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Elimination of the Black Box Warning on Menopausal Hormone Therapy. 消除更年期激素治疗的黑箱警告。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-13 DOI: 10.1097/AOG.0000000000006226
Intira Sriprasert, Howard N Hodis, Wendy J Mack, Mary Rosser, Megan L Evans, Xiao Xu, Jason D Wright

In 2003, the U.S. Food and Drug Administration (FDA) issued a black box warning on menopausal hormone therapy (MHT) products based on putative harm of secondary outcomes and incompletely collected and adjudicated data from the Women's Health Initiative (WHI) oral conjugated equine estrogens and medroxyprogesterone acetate study. Despite the specific parameters and limitations of the WHI study, these warnings were inappropriately generalized across all doses, formulations, and routes of administration, including local vaginal therapies, under the mandate to prescribe the "lowest effective dose for the shortest duration." After 22 years of clinical controversy, the U.S. Department of Health and Human Services and the FDA announced removal of the boxed warning on November 10, 2025. This decision was based on the FDA's independent and comprehensive review of the scientific literature, deliberations from an expert panel on July 17, 2025, and a 60-day public comment period. The FDA's transition to product-specific labeling, the removal of the mandate for the lowest effective dose for the shortest duration, and the inclusion of guidance on the optimal timing of MHT initiation within 10 years of menopause or before age 60 years, represent critical steps toward evidence-based menopause management. By replacing misleading information with accurate data, this regulatory shift facilitates individualized benefit-risk assessments and empowers shared decision making. Ultimately, these updates ensure that MHT use is optimized for the specific needs of each patient, integrating modern risk assessment with the latest clinical evidence to improve long-term health outcomes.

2003年,美国食品和药物管理局(FDA)发布了一个关于绝经期激素治疗(MHT)产品的黑箱警告,基于次要结果的推定危害和来自妇女健康倡议(WHI)口服结合马雌激素和醋酸甲孕酮研究的不完整收集和裁决数据。尽管WHI研究有特定的参数和局限性,但这些警告不适当地推广到所有剂量、配方和给药途径,包括局部阴道治疗,在规定“最低有效剂量、最短持续时间”的要求下。经过22年的临床争议,美国卫生与公众服务部和FDA于2025年11月10日宣布取消黑框警告。这一决定是基于FDA对科学文献的独立和全面审查,专家小组于2025年7月17日的审议,以及60天的公众评论期。FDA向产品特异性标签的转变,取消了最短持续时间最低有效剂量的要求,以及纳入了绝经后10年内或60岁之前MHT起始最佳时间的指导,这些都是循证绝经管理的关键步骤。通过用准确的数据取代误导性信息,这种监管转变促进了个性化的利益风险评估,并赋予了共同决策的权力。最终,这些更新确保MHT的使用针对每个患者的特定需求进行优化,将现代风险评估与最新临床证据相结合,以改善长期健康结果。
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引用次数: 0
Trends in Comparative Growth in Obstetrics and Gynecology Residency Programs Over the Past 20 Years (2005-2024). 过去20年妇产科住院医师项目比较增长趋势(2005-2024)。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-12 DOI: 10.1097/AOG.0000000000006184
Anchal Dhawan, Natalia Gontarczyk Uczkowski, Amy Godecker, Emily Morris Hawes, Ryan Spencer

Objective: To examine the growth of obstetrics and gynecology residency programs and positions compared with other core medical specialties over the past 20 years.

Methods: Obstetrics and gynecology, family medicine, emergency medicine, internal medicine, general surgery, psychiatry, pediatrics, and anesthesiology match data were obtained from the National Resident Matching Program from 2005 to 2024. Generalized least-squares regression models accounting for autocorrelation and heteroskedasticity were used to obtain yearly changes in the number of positions offered and number of programs for each specialty, as well as P values comparing the trends relative to obstetrics and gynecology before and after 2015 (the year of the transition to a single accreditation system).

Results: Between 2005 and 2015, obstetrics and gynecology residency positions increased at an average annual rate of 1.0%, along with a slight decline in the number of programs (-0.5%). In contrast, from 2016 onward, obstetrics and gynecology residency positions increased by approximately 1.3% annually, with a 2.9% growth in programs. Up to 2015, obstetrics and gynecology experienced significantly slower growth in residency positions compared with almost all other specialties (P≤.05 in all instances) apart from family medicine and surgery. During that same period up to 2015, obstetrics and gynecology programs grew more slowly than emergency medicine, psychiatry, anesthesiology, and combined anesthesiology. Beginning in 2016, all specialties except family medicine, internal medicine, and combined anesthesia increased residency positions at significantly higher rates than obstetrics and gynecology (P≤.05). Since 2016, the growth of residency programs has remained slower for obstetrics and gynecology compared with family medicine, emergency medicine, internal medicine, and psychiatry.

Conclusion: Obstetrics and gynecology residency growth has lagged behind that of other specialties both before and since the single accreditation system transition in 2015, highlighting a persistent gap in capacity to meet increasing demand. These findings highlight the need for focused efforts to match the growth of obstetrics and gynecology residency positions and programs with the expanding health care demands.

目的:比较近20年来妇产科住院医师项目和职位与其他核心医学专业的增长情况。方法:从2005 - 2024年全国住院医师匹配计划中获取妇产科、家庭医学、急诊医学、内科、普外科、精神病学、儿科和麻醉学的匹配数据。采用考虑自相关和异方差的广义最小二乘回归模型,获得各专科提供的职位数量和专业数量的年度变化,以及2015年(向单一认证制度过渡的年份)前后妇产科相关趋势的P值比较。结果:2005年至2015年间,妇产科住院医师职位以年均1.0%的速度增长,而项目数量略有下降(-0.5%)。相比之下,从2016年开始,妇产科住院医师职位每年增长约1.3%,项目增长2.9%。截至2015年,除了家庭医学和外科,与几乎所有其他专科相比,妇产科住院医师职位的增长明显放缓(所有情况下P≤0.05)。在截至2015年的同一时期,妇产科专业的增长速度低于急诊医学、精神病学、麻醉学和综合麻醉学。从2016年开始,除家庭医学、内科和综合麻醉外,所有专科住院医师岗位增加率均显著高于妇产科(P≤0.05)。自2016年以来,与家庭医学、急诊医学、内科和精神病学相比,妇产科住院医师项目的增长速度仍然较慢。结论:在2015年单一认证制度转型之前和之后,妇产科住院医师的增长都落后于其他专科,凸显了满足日益增长的需求的能力持续存在差距。这些发现强调需要集中努力,使妇产科住院医师职位和项目的增长与不断扩大的医疗保健需求相匹配。
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引用次数: 0
Timing of Hypertensive Disorders of Pregnancy in Nulliparous Individuals and Risk of Incident Chronic Hypertension 2-7 Years Postpartum. 未产个体妊娠期高血压疾病的发生时间和产后2-7年发生慢性高血压的风险
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-12 DOI: 10.1097/AOG.0000000000006191
Alisse Hauspurg, William Grobman, McKenzie K Jancsura, Lynn M Yee, Ashten Waks, Hyagriv Simhan, Lisa D Levine, Lauren Theilen, Philip Greenland, Rebecca McNeil, C Noel Bairey Merz, Nikka Shahrokni, David Haas, Sadiya S Khan, Kartik K Venkatesh, Janet Catov
<p><strong>Objective: </strong>We sought to evaluate the association between the timing of new-onset hypertensive disorders of pregnancy (HDP) development (ie, antepartum, intrapartum, or postpartum) and the risk of incident hypertension 2-7 years after delivery in nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be) and nuMoM2b-HHS (the nuMoM2b Heart Health Study).</p><p><strong>Methods: </strong>This is a secondary analysis of a multisite prospective observational cohort study conducted at eight clinical sites that enrolled nulliparous individuals with singleton pregnancies in their first trimester who were followed during pregnancy and subsequently underwent a cardiovascular screening visit 2-7 years after delivery. For this analysis, we excluded individuals with prepregnancy chronic hypertension in their nuMoM2b pregnancy. We compared rates of stage 1 hypertension (blood pressure 130/80 mm Hg or higher or use of antihypertensive medications) at the 2-7 year postpartum study visit based on the timing of the onset of HDP (categorized as antepartum, intrapartum, postpartum) with no HDP (referent). Multivariable logistic regression models adjusted for baseline covariates (age, insurance, tobacco use, diabetes, and early pregnancy body mass index [BMI]) were used to generate adjusted odds ratios (aOR) and 95% CIs. Interaction analysis was performed to evaluate effect modification by the presence of severe features of HDP. P<.05 was considered statistically significant.</p><p><strong>Results: </strong>Of 4,342 individuals included in this analysis (mean age 27.0 years [SD 5.6 years]), 23.2%% (n=1,007) had new-onset HDP. Among those with HDP, 53.6% (n=540) were diagnosed antepartum, 42.4% (n=427) were diagnosed intrapartum, and 4.0% (n=40) were diagnosed postpartum. At a mean follow-up of 3.2±0.9 years after delivery, the frequency of incident hypertension was elevated regardless of whether HDP occurred antepartum (37.6%, n=203), intrapartum (26.0%, n=111), or postpartum (40.0%, n=16) (compared with no HDP [16.5%, n=550]). After adjustment for maternal age, insurance type, tobacco use, prepregnancy diabetes, and early pregnancy BMI, the risk of chronic hypertension remained elevated regardless of when HDP was diagnosed, although the risk was higher when it developed antepartum (aOR 2.40, 95% CI, 1.95-2.95) or postpartum (aOR 2.90, 95% CI, 1.49-5.64) compared with when it developed intrapartum (aOR 1.55, 95% CI, 1.21-1.97; referent no HDP, P<.01 for all).</p><p><strong>Conclusion: </strong>New-onset HDP, regardless of whether it is diagnosed antepartum, intrapartum, or postpartum, is associated with an increased risk of incident hypertension 2-7 years after delivery, compared with individuals without HDP during their first birth. Greater awareness of cardiovascular disease risk after HDP-even when HDP is diagnosed during labor or postpartum-is needed to appropriately risk stratify and help prevent hypertension after delivery.</p><
目的:我们试图在nuMoM2b(无产妊娠结局研究:监测准妈妈)和nuMoM2b- hhs (nuMoM2b心脏健康研究)中评估新发妊娠高血压疾病(HDP)发展的时间(即产前、产时或产后)与分娩后2-7年发生高血压的风险之间的关系。方法:这是对一项在8个临床地点进行的多地点前瞻性观察队列研究的二次分析,该研究纳入了在妊娠期间随访并随后在分娩后2-7年进行心血管筛查的妊娠前三个月单胎未生育个体。在这项分析中,我们排除了患有nuMoM2b妊娠的孕前慢性高血压患者。在产后2-7年的研究访问中,我们比较了基于HDP发病时间(产前、产时、产后)和无HDP(参照)的1期高血压(血压130/80毫米汞柱或更高或使用降压药物)的发生率。采用校正基线协变量(年龄、保险、吸烟、糖尿病和妊娠早期体重指数[BMI])的多变量logistic回归模型生成校正优势比(aOR)和95% ci。通过相互作用分析来评估HDP严重特征的存在对效果的影响。结果:在该分析中纳入的4342例个体(平均年龄27.0岁[SD 5.6岁])中,23.2% (n= 1007)为新发HDP。在HDP患者中,53.6% (n=540)为产前诊断,42.4% (n=427)为产时诊断,4.0% (n=40)为产后诊断。在分娩后平均3.2±0.9年的随访中,无论产前(37.6%,n=203)、产时(26.0%,n=111)或产后(40.0%,n=16)是否发生HDP(与未发生HDP的[16.5%,n=550]相比),高血压发生率均升高。在调整了母亲年龄、保险类型、吸烟、孕前糖尿病和妊娠早期BMI后,无论何时诊断出HDP,慢性高血压的风险仍然升高,尽管产前(aOR 2.40, 95% CI, 1.95-2.95)或产后(aOR 2.90, 95% CI, 1.49-5.64)的风险高于分娩时(aOR 1.55, 95% CI, 1.21-1.97;结论:新发HDP,无论是产前、产时还是产后诊断,与首次分娩时没有HDP的个体相比,分娩后2-7年发生高血压的风险增加。即使在分娩或产后诊断出高血压,也需要提高对高血压后心血管疾病风险的认识,以适当地进行风险分层,并帮助预防分娩后的高血压。临床试验注册:ClinicalTrials.gov, NCT02231398。
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引用次数: 0
Performance Metrics of Noninvasive Prenatal Testing Panels for Dominant Single-Gene Disorders: A Systematic Review and Meta-Analysis. 显性单基因疾病无创产前检测面板的性能指标:系统回顾和荟萃分析。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-12 DOI: 10.1097/AOG.0000000000006192
Yangyi Liu, Yanting Yang, Jincheng Zhang, Dan Mu, Yana Zhou, Hongqian Liu

Objective: To evaluate the clinical utility and methodologic validity of noninvasive prenatal testing (NIPT) for dominant single-gene disorders by performing a systematic review and meta-analysis.

Data sources: From database inception through April 2025, we explored PubMed, EMBASE, Cochrane Library, and Web of Science.

Method of study selection: Studies that reported NIPT panels to screen for dominant single-gene disorders with confirmation testing and involved at least 50 cases were included. The Quality Assessment of Diagnostic Accuracy Studies 2 tool was used for study appraisal. Clinical utility was evaluated by using positivity rate and positive predictive value (PPV), with pooled estimates calculated through fixed- or random-effects models. Methodologic validity was assessed through sensitivity and specificity by using a bivariate random-effects model and summary receiver operating characteristic curve analysis.

Tabulation, integration and results: Ten articles comprising 12,577 cases were included. Positivity rate and PPV were calculated from nine studies, with sensitivity and specificity from seven studies. The pooled positivity rate was 2.2% (95% CI, 0.8-5.6%), and pooled PPV was 93.8% (95% CI, 86.4-97.3%). The bivariate model yielded a pooled sensitivity of 94.5% (95% CI, 85.7-98.0%) and specificity of 99.7% (95% CI, 98.8-99.9%), with an area under the curve of 0.98 (95% CI, 0.94-0.99). Subgroup analysis revealed positivity rates of 0.3% in low-risk populations, 1.2% in mixed-risk populations, and 6.0% in high-risk populations. High heterogeneity was observed in the positivity rate analysis (I2=96%). In contrast, heterogeneity was low (I2=16%) for PPV but with publication bias being detected (P=.004).

Conclusion: Noninvasive prenatal testing panels for dominant single-gene disorders achieve a high PPV with high sensitivity and specificity.

Systematic review registration: PROSPERO, CRD42024571768.

目的:通过系统回顾和荟萃分析,评估无创产前检查(NIPT)在显性单基因疾病中的临床应用和方法学有效性。数据来源:从数据库建立到2025年4月,我们探索了PubMed, EMBASE, Cochrane Library和Web of Science。研究选择方法:研究报告了NIPT小组筛选显性单基因疾病与确认测试,涉及至少50例纳入。使用诊断准确性研究质量评估2工具进行研究评估。通过使用阳性率和阳性预测值(PPV)评估临床效用,并通过固定或随机效应模型计算汇总估计值。采用双变量随机效应模型和综合受试者工作特征曲线分析,通过灵敏度和特异性评估方法的有效性。制表、整合和结果:纳入10篇文章,共12,577例。从9项研究中计算阳性率和PPV,从7项研究中计算敏感性和特异性。合并阳性率为2.2% (95% CI, 0.8 ~ 5.6%),合并PPV为93.8% (95% CI, 86.4 ~ 97.3%)。双变量模型的总灵敏度为94.5% (95% CI, 84.7 -98.0%),特异性为99.7% (95% CI, 98.8-99.9%),曲线下面积为0.98 (95% CI, 0.94-0.99)。亚组分析显示,低危人群的阳性率为0.3%,混合危人群为1.2%,高危人群为6.0%。在阳性率分析中发现高度异质性(I2=96%)。相比之下,PPV的异质性较低(I2=16%),但存在发表偏倚(P= 0.004)。结论:显性单基因遗传病无创产前筛查具有较高的敏感性和特异性。系统评价注册:PROSPERO, CRD42024571768。
{"title":"Performance Metrics of Noninvasive Prenatal Testing Panels for Dominant Single-Gene Disorders: A Systematic Review and Meta-Analysis.","authors":"Yangyi Liu, Yanting Yang, Jincheng Zhang, Dan Mu, Yana Zhou, Hongqian Liu","doi":"10.1097/AOG.0000000000006192","DOIUrl":"https://doi.org/10.1097/AOG.0000000000006192","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the clinical utility and methodologic validity of noninvasive prenatal testing (NIPT) for dominant single-gene disorders by performing a systematic review and meta-analysis.</p><p><strong>Data sources: </strong>From database inception through April 2025, we explored PubMed, EMBASE, Cochrane Library, and Web of Science.</p><p><strong>Method of study selection: </strong>Studies that reported NIPT panels to screen for dominant single-gene disorders with confirmation testing and involved at least 50 cases were included. The Quality Assessment of Diagnostic Accuracy Studies 2 tool was used for study appraisal. Clinical utility was evaluated by using positivity rate and positive predictive value (PPV), with pooled estimates calculated through fixed- or random-effects models. Methodologic validity was assessed through sensitivity and specificity by using a bivariate random-effects model and summary receiver operating characteristic curve analysis.</p><p><strong>Tabulation, integration and results: </strong>Ten articles comprising 12,577 cases were included. Positivity rate and PPV were calculated from nine studies, with sensitivity and specificity from seven studies. The pooled positivity rate was 2.2% (95% CI, 0.8-5.6%), and pooled PPV was 93.8% (95% CI, 86.4-97.3%). The bivariate model yielded a pooled sensitivity of 94.5% (95% CI, 85.7-98.0%) and specificity of 99.7% (95% CI, 98.8-99.9%), with an area under the curve of 0.98 (95% CI, 0.94-0.99). Subgroup analysis revealed positivity rates of 0.3% in low-risk populations, 1.2% in mixed-risk populations, and 6.0% in high-risk populations. High heterogeneity was observed in the positivity rate analysis (I2=96%). In contrast, heterogeneity was low (I2=16%) for PPV but with publication bias being detected (P=.004).</p><p><strong>Conclusion: </strong>Noninvasive prenatal testing panels for dominant single-gene disorders achieve a high PPV with high sensitivity and specificity.</p><p><strong>Systematic review registration: </strong>PROSPERO, CRD42024571768.</p>","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146181493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Breast Cancer in Young Women: Implications for Pregnancy, Lactation, and Fertility Preservation. 年轻女性乳腺癌:对妊娠、哺乳和生育能力保存的影响。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-06 DOI: 10.1097/AOG.0000000000006187
Amanda N Labora, Nimmi S Kapoor

The care of young women with breast cancer can be influenced by pregnancy and desire for future fertility. Here, we provide an overview of breast cancer management in young women with special emphasis on gestational breast cancer and postpartum breast cancer, which are now understood to be distinct clinical entities with disparate outcomes. Typically, breast cancer is detected in young women after self-identification of a breast mass. The initial workup consists of diagnostic breast ultrasonogram and mammogram. Breast cancer treatments vary by histologic subtype of cancer and stage. Chemotherapy and surgery are safe during pregnancy, and it is now known that pregnant women with breast cancer have oncologic outcomes equivalent to those of nonpregnant women when treated according to standard of care. Postpartum breast cancer, however, has higher rates of metastatic disease and mortality. In general, breastfeeding can be safely continued during treatment with appropriate counseling and guidance from a breastfeeding medicine expert. Similarly, fertility preservation and future fertility can be safely pursued with appropriate interventions in young women with breast cancer.

对患有乳腺癌的年轻妇女的护理可能会受到怀孕和对未来生育能力的渴望的影响。在这里,我们概述了年轻女性乳腺癌的治疗,特别强调妊娠期乳腺癌和产后乳腺癌,这两种癌症现在被认为是不同的临床实体,具有不同的结果。通常,年轻女性在自我确认乳房肿块后才会发现乳腺癌。最初的检查包括诊断性乳房超声检查和乳房x光检查。乳腺癌的治疗方法因癌症的组织学亚型和分期而异。化疗和手术在怀孕期间是安全的,现在已知,如果按照标准护理治疗,患有乳腺癌的孕妇的肿瘤预后与未怀孕的妇女相当。然而,产后乳腺癌的转移率和死亡率较高。一般来说,在母乳喂养医学专家的适当咨询和指导下,在治疗期间可以安全地继续母乳喂养。同样,年轻的乳腺癌妇女通过适当的干预措施可以安全地保持生育能力和将来的生育能力。
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引用次数: 0
Maximizing Benefit From Antenatal Steroid Use While Avoiding Overuse. 最大限度地从产前类固醇使用中获益,同时避免过度使用。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-05 DOI: 10.1097/AOG.0000000000006178
Mark A Clapp, Siguo Li, Alexander Melamed, Emily Reiff, Cynthia Gyamfi-Bannerman, Anjali J Kaimal
<p><strong>Objective: </strong>To provide real-world data to inform benchmarking goals and practical issues that influence optimal antenatal corticosteroid timing and to examine patient factors, such as gestational age at steroid administration and presenting diagnoses, associated with steroid administration in relation to delivery.</p><p><strong>Methods: </strong>This is a retrospective cohort study of singleton deliveries between July 1, 2016, and December 31, 2024, at two large academic hospitals with level IV neonatal intensive care units in a single health system. The primary cohort of interest was individuals who delivered between 24 0/7 and 33 6/7 weeks of gestation. The primary outcome of interest was the timing of antenatal corticosteroid administration in relation to delivery, categorized as none, delivery between 6 hours and 7 days after the first dose of antenatal corticosteroid ("optimally timed" per the Society for Maternal-Fetal Medicine's quality metric), and delivery less than 6 hours or more than 7 days after the first dose of antenatal corticosteroid ("suboptimally timed"). As a balancing measure to optimally timed antenatal corticosteroid administration, we also examined those who received antenatal corticosteroids before 34 weeks of gestation and delivered at term (after 37 weeks). We reported the rates of optimal timing and term delivery by their corresponding weeks of gestation and performed multivariable logistic regression modeling to understand patient factors and diagnoses associated with antenatal corticosteroid timing.</p><p><strong>Results: </strong>Among the 1,694 pregnant patients who delivered before 34 weeks of gestation, 961 (56.7%) had optimally timed antenatal corticosteroid administration, 162 (9.6%) received the first dose of antenatal corticosteroids less than 6 hours before delivery, 320 (18.9%) delivered more than 7 days after antenatal corticosteroid administration, and 251 (14.8%) did not receive antenatal corticosteroids. Of those who received antenatal steroids before 34 weeks of gestation, 747 of 2,879 (25.9%) delivered at term. There was little variation in optimal timing or term delivery by gestational age. Clinical factors associated with optimally timed antenatal corticosteroid administration compared with delivery more than 7 days after administration included pregnancy-related hypertensive disorder (adjusted odds ratio [aOR] 1.88, 95% CI, 1.31-2.69), preterm labor (aOR 2.78, 95% CI, 1.32-5.81), premature rupture of membranes (1.37, 95% CI, 1.33-1.42), anxiety disorder (aOR 079, 95% CI, 0.76-0.83), multiparous with no history of preterm birth (aOR 0.81, 95% CI, 0.77-0.86), placenta previa (aOR 0.76, 95% CI, 0.68-0.84), and placenta accreta (aOR 0.83, 95% CI, 0.81-0.85).</p><p><strong>Conclusion: </strong>Achieving optimal timing of antenatal corticosteroid administration remains challenging. These findings underscore the need for improved prediction of preterm delivery and individualized patient
目的:提供真实世界的数据,以告知基准目标和影响最佳产前皮质类固醇时间的实际问题,并检查患者因素,如类固醇给药时的胎龄和提出的诊断,与类固醇给药与分娩相关。方法:回顾性队列研究2016年7月1日至2024年12月31日,在同一卫生系统的两家大型学术医院设有新生儿四级重症监护病房的单胎分娩。主要研究对象为妊娠24 /7周至33 /7周分娩的孕妇。主要结局是产前皮质类固醇给药时间与分娩的关系,分类为无,分娩时间在第一次给药后6小时到7天之间(根据母胎医学协会的质量指标为“最佳时间”),分娩时间在第一次给药后6小时或7天以上(“次最佳时间”)。为了平衡产前皮质类固醇给药的最佳时间,我们还检查了那些在妊娠34周前接受产前皮质类固醇治疗并在足月(37周后)分娩的妇女。我们报告了相应妊娠周的最佳时间和足月分娩率,并进行了多变量logistic回归模型,以了解与产前皮质类固醇时间相关的患者因素和诊断。结果:在1694例妊娠34周前分娩的孕妇中,961例(56.7%)的产前皮质激素给药时间最佳,162例(9.6%)的产前皮质激素首次给药时间少于分娩前6小时,320例(18.9%)的产前皮质激素给药时间超过7天,251例(14.8%)的产前皮质激素未给药。在妊娠34周前接受产前类固醇治疗的患者中,2,879例中有747例(25.9%)足月分娩。不同胎龄的最佳分娩时间和足月变化不大。与给药后7天以上分娩相比,最佳产前皮质类固醇给药时间相关的临床因素包括妊娠相关高血压疾病(调整优势比[aOR] 1.88, 95% CI, 1.31-2.69)、早产(调整优势比[aOR] 2.78, 95% CI, 1.32-5.81)、胎膜早破(aOR = 1.37, 95% CI, 1.33-1.42)、焦虑障碍(aOR = 079, 95% CI, 0.76-0.83)、多胎且无早产史(aOR = 0.81, 95% CI, 0.77-0.86)、前置胎盘(aOR 0.76, 95% CI, 0.68-0.84)和胎盘增生(aOR 0.83, 95% CI, 0.81-0.85)。结论:实现产前皮质类固醇给药的最佳时机仍然具有挑战性。这些发现强调需要改进早产预测和个体化患者评估,以确保有早产风险的妇女及时获得产前皮质类固醇,同时减少不必要的暴露。
{"title":"Maximizing Benefit From Antenatal Steroid Use While Avoiding Overuse.","authors":"Mark A Clapp, Siguo Li, Alexander Melamed, Emily Reiff, Cynthia Gyamfi-Bannerman, Anjali J Kaimal","doi":"10.1097/AOG.0000000000006178","DOIUrl":"10.1097/AOG.0000000000006178","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To provide real-world data to inform benchmarking goals and practical issues that influence optimal antenatal corticosteroid timing and to examine patient factors, such as gestational age at steroid administration and presenting diagnoses, associated with steroid administration in relation to delivery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a retrospective cohort study of singleton deliveries between July 1, 2016, and December 31, 2024, at two large academic hospitals with level IV neonatal intensive care units in a single health system. The primary cohort of interest was individuals who delivered between 24 0/7 and 33 6/7 weeks of gestation. The primary outcome of interest was the timing of antenatal corticosteroid administration in relation to delivery, categorized as none, delivery between 6 hours and 7 days after the first dose of antenatal corticosteroid (\"optimally timed\" per the Society for Maternal-Fetal Medicine's quality metric), and delivery less than 6 hours or more than 7 days after the first dose of antenatal corticosteroid (\"suboptimally timed\"). As a balancing measure to optimally timed antenatal corticosteroid administration, we also examined those who received antenatal corticosteroids before 34 weeks of gestation and delivered at term (after 37 weeks). We reported the rates of optimal timing and term delivery by their corresponding weeks of gestation and performed multivariable logistic regression modeling to understand patient factors and diagnoses associated with antenatal corticosteroid timing.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among the 1,694 pregnant patients who delivered before 34 weeks of gestation, 961 (56.7%) had optimally timed antenatal corticosteroid administration, 162 (9.6%) received the first dose of antenatal corticosteroids less than 6 hours before delivery, 320 (18.9%) delivered more than 7 days after antenatal corticosteroid administration, and 251 (14.8%) did not receive antenatal corticosteroids. Of those who received antenatal steroids before 34 weeks of gestation, 747 of 2,879 (25.9%) delivered at term. There was little variation in optimal timing or term delivery by gestational age. Clinical factors associated with optimally timed antenatal corticosteroid administration compared with delivery more than 7 days after administration included pregnancy-related hypertensive disorder (adjusted odds ratio [aOR] 1.88, 95% CI, 1.31-2.69), preterm labor (aOR 2.78, 95% CI, 1.32-5.81), premature rupture of membranes (1.37, 95% CI, 1.33-1.42), anxiety disorder (aOR 079, 95% CI, 0.76-0.83), multiparous with no history of preterm birth (aOR 0.81, 95% CI, 0.77-0.86), placenta previa (aOR 0.76, 95% CI, 0.68-0.84), and placenta accreta (aOR 0.83, 95% CI, 0.81-0.85).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Achieving optimal timing of antenatal corticosteroid administration remains challenging. These findings underscore the need for improved prediction of preterm delivery and individualized patient","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12880614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146125993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Between Medicine's Reach and Its Limits. 在医学的范围和极限之间。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-05 DOI: 10.1097/AOG.0000000000006182
Alixandria F Pfeiffer
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引用次数: 0
Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial. 卡麦角林用于早期中期流产或妊娠丢失后的泌乳抑制:一项随机对照试验。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-05 DOI: 10.1097/AOG.0000000000006137
Andrea Henkel, Erica P Cahill, Sonia Chavez, Jade M Shorter, Stephanie I Amaya, Simranvir Kaur, Amythis Soltani, Jayne Caron, Susan Crowe, Zakiyah Williams, Namrata Mastey, Deirdre J Lyell, Kate A Shaw

Objective: To evaluate cabergoline's efficacy at decreasing lactation symptoms after early second-trimester abortion or pregnancy loss.

Methods: This is a multisite, double-blind, gestational-age stratified superiority trial that compared cabergoline 1 mg once with placebo for preventing bothersome breast symptoms immediately after uterine evacuation. We enrolled pregnant people at 16-20 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants received cabergoline within 4 hours of uterine evacuation or fetal expulsion and, at baseline and at multiple time points through 2 weeks postprocedure, completed a validated electronic survey that assessed breast symptoms, side effects, and bother. Our primary outcome was breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 30 participants in each gestational duration strata to show a 40% difference in breast symptoms (80% power, α=0.049).

Results: After screening 145 patients from February 2024 through May 2025, we enrolled 69 eligible participants. Baseline demographics were balanced between groups: Median gestational duration was 18 weeks (range 16 0/7-19 6/7 weeks), 53.0% were nulliparous, 63.6% self-identified as Hispanic, and 68.2% had public insurance. On day 4, significantly fewer participants who received cabergoline reported any breast symptoms compared with placebo (50.0% vs 88.2%, P<.001) (primary outcome) and fewer participants reported significant bother from breast symptoms (3.1% vs 20.6%, P=.05) (secondary outcome). These differences persist even in the earlier gestational duration strata.

Conclusion: Cabergoline is an effective and well-tolerated medication to prevent breast symptoms after early second-trimester abortion or pregnancy loss.

Clinical trial registration: ClinicalTrials.gov: NCT06029673.

目的:评价卡麦角林对早期中期流产或流产后泌乳症状的疗效。方法:这是一项多地点、双盲、胎龄分层的优势试验,比较卡麦角林1mg 1次与安慰剂预防子宫排出后立即出现乳房不适症状的效果。我们招募了孕16-20周的孕妇,她们说英语或西班牙语,没有研究药物的禁忌症。参与者在子宫排出或胎儿排出4小时内接受卡麦角林治疗,并在基线和术后2周的多个时间点完成一项有效的电子调查,评估乳房症状、副作用和麻烦。我们的主要结局是第4天的乳房症状(充血、漏奶、压痛和需要缓解疼痛的综合症状);我们计划在每个妊娠阶段招募30名参与者,以显示40%的乳房症状差异(80%幂,α=0.049)。结果:在2024年2月至2025年5月筛选了145名患者后,我们招募了69名符合条件的参与者。各组之间的基线人口统计数据是平衡的:中位妊娠期为18周(范围16 0/7-19 6/7周),53.0%为未生育,63.6%为西班牙裔,68.2%有公共保险。在第4天,与安慰剂相比,接受卡麦角林治疗的参与者报告的任何乳房症状明显减少(50.0% vs 88.2%)。结论:卡麦角林是一种有效且耐受性良好的药物,可预防早期中期妊娠流产或流产后的乳房症状。临床试验注册:ClinicalTrials.gov: NCT06029673。
{"title":"Cabergoline for Lactation Inhibition After Early Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial.","authors":"Andrea Henkel, Erica P Cahill, Sonia Chavez, Jade M Shorter, Stephanie I Amaya, Simranvir Kaur, Amythis Soltani, Jayne Caron, Susan Crowe, Zakiyah Williams, Namrata Mastey, Deirdre J Lyell, Kate A Shaw","doi":"10.1097/AOG.0000000000006137","DOIUrl":"10.1097/AOG.0000000000006137","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate cabergoline's efficacy at decreasing lactation symptoms after early second-trimester abortion or pregnancy loss.</p><p><strong>Methods: </strong>This is a multisite, double-blind, gestational-age stratified superiority trial that compared cabergoline 1 mg once with placebo for preventing bothersome breast symptoms immediately after uterine evacuation. We enrolled pregnant people at 16-20 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants received cabergoline within 4 hours of uterine evacuation or fetal expulsion and, at baseline and at multiple time points through 2 weeks postprocedure, completed a validated electronic survey that assessed breast symptoms, side effects, and bother. Our primary outcome was breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 30 participants in each gestational duration strata to show a 40% difference in breast symptoms (80% power, α=0.049).</p><p><strong>Results: </strong>After screening 145 patients from February 2024 through May 2025, we enrolled 69 eligible participants. Baseline demographics were balanced between groups: Median gestational duration was 18 weeks (range 16 0/7-19 6/7 weeks), 53.0% were nulliparous, 63.6% self-identified as Hispanic, and 68.2% had public insurance. On day 4, significantly fewer participants who received cabergoline reported any breast symptoms compared with placebo (50.0% vs 88.2%, P<.001) (primary outcome) and fewer participants reported significant bother from breast symptoms (3.1% vs 20.6%, P=.05) (secondary outcome). These differences persist even in the earlier gestational duration strata.</p><p><strong>Conclusion: </strong>Cabergoline is an effective and well-tolerated medication to prevent breast symptoms after early second-trimester abortion or pregnancy loss.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov: NCT06029673.</p>","PeriodicalId":19483,"journal":{"name":"Obstetrics and gynecology","volume":"147 2","pages":"277-284"},"PeriodicalIF":4.7,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145985186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
ACOG Clinical Consensus No. 11: Management of Positive Human Chorionic Gonadotropin Test Results in Nonpregnant Patients Without Gynecologic Malignancy. ACOG临床共识第11号:未怀孕无妇科恶性肿瘤患者人绒毛膜促性腺激素试验阳性结果的处理。
IF 7.2 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 DOI: 10.1097/aog.0000000000006155
Positive human chorionic gonadotropin (hCG) test results have been associated with unnecessary workup and treatment, including invasive procedures and chemotherapy. It is important for health care professionals to consider alternative explanations for positive hCG results when pregnancy and malignancy have been excluded, particularly before proceeding with more invasive interventions. Due to the multiple potential etiologies of persistently elevated hCG, health care professionals should evaluate test results according to a systematic framework. When serum hCG test results are elevated, the first steps are to evaluate for pregnancy (both intrauterine and ectopic). Appropriate retesting to rule out various etiologies and to identify the main cause of persistently elevated hCG is necessary to avoid misdiagnosis or mismanagement of elevated hCG levels.
人绒毛膜促性腺激素(hCG)测试结果阳性与不必要的检查和治疗有关,包括侵入性手术和化疗。在排除妊娠和恶性肿瘤的情况下,特别是在进行更具侵入性的干预之前,医疗保健专业人员考虑hCG阳性结果的其他解释是很重要的。由于hCG持续升高的多种潜在病因,卫生保健专业人员应根据系统框架评估测试结果。当血清hCG测试结果升高时,第一步是评估妊娠(包括宫内妊娠和异位妊娠)。适当的重新检测以排除各种病因并确定hCG持续升高的主要原因是必要的,以避免hCG水平升高的误诊或管理不当。
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引用次数: 0
Executive Summary of the Vulvodynia Therapeutic Research Summit. 外阴痛治疗研究高峰会议摘要。
IF 4.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-06 DOI: 10.1097/AOG.0000000000006118
Jill M Krapf, Paul J Yong, Marlene D Berke, Nina Bohm-Starke, Jacob Bornstein, Emanuelle Chrysilla, Tania T Dempsey, Megan L Falsetta, David Foster, Sue W Goldstein, Michael J Iadarola, Susan Kellogg-Spadt, Andrew J Mannes, John Vogel, Andrew T Goldstein

The current treatment of provoked vestibulodynia involving neuroproliferation is often complete vestibulectomy; however, less invasive treatments are biologically plausible, yet lack study. The International Society for the Study of Women's Sexual Health, the National Vulvodynia Association, the Gynecologic Cancers Research Foundation, and Tight Lipped, a grassroots nonprofit organization that supports people with chronic vulvovaginal and pelvic pain, collectively sponsored a conference, the Vulvodynia Therapeutic Research Summit, held in April 2024. The primary objective of the Vulvodynia Therapeutic Research Summit was to identify options for further research of the treatment of provoked vestibulodynia through expert consensus. After the conference, attendees scored the presented therapeutics in rank order, leading to a hierarchy of merit. Fifteen therapeutic options were presented and ranked in order of most promising to least promising for further study on treating the neuroinflammation of provoked vestibulodynia. The top identified therapeutics for further research were: 1) ketotifen fumarate (mast cell stabilizer with potential to prevent mast cell activation), 2) resiniferatoxin (transient receptor vanilloid 1 agonist causing chemo-inactivation of nerve terminals), 3) specialized pro-resolving mediators or strategies to boost their levels (eg, maresin 1 and 1-trifluoromethoxy-phenyl-3-[1-propionylpiperidin-4-yl] urea), 4) luteolin (flavonoid with potent anti-inflammatory, antioxidant, and neuroprotective properties), 5) alpha-lipoic acid (antioxidant with nerve-specific anti-inflammatory and mast cell stabilizing qualities), and 6) NGFR121W -SNAP IR700 trimer exposed to near-infared light (photoablation targeting nociceptors and sparing surrounding tissue). This executive summary describes the rationale for identifying specific pharmacologic agents and medical devices as targets for research directed toward treatment of the neuroinflammatory process found in the vestibular mucosa of provoked vestibulodynia.

目前治疗诱发性前庭痛并伴有神经增生的通常是完整的前庭切除术;然而,较少侵入性的治疗在生物学上是合理的,但缺乏研究。国际女性性健康研究学会、国家外阴痛协会、妇科癌症研究基金会和支持慢性外阴阴道和盆腔疼痛患者的草根非营利组织Tight lips共同主办了一次会议,即外阴痛治疗研究峰会,于2024年4月举行。外阴痛治疗研究峰会的主要目的是通过专家共识确定诱发性前庭痛治疗的进一步研究方案。会议结束后,与会者按等级顺序对所提出的治疗方法进行评分,从而形成一个等级制度。提出了15种治疗方案,并按最有希望的顺序排列,以进一步研究治疗诱发性前庭痛的神经炎症。最值得进一步研究的治疗方法是:1)富马酸酮替芬(可能阻止肥大细胞活化的肥大细胞稳定剂),2)树脂干扰素(引起神经末梢化学失活的瞬时受体香草酸1激动剂),3)专门的促溶解介质或提高其水平的策略(例如,马瑞辛1和1-三氟甲氧基苯基-3-(1-丙酰哌啶-4-基)尿素),4)木犀草素(具有有效抗炎,抗氧化和神经保护特性的类黄酮),5) α -硫辛酸(具有神经特异性抗炎和肥大细胞稳定特性的抗氧化剂),以及6)暴露于近红外光下的NGFR121W-SNAP IR700三聚体(针对伤害感受器并保留周围组织的光消融)。本执行摘要描述了确定特定药物和医疗器械作为研究目标的基本原理,这些研究目标指向治疗诱发性前庭痛的前庭粘膜中发现的神经炎症过程。
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引用次数: 0
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Obstetrics and gynecology
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