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Joint Effect of Body Mass Index and Obstructive Sleep Apnea on Preeclampsia Risk. 体重指数和阻塞性睡眠呼吸暂停对子痫前期风险的共同影响。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2026-01-01 Epub Date: 2025-04-07 DOI: 10.1055/a-2576-4082
Nana A Mensah, Michael J Fassett, Morgan R Peltier, Jiaxiao Shi, Vicki Y Chiu, Nehaa Khadkha, Darios Getahun

Preeclampsia remains one of the leading causes of perinatal mortality worldwide. Little is known about the modifiable risk factors that can be identified and addressed early in pregnancy to reduce the risk of preeclampsia and its associated adverse outcomes. We sought to determine if there is a synergistic effect of prepregnancy body-mass index and obstructive sleep apnea (OSA) on the risk of preeclampsia.We conducted a retrospective cohort study of singleton pregnancies delivered in Kaiser Permanente Southern California hospitals between January 1, 2010, and December 31, 2020 (n = 342,349). Preeclampsia and sleep apnea were ascertained using clinical diagnosis codes. Body mass index (BMI) in kg/m2 measured during prenatal care visits was categorized as normal (18.5-24.9), overweight (25-29.9), and obese (≥30). Multivariable logistic regression was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI).Compared with normal weight in pregnancy, overweight (aRR : 1.6; 95% CI: 1.5, 1.7) and obese BMI (aRR: 2.5; 95% CI: 2.4, 2.6) were associated with an increased risk of preeclampsia. Independent of prepregnancy body-mass index, a pregnancy with OSA was associated with an increased risk of preeclampsia (aRR: 2.2; 95% CI: 1.8, 2.6). Compared with normal weight without the diagnosis of OSA in a pregnancy, overweight (aRR: 4.6; 95% CI: 2.9, 7.4) and obese BMI (aRR: 3.8; 95% CI: 3.2, 4.6) with the diagnosis of OSA were associated with an increased risk of preeclampsia.OSA and elevated body-mass index have an independent and additive relationship with preeclampsia. Overweight women at risk of preeclampsia should be advised of a higher likelihood of developing preeclampsia when both conditions occur together and may benefit from close monitoring and early interventions for these modifiable risk factors. · There is a dose-dependent association between BMI and the risk of preeclampsia.. · Coexistent obesity and OSA resulted in a stronger risk for preeclampsia.. · The combined effect of obesity and OSA on preeclampsia risk is additive rather than synergistic..

目的:子痫前期仍然是世界范围内围产期死亡的主要原因之一。很少有人知道可以在妊娠早期识别和处理的可改变的危险因素,以减少子痫前期的风险及其相关的不良后果。我们试图确定孕前体重指数和阻塞性睡眠呼吸暂停是否对子痫前期风险有协同作用。研究设计:我们对2010年1月1日至2020年12月31日期间在Kaiser Permanente南加州医院分娩的单胎妊娠进行了回顾性队列研究(n=342,349)。使用临床诊断代码确定先兆子痫和睡眠呼吸暂停。产前保健期间测量的体重指数(kg/m2)分为正常(18.5 ~ 24.9)、超重(25 ~ 29.9)和肥胖(≥30)。采用多变量logistic回归估计校正相对风险(校正RR)和95%置信区间(CI)。结果:与妊娠期正常体重相比,超重(调整RR: 1.6;95% CI: 1.5, 1.7)和肥胖体重指数(校正RR: 2.5;95% CI: 2.4, 2.6)与子痫前期风险增加相关。与孕前体重指数无关,患有阻塞性睡眠呼吸暂停的妊娠与子痫前期风险增加相关(校正RR: 2.2;95% ci: 1.8, 2.6)。与未诊断为阻塞性睡眠呼吸暂停的正常体重孕妇相比,超重(调整RR: 4.6;95% CI: 2.9, 7.4)和肥胖体重指数(校正RR: 3.8;95% CI: 3.2, 4.6)诊断为阻塞性睡眠呼吸暂停的患者与子痫前期风险增加相关。结论:阻塞性睡眠呼吸暂停、体质指数升高与子痫前期存在独立关系和叠加关系。有子痫前期风险的超重妇女应被告知,当这两种情况同时发生时,发生子痫前期的可能性更高,并可能受益于对这些可改变的风险因素的密切监测和早期干预。
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引用次数: 0
National Survey of Neonatal-Perinatal Medicine Fellows on Postresuscitation Debriefing. 全国新生儿-围产期医学医师复苏后述职情况调查。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2026-01-01 Epub Date: 2025-05-12 DOI: 10.1055/a-2591-8200
Lily Guo, Nicole K Sather, Nadia Khan, Lauren E Zinns, Vinod Havalad, Gillian Brennan

Debriefing can be a powerful tool to facilitate improvement of performance after a resuscitation event. This study characterizes the debriefing experience of neonatal-perinatal medicine (NPM) fellows in the neonatal intensive care unit (NICU), operating room, and delivery room in the United States.An anonymous 13-item electronic survey was distributed to NPM program directors across the United States, who were asked to forward it to their respective NPM fellows. The survey addressed the frequency and timing of debriefings, access to formal training, and comfort levels with debriefing.Ninety-five responses were collected, with all participants having taken part in at least one medical resuscitation. Debriefings occurred approximately 25% of the time following a resuscitation, typically within 6 hours. Twenty percent of respondents reported feeling somewhat or very uncomfortable leading a debriefing, while 84% believed debriefings improve team performance. Despite 72% reporting no formal debriefing training, 94% expressed interest in receiving such training.This national survey on NPM fellows highlights inconsistent debriefing practices despite recognized benefits. Limited formal training remains a barrier, but a strong interest in further education presents an opportunity to improve training through the incorporation of structured debriefing frameworks into fellowship curricula. · Although NPM fellows often debrief resuscitations, 72% reported no formal training.. · Formal debriefing training can improve debriefing quality and enhance patient outcomes.. · NPM programs should implement structured debriefing to better prepare their fellows..

汇报是一种强有力的工具,可以促进复苏事件后的表现。本研究描述了美国新生儿重症监护病房(NICU)、手术室和产房的新生儿-围产期医学(NPM)研究员的述职经历。一份包含13个项目的匿名电子调查被分发给美国各地的NPM项目主管,他们被要求将其转发给各自的NPM研究员。调查涉及述职汇报的频率和时间、接受正式培训的机会以及对述职汇报的满意程度。收集了95份答复,所有参与者都至少参加过一次医疗复苏。复苏术后大约25%的时间会进行情况汇报,通常在6小时内。20%的受访者表示,在领导汇报时感到有些或非常不舒服,而84%的人认为汇报能提高团队绩效。尽管72%的人表示没有接受过正式的汇报培训,但94%的人表示有兴趣接受此类培训。这项关于NPM研究员的全国调查突出了尽管公认的好处,但不一致的汇报实践。有限的正式培训仍然是一个障碍,但对继续教育的强烈兴趣提供了一个机会,可以通过将有组织的汇报框架纳入研究金课程来改进培训。·尽管NPM研究员经常汇报复苏情况,但72%的人报告没有接受过正式培训。·正式的述职培训可以提高述职质量,提高患者治疗效果。·NPM项目应实施结构化的汇报,以更好地为其成员做好准备。
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引用次数: 0
The Relationship between Various Measures of Perinatal Quality. 围产期质量各项指标之间的关系。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2026-01-01 Epub Date: 2025-01-16 DOI: 10.1055/a-2517-2501
Nansi S Boghossian, Lucy T Greenberg, Jeffrey S Buzas, Ciaran S Phibbs, Molly Passarella, Jeannette Rogowski, George R Saade, Scott A Lorch

This study aimed to examine the correlations between pairs of maternal, infant, and maternal-infant dyad quality measures to provide a comprehensive assessment of perinatal care.In a retrospective cohort study using birth and fetal death certificates linked to hospital discharge data from Michigan, Oregon, Pennsylvania, and South Carolina (2016-2018), we examined correlations between pairs of maternal, infant, and maternal-infant dyad quality measures. Maternal quality measures included nulliparous term singleton vertex (NTSV) cesarean birth, nontransfusion severe maternal morbidity (SMM), and a composite maternal outcome. Infant quality was assessed with a composite outcome measure, whereas the dyad measure combined maternal and infant outcomes.Among 955,904 dyads across 266 hospitals, 25.9% had NTSV, 0.7% had nontransfusion SMM, 12.3% had the composite infant measure, and 19.3% had the dyad measure. The correlation between nontransfusion SMM and the dyad measure was 0.12, whereas the correlation between the composite infant measure and the dyad measure was 0.86, which was higher than the correlation between the composite maternal measure and the dyad measure (0.47).We observed minimal correlations among these perinatal quality measures, especially when aggregated beyond individual outcomes. · There are minimal correlations among different perinatal quality measures.. · Quality is multifaceted, and hospitals vary in the level of quality they achieve.. · Assessing hospital care for pregnant patients and infants requires multiple quality measures..

目的:探讨母婴对和母婴双质量指标之间的相关性,为围产期护理提供综合评价。研究设计:在一项回顾性队列研究中,我们使用了密歇根州、俄勒冈州、宾夕法尼亚州和南卡罗来纳州(2016-2018年)与医院出院数据相关的出生和胎儿死亡证明,研究了孕产妇、婴儿和母婴双体质量指标之间的相关性。产妇质量测量包括无产足月单胎顶点(NTSV)剖宫产、非输血严重产妇发病率(SMM)和综合产妇结局。婴儿质量通过综合结果测量来评估,而二元测量结合了母亲和婴儿的结果。结果:266家医院955,904对婴儿中,25.9%有NTSV, 0.7%有非输血SMM, 12.3%有复合婴儿测量,19.3%有双体测量。非输血SMM与dyad测量的相关性为0.12,而婴儿综合测量与dyad测量的相关性为0.86,高于母亲综合测量与dyad测量的相关性(0.47)。结论:我们观察到这些围产期质量测量之间的相关性很小,特别是当汇总超出个体结果时。
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引用次数: 0
Understanding the Impact of Patent Ductus Arteriosus and Treatment Strategies on Acute Kidney Injury in Preterm Infants. 了解动脉导管未闭对早产儿急性肾损伤的影响及治疗策略。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-31 DOI: 10.1055/a-2779-7276
Vignesh Gunasekaran, Soowan Woo, Andrew Michael South, Jeffrey Shenberger, David Askenazi, Parvesh M Garg

Acute kidney injury (AKI) is a clinically significant complication in preterm neonates, leading to increased morbidity, mortality, and risk of long-term kidney dysfunction. Within this vulnerable population, the presence of a hemodynamically significant patent ductus arteriosus (PDA) may further exacerbate AKI risk. The relationship between PDA and AKI is complex, involving both the pathophysiological consequences of altered hemodynamics (e.g., ductal steal) causing renal ischemia and the potential nephrotoxic effects of therapeutic interventions. However, the existing literature provided limited insight into the impact of PDA and its management on acute kidney injury in preterm infants, with most studies relying on retrospective designs. There is a notable absence of consensus regarding the comparative effects of conservative, pharmacologic, and surgical PDA management strategies on AKI outcomes. This review article directly addresses these knowledge gaps by synthesizing findings from diverse clinical trials, cohort studies, and meta-analyses into a single, comprehensive resource, aiming to inform future research and guide best practices for managing PDA-related AKI in preterm neonates.

急性肾损伤(AKI)是早产新生儿的临床重要并发症,可导致发病率、死亡率和长期肾功能障碍的风险增加。在这些易感人群中,血流动力学上显著的动脉导管未闭(PDA)的存在可能进一步加剧AKI的风险。PDA和AKI之间的关系是复杂的,既涉及血流动力学改变(如导管偷血)引起肾缺血的病理生理后果,也涉及治疗干预的潜在肾毒性作用。然而,现有文献对PDA对早产儿急性肾损伤的影响及其处理提供的见解有限,大多数研究依赖于回顾性设计。关于保守、药理学和外科PDA管理策略对AKI结果的比较效果,值得注意的是缺乏共识。这篇综述文章通过综合不同临床试验、队列研究和荟萃分析的结果,直接解决了这些知识空白,旨在为未来的研究提供信息,并指导管理早产儿pda相关AKI的最佳实践。
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引用次数: 0
Utility of Fetal Echocardiography in First-Degree Relatives with Bicuspid Aortic Valve and Normal Obstetric Ultrasound. 胎儿超声心动图在有二尖瓣主动脉瓣和正常产科超声的一级亲属中的应用。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-31 DOI: 10.1055/a-2772-6471
Alaa Ismail, Jena Schmidt, Elijah Bolin, Benjamin Ittleman

This study aimed to evaluate the diagnostic yield of fetal echocardiography (f-Echo) in detecting significant congenital heart disease (CHD) in pregnancies with a first-degree relative with a history of bicuspid aortic valve (BAV) and a normal level II obstetric ultrasound.A retrospective review was conducted of all f-Echos performed between 2019 and 2023 for the sole indication of family history of BAV. Cases with additional indications or affected nonfirst-degree relative were excluded. Postnatal transthoracic echocardiography (t-Echo) data were reviewed when available. Significant CHD was defined as requiring catheter or surgical intervention in the first year of life.Sixty-five f-Echos were included (mean gestational age: 26.6 ± 3.7 weeks). No significant CHD was identified prenatally. Postnatal t-Echo was performed in 41 (63%) cases, with no significant CHD detected. Two (5%) infants were diagnosed postnatally with BAV, neither requiring intervention during the study interval. Minor findings included one case each of pulmonary valve stenosis and atrial septal defect.In pregnancies with a first-degree relative with BAV and a normal obstetric ultrasound, f-Echo showed no added diagnostic value for detecting significant CHD. Based on the state's birth rate (approximately 35,000/year), BAV prevalence (1-2%), and an average family size of 3.08, an estimated 733 to 1,466 pregnancies annually in Arkansas could qualify for f-Echo under current guidelines. At a cost of $1,000 to 5,000 per study, this translates to an annual healthcare expenditure ranging from $733,000 to 7.33 million. These findings support more targeted screening and the need for multicenter studies. · No significant CHD detected with f-Echo.. · Postnatal t-Echo remains definitive.. · Routine f-Echo may add limited value.. · Cost implications warrant reconsideration.

本研究旨在评估胎儿超声心动图(f-Echo)在检测有双尖瓣主动脉瓣(BAV)病史且二级产科超声正常的一级亲属妊娠中明显先天性心脏病(CHD)的诊断率。对2019年至2023年期间进行的所有f-Echos进行回顾性审查,以确定BAV家族史的唯一指征。有其他适应症或受影响的非一级亲属的病例被排除。产后经胸超声心动图(t-Echo)数据在可用时进行回顾。显著的冠心病被定义为在生命的第一年需要导管或手术干预。纳入65例f-Echos(平均胎龄:26.6±3.7周)。产前未发现明显的冠心病。41例(63%)患者在出生后进行t-Echo检查,未发现明显的冠心病。两名(5%)婴儿出生后被诊断为BAV,在研究期间均不需要干预。轻微的发现包括肺动脉瓣狭窄和房间隔缺损各1例。在一级亲属患有BAV且产科超声检查正常的孕妇中,f-Echo对检测明显的冠心病没有额外的诊断价值。根据该州的出生率(约35,000/年),BAV患病率(1-2%)和平均家庭规模3.08,在目前的指导方针下,阿肯色州每年估计有733至1466例怀孕符合f-Echo的条件。每项研究的成本为1,000至5,000美元,这意味着每年的医疗保健支出从73.3万美元到733万美元不等。这些发现支持更有针对性的筛查和多中心研究的必要性。·f-Echo未检测到明显的冠心病。·产后t-Echo仍然是明确的…·常规f-Echo可能增加有限的价值。·成本影响值得重新考虑。
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引用次数: 0
Assessing Oxygenation Instability in Premature Infants <1,500 Grams: Nursing Charts versus SpO2 Histograms-Is Two Better Than One? 评估< 1500克早产儿的氧合不稳定性:护理图表与SpO2直方图-两个比一个好吗?
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-31 DOI: 10.1055/a-2771-5370
Viktoria Leikin Zach, Arieh Riskin, Irina Raizberg, Ori Hochwald, Amir Kugelman, Liron Borenstein-Levin

Despite availability of advanced monitoring tools, most neonatologists still primarily rely on nursing documentation of desaturation and bradycardia events to assess the respiratory status of very low birth weight (VLBW) premature infants. We aimed to compare oxygenation instability as recorded in nursing charts versus SpO2 histograms in VLBW infants during their first weeks of life.An observational study including VLBW premature infants who required respiratory support on day 1 of life. We recorded the daily number of desaturation events <90% from nursing charts and the cumulative duration of SpO2 <90% from 24 hours SpO2 histograms. Data were collected from birth until respiratory support was discontinued.Data from 1,749 chart days of 77 VLBW infants (mean ± SD birth weight 1,040 ± 243 g; gestational age: 28.5 ± 2.1weeks) were analyzed. A strong Pearson correlation was found between the number of desaturation events and total time in SpO2 <90% (r = 0.8). However, similar event counts often reflected different hypoxemia burden. Eight or more daily desaturation events predict an unstable SpO2 histogram (sensitivity: 90.3%, specificity: 76.1%).Nursing charts and SpO2 histograms strongly correlate but offer unique insights-charts capture the frequency and distribution of desaturation events, while histograms quantify overall hypoxemic exposure. Used together, they provide a more comprehensive assessment of respiratory status in VLBW infants. · Oxygenation instability is common among VLBW premature infants.. · We compared oxygenation instability documentation in the NICU by nursing charts versus SpO2 histograms.. · Strong Pearson correlation was found between documented desaturation events and time with SpO2 <90%.. · However, for a given number of desaturation events, the time in SpO2 <90% varied significantly.. · Combining charts and SpO2 histograms gives a more complete respiratory assessment in VLBW infants..

尽管有先进的监测工具,大多数新生儿科医生仍然主要依赖于去饱和和心动过缓事件的护理文件来评估极低出生体重(VLBW)早产儿的呼吸状态。我们的目的是比较VLBW婴儿在生命最初几周的护理图表和SpO2直方图中记录的氧合不稳定性。一项观察性研究,包括在出生第1天需要呼吸支持的VLBW早产儿。我们记录了每天去饱和事件的数量22个直方图。数据从出生到停止呼吸支持收集。对77例VLBW婴儿(平均±SD出生体重1040±243 g,胎龄28.5±2.1周)1749个图表日的数据进行分析。在SpO2直方图中,去饱和事件数与总时间之间存在很强的Pearson相关性(灵敏度:90.3%,特异性:76.1%)。护理图表和SpO2直方图密切相关,但提供了独特的见解-图表捕获去饱和事件的频率和分布,而直方图量化总体低氧暴露。它们一起使用,可以更全面地评估VLBW婴儿的呼吸状态。·氧合不稳定在VLBW早产儿中很常见。·我们通过护理图表和SpO2直方图比较了NICU的氧合不稳定记录。·在记录的去饱和事件和时间与SpO2之间发现了很强的Pearson相关性
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引用次数: 0
Timing and Severity of Fetal Growth Restriction Diagnosis and Association with Perinatal Morbidity. 胎儿生长受限诊断的时间和严重程度及其与围产期发病率的关系。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-31 DOI: 10.1055/a-2764-2151
Lilian N Bui, Sonia Ahluwalia, Nkechinyelum Q Ogu, Sydney L Raucher, Emily S Miller, Priya R Rajan, Stephanie A Fisher

In 2020, the Society of Maternal Fetal Medicine refined fetal growth restriction (FGR) diagnostic criteria by temporal (early-, <32 weeks 0 days [320] weeks; late-onset, ≥320 weeks) and measurement-specific definitions (severe, estimated fetal weight <3rd; mild, estimated fetal weight 3rd-9th percentile and/or abdominal circumference <10th percentile). Using these updated clinical definitions, we sought to determine the association of timing and severity of FGR diagnosis with, and their discriminatory ability for, adverse pregnancy outcomes.This retrospective cohort study included singleton, non-anomalous pregnancies with sonographic FGR diagnosis at ≥180 weeks' gestation from May 2020 to December 2021. We evaluated four FGR classification exposure groups: (1) early-onset, severe FGR; (2) early-onset, mild FGR; (3) late-onset, severe FGR; and (4) late-onset, mild FGR. Outcomes assessed were hypertensive disorders of pregnancy, preterm birth, and small-for-gestational age. Multivariable logistic regression estimated the odds of each outcome associated with each exposure, adjusted for maternal age, insurance, and parity. Receiver-operating characteristic analysis determined test characteristics for the ability of these FGR classification groups to identify the postnatal outcomes, using late-onset, mild FGR as the reference group.Among 566 eligible pregnancies, early-onset, severe FGR had higher adjusted odds of hypertensive disorders of pregnancy (aOR = 1.3, 95% CI: 1.1-1.7), preterm birth (aOR = 2.1, 95% CI: 1.6-2.6), and small-for-gestational age (aOR = 1.6, 95% CI: 1.3-1.9), compared to late-onset, mild FGR. Late-onset, severe FGR also had higher adjusted odds of preterm birth (aOR = 7.2, 95% CI: 2.9-18.3) and small-for-gestational age (aOR = 5.8, 95% CI: 2.5-13.6). Odds of adverse pregnancy outcomes were similar with early- and late-onset mild FGR. Overall, discriminatory ability of these FGR classification groups for adverse pregnancy outcomes were poor.Early- and late-onset, severe FGR (versus late-onset, mild FGR) are positively associated with, but have poor discriminatory ability for, adverse pregnancy outcomes. · Early-onset, severe FGR (vs. late-onset, mild FGR) is significantly associated with hypertensive disorders of pregnancy.. · Compared to late-onset mild FGR, severe FGR, whether early- or late-onset, has greater odds of preterm birth and small-for-gestational age.. · All FGR classification groups had weak discriminatory ability for identification of these adverse pregnancy outcomes..

目的:2020年,母胎医学学会细化胎儿生长受限(FGR)的时间(早期)诊断标准。研究设计:本回顾性队列研究纳入2020年5月至2021年12月妊娠≥180周超声诊断胎儿生长受限的单胎、非异常妊娠。我们评估了4个FGR分级暴露组:1)早发性严重FGR;2)早发,轻度FGR;3)迟发性、重度FGR;4)迟发性轻度FGR。评估的结局是妊娠高血压疾病、早产和小胎龄。多变量logistic回归估计了与每次暴露相关的每个结果的几率,调整了母亲年龄、保险和胎次。接受者-操作特征分析确定了FGR分类组识别产后结局能力的测试特征,以迟发性轻度FGR为参照组。结果:在566例符合条件的妊娠中,与迟发性轻度FGR相比,早发性重度FGR发生妊娠高血压疾病(aOR为1.3,95% CI为1.1-1.7)、早产(aOR为2.1,95% CI为1.6-2.6)和小胎龄(aOR为1.6,95% CI为1.3-1.9)的调整后几率更高。迟发性严重FGR也有较高的早产调整几率(aOR为7.2,95% CI为2.9-18.3)和胎龄小(aOR为5.8,95% CI为2.5-13.6)。不良妊娠结局的几率与早发性和晚发性轻度FGR相似。总体而言,这些FGR分类组对不良妊娠结局的区分能力较差。结论:早发型和晚发型、重度FGR(相对于晚发型、轻度FGR)与不良妊娠结局呈正相关,但对不良妊娠结局的区分能力较差。
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引用次数: 0
The Ethics of Clinical Research on Diseases of the Fetus and Newborn: Balancing Benefit-Risk, Autonomy, and Maternal-Fetal Interests. 胎儿和新生儿疾病临床研究的伦理:平衡利益-风险、自主和母胎利益。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-30 DOI: 10.1055/a-2764-2202
Robert M Nelson, Karla Childers, Leona E Ling, Lori Alquier, Yosuke Komatsu, Lisa Schwartz, Anne M Stevens, May Lee Tjoa, Kenneth J Moise, Sara F Goldkind

Pregnant persons historically have been excluded from clinical trials. Recently, there has been a shift from exclusion toward inclusion of pregnant persons in research while acknowledging the complexity of reproductive ethics and the intertwined interests of the pregnant person and fetus. Our objective was to use a principle-based approach to review the ethics of clinical research concerning pregnancy-related disorders that predominantly affect fetal well-being.Ethical principles are applied to the design of interventional trials in two rare conditions of pregnancy, hemolytic disease of the fetus and newborn (HDFN) and fetal and neonatal alloimmune thrombocytopenia (FNAIT).Severe HDFN and FNAIT are fetal and neonatal diseases caused by maternal alloantibodies with potential outcomes including maternal and neonatal morbidity, preterm delivery, and fetal or neonatal death. Early-onset severe HDFN was the initial indication for a phase 2 open-label study of nipocalimab in pregnancy, given poor outcomes after prior severe HDFN pregnancy(s). After establishing proof of concept, a phase 3 randomized placebo-controlled study was initiated based on the ethical principles of equipoise and generating socially valuable data to support the efficacy and safety of nipocalimab in severe HDFN. However, off-label use of antenatal intravenous immunoglobulin (IVIg) in standard-risk FNAIT pregnancies made a randomized placebo-controlled study challenging. Thus, the FNAIT clinical program for nipocalimab in pregnant persons with standard-risk FNAIT includes a randomized, placebo-controlled study limited to sites that do not use antenatal IVIg, and a global randomized open-label study of nipocalimab or IVIg.Knowledge of the clinical course and management of severe HDFN and FNAIT, the non-clinical and non-pregnant human clinical evidence, and input from physicians, patients, and health authorities permitted the design of clinical protocols that satisfy the principles of beneficence and non-maleficence in these rare and complex diseases. · Ethical principles apply to pregnancy-related disorders affecting fetal well-being.. · Placebo-controlled randomized trials in HDFN are based on equipoise.. · FNAIT programs must account for the off-label use of IVIg..

孕妇历来被排除在临床试验之外。最近,在承认生殖伦理的复杂性以及孕妇和胎儿相互交织的利益的同时,研究已经从排斥孕妇转向包容孕妇。我们的目的是使用基于原则的方法来审查主要影响胎儿健康的妊娠相关疾病的临床研究的伦理。伦理原则适用于两种罕见妊娠情况的介入试验设计,即胎儿和新生儿溶血性疾病(hddn)和胎儿和新生儿同种免疫性血小板减少症(FNAIT)。重度HDFN和FNAIT是由母体同种异体抗体引起的胎儿和新生儿疾病,其潜在结局包括孕产妇和新生儿发病率、早产、胎儿或新生儿死亡。早发性严重HDFN是nipocalimab妊娠期开放标签研究的初始适应症,考虑到先前严重HDFN妊娠后的不良结局。在建立概念验证后,基于平衡的伦理原则和产生有社会价值的数据,启动了一项3期随机安慰剂对照研究,以支持nipocalimab治疗严重hdf的有效性和安全性。然而,在标准风险的FNAIT妊娠中,产前静脉注射免疫球蛋白(IVIg)的标签外使用使随机安慰剂对照研究具有挑战性。因此,nipocalimab用于标准风险FNAIT孕妇的FNAIT临床项目包括一项随机、安慰剂对照研究,该研究仅限于不使用产前IVIg的地点,以及一项全球随机、开放标签的nipocalimab或IVIg研究。对严重HDFN和FNAIT的临床病程和管理、非临床和非妊娠人类临床证据以及医生、患者和卫生当局的投入的了解,允许设计临床方案,满足这些罕见和复杂疾病的有益和无害原则。·伦理原则适用于影响胎儿健康的妊娠相关疾病。·hdf的安慰剂对照随机试验基于平衡。·FNAIT项目必须考虑到IVIg的标签外使用。
{"title":"The Ethics of Clinical Research on Diseases of the Fetus and Newborn: Balancing Benefit-Risk, Autonomy, and Maternal-Fetal Interests.","authors":"Robert M Nelson, Karla Childers, Leona E Ling, Lori Alquier, Yosuke Komatsu, Lisa Schwartz, Anne M Stevens, May Lee Tjoa, Kenneth J Moise, Sara F Goldkind","doi":"10.1055/a-2764-2202","DOIUrl":"https://doi.org/10.1055/a-2764-2202","url":null,"abstract":"<p><p>Pregnant persons historically have been excluded from clinical trials. Recently, there has been a shift from exclusion toward inclusion of pregnant persons in research while acknowledging the complexity of reproductive ethics and the intertwined interests of the pregnant person and fetus. Our objective was to use a principle-based approach to review the ethics of clinical research concerning pregnancy-related disorders that predominantly affect fetal well-being.Ethical principles are applied to the design of interventional trials in two rare conditions of pregnancy, hemolytic disease of the fetus and newborn (HDFN) and fetal and neonatal alloimmune thrombocytopenia (FNAIT).Severe HDFN and FNAIT are fetal and neonatal diseases caused by maternal alloantibodies with potential outcomes including maternal and neonatal morbidity, preterm delivery, and fetal or neonatal death. Early-onset severe HDFN was the initial indication for a phase 2 open-label study of nipocalimab in pregnancy, given poor outcomes after prior severe HDFN pregnancy(s). After establishing proof of concept, a phase 3 randomized placebo-controlled study was initiated based on the ethical principles of equipoise and generating socially valuable data to support the efficacy and safety of nipocalimab in severe HDFN. However, off-label use of antenatal intravenous immunoglobulin (IVIg) in standard-risk FNAIT pregnancies made a randomized placebo-controlled study challenging. Thus, the FNAIT clinical program for nipocalimab in pregnant persons with standard-risk FNAIT includes a randomized, placebo-controlled study limited to sites that do not use antenatal IVIg, and a global randomized open-label study of nipocalimab or IVIg.Knowledge of the clinical course and management of severe HDFN and FNAIT, the non-clinical and non-pregnant human clinical evidence, and input from physicians, patients, and health authorities permitted the design of clinical protocols that satisfy the principles of beneficence and non-maleficence in these rare and complex diseases. · Ethical principles apply to pregnancy-related disorders affecting fetal well-being.. · Placebo-controlled randomized trials in HDFN are based on equipoise.. · FNAIT programs must account for the off-label use of IVIg..</p>","PeriodicalId":7584,"journal":{"name":"American journal of perinatology","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145861479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utility of Serial Cranial Ultrasound in Preterm Infants. 连续颅超声在早产儿中的应用。
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-30 DOI: 10.1055/a-2779-7336
Victoria Johnson, Sarah Batt, Hadi Berbari, Courtney Mitchell, Hemananda Kumar Muniraman

Objectives: To describe and evaluate our single-center practice of serial cranial ultrasound (CUS) in preterm infants following the 2020 American Academy of Pediatrics (AAP) clinical report. To evaluate the rate of cranial abnormalities following the first normal scan and identify risk factors for severe intraventricular hemorrhage (IVH) in the first week of life.

Methods: A single-center retrospective study over an eight-year study period, from 2016-2023. Rates and types of CUS are described and compared over pre- and post-AAP clinical report time epochs. Risk factors associated with severe IVH were analyzed with logistic regression.

Results: A total of 727 infants were included. Median number of CUS was 3 (2, 4, IQR) in both pre- and post-AAP cohort periods. CUS were performed in 289 (39.8%) infants before 7 days of life (DOL), 595 (81.8%) at 7-10 DOL, 623 (85.7%) at 4-6 weeks, and 361 (49.7%) at term equivalent age (TEA). The rates of abnormal CUS were 139 (48.1%), 364 (61.2%), 401 (64.4%), and 227 (62.9%) of the infants who had CUS at less than 7 days, 7-10 days, 4-6 weeks, and TEA, respectively. New abnormalities were detected in 13% (48/364) infants following a normal 7-10 DOL scan and 3% (9/290) following a normal 7-10 days and 4-6 weeks scan. Decreased birth gestational age (Odds Ratio, OR = 0.7) advanced resuscitation (OR = 3.4) and birth at outside hospital (OSH) (OR = 2.6) were associated with severe IVH before 7 DOL.

Conclusion: Our single-center practice of serial CUS was largely consistent with the AAP clinical report. We report that new findings of abnormality following a normal 7-10 DOL scan are infrequent and limited to grade 1 IVH and benign cysts. We identified birth gestation below 25 weeks, birth at an OSH, and advanced resuscitation as risk factors for severe IVH.

目的:根据2020年美国儿科学会(AAP)临床报告,描述和评估我们在早产儿中进行连续颅超声(CUS)的单中心实践。评估首次正常扫描后颅内异常的发生率,并确定生命第一周发生严重脑室内出血(IVH)的危险因素。方法:一项为期8年的单中心回顾性研究,从2016年到2023年。发生率和类型的CUS描述和比较前和后aap临床报告的时间点。采用logistic回归分析重症IVH相关危险因素。结果:共纳入727例婴儿。在aap之前和之后的队列期间,CUS的中位数为3 (2,4,IQR)。新生儿7天前(DOL) 289例(39.8%),7-10天(DOL) 595例(81.8%),4-6周(623例),足月等龄(TEA) 361例(49.7%)。在小于7天、7-10天、4-6周和TEA发生CUS的患儿中,异常发生率分别为139(48.1%)、364(61.2%)、401(64.4%)和227(62.9%)。在正常的7-10 DOL扫描后,13%(48/364)的婴儿发现了新的异常,在正常的7-10天和4-6周扫描后,3%(9/290)的婴儿发现了新的异常。出生胎龄降低(优势比,OR = 0.7)、晚期复苏(OR = 3.4)和院外分娩(OR = 2.6)与7 DOL前严重IVH相关。结论:我们的系列CUS单中心实践与AAP临床报告基本一致。我们报告在正常的7-10 DOL扫描后发现的新异常是罕见的,并且仅限于1级IVH和良性囊肿。我们确定了小于25周的出生妊娠、在职业安全环境下出生和晚期复苏是严重IVH的危险因素。
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引用次数: 0
Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia. 发表摘要:Nipocalimab治疗胎儿和新生儿同种免疫性血小板减少症的3期FREESIA-1和FREESIA-3试验设计
IF 1.2 4区 医学 Q3 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-29 DOI: 10.1055/a-2761-1775
Pamela Baker, Babajide Keshinro, Barbara Stegmann, Abbie Oey, Cathye Shu, Dirk Heerwegh, Rebecca Zaha, Hillary Van Valkenburgh

This article is a plain language summary of publication (PLSP) of the following articles: "Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-1)" by Tiller et al published in American Journal of Perinatology on July 28, 2025 (doi:10.1055/a-2666-5642) and "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 (FREESIA-3)" by Bussel et al published in American Journal of Perinatology on November 25, 2025 (doi: 10.1055/a-2753-9323). This PLSP describes the design of the phase 3, placebo-controlled FREESIA-1 and open-label FREESIA-3 trials, which will help researchers understand if nipocalimab, an investigational treatment, can be used to safely treat pregnant individuals who are at risk for fetal and neonatal alloimmune thrombocytopenia (FNAIT). This PLSP will help the general public, including those affected by FNAIT, and health care professionals understand the two studies. It provides information on the eligibility criteria, study design, treatments, and outcomes of interest. An infographic summary of this article is available in the Supplementary Material (available in the online version only).

本文是以下文章的通俗易懂的出版摘要(PLSP):Tiller等发表于2025年7月28日的《美国围产期杂志》(doi:10.1055/a-2666-5642)和《Nipocalimab在有胎儿和新生儿同种免疫性血小板减少症风险的妊娠中的三期、多中心、随机、安慰剂对照、双盲研究设计》。由Bussel等人于2025年11月25日发表在《美国围产期杂志》(doi: 10.1055/a-2753-9323)上的Nipocalimab或IVIG和强尼松在胎儿和新生儿同种免疫性血小板减少症风险孕妇中的开放标签研究(FREESIA-3)。本PLSP描述了3期安慰剂对照FREESIA-1和开放标签FREESIA-3试验的设计,这将有助于研究人员了解nipocalimab(一种研究性治疗药物)是否可以安全地用于治疗有胎儿和新生儿同种免疫性血小板减少症(FNAIT)风险的孕妇。本PLSP将帮助公众,包括那些受FNAIT影响的人,以及卫生保健专业人员了解这两项研究。它提供了有关资格标准、研究设计、治疗和感兴趣的结果的信息。本文的信息图表摘要可在补充材料中找到(仅提供在线版本)。
{"title":"Plain Language Summary of Publication: Design of the Phase 3 FREESIA-1 and FREESIA-3 Trials of Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia.","authors":"Pamela Baker, Babajide Keshinro, Barbara Stegmann, Abbie Oey, Cathye Shu, Dirk Heerwegh, Rebecca Zaha, Hillary Van Valkenburgh","doi":"10.1055/a-2761-1775","DOIUrl":"https://doi.org/10.1055/a-2761-1775","url":null,"abstract":"<p><p>This article is a plain language summary of publication (PLSP) of the following articles: \"Design of a Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-1)\" by Tiller et al published in <i>American Journal of Perinatology</i> on July 28, 2025 (doi:10.1055/a-2666-5642) and \"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 (FREESIA-3)\" by Bussel et al published in <i>American Journal of Perinatology</i> on November 25, 2025 (doi: 10.1055/a-2753-9323). This PLSP describes the design of the phase 3, placebo-controlled FREESIA-1 and open-label FREESIA-3 trials, which will help researchers understand if nipocalimab, an investigational treatment, can be used to safely treat pregnant individuals who are at risk for fetal and neonatal alloimmune thrombocytopenia (FNAIT). This PLSP will help the general public, including those affected by FNAIT, and health care professionals understand the two studies. It provides information on the eligibility criteria, study design, treatments, and outcomes of interest. An infographic summary of this article is available in the Supplementary Material (available in the online version only).</p>","PeriodicalId":7584,"journal":{"name":"American journal of perinatology","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145853109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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American journal of perinatology
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