Shuyue Zheng, Kai Zhu, Minyue Tang, Tianjing Wang, Xiaoling Liang, Xiaolu Xu, Jin Lin, Xuemei He, Haijie Gao, Yingying Shi, Bingbing Deng, Yaping Ye, Wanyi Xie, Jiahui Lin, Rongjuan Chen, Xiufang Gong, Ping Li, Guiquan Wang
{"title":"Predictive Value and Optimal Threshold of Follicle Size in IVF: Systematic Review and Multiple-Threshold Meta-Analysis","authors":"Shuyue Zheng, Kai Zhu, Minyue Tang, Tianjing Wang, Xiaoling Liang, Xiaolu Xu, Jin Lin, Xuemei He, Haijie Gao, Yingying Shi, Bingbing Deng, Yaping Ye, Wanyi Xie, Jiahui Lin, Rongjuan Chen, Xiufang Gong, Ping Li, Guiquan Wang","doi":"10.1111/1471-0528.18203","DOIUrl":"10.1111/1471-0528.18203","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Follicle size was generally monitored during controlled ovarian stimulation, yet its predictive value for oocyte developmental potential and the discriminating threshold is debated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To explore the predictive value of follicle size for oocyte developmental competency and establish the corresponding optimal threshold.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Search Strategy</h3>\u0000 \u0000 <p>We searched PubMed, Web of Science, EMBASE and Cochrane Library up to February 29th, 2024.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Selection Criteria</h3>\u0000 \u0000 <p>Included studies investigated the association between follicle size and oocyte developmental competency in IVF treatments.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Data Collection and Analysis</h3>\u0000 \u0000 <p>Data extraction followed the Cochrane Handbook. A multiple-threshold meta-analysis and standard bivariate meta-analysis were used.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Results</h3>\u0000 \u0000 <p>This meta-analysis included 14 studies comprising 25 528 follicles. Results showed follicle size is predictive for oocyte developmental competence, including oocyte maturity (area under the receiver operation characteristic curve [AUC]: 0.72, 95% confidence interval 0.66–0.77; <i>n</i> = 24 116; follicle size ≥ 15 mm), normal fertilisation (0.62, 0.55–0.69; <i>n</i> = 25 321; follicle size ≥ 16 mm), blastocyst formation (0.61, 0.53–0.69; <i>n</i> = 12 859; follicle size ≥ 15 mm) and good-quality embryo (0.64, 0.54–0.71; <i>n</i> = 16 631; follicle size ≥ 16 mm) per oocyte. Based on per mature oocyte or two-pronuclei zygote, follicle size showed little predictive capacity for embryological parameters.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Follicle size could predict oocyte developmental competence with corresponding optimal thresholds identified. However, the benefits for embryological fate may plateau at follicle sizes ≥ 15–16 mm once the oocytes achieve maturation or fertilisation.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 10","pages":"1378-1398"},"PeriodicalIF":4.3,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914874","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}
Ian Henderson, Ipek Gurol-Urganci, Alissa Frémeaux, Alessandra Morelli, Kirstin Webster, Amar M. Karia, Fran Carroll, George Dunn, James Harris, Sam Oddie, Asma Khalil, Jan van der Meulen
{"title":"A Comparison of Regulatory Maternity Unit Ratings With Clinical Outcomes and Practice Measures: An Observational Study Using Routinely Collected Data","authors":"Ian Henderson, Ipek Gurol-Urganci, Alissa Frémeaux, Alessandra Morelli, Kirstin Webster, Amar M. Karia, Fran Carroll, George Dunn, James Harris, Sam Oddie, Asma Khalil, Jan van der Meulen","doi":"10.1111/1471-0528.18188","DOIUrl":"10.1111/1471-0528.18188","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To compare inspection-informed ratings of individual maternity units published by the Care Quality Commission (CQC) with clinical outcomes and practice measures.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Observational study using linked national maternity and administrative hospital data.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>The English NHS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population</h3>\u0000 \u0000 <p>Women with singleton pregnancies who gave birth at term, April 2018–March 2019.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Outcomes and practice measures were compared with ratings using hierarchical models and empirical Bayes estimates adjusted for case-mix and unit characteristics.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>Severe maternal and severe neonatal morbidity. Practice measures included non-spontaneous birth (either caesarean birth before labour or the induction of labour) and intrapartum caesarean birth.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 501 719 included women, 39 930 (8.0%) gave birth in 11 units rated ‘outstanding’, 357 114 (71.2%) in 110 units rated ‘good’, and 104 675 (20.9%) in 35 units rated ‘requires improvement/inadequate’. Severe maternal morbidity did not vary by rating: 1.2% [95% confidence interval 0.87–1.5], 1.3% [1.1–1.4], and 1.0% [0.87–1.1], respectively (<i>p</i> = 0.59), nor did the risk of severe neonatal morbidity: 4.3% [3.3–5.6], 4.0% [3.6–4.5], and 3.4% [2.9–3.9], respectively (<i>p</i> = 0.48). There was no variation across the ratings in the rate of non-spontaneous birth (48.1% [42.2–53.9], 47.9% [46.4–49.4], and 47.9% [45.1–50.8], respectively; <i>p</i> = 0.87) nor intrapartum caesarean (16.8% [14.6–19.3], 16.6% [15.8–17.3], and 15.8% [14.9–16.7], respectively; <i>p</i> = 0.87).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>There was no association between ratings of maternity units published by the national healthcare regulator and clinical outcomes and practice measures derived from routinely collected data. Concerted action is urgently needed to improve the inspection-informed ratings of maternity services.</p>\u0000 </sectio","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 9","pages":"1285-1296"},"PeriodicalIF":4.3,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18188","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143910829","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}
{"title":"Revisiting LH Levels on Trigger Day in IVF Protocols","authors":"Xiushen Li, Wenhao Wu, Sailing Lin, Huimin Wang, Xiaoyong Chen, Xueqing Wu","doi":"10.1111/1471-0528.18205","DOIUrl":"10.1111/1471-0528.18205","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 10","pages":"1528-1529"},"PeriodicalIF":4.3,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905582","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}
Neerujah Balachandren, Meenakshi Veeramani, Sureka Suriyakumar, Sarah Wiley, Dimitrios Mavrelos, Ephia Yasmin, Stavroula L. Kastora
{"title":"Comparison of Luteal Support Protocols in Frozen IVF/ICSI Cycles: A Network Meta-Analysis","authors":"Neerujah Balachandren, Meenakshi Veeramani, Sureka Suriyakumar, Sarah Wiley, Dimitrios Mavrelos, Ephia Yasmin, Stavroula L. Kastora","doi":"10.1111/1471-0528.18172","DOIUrl":"10.1111/1471-0528.18172","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Luteal support is a core success factor of frozen embryo transfers (FET). However, inconsistency across recommended protocols generates notable heterogeneity across reproductive outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To determine the most effective luteal support strategy (LPS) based on five key factors related to the effectiveness of FET cycles.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Search Strategy</h3>\u0000 \u0000 <p>Twelve databases and two prospective registers were searched from inception to 1st January 2024. The study was prospectively registered under the PROSPERO database (CRD42024513549).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Selection Criteria</h3>\u0000 \u0000 <p>Randomised Controlled Trials (RCTs) and observational studies of women undergoing frozen embryo transfers were included.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Data Collection and Analysis</h3>\u0000 \u0000 <p>Bayesian network meta-analysis (NMA) model presenting random effects, risk ratios (RRs) with 95% credibility intervals (CrIs) was employed. Primary outcomes included clinical pregnancy, live birth, and miscarriage. Secondary outcomes included biochemical pregnancy and multiple pregnancy events.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Results</h3>\u0000 \u0000 <p>Fourteen studies, of which eight RCTs, comparing 12 interventions upon 4688 participants, were included. Overall, CiNeMa risk of bias was moderate, and network inconsistency per outcome was low. Thirteen studies reported on clinical pregnancy events with vaginal progesterone (VP) and a single or double dose of subcutaneous GnRH agonist (GnRHa), significantly improving clinical pregnancy, RR 1.86 [95% CrI 1.18, 2.93].</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The addition of 0.1 mg subcutaneous GnRH agonist in a single (Day 3 post ET) or double (Day 3 and Day 6 post ET) schema upon a vaginal progesterone regimen till Week 12 appears to improve clinical pregnancy events in FET cycles.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 9","pages":"1187-1201"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18172","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897834","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}
Zhuyan Shao, Qiang Wen, Xi Chen, Junjie Hong, Wen Yu, Haifei Zhou, Yuyang Zhu, Tao Zhu
{"title":"Clinical Practice of Poly (ADP-Ribose) Polymerase Inhibitors for Maintenance Treatment of Platinum-Sensitive Recurrent Ovarian Cancer in China","authors":"Zhuyan Shao, Qiang Wen, Xi Chen, Junjie Hong, Wen Yu, Haifei Zhou, Yuyang Zhu, Tao Zhu","doi":"10.1111/1471-0528.18182","DOIUrl":"10.1111/1471-0528.18182","url":null,"abstract":"<div>\u0000 \u0000 <p>Clinical trials of three poly (ADP-ribose) polymerase (PARP) inhibitors, olaparib, niraparib and fuzuloparib, in platinum-sensitive recurrent ovarian cancer (PSR OC) in China showed that PARP inhibitors improved progression-free survival and achieved an all-comer indication in this population. We reviewed the efficacy and safety of these PARP inhibitors in patient populations studied in clinical trials and highlighted the positive role of PARP inhibitors in improving patient outcomes using clinical trials and real-world studies conducted in China. This article also discusses the issues encountered in clinical practice and how to evaluate the different indications for PSR OC in China and abroad.</p>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 S4","pages":"13-19"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897833","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}
Frederieke A. J. Gigase, Myrthe M. G. B. M. Boekhorst, Anna Suleri, Anna-Sophie Rommel, Michael Breen, Ryan L. Muetzel, Manon H. J. Hillegers, Michal A. Elovitz, Eric A. P. Steegers, Lot D. De Witte, Veerle Bergink
{"title":"Maternal Immune Activation During Pregnancy and Obstetric Outcomes: A Population-Based Cohort Study","authors":"Frederieke A. J. Gigase, Myrthe M. G. B. M. Boekhorst, Anna Suleri, Anna-Sophie Rommel, Michael Breen, Ryan L. Muetzel, Manon H. J. Hillegers, Michal A. Elovitz, Eric A. P. Steegers, Lot D. De Witte, Veerle Bergink","doi":"10.1111/1471-0528.18191","DOIUrl":"10.1111/1471-0528.18191","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Maternal immune activation has been proposed as a mechanism for adverse pregnancy outcomes, yet the mechanisms and effects of timing remain unclear. Immune disruption in early gestation may be particularly detrimental as this is an important period for placental development, which has been associated with the pathology of adverse obstetric outcomes. To increase our understanding of risk factors for adverse obstetric outcomes, we aim to investigate the association between multiple inflammatory and angiogenic markers during early pregnancy and adverse pregnancy outcomes in a large population-based cohort.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Prospective population-based pregnancy cohort study (<i>n</i> = 7513).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>Rotterdam, the Netherlands.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population</h3>\u0000 \u0000 <p>Pregnant women in Rotterdam between April 2002 and January 2006.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Serum inflammatory markers (high-sensitivity (HS)-C-reactive protein (CRP), interleukin (IL)-1β, IL-6, IL-17a, IL-23, interferon (IFN)-<i>γ</i>) and angiogenic factors (sFlt-1 and PlGF) were analysed in repeated measures around 13–20 weeks gestation. A cytokine index was created using principal component analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>Hypertensive disorders of pregnancy, spontaneous preterm birth and small for gestational age at birth.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>HS-CRP, but not the cytokine index, was associated with increased risk of spontaneous preterm birth after multiple testing correction. We found no association of HS-CRP or the cytokine index with hypertensive disorders of pregnancy and small for gestational age at birth after multiple testing correction. Inflammatory and angiogenic factors were associated with each other, yet effect sizes were small.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>We found no strong evidence of a link between early gestation typical inflammatory marker levels and the risk of adverse pregnancy outcomes.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 9","pages":"1307-1318"},"PeriodicalIF":4.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18191","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897532","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}
Seyran Naghdi, Stavros Petrou, Martin Underwood, Sanjeev Deshpande, Siobhan Quenby, Lauren Ewington, Jason Gardosi, Hema Mistry
{"title":"Is It Cost-Effective to Induce Labour Early to Prevent Shoulder Dystocia? Evidence From the Big Baby Trial","authors":"Seyran Naghdi, Stavros Petrou, Martin Underwood, Sanjeev Deshpande, Siobhan Quenby, Lauren Ewington, Jason Gardosi, Hema Mistry","doi":"10.1111/1471-0528.18160","DOIUrl":"10.1111/1471-0528.18160","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The cost-effectiveness of early induction of labour for suspected large-for-gestational-age foetuses to prevent shoulder dystocia is unknown.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A within-trial economic evaluation of induction at 38 + 0 to 38 + 4 weeks' gestation for suspected large-for-gestational-age foetuses. Resource use and costs were measured to 6 months postpartum. We estimated incremental cost per case of shoulder dystocia prevented and incremental cost per maternal quality-adjusted life year (QALY) gained. We collected data for planned caesarean sections in a cohort study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Findings</h3>\u0000 \u0000 <p>Mean combined woman and infant costs in the induction arm were £89 (95% confidence interval (CI): −£79, £257) higher than the standard care arm, driven by increased neonatal costs. The incremental cost of preventing one case of shoulder dystocia was £11 879 and the incremental cost per maternal QALY gained was £39 518. The probability of early induction being cost-effective was 0.65 at a cost-effectiveness threshold of £20 000 per case of shoulder dystocia prevented, but 0.36 at a cost-effectiveness threshold of £20 000 per maternal QALY gained. The cohort study found the mean cost was £310 (95% CI: £74, £545) higher in the induction arm than in the planned caesarean group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Interpretation</h3>\u0000 \u0000 <p>Early induction of labour increased neonatal care costs. It is not a cost-effective approach when effects are restricted to maternal QALYs. Planned caesarean section might be cost-saving when compared to early induction, although we did not assess longer-term effects such as an increased risk of repeat caesarean sections. Assessments of long-term effects on the mother and infant should be incorporated into future studies.</p>\u0000 \u0000 <p><b>Trial Registration:</b> ISRCTN18229892</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 9","pages":"1250-1258"},"PeriodicalIF":4.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18160","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143897534","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}
{"title":"Job Stress, Psychological Distress, and Menstruation-Related Symptoms in Female Workers: A Cross-Sectional Study","authors":"Liqiu Kou","doi":"10.1111/1471-0528.18202","DOIUrl":"10.1111/1471-0528.18202","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 11","pages":"1701-1702"},"PeriodicalIF":4.3,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889447","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}
Angret de Boer, André Krom, Rania Kalaai, Marieke de Vries, Marije Hogeveen, Sylvia A. Obermann-Borst, Marijn Vermeulen, M. Beatrijs van der Hout-van der Jagt, Juliette S. van Haren, Peter Andriessen, Martine C. de Vries, Rosa Geurtzen, E. J. T. Verweij, Joanne
{"title":"Stakeholder Perspectives on the Design of First-In-Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study","authors":"Angret de Boer, André Krom, Rania Kalaai, Marieke de Vries, Marije Hogeveen, Sylvia A. Obermann-Borst, Marijn Vermeulen, M. Beatrijs van der Hout-van der Jagt, Juliette S. van Haren, Peter Andriessen, Martine C. de Vries, Rosa Geurtzen, E. J. T. Verweij, Joanne","doi":"10.1111/1471-0528.18189","DOIUrl":"10.1111/1471-0528.18189","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Artificial Amnion and Placenta Technology (AAPT), designed to improve outcomes in extreme prematurity, has shown promise in animal studies, with human trials anticipated soon. This study seeks to inform the responsible design of future trials by utilising insights from parents who experienced an (imminent) extremely premature birth and perinatal healthcare professionals (HCPs).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>A qualitative study using individual and focus group interviews.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>This study was part of a Dutch study called Toward Individualised care of the Youngest.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Sample</h3>\u0000 \u0000 <p>Fifteen parents who experienced an (imminent) extremely premature birth and 46 HCPs were interviewed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Eight focus-group and five individual interviews were performed and transcribed. The transcripts were thematically analysed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcomes and Measures</h3>\u0000 \u0000 <p>The perspectives of HCPs and experienced parents on what they considered essential for human AAPT trials.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Analyses revealed some critical considerations represented in six themes: (1) optimise the animal model, (2) determine the goal of human trials, (3) carefully establish the research population, (4) formulate stop criteria, success criteria and outcome measures, (5) determine the role for parents during the AAPT trial, and (6) develop protocols for the trial and address logistical considerations.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study emphasises the critical role of stakeholder involvement in safeguarding the responsible design of human AAPT trials. Defining the trial objectives including well-defined stop criteria and follow-up schemes is a key element for the human AAPT trials. Establishing consensus among stakeholders is essential, as shared recommendations will facilitate alignment of expectations and promote engagement.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 11","pages":"1574-1583"},"PeriodicalIF":4.3,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18189","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889449","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}
Robert-Jan Alers, Chahinda Ghossein-Doha, Yentl Brandt, M. Eline Kooi, Suzanne C. Gerretsen, Jacobus F. A. Jansen, Walter H. Backes, Vincent van de Ven, Petra P. M. Hurks, Marc E. A. Spaanderman
{"title":"Associations of Metabolic Syndrome and Insulin Resistance With Attenuated Executive Function Post-Preeclampsia: A Nested Case–Control Study","authors":"Robert-Jan Alers, Chahinda Ghossein-Doha, Yentl Brandt, M. Eline Kooi, Suzanne C. Gerretsen, Jacobus F. A. Jansen, Walter H. Backes, Vincent van de Ven, Petra P. M. Hurks, Marc E. A. Spaanderman","doi":"10.1111/1471-0528.18186","DOIUrl":"10.1111/1471-0528.18186","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>Preeclampsia contributes to maternal cognitive problems, particularly involving executive functions. These higher-order cognitive functions—including working memory, organisation of materials, and task focus—are essential for adaptive, purposeful, and goal-directed behaviour. Similar cognitive problems are observed in metabolic syndrome and insulin resistance. This study investigates whether these conditions are also associated with executive function after preeclampsia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>Nested case–control study.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>Maastricht University Medical Centre+, a tertiary care hospital.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population</h3>\u0000 \u0000 <p>Women 0.5 to 30 years after preeclampsia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The Behaviour Rating Inventory of Executive Function for Adults provided a measure of executive function performance. The National Cholesterol Education Program Adult Treatment Panel III defined metabolic syndrome. The Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) quantified insulin resistance. Participants were matched on age, postpartum time, and educational attainment. Associations of attenuated executive function with metabolic syndrome, its constituents, and insulin resistance were examined with conditional logistic regression.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>Odds ratios and population attributable fractions for the associations of attenuated executive function with metabolic syndrome, its constituents, and insulin resistance.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In 155 matched pairs, attenuated executive function was associated with metabolic syndrome (odds ratio 4.20 (95% confidence interval 1.58–11.14)), hyperglycaemia (2.96 (1.13–7.79)), and obesity (3.86 (2.00–7.47)). Attenuated executive function related to HOMA-IR (7.26 (3.75–14.07)), and was 13% (6%–20%) attributable to metabolic syndrome and 56% (49%–67%) to insulin resistance.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Metabolic syndrome and insulin resistance are associated with attenuated executive funct","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 9","pages":"1269-1277"},"PeriodicalIF":4.3,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18186","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143889448","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}