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Differential Analysis of Neonatal Adverse Drug Events from Intrauterine and Extrauterine Exposure: Insights into Administration Routes Using the FAERS Database. 新生儿宫内和宫外用药不良事件的差异分析:使用FAERS数据库对给药途径的见解。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-22 DOI: 10.1055/a-2767-2466
Zhuqing Yang, Meng Hou, Tingting Li

This study aimed to systematically characterize the features and drug distribution of neonatal adverse drug reactions using data from the FAERS, with a focus on exposure-specific patterns and stratified analyses by sex and clinical outcomes.Reports submitted to FAERS from the first quarter of 2004 to the fourth quarter of 2024 were utilized. Patients experienced the ADR at an age of no more than 28 days. Four quantitative disproportionality analysis methods, including ROR, PRR, BCPNN, and MGPS, were used to detect signals of adverse drug events.A total of 15,456 neonatal cases exposed to the target drugs were included, yielding 60,611 adverse event reports, 95.45% of which were classified as serious. The median time to onset of ADRs was 264 days for intrauterine drug exposure, compared to 1-3 days for extrauterine exposure. The most affected SOCs were injury and procedural complications (19.53%), congenital disorders (15.96%), and pregnancy/perinatal conditions (8.65%). Transplacental exposure accounted for the highest proportion (52.47%), followed by intravenous (9.34%), oral (6.77%), breastfeeding (1.80%), intramuscular (1.48%), and inhalation (1.29%). The top maternal exposure drugs included venlafaxine, sertraline, quetiapine, lamotrigine, and levetiracetam. For intravenous use, levetiracetam, zidovudine, indomethacin, ibuprofen, and vancomycin were most common. Female neonates had higher risks of microcephaly, ventricular septal defect, and growth restriction, while male neonates were more prone to hypospadias, cryptorchidism, and agitation. Serious AEs were mainly linked to maternal drug exposure during pregnancy.These results showed that the use of antidepressants, antiepileptics, and antivirals during pregnancy represents a significant risk factor for neonatal adverse reactions, particularly congenital malformations. Consequently, it is imperative to implement precise prevention strategies tailored to specific exposure stages and to advocate for the establishment of an international pharmacovigilance network for neonates.

本研究旨在利用FAERS的数据系统地描述新生儿药物不良反应的特征和药物分布,重点是暴露特异性模式和按性别和临床结果分层分析。从2004年第一季度到2024年第四季度提交给FAERS的报告被利用。患者出现不良反应的年龄不超过28天。采用ROR、PRR、BCPNN和MGPS四种定量歧化分析方法检测药物不良事件的信号。共纳入15456例新生儿靶药暴露病例,报告不良事件60611例,其中严重不良事件占95.45%。宫内药物暴露的中位不良反应发生时间为264天,而宫外药物暴露的中位不良反应发生时间为1-3天。影响最大的SOCs是损伤和手术并发症(19.53%)、先天性疾病(15.96%)和妊娠/围产期疾病(8.65%)。经胎盘暴露所占比例最高(52.47%),其次为静脉注射(9.34%)、口服(6.77%)、母乳喂养(1.80%)、肌肉注射(1.48%)和吸入(1.29%)。产妇接触最多的药物包括文拉法辛、舍曲林、喹硫平、拉莫三嗪和左乙拉西坦。静脉注射用左乙拉西坦、齐多夫定、吲哚美辛、布洛芬和万古霉素最为常见。女性新生儿小头畸形、室间隔缺损和生长受限的风险较高,而男性新生儿更容易出现尿道下裂、隐睾和躁动。严重不良反应主要与母亲在怀孕期间接触药物有关。这些结果表明,在怀孕期间使用抗抑郁药、抗癫痫药和抗病毒药物是新生儿不良反应,特别是先天性畸形的重要危险因素。因此,必须实施针对特定暴露阶段的精确预防战略,并倡导建立新生儿国际药物警戒网络。
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引用次数: 0
[The possible impact of the COVID-19 lockdown measures on the perinatal/neonatal outcome - a data analysis of the years 2019, 2020, 2021]. [COVID-19封锁措施对围产期/新生儿结局的可能影响——2019年、2020年和2021年数据分析]。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-15 DOI: 10.1055/a-2754-0634
René Hennrich, Moritz Schmid, Dirk Olbertz, Sven Armbrust, Eva Rieck

This study aims to contribute to investigating the potential impact of the SARS-CoV-2 pandemic and lockdown measures on perinatal care.A statistical analysis of diagnoses (ICD-10) of 21,393 newborns born between 2019 and 2021 from three Level 1 perinatal centers was conducted. During the study period, a statistical decrease in full-term births and very early preterm births (VLBW), coupled with an increase in infants born between 28 and 37.0 weeks of gestation, was observed in 2020 and 2021. Likewise, a significantly higher number of infants were born after 42.0 weeks of gestation. Neonatal morbidity, characterized by increased rates of asphyxiated newborns and umbilical artery pH values<7.1 as well as infant damage due to maternal pregnancy complications increased significantly. Furthermore, a statistically significant increase in the number of IUGR/SGA births was observed.While the reduction in the number of very premature infants observed in many places can be interpreted as a positive result of the lockdown measures, our data demonstrate an increase in pathological perinatal parameters. An increase in perinatally depressed newborns and a significantly increased postnatal morbidity of the children can possibly be indicators for an inadequate prenatal and/or intranatal care. Implications for similar, anticipated situations should be drawn.

本研究旨在探讨新冠肺炎大流行和封锁措施对围产期护理的潜在影响。对3个一级围产中心2019 - 2021年出生的21393例新生儿的诊断(ICD-10)进行统计分析。在研究期间,2020年和2021年观察到足月出生和极早期早产(VLBW)的统计下降,以及妊娠28至37.0周出生的婴儿的增加。同样,在怀孕42.0周后出生的婴儿数量也显著增加。新生儿发病率,特点是新生儿窒息率和脐动脉pH值增加
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引用次数: 0
Antenatal course and clinical outcomes of fetal intra-abdominal cystic lesions: a single tertiary center experience. 胎儿腹腔内囊性病变的产前过程和临床结果:一个单一的三级中心经验。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-09 DOI: 10.1055/a-2754-0562
Verda Alpay, Kubra Kurt Bilirer, Barış Boza, Firat Ersan, Ibrahim Polat

Fetal intra-abdominal cystic lesions are relatively common. The morphological assessment of the cyst, determination of the fetal sex, and evaluation of its relationship with adjacent structures can guide the differential diagnosis. The aims of this study were to evaluate the diagnostic accuracy of ultrasound in detecting fetal intra-abdominal cysts and to develop a predictive model for spontaneous regression or persistence.We retrospectively reviewed 61 fetuses with intra-abdominal cystic lesions between October 2020 and November 2024. Maternal-fetal characteristics, ultrasonographic features of cystic lesions, and postnatal outcomes were collected. A total of 61 fetuses with intra-abdominal cysts were analyzed. Spontaneous regression occurred in 15 cases (24.6%) during the prenatal period, while 46 (75.4%) persisted postnatally. Mean cyst size was 24.1 mm (+/- 11.2) in the regression group and 40 mm (- 16.5) in the persistent group. Cysts that regressed were diagnosed at a median of 25 weeks, whereas persistent cases were diagnosed at 30 weeks. In univariate logistic regression analyses, gestational age at diagnosis and initial cyst diameter were identified as significant predictors of spontaneous prenatal regression (p=0.006, 0.003, respectively). Prenatal US is an effective tool to accurately diagnose fetal intra-abdominal cysts. The combination of a lower gestational age at diagnosis and a smaller initial cyst diameter is associated with a higher likelihood of spontaneous prenatal regression. An evaluation based on gestational age at diagnosis and ultrasound characteristics with a primary focus on the largest diameter of the cystic lesions may help to guide parental counseling.

胎儿腹腔内囊性病变相对常见。囊肿的形态学评估,胎儿性别的确定,以及与邻近结构的关系的评估可以指导鉴别诊断。本研究的目的是评估超声检测胎儿腹内囊肿的诊断准确性,并建立一个自发消退或持续的预测模型。我们回顾性分析了2020年10月至2024年11月间61例腹腔内囊性病变胎儿。收集母胎特征、囊性病变超声特征及产后结局。本文对61例腹内囊肿胎儿进行分析。产前自发性消退15例(24.6%),产后持续消退46例(75.4%)。回归组平均囊肿大小为24.1 mm(+/- 11.2),持久组平均囊肿大小为40 mm(- 16.5)。囊肿消退的中位诊断时间为25周,而持续性囊肿的诊断时间为30周。在单因素logistic回归分析中,诊断时的胎龄和初始囊肿直径被确定为自发产前回归的重要预测因素(p分别=0.006,0.003)。产前超声是准确诊断胎儿腹内囊肿的有效工具。诊断时较低的胎龄和较小的初始囊肿直径的结合与自发产前退化的可能性较高有关。基于诊断时的胎龄和超声特征的评估,主要关注囊性病变的最大直径,可能有助于指导父母咨询。
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引用次数: 0
Schwanger mit Leib und Seele. 有身体和灵魂的女人。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-12-03 DOI: 10.1055/a-2687-7865
Dominique Singer
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引用次数: 0
Acute peripartum pontine ischemic stroke during epidural analgesia. 急性围生期脑桥缺血性卒中硬膜外镇痛。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-01 DOI: 10.1055/a-2683-6349
Ivan Šklebar, Tanja Goranović, Jasna Čerkez Habek, Dubravko Habek

We report a rare case of peripartum pontine stroke in a 34-year-old primipara initially attributed to an episode of severe transient hypotension caused by the subdural spread of local anesthetic during epidural analgesia for delivery. The rapid intrapartum intervention by the obstetric team because of spinal shock clinical pictures and fetal bradycardia using high vacuum extraction prevented the risk of fetal ischemic-hypoxic damage. A healthy child was born with an Apgar score of 8/10, 3790 grams /53 cm, with a normal neonatal course. On the third postpartum day, because of persistent neurologic symptoms (headache, urinary, and fecal incontinence), brain magnetic resonance imaging indicated a pontine ischemic lesion. The symptoms gradually regressed with acetylsalicylic acid and physical therapy, and on the 17th day, the patient was discharged home. After puerperium and recovery, thrombophilia were detected. The case indicates the importance of rapid intervention by the obstetric team in case of sudden peripartum maternal and fetal complications.

我们报告一个罕见的围生期脑桥中风病例,34岁的初产妇最初是由于硬膜外分娩时局部麻醉剂在硬膜下扩散引起的严重短暂性低血压。由于脊髓休克的临床表现和胎儿心动过缓,产科小组采用高真空抽吸的方法迅速进行产时干预,防止了胎儿缺血-缺氧损伤的风险。一名健康婴儿出生,Apgar评分为8/10,3790克/53厘米,新生儿病程正常。产后第三天,由于持续的神经系统症状(头痛、尿失禁和大便失禁),脑磁共振成像提示脑桥缺血性病变。经乙酰水杨酸和物理治疗后症状逐渐消退,第17天出院。产褥期及恢复期检测血栓形成。该病例表明了产科小组在围产期突然出现产妇和胎儿并发症时快速干预的重要性。
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引用次数: 0
Correction: The value of prenatal indicators in predicting adverse fetal outcomes in patients with ICP. 更正:产前指标在预测ICP患者不良胎儿结局中的价值。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-25 DOI: 10.1055/a-2678-8186
Jiahong Jiang, Jun Zhou, Litao Zhang, Jie Li
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引用次数: 0
Retraction Note: Gestationsdiabetes, übermäßige Gewichtszunahme in der Schwangerschaft und maternale Adipositas als Risikofaktoren für die Entstehung von LGA-Neugeborenen. 妊娠期糖尿病、妊娠期体重超标和母体肥胖是LGA新生儿发展的危险因素。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2026-01-22 DOI: 10.1055/a-2787-5372
J H Stupin, M Kappelmeyer, R Prager, M Rauh, A Köninger
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引用次数: 0
[Introduction of the S3 guideline "Vaginal Birth at Term" - What has changed in intrapartum fetal monitoring?] 【S3指南“足月顺产”的介绍——产时胎儿监测发生了什么变化?】]
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-09-12 DOI: 10.1055/a-2678-7980
Rebecca Felicitas Adams, Sven Schiermeier

Subpartum fetal monitoring is a debated topic in obstetrics. Studies have shown that CTG monitoring can lead to not always necessary interventions such as C-sections and vaginal-operative deliveries. Therefore, the 2021 AWMF S3 guideline "Vaginal Birth at Term" recommends structured intermittent auscultation instead of CTG monitoring in low-risk pregnancies for the first time.In a retrospective cross-sectional study, all German maternity clinics (n=616) were asked using an online questionnaire whether they use intermittent auscultation for low-risk pregnancies as well as reasons for and against it. The response rate was 16% (n=96). RESULTS:  22% (n=21) of clinics reported using intermittent auscultation always or sometimes. A significant correlation was found if changes had occurred and the application of intermittent auscultation (X2=12.95, df=2, p=0.001). Other factors such as the availability of one-to-one care (>95%), midwife-led delivery rooms, and differentiation between high- and low-risk pregnancies had no significant influence on the use of intermittent auscultation.The guideline has not led to the use of intermittent auscultation for monitoring in low-risk pregnancies. Clear low-risk definition, one-to-one care, qualified staff and updated studies on intermittent auscultation vs. CTG are needed.

产后胎儿监护是产科学中一个有争议的话题。研究表明,CTG监测可能导致不一定必要的干预措施,如剖腹产和阴道手术分娩。因此,2021年AWMF S3指南“足月阴道分娩”首次建议在低风险妊娠中采用结构化间歇听诊而不是CTG监测。在一项回顾性横断面研究中,使用在线问卷询问所有德国产科诊所(n=616)他们是否对低风险妊娠使用间歇听诊,以及支持和反对的原因。有效率为16% (n=96)。结果:22% (n=21)的诊所报告经常或有时使用间歇听诊。如果发生改变与间歇听诊的应用存在显著相关性(X2=12.95, df=2, p=0.001)。其他因素,如一对一护理的可获得性(>95%)、助产士主导的产房以及高风险和低风险妊娠的区分,对间歇性听诊的使用没有显著影响。该指南并未建议在低风险妊娠中使用间歇听诊进行监测。需要明确的低风险定义,一对一护理,合格的工作人员和间歇性听诊与CTG的最新研究。
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引用次数: 0
The value of prenatal indicators in predicting adverse fetal outcomes in patients with ICP. 产前指标在预测ICP患者不良胎儿结局中的价值。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-08-01 DOI: 10.1055/a-2659-7707
Jiahong Jiang, Jun Zhou, Litao Zhang, Jie Li

Search for laboratory markers that can predict adverse fetal pregnancy outcomes in patients with cholestasis of pregnancy.This was an observational case-control study conducted from December 2016 to December 2019. Pregnancy outcome data and maternal antenatal laboratory markers were collected in the intrahepatic cholestasis of pregnancy (ICP) (N=117) and normal pregnancy controls (N=100), laboratory indictors including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), γ-glutamyl transpeptidase (γ-GT), total bilirubin (TB), direct bilirubin (DB), total bile acids (TBA), cholyglycine (CG), prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), fibrinogen (FIB), etc. The ICP group was divided into an adverse outcome and normal outcome group according to fetal pregnancy outcomes. Descriptive statistics and regression analysis were performed on the prenatal indicators of the two groups to evaluate the association between prenatal laboratory indicators in ICP patients and adverse neonatal outcomes.ALT, TBA, CG, PT, APTT, hemoglobin, red blood cell distribution width, hematocrit, mean platelet volume, and platelet distribution width in ICP patients differed significantly from those in the normal control group, which led to premature birth, amniotic fluid pollution, low birth weight and other adverse outcomes. In terms of fetal outcomes, TBA [(39.16±35.70) μmol/L vs. (24.17±18.76) μmol/L], CG [(22.17±19.42) μg/mL vs. ( 13.91±13.18) μg/mL], DB [(22.17±19.42) μg/mL vs. (13.91±13.18) μg/mL] were higher than those in the normal outcome group, while fibrinogen was lower [(4.16±1.30) g/L vs. (4.78±0.91) g/L]; the difference was statistically significant. Multivariate logistic regression analysis showed that CG(OR=1.06, 95%CI:1.01~1.12, P=0.02, FIB(OR=0.54, 95%CI:0.31~0.92, P=0.02) was independently associated with the occurrence ofadverse fetal outcomes in ICP.Prenatal CG and FIB levels were independently associated with adverse fetal outcomes in patients with ICP.

寻找可预测妊娠期胆汁淤积症患者不良胎儿妊娠结局的实验室标记物。这是一项观察性病例对照研究,于2016年12月至2019年12月进行。收集妊娠肝内胆汁淤积症(ICP) 117例和正常妊娠对照组(N=100例)的妊娠结局资料和产前实验室标志物,实验室指标包括天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、碱性磷酸酶(ALP)、γ-谷氨酰转肽酶(γ-GT)、总胆红素(TB)、直接胆红素(DB)、总胆汁酸(TBA)、甘氨酸(CG)、凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活素时间(APTT)、纤维蛋白原(FIB)等。根据胎儿妊娠结局将ICP组分为不良结局组和正常结局组。对两组产前指标进行描述性统计和回归分析,评价ICP患者产前实验室指标与新生儿不良结局的相关性。ICP患者的ALT、TBA、CG、PT、APTT、血红蛋白、红细胞分布宽度、红细胞压积、平均血小板体积、血小板分布宽度与正常对照组差异显著,导致早产、羊水污染、低出生体重等不良结局。胎儿结局方面,TBA[(39.16±35.70)μmol/L比(24.17±18.76)μmol/L]、CG[(22.17±19.42)μmol/ mL比(13.91±13.18)μmol/ mL]、DB[(22.17±19.42)μmol/ mL比(13.91±13.18)g/mL]高于正常结局组,纤维蛋白原[(4.16±1.30)g/L比(4.78±0.91)g/L]低于正常结局组;差异有统计学意义。多因素logistic回归分析显示,CG(OR=1.06, 95%CI:1.01~1.12, P=0.02)和FIB(OR=0.54, 95%CI:0.31~0.92, P=0.02)与ICP不良胎儿结局的发生独立相关。产前CG和FIB水平与ICP患者的不良胎儿结局独立相关。
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引用次数: 0
Postpartum Balance and Kinesiophobia in Cesarean Delivery: Impact of Abdominal Fascial Scars. 剖宫产的产后平衡和运动恐惧症:腹部筋膜疤痕的影响。
IF 0.6 4区 医学 Q4 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-01 Epub Date: 2025-06-18 DOI: 10.1055/a-2629-6700
Yağmur Mengü, Emine Atici

Considering that the incisions made during cesarean delivery may damage subcutaneous tissue and fascia, and pelvic floor muscle contractions are effective in femoral head movements, it is hypothesized that the mode of delivery may have an impact on balance and kinesiophobia. This study aimed to investigate the effect of cesarean delivery on balance, kinesiophobia, and body awareness.A total of 70 women participated in the study. Demographic and obstetric data of the participants were recorded. Thoracolumbar fascia was assessed using a goniometric platform, trunk flexibility with the Modified Schober test, static balance with the Flamingo Balance test, and dynamic balance with the Y Balance Test. The Tampa Scale of Kinesiophobia was used to evaluate movement fear, and the Body Awareness Questionnaire was used to assess body awareness.No significant differences were found between cesarean and vaginal deliveries in terms of thoracolumbar fascia assessment, static balance, or dynamic balance measurements (p>0.05). In women who delivered vaginally, dynamic balance was observed to decrease with advancing age (p<0.05). Moreover, in vaginal deliveries, a shorter time since last birth was associated with improved anterior dynamic balance, while an increased number of deliveries was linked to impaired anterior dynamic balance (p<0.05). Regardless of the mode of delivery, all women experienced a decline in static balance and reduced anterior reach with increasing age. Additionally, an increased number of deliveries was associated with impaired static balance, and shorter postpartum duration was linked to decreased dynamic balance (p<0.05). No significant difference was found between vaginal and cesarean deliveries in terms of kinesiophobia (p>0.05). However, in women who delivered vaginally, body awareness decreased with age (p<0.05). In conclusion, the study found that cesarean scars had no adverse effects on balance, kinesiophobia, or body awareness. Nevertheless, further research focusing on balance is recommended.

考虑到剖宫产时的切口可能会损伤皮下组织和筋膜,而盆底肌收缩在股骨头运动中是有效的,假设分娩方式可能对平衡和运动恐惧症有影响。本研究旨在探讨剖宫产对平衡、运动恐惧症和身体意识的影响。共有70名女性参与了这项研究。记录了参与者的人口统计和产科数据。胸腰筋膜采用测量平台评估,躯干柔韧性采用改良Schober测试,静态平衡采用Flamingo平衡测试,动态平衡采用Y平衡测试。采用坦帕运动恐惧量表评估运动恐惧,采用身体意识问卷评估身体意识。剖宫产和阴道分娩在胸腰筋膜评估、静态平衡或动态平衡测量方面无显著差异(p < 0.05)。顺产妇女的动态平衡随着年龄的增长而下降(p0.05)。然而,在阴道分娩的女性中,身体意识随着年龄的增长而下降
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