对各组进行比较。评估温度稳定性和复温变异性,并使用95%置信区间的风险比和根据脑病严重程度调整的逻辑回归分析次要结局。在研究期间,56例中重度HIE新生儿采用了降温方法,其中31例(55.4%)采用了MC系统,25例(44.6%)采用了SC系统。基线特征和达到目标温度的时间相似。SC实现了更稳定的低温,变异性更小(p = 0.014),治疗范围外的时间也更短(2.7% vs. 8.1%, p = 0.005)。极端的温度偏差只发生在MC组。临床结果显示,SC组出现低血压(RR: 0.647, 95% CI: 0.409-1.02; p = 0.044)、肌力药物使用(RR: 0.647, 95% CI: 0.409-1.02; p = 0.044)和磁共振成像(MRI)异常(12.0 vs. 46.2%; RR: 0.26, 95% CI: 0.08-0.81; p = 0.013)的风险较低。在调整临床脑病严重程度后,SC对异常MRI (aOR: 0.19; 95% CI: 0.04-0.865; p = 0.03)和低血压(aOR: 0.27; 95% CI: 0.08-0.95; p = 0.04)保持独立保护作用。死亡仅发生在MC组。虽然两种方法都有效,但SC系统提供了更稳定的温度控制,并可能减少TH期间和之后的并发症。·温度稳定性对TH的有效性至关重要。·SC冷却提供了比MC更稳定的温度控制。·SC冷却和MC在新生儿重症监护病房设置是可行的。·SC冷却可减少TH期间和之后的神经系统并发症。
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引用次数: 0
Low Molecular Weight Heparin Thromboprophylaxis or No Treatment following Cesarean Delivery: A Pilot Randomized Controlled Trial. 低分子肝素预防或不治疗剖宫产后血栓:一项试点随机对照试验。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-05 DOI: 10.1055/a-2753-9286
Ann M Bruno, Amanda A Allshouse, D W Branch, Robert M Silver, Torri D Metz

This study aimed to evaluate the feasibility of randomizing patients to weight-based low molecular weight heparin (LMWH) versus no pharmacologic thromboprophylaxis following cesarean delivery (CD).Single-center, open-label pilot randomized controlled trial of individuals aged 18+ undergoing CD at the University of Utah Health from November 2023 to June 2024. Those with a contraindication to anticoagulation, a plan for therapeutic anticoagulation, or considered at highest risk for postpartum venous thromboembolism (VTE; i.e., undergoing cesarean-hysterectomy, high-risk thrombophilia, personal history of thromboembolism) were excluded. Enrolled individuals were randomized in a 1:1 ratio utilizing block randomization with randomly varying block sizes to receive weight-based LMWH for 14 days or no pharmacologic thromboprophylaxis. The primary outcome was feasibility, defined as ≥35% enrollment of eligible individuals and retention of ≥85% of enrolled individuals through all study procedures. Secondary feasibility outcomes included the number of eligible patients per month, approach rate, enrollment rate, and retention rate. Additional outcomes included VTE, wound hematoma, patient-reported symptoms, or a bleeding complication within 6 weeks postpartum. Baseline characteristics were compared between those approached and enrolled and those not enrolled. The proportion meeting each of the outcomes was reported with 95% confidence intervals (CI).Over the 6-month study period, 694 patients were screened and found eligible for an average of 106 eligible patients per month. There were 611 patients approached (88%, 95% CI: 85.6-90.5), of which 64 enrolled (10.5%, 95% CI: 8-12.9), and 61 participants were retained through all study procedures (95.3%, 95% CI: 90-100). Thus, the overall primary outcome feasibility parameters were not met. Among the 64 individuals enrolled and randomized, the mean age was 31.0 years (standard deviation: 5.5 years), and the majority were non-Hispanic White (56%). Baseline characteristics were similar between those who were approached and enrolled compared with those not enrolled. There were no differences in additional clinical outcomes (VTE, wound hematoma, patient-reported symptoms, or bleeding complications) by prophylaxis group.In this pilot trial, individual patient randomization to weight-based LMWH or no pharmacologic thromboprophylaxis after CD was not feasible due to low enrollment rates. Future trials addressing postpartum thromboembolism prevention should consider alternative study designs. · Individual patient randomization to enoxaparin or no therapy after CD was not feasible.. · The approach rate, enrollment rate, and retention rate were 88, 11, and 95%, respectively, in this single-center pilot.. · Future prospective studies may need to consider alternative designs..

目的:评价剖宫产(CD)后随机分配患者低分子肝素(LMWH)与无药物预防的可行性。研究设计:从2023年11月至2024年6月,对18岁以上的CD患者进行单中心、开放标签试点随机对照试验。排除有抗凝禁忌症、治疗性抗凝计划、已知肾功能不全或产后静脉血栓栓塞风险最高的患者(即高危血栓患者、个人血栓栓塞史)。符合条件和入组的个体以1:1的比例随机分组,随机改变分组大小到基于体重的低分子肝素,为期14天或没有药物血栓预防。主要终点是可行性,定义为≥35%的符合条件的个体入组,≥85%的入组个体保留率。次要可行性结果包括每月符合条件的患者数量、就诊率、入组率和留置率。基线特征在接近并入组的患者和未入组的患者之间进行比较。满足每个结果的比例以95%置信区间(CI)报告。结果:在6个月的研究期间,694名患者被筛选并发现符合条件,平均每月106名符合条件的患者。共纳入611例患者(88%,95% CI 85.6-90.5%),其中64例入组(10.5%,95% CI 8-12.9%), 61例参与者在所有研究过程中均被保留(n=61/64, 95.3%, 95% CI 90-100%)。因此,总体主要结局可行性参数不满足。入组的64人平均年龄为31.0岁,多数为非西班牙裔白人(56%)。与未入组的患者相比,接近和入组的患者的基线特征相似。结论:在这项试点试验中,由于低入组率,将个体患者随机分配到低分子肝素或不进行药物血栓预防治疗是不可行的。未来针对产后血栓栓塞预防的试验应考虑其他研究设计。
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引用次数: 0
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American journal of perinatology
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