Pub Date : 2025-02-01Epub Date: 2024-07-30DOI: 10.1016/j.ajog.2024.07.031
Emerson Keenan, Antoniya Georgieva, Fiona C Brownfoot
{"title":"Deep learning to predict fetal acidemia.","authors":"Emerson Keenan, Antoniya Georgieva, Fiona C Brownfoot","doi":"10.1016/j.ajog.2024.07.031","DOIUrl":"10.1016/j.ajog.2024.07.031","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"e45"},"PeriodicalIF":8.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141858770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-20DOI: 10.1016/j.ajog.2024.08.022
Alma Larsdotter Zweygberg, Viktor H Ahlqvist, Cecilia Magnusson
{"title":"Defining mode of delivery as \"instrumental vaginal delivery\".","authors":"Alma Larsdotter Zweygberg, Viktor H Ahlqvist, Cecilia Magnusson","doi":"10.1016/j.ajog.2024.08.022","DOIUrl":"10.1016/j.ajog.2024.08.022","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"e54-e55"},"PeriodicalIF":8.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-27DOI: 10.1016/j.ajog.2024.08.035
Eline E R Lust, Kim Bronsgeest, Monique C Haak, Mireille N Bekker
{"title":"Nationwide introduction of first-trimester anomaly scan in the screening program: a response.","authors":"Eline E R Lust, Kim Bronsgeest, Monique C Haak, Mireille N Bekker","doi":"10.1016/j.ajog.2024.08.035","DOIUrl":"10.1016/j.ajog.2024.08.035","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"e82"},"PeriodicalIF":8.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142091390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01Epub Date: 2024-08-25DOI: 10.1016/j.ajog.2024.08.036
Pamela Duran, Emma I Zelus, Lindsey A Burnett, Karen L Christman, Marianna Alperin
<p><strong>Background: </strong>Vaginal childbirth is a key risk factor for pelvic floor muscle injury and dysfunction, and subsequent pelvic floor disorders. Multiparity further exacerbates these risks. Using the rat model, validated for the studies of the human pelvic floor muscles, we have previously identified that a single simulated birth injury results in pelvic floor muscle atrophy and fibrosis.</p><p><strong>Objective: </strong>To test the hypothesis that multiple birth injuries would further overwhelm the muscle regenerative capacity, leading to functionally relevant pathological alterations long-term.</p><p><strong>Study design: </strong>Sprague-Dawley rats underwent simulated birth injury and were allowed to recover for 8 weeks before undergoing additional birth injury. Animals were sacrificed at acute (3 and 7 days postinjury), subacute (21, 28, and 35 days postinjury), and long-term (8 and 12 weeks postinjury) time points post second injury (N=3-8/time point), and the pubocaudalis portion of the rat levator ani complex was harvested to assess the impact of repeated birth injuries on muscle mechanical and histomorphological properties. The accompanying transcriptional changes were assessed by a customized NanoString panel. Uninjured animals were used as controls. Data with a parametric distribution were analyzed by a 2-way analysis of variance followed by post hoc pairwise comparisons using Tukey's or Sidak's tests; nonparametrically distributed data were compared with Kruskal-Wallis test followed by pairwise comparisons with Dunn's test. Data, analyzed using GraphPad Prism v8.0, San Diego, CA, are presented as mean ± standard error of the mean or median (range).</p><p><strong>Results: </strong>Following the first simulated birth injury, active muscle force decreased acutely relative to uninjured controls (12.9±0.9 vs 25.98±2.1 g/mm<sup>2</sup>, P<.01). At 4 weeks, muscle active force production recovered to baseline and remained unchanged at 8 weeks after birth injury (P>.99). Similarly, precipitous decrease in active force was observed immediately after repeated birth injury (18.07±1.2 vs 25.98±2.1 g/mm<sup>2</sup>, P<.05). In contrast to the functional recovery after a single birth injury, a long-term decrease in muscle contractile function was observed up to 12 weeks after repeated birth injuries (18.3±1.6 vs 25.98±2.1 g/mm<sup>2</sup>, P<.05). Fiber size was smaller at the long-term time points after second injury compared to the uninjured group (12 weeks vs uninjured control: 1485 (60.7-5000) vs 1989 (65.6-4702) μm<sup>2</sup>, P<.0001). The proportion of fibers with centralized nuclei, indicating active myofiber regeneration, returned to baseline at 8 weeks post-first birth injury, (P=.95), but remained elevated as far as 12 weeks post-second injury (12 weeks vs uninjured control: 7.1±1.5 vs 0.84±0.13%, P<0.0001). In contrast to the plateauing intramuscular collagen content after 4 weeks post-first injury, fibrotic degeneration
目的:阴道分娩是导致盆底肌肉损伤和功能障碍以及后续盆底疾病的主要风险因素。多胎妊娠会进一步加剧这些风险。我们曾利用大鼠模型对人类盆底肌肉进行过验证研究,发现单次模拟分娩损伤会导致盆底肌肉萎缩和纤维化。我们假设,多次产伤会进一步削弱肌肉再生能力,导致长期功能性病理改变:研究设计:对 Sprague-Dawley 大鼠进行模拟产伤,让其恢复 8 周后再进行产伤。在第二次损伤后的急性期(损伤后 3 天和 7 天)、亚急性期(损伤后 21 天、28 天和 35 天)和长期期(损伤后 8 周和 12 周)的时间点(N=3-8/时间点)处死动物,并采集大鼠提肛肌复合体的耻骨肌部分,以评估重复产伤对肌肉机械和组织形态学特性的影响。随之而来的转录变化由定制的 NanoString 面板进行评估。未受伤的动物作为对照组。参数分布数据通过双向方差分析进行分析,然后使用 Tukey's 或 Sidak's 检验进行配对比较;非参数分布数据通过 Kruskal-Wallis 检验进行比较,然后使用 Dunn's 检验进行配对比较。数据用GraphPad Prism v8.0(加利福尼亚州圣迭戈)分析,以均数±SEM或中位数(范围)表示:第一次模拟产伤后,与未受伤的对照组相比,主动肌力急剧下降(12.9±0.9 vs 25.98±2.1 g/mm2,P0.99)。同样,与未受伤组(12 周 vs 未受伤对照组:1485 (60.7-5000) vs 1989 (65.6-4702) μm2,Pst 产伤,P=0.95)相比,重复产伤后活性肌力立即急剧下降(18.07±1.2 vs 25.98±2.1 g/mm2,P2,Pnd 产伤)。95),但在第 2 次损伤后 12 周仍保持升高(12 周 vs 未损伤对照组:7.1±1.5 vs 0.84±0.13%,Pst 损伤,纤维化变性在反复损伤后 12 周内逐渐增加(12 周 vs 未损伤对照组:6.7±1.1 vs 2.03±0.2%,PConclusions):总体而言,与单次损伤相比,反复产伤导致的病理改变幅度更大,从而使大鼠模型中的盆底肌肉变性和肌肉功能障碍更加明显。上述研究提供了多胎妊娠与妇女盆底功能障碍风险增加之间的潜在机制联系。
{"title":"Repeated birth injuries lead to long-term pelvic floor muscle dysfunction in the preclinical rat model.","authors":"Pamela Duran, Emma I Zelus, Lindsey A Burnett, Karen L Christman, Marianna Alperin","doi":"10.1016/j.ajog.2024.08.036","DOIUrl":"10.1016/j.ajog.2024.08.036","url":null,"abstract":"<p><strong>Background: </strong>Vaginal childbirth is a key risk factor for pelvic floor muscle injury and dysfunction, and subsequent pelvic floor disorders. Multiparity further exacerbates these risks. Using the rat model, validated for the studies of the human pelvic floor muscles, we have previously identified that a single simulated birth injury results in pelvic floor muscle atrophy and fibrosis.</p><p><strong>Objective: </strong>To test the hypothesis that multiple birth injuries would further overwhelm the muscle regenerative capacity, leading to functionally relevant pathological alterations long-term.</p><p><strong>Study design: </strong>Sprague-Dawley rats underwent simulated birth injury and were allowed to recover for 8 weeks before undergoing additional birth injury. Animals were sacrificed at acute (3 and 7 days postinjury), subacute (21, 28, and 35 days postinjury), and long-term (8 and 12 weeks postinjury) time points post second injury (N=3-8/time point), and the pubocaudalis portion of the rat levator ani complex was harvested to assess the impact of repeated birth injuries on muscle mechanical and histomorphological properties. The accompanying transcriptional changes were assessed by a customized NanoString panel. Uninjured animals were used as controls. Data with a parametric distribution were analyzed by a 2-way analysis of variance followed by post hoc pairwise comparisons using Tukey's or Sidak's tests; nonparametrically distributed data were compared with Kruskal-Wallis test followed by pairwise comparisons with Dunn's test. Data, analyzed using GraphPad Prism v8.0, San Diego, CA, are presented as mean ± standard error of the mean or median (range).</p><p><strong>Results: </strong>Following the first simulated birth injury, active muscle force decreased acutely relative to uninjured controls (12.9±0.9 vs 25.98±2.1 g/mm<sup>2</sup>, P<.01). At 4 weeks, muscle active force production recovered to baseline and remained unchanged at 8 weeks after birth injury (P>.99). Similarly, precipitous decrease in active force was observed immediately after repeated birth injury (18.07±1.2 vs 25.98±2.1 g/mm<sup>2</sup>, P<.05). In contrast to the functional recovery after a single birth injury, a long-term decrease in muscle contractile function was observed up to 12 weeks after repeated birth injuries (18.3±1.6 vs 25.98±2.1 g/mm<sup>2</sup>, P<.05). Fiber size was smaller at the long-term time points after second injury compared to the uninjured group (12 weeks vs uninjured control: 1485 (60.7-5000) vs 1989 (65.6-4702) μm<sup>2</sup>, P<.0001). The proportion of fibers with centralized nuclei, indicating active myofiber regeneration, returned to baseline at 8 weeks post-first birth injury, (P=.95), but remained elevated as far as 12 weeks post-second injury (12 weeks vs uninjured control: 7.1±1.5 vs 0.84±0.13%, P<0.0001). In contrast to the plateauing intramuscular collagen content after 4 weeks post-first injury, fibrotic degeneration","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":"198.e1-198.e23"},"PeriodicalIF":8.7,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142078861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-24DOI: 10.1016/j.ajog.2025.01.024
Miriam Lopian, Can Ozan Ulusoy, Smriti Prasad, Ella Segal, Asma Khalil
{"title":"Accurate prediction of growth-restricted neonates at term using machine learning.","authors":"Miriam Lopian, Can Ozan Ulusoy, Smriti Prasad, Ella Segal, Asma Khalil","doi":"10.1016/j.ajog.2025.01.024","DOIUrl":"https://doi.org/10.1016/j.ajog.2025.01.024","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-24DOI: 10.1016/j.ajog.2025.01.023
Long Nguyen-Hoang, Daljit S Sahota, Liona C Poon
{"title":"Effect of aspirin on biomarker profile in women at high-risk for preeclampsia.","authors":"Long Nguyen-Hoang, Daljit S Sahota, Liona C Poon","doi":"10.1016/j.ajog.2025.01.023","DOIUrl":"https://doi.org/10.1016/j.ajog.2025.01.023","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1016/j.ajog.2025.01.025
Diana C Soria-Contreras, Siwen Wang, Makiko Mitsunami, Jiaxuan Liu, Rebecca B Lawn, Jan L Shifren, Alexandra C Purdue-Smithe, Emily Oken, Jorge E Chavarro
Background: Menstrual cycle characteristics are potential indicators of hormonal exposures and may also signal cardiovascular disease risk factors, both of which are relevant to cognitive health. However, there is scarce epidemiological evidence on the association between cycle characteristics and cognitive function.
Objectives: We studied the associations of menstrual cycle characteristics at three stages of a woman's reproductive lifespan with cognitive function in midlife.
Study design: We studied participants from the Nurses' Health Study II, an ongoing longitudinal cohort of female nurses initially enrolled in 1989. Exposures were cycle regularity at 14-17 and 18-22 years, and cycle length (the interval between two consecutive cycles) at 18-22 years (all retrospectively reported at enrollment), and current cycle regularity and length at 29-46 years (reported in 1993). Outcomes were composite z-scores measuring psychomotor speed/attention and learning/working memory obtained with one self-administered Cogstate Brief Battery assessment, measured among a subset of participants in 2014-2022. We included 19,904 participants with data on at least one menstrual cycle characteristic and a cognitive assessment. We estimated mean differences (β, 95% confidence intervals [CIs]) using linear regression models adjusted for age at cognitive assessment, race and ethnicity, participants' education, wave of cognitive assessment, parental education and occupation, neighborhood socioeconomic status, age at menarche, adiposity, oral contraceptive use, and lifestyle factors (smoking, alcohol intake, physical activity, diet quality).
Results: In the analytical sample, the mean (SD) age at cognitive assessment was 62.0 (4.9) years. Women with irregular cycles at 29-46 years scored lower in learning/working memory (β, -0.05 SD; 95% CI, -0.08 to -0.01) than those with very regular cycles. We did not observe associations for cycle regularity at 14-17 or 18-22 years. Women with cycle length ≤25 days at 18-22 years scored lower in learning/working memory in later life (β, -0.05 SD; -0.09 to -0.02) than those with cycles 26-31 days. We did not observe associations of cycle length at 29-46 years with later cognitive function. In a secondary analysis, women whose cycles were regular at 14-17 or 18-22 years but became irregular by 29-46 years also had lower learning/working memory scores, compared to women whose cycles remained regular across timepoints.
Conclusions: In this large longitudinal study, cycles ≤25 days at 18-22 years and irregular cycles at 29-46 years were associated with lower performance in learning/working memory. Future studies in other populations should confirm our findings and investigate the biological processes underlying these associations.
{"title":"Menstrual cycle characteristics across the reproductive lifespan and cognitive function in midlife women.","authors":"Diana C Soria-Contreras, Siwen Wang, Makiko Mitsunami, Jiaxuan Liu, Rebecca B Lawn, Jan L Shifren, Alexandra C Purdue-Smithe, Emily Oken, Jorge E Chavarro","doi":"10.1016/j.ajog.2025.01.025","DOIUrl":"https://doi.org/10.1016/j.ajog.2025.01.025","url":null,"abstract":"<p><strong>Background: </strong>Menstrual cycle characteristics are potential indicators of hormonal exposures and may also signal cardiovascular disease risk factors, both of which are relevant to cognitive health. However, there is scarce epidemiological evidence on the association between cycle characteristics and cognitive function.</p><p><strong>Objectives: </strong>We studied the associations of menstrual cycle characteristics at three stages of a woman's reproductive lifespan with cognitive function in midlife.</p><p><strong>Study design: </strong>We studied participants from the Nurses' Health Study II, an ongoing longitudinal cohort of female nurses initially enrolled in 1989. Exposures were cycle regularity at 14-17 and 18-22 years, and cycle length (the interval between two consecutive cycles) at 18-22 years (all retrospectively reported at enrollment), and current cycle regularity and length at 29-46 years (reported in 1993). Outcomes were composite z-scores measuring psychomotor speed/attention and learning/working memory obtained with one self-administered Cogstate Brief Battery assessment, measured among a subset of participants in 2014-2022. We included 19,904 participants with data on at least one menstrual cycle characteristic and a cognitive assessment. We estimated mean differences (β, 95% confidence intervals [CIs]) using linear regression models adjusted for age at cognitive assessment, race and ethnicity, participants' education, wave of cognitive assessment, parental education and occupation, neighborhood socioeconomic status, age at menarche, adiposity, oral contraceptive use, and lifestyle factors (smoking, alcohol intake, physical activity, diet quality).</p><p><strong>Results: </strong>In the analytical sample, the mean (SD) age at cognitive assessment was 62.0 (4.9) years. Women with irregular cycles at 29-46 years scored lower in learning/working memory (β, -0.05 SD; 95% CI, -0.08 to -0.01) than those with very regular cycles. We did not observe associations for cycle regularity at 14-17 or 18-22 years. Women with cycle length ≤25 days at 18-22 years scored lower in learning/working memory in later life (β, -0.05 SD; -0.09 to -0.02) than those with cycles 26-31 days. We did not observe associations of cycle length at 29-46 years with later cognitive function. In a secondary analysis, women whose cycles were regular at 14-17 or 18-22 years but became irregular by 29-46 years also had lower learning/working memory scores, compared to women whose cycles remained regular across timepoints.</p><p><strong>Conclusions: </strong>In this large longitudinal study, cycles ≤25 days at 18-22 years and irregular cycles at 29-46 years were associated with lower performance in learning/working memory. Future studies in other populations should confirm our findings and investigate the biological processes underlying these associations.</p>","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1016/j.ajog.2025.01.027
Mohammad A Parvez, Shalem Y Leemaqz, Michael S Irwig
{"title":"The desire for parenthood and biological children among adult transgender and gender diverse individuals seeking gender-affirming care.","authors":"Mohammad A Parvez, Shalem Y Leemaqz, Michael S Irwig","doi":"10.1016/j.ajog.2025.01.027","DOIUrl":"https://doi.org/10.1016/j.ajog.2025.01.027","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1016/j.ajog.2025.01.026
Gabriel Levin, Bradley J Monk, Bhavana Pothuri, Robert Coleman, Thomas Herzog, Lucy Gilbert, Laurance Bernard, Xing Zeng, Peter Scalia, Brian Slomovitz
<p><strong>Background: </strong>Black women and other minorities have higher age adjusted incidence risk for cervical and endometrial cancer than White women. However, the extent of racial and ethnic disparities in clinical trial enrollment among studies performed mainly in North America and Europe for gynecologic malignancy is unknown.</p><p><strong>Objective: </strong>This study analyzed enrollment rates by race/ethnicity in trials that led to Food and Drug Administration (FDA) approvals for gynecological cancers from 2010 to 2024.</p><p><strong>Study design: </strong>This cross-sectional study examined clinical trials registered with ClinicalTrials.gov that resulted in new FDA approvals for gynecologic malignancies between 2010 and 2024. Exclusion criteria were studies not conducted in North America or Europe. Enrollment fractions were obtained by dividing the number of trial participants segregated by the racial/ethnic group by the corresponding U.S. cancer prevalence (uterine, ovarian, and cervical cancer) for 2016-2020 for each racial/ethnic group. Odds ratios (OR) and 95% confidence intervals (CI) were calculated to compare enrollment fractions of minority groups to non-Hispanic (NH) Whites.</p><p><strong>Results: </strong>A total of 31 studies met the inclusion criteria, with 21 reporting race/ethnicity data. Three (3/21) studies dichotomized race as NH-White and Non-White, and Seven (7/21) reported ethnicity. The median number of participants was 494 [interquartile range 150-674]. Fifteen studies were phase III, and six were phase IB/II trials. Treatments included immune checkpoint inhibitors (seven studies), PARP inhibitors (five), VEGF inhibitors (four), antibody-drug conjugates (four), and an imaging marker (one). Across all studies, 11,258 patients were included, 5,563 (49.4%) in ovarian cancer studies, 2,963 (26.3%) in endometrial cancer studies, and 2,732 (24.3%) in cervical cancer studies. Three studies (n=1,734) dichotomized participants into NH-White and Non-White (NH-White 1,291 [74.4%] and Non-White 443 [25.6%], and enrollment fractions were 0.51% for NH-White and 0.43% for No-White, with Non-White being underrepresented odds ratio (OR) 0.85. 95% confidence interval (CI) [0.76-0.95], p=.004. In an Analysis of 18 studies reporting race categories, NH-Black patients were significantly underrepresented (OR 0.50, 95% CI [0.45-0.54], p<.001), while Asian patients were overrepresented (OR 2.81, 95% CI [2.64-2.99], p<.001). In the four studies reporting ethnicity, Hispanic patients were also significantly underrepresented (OR 0.69, 95% CI [0.61-0.78], p<.001).</p><p><strong>Conclusions: </strong>In clinical trials, performed in North America and Europe mainly, leading to FDA approvals for gynecologic malignancies - NH-Black and Hispanic patients are significantly underrepresented compared to NH-White participants when enrollment is benchmarked to the U.S. female population with gynecological cancer. These trials do not adequately ref
{"title":"Racial and ethnic enrollment disparities in clinical trials leading to FDA approvals for gynecologic malignancies.","authors":"Gabriel Levin, Bradley J Monk, Bhavana Pothuri, Robert Coleman, Thomas Herzog, Lucy Gilbert, Laurance Bernard, Xing Zeng, Peter Scalia, Brian Slomovitz","doi":"10.1016/j.ajog.2025.01.026","DOIUrl":"https://doi.org/10.1016/j.ajog.2025.01.026","url":null,"abstract":"<p><strong>Background: </strong>Black women and other minorities have higher age adjusted incidence risk for cervical and endometrial cancer than White women. However, the extent of racial and ethnic disparities in clinical trial enrollment among studies performed mainly in North America and Europe for gynecologic malignancy is unknown.</p><p><strong>Objective: </strong>This study analyzed enrollment rates by race/ethnicity in trials that led to Food and Drug Administration (FDA) approvals for gynecological cancers from 2010 to 2024.</p><p><strong>Study design: </strong>This cross-sectional study examined clinical trials registered with ClinicalTrials.gov that resulted in new FDA approvals for gynecologic malignancies between 2010 and 2024. Exclusion criteria were studies not conducted in North America or Europe. Enrollment fractions were obtained by dividing the number of trial participants segregated by the racial/ethnic group by the corresponding U.S. cancer prevalence (uterine, ovarian, and cervical cancer) for 2016-2020 for each racial/ethnic group. Odds ratios (OR) and 95% confidence intervals (CI) were calculated to compare enrollment fractions of minority groups to non-Hispanic (NH) Whites.</p><p><strong>Results: </strong>A total of 31 studies met the inclusion criteria, with 21 reporting race/ethnicity data. Three (3/21) studies dichotomized race as NH-White and Non-White, and Seven (7/21) reported ethnicity. The median number of participants was 494 [interquartile range 150-674]. Fifteen studies were phase III, and six were phase IB/II trials. Treatments included immune checkpoint inhibitors (seven studies), PARP inhibitors (five), VEGF inhibitors (four), antibody-drug conjugates (four), and an imaging marker (one). Across all studies, 11,258 patients were included, 5,563 (49.4%) in ovarian cancer studies, 2,963 (26.3%) in endometrial cancer studies, and 2,732 (24.3%) in cervical cancer studies. Three studies (n=1,734) dichotomized participants into NH-White and Non-White (NH-White 1,291 [74.4%] and Non-White 443 [25.6%], and enrollment fractions were 0.51% for NH-White and 0.43% for No-White, with Non-White being underrepresented odds ratio (OR) 0.85. 95% confidence interval (CI) [0.76-0.95], p=.004. In an Analysis of 18 studies reporting race categories, NH-Black patients were significantly underrepresented (OR 0.50, 95% CI [0.45-0.54], p<.001), while Asian patients were overrepresented (OR 2.81, 95% CI [2.64-2.99], p<.001). In the four studies reporting ethnicity, Hispanic patients were also significantly underrepresented (OR 0.69, 95% CI [0.61-0.78], p<.001).</p><p><strong>Conclusions: </strong>In clinical trials, performed in North America and Europe mainly, leading to FDA approvals for gynecologic malignancies - NH-Black and Hispanic patients are significantly underrepresented compared to NH-White participants when enrollment is benchmarked to the U.S. female population with gynecological cancer. These trials do not adequately ref","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-22DOI: 10.1016/j.ajog.2025.01.020
Yvette S Groszmann, Sarah C Lassey, Thomas D Shipp
{"title":"Should Müllerian duct abnormalities be diagnosed in early pregnancy?","authors":"Yvette S Groszmann, Sarah C Lassey, Thomas D Shipp","doi":"10.1016/j.ajog.2025.01.020","DOIUrl":"https://doi.org/10.1016/j.ajog.2025.01.020","url":null,"abstract":"","PeriodicalId":7574,"journal":{"name":"American journal of obstetrics and gynecology","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}