Bjog-An International Journal of Obstetrics and Gynaecology最新文献

{"title":"Author Reply.","authors":"Lisa M Van Den Bersselaar, Ingrid M B H Van De Laar, Marieke J H Baars, Annette Baas, Eelco Dulfer, Apollonia T J M Helderman-Van Den Enden, Yvonne Hilhorst-Hofstee, Robert M Kauling, Marlies J E Kempers, Martijn A Oudijk, Alessandra Maugeri, Hennie T Brüggenwirth, Arjan C Houweling, Serwet Demirdas","doi":"10.1111/1471-0528.70046","DOIUrl":"https://doi.org/10.1111/1471-0528.70046","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245797","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}

{"title":"Author Reply.","authors":"Fride Efjestad Austad, Jörg Kessler, Elisabeth Balstad Magnussen, Are Hugo Pripp, Janne Rossen","doi":"10.1111/1471-0528.70042","DOIUrl":"https://doi.org/10.1111/1471-0528.70042","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145201528","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}

{"title":"Author Reply.","authors":"Biresaw Wassihun Alemu, Michael Waller, Leigh R Tooth","doi":"10.1111/1471-0528.70009","DOIUrl":"https://doi.org/10.1111/1471-0528.70009","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145076486","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}

{"title":"Serum Bile Acid Composition in Women With Gestational Diabetes and Fasting Hyperglycaemia (HAPO): A Cohort Study.","authors":"Josca M Schoonejans, Hanns-Ulrich Marschall, M Martineau, David McCance, Catherine Williamson","doi":"10.1111/1471-0528.18363","DOIUrl":"10.1111/1471-0528.18363","url":null,"abstract":"","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144977431","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}

{"title":"Differences in Risk Factors for Severe Preeclampsia and HELLP Syndrome in Singleton Versus Twin Pregnancies: A Population-Based Cohort Study.","authors":"Mackenzie Campbell, Johanna Koegl, Jeffrey N Bone, Sofia Nicolls, Janet Lyons, Chantal Mayer, Kenneth I Lim, Julie Van Schalkwyk, K S Joseph, Sarka Lisonkova","doi":"10.1111/1471-0528.18351","DOIUrl":"https://doi.org/10.1111/1471-0528.18351","url":null,"abstract":"<p><strong>Objective: </strong>To examine whether the associations between pre-pregnancy risk factors and severe preeclampsia/eclampsia (SPE) and/or HELLP syndrome differ between singleton and twin pregnancies.</p><p><strong>Design: </strong>A population-based retrospective cohort study.</p><p><strong>Setting: </strong>British Columbia (BC), Canada.</p><p><strong>Population: </strong>All pregnancies with singletons or twins that resulted in a stillbirth or live birth at ≥ 20 weeks' gestation from 2008/09 to 2020/21.</p><p><strong>Methods: </strong>Data were obtained from the BC Perinatal Database Registry. Logistic regression was used to estimate the association between each risk factor for SPE/HELLP (e.g., body-mass-index (BMI), in vitro-fertilisation (IVF), chronic hypertension, and diabetes) and the modifying effect of plurality by including interaction terms between these risk factors and plurality in the model.</p><p><strong>Main outcome measures: </strong>Severe preeclampsia, eclampsia, and/or HELLP syndrome.</p><p><strong>Results: </strong>Among 563 252 pregnancies (8841 twin, 554 411 singleton), the rate of SPE/HELLP was 4.7 per 1000 singleton pregnancies and 31.1 per 1000 twin pregnancies (relative risk 6.61; 95% confidence interval (CI) 5.84-7.49). Older maternal age (≥ 35 years), nulliparity, pre-pregnancy and gestational diabetes, chronic hypertension, prior mental health problems, substance use during pregnancy, and prior stillbirth increased the odds, while smoking decreased the odds of SPE/HELLP among both singleton and twin pregnancies. However, the adjusted associations between BMI, IVF, prior abortions, and SPE/HELLP differed by plurality (interaction p-values 0.002, < 0.0001, and 0.04, respectively). IVF was associated with increased odds of SPE/HELLP in singleton pregnancies (adjusted odds ratio (aOR) 1.93; 95% CI 1.64-2.27) but not in twins (aOR 0.85; CI 0.65-1.11). Similarly, overweight BMI was associated with elevated odds in singleton pregnancies (aOR 1.47; CI 1.32-1.64) but not in twins (aOR 0.86; CI 0.59-1.25), as was obese BMI (singleton aOR 1.88; CI 1.67-2.12; twin aOR 0.80; CI 0.51-1.24). Conversely, a history of prior abortions was associated with decreased odds in twin pregnancies (aOR 0.70; CI 0.54-0.92) but not singleton pregnancies (aOR 0.95; CI 0.88-1.04).</p><p><strong>Conclusions: </strong>High BMI and IVF are associated with elevated risk of SPE/HELLP syndrome in singleton pregnancies, but not in twin pregnancies. This study provides insights regarding SPE/HELLP syndrome among singleton and twin pregnancies, and useful information for pre-pregnancy counselling.</p>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":" ","pages":""},"PeriodicalIF":4.3,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144977435","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}

{"title":"Standardising Simulation-Based Obstetric Emergency Training: A Delphi Consensus Study","authors":"Paolo Mannella,&nbsp;Chiara Benedetto,&nbsp;Emilie Canuto,&nbsp;Brigida Carducci,&nbsp;Ilma Floriana Carbone,&nbsp;Elena Cesari,&nbsp;Irene Cetin,&nbsp;Andrea Ciavattini,&nbsp;Nicola Colacurci,&nbsp;Antonella Cromi,&nbsp;Lorenza Driul,&nbsp;Nicoletta Di Simone,&nbsp;Sergio Ferrazzani,&nbsp;Tiziana Frusca,&nbsp;Serafina Garofalo,&nbsp;Tullio Ghi,&nbsp;Valentina Giardini,&nbsp;Pantaleo Greco,&nbsp;Annalisa Inversetti,&nbsp;Antonio Lanzone,&nbsp;Luca Marozio,&nbsp;Carmelinda Martino,&nbsp;Federico Mecacci,&nbsp;Maddalena Morlando,&nbsp;Caterina Neri,&nbsp;Gianluigi Pilu,&nbsp;Federico Prefumo,&nbsp;Giuseppe Rizzo,&nbsp;Giovanni Scambia,&nbsp;Tommaso Simoncini,&nbsp;Emanuela Taricco,&nbsp;Patrizia Vergani,&nbsp;Barbara Zaina,&nbsp;Rossella Nappi","doi":"10.1111/1471-0528.18332","DOIUrl":"10.1111/1471-0528.18332","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To develop standardised Objective Structured Assessment of Technical Skills (OSATS) forms for major obstetric emergencies, thereby improving the quality and consistency of obstetric simulation training.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design and Setting</h3>\u0000 \u0000 <p>A panel of national experts with extensive experience in teaching Gynaecology and Obstetrics, simulation training, and the clinical management of labour complications and peripartum emergencies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population and Methods</h3>\u0000 \u0000 <p>A Delphi process with four iterative rounds was conducted to create, evaluate, revise, and finalise OSATS checklists for 11 obstetric emergencies. Each OSATS form was rated using a Likert scale (0–9), refined according to expert feedback, and validated through structured discussions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>The creation and approval of OSATS forms for shoulder dystocia, vacuum delivery, assisted breech delivery, third- and fourth-degree laceration repair, external cephalic version, abnormal CTG management, postpartum haemorrhage, non-cephalic second twin delivery, reverse breech extraction at caesarean section, maternal collapse and forceps application.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Consensus was achieved for all emergencies with good to excellent ratings: shoulder dystocia (82%), external cephalic version (94%), vacuum delivery (75%), abnormal CTG management (42%), postpartum haemorrhage (96%), reverse breech extraction (72%), maternal collapse (94%), forceps application (76%), non-cephalic second twin delivery (96%), assisted breech delivery (94%) and third- and fourth-degree laceration repair (82%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The Delphi study successfully developed consensus-based OSATS forms, addressing the need for standardised assessments in obstetric simulation training. These tools enhance training quality, identify skill gaps and improve clinical preparedness. This study was supported by AGUI (Associazione Ginecologi Universitari Italiani).</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 12","pages":"1875-1883"},"PeriodicalIF":4.3,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144910741","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}

{"title":"Prediction Models for Obstetric Anal Sphincter Injuries (OASIS): A Systematic Review and Critical Appraisal","authors":"Ellen S. Mooren,&nbsp;Jeroen van Bavel,&nbsp;Anita C. J. Ravelli,&nbsp;Jan Willem de Leeuw","doi":"10.1111/1471-0528.18334","DOIUrl":"10.1111/1471-0528.18334","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Obstetric anal sphincter injuries (OASIS) are complications with a risk of maternal morbidity. To estimate the individual risk of OASIS, prediction models have been developed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>Identifying studies on development and validation of prediction models for OASIS, with a critical assessment of methodology and clinical applicability.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Search Strategy</h3>\u0000 \u0000 <p>This systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the CHecklist for Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS). PubMed, Embase, Cochrane Library and Scopus were searched up to 26 June 2024.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Selection Criteria</h3>\u0000 \u0000 <p>Studies with description of model performance used for the development of prediction models.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Data Collection and Analysis</h3>\u0000 \u0000 <p>Data extraction and assessment were performed by two independent researchers. The Prediction model Risk of Bias Assessment Tool (PROBAST) was used to assess risk of bias and applicability.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Results</h3>\u0000 \u0000 <p>Of the 855 retrieved papers, 16 papers with 25 prediction models for OASIS were included. In these models, 2 to 15 variables were used. Model discrimination ranged from 0.64 to 0.83. All studies had shortcomings, particularly because of small or non-generalisable cohorts and were at risk of bias. Nine studies were of concern regarding clinical applicability. There were no geographical external validation studies of the 25 pre-existing models.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The included prediction models for OASIS were of low or moderate quality and not applicable for use in clinical care yet. Future studies should focus on developing models based on larger generalisable multicentre cohorts, with clinically applicable predictors and with internal and external validation.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 12","pages":"1734-1741"},"PeriodicalIF":4.3,"publicationDate":"2025-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144910742","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}

{"title":"Pregnancy and Breast Cancer","authors":"Anne Armstrong,&nbsp;Ashu Gandhi,&nbsp;Suzanne Frank,&nbsp;David Williams,&nbsp;Samantha Nimalasena,&nbsp;the Royal College of Obstetricians and Gynaecologists","doi":"10.1111/1471-0528.18270","DOIUrl":"10.1111/1471-0528.18270","url":null,"abstract":"&lt;p&gt;The purpose of this guideline is to describe the diagnosis, management and treatment of breast cancer during and immediately after pregnancy. It also provides advice on future fertility considerations after a breast cancer diagnosis.&lt;/p&gt;&lt;p&gt;This guideline is for healthcare professionals who care for women, non-binary and trans people who experience pregnancy associated breast cancer (PABC). Within this document we use the terms woman and women's health. However, it is important to acknowledge that it is not only women for whom it is necessary to access women's health and reproductive services in order to maintain their gynaecological health and reproductive wellbeing. Gynaecological and obstetric services and delivery of care must therefore be appropriate, inclusive and sensitive to the needs of those individuals whose gender identity does not align with the sex they were assigned at birth.&lt;/p&gt;&lt;p&gt;Breast cancer is the most common cancer in the UK, accounting for 15% of all new cancer cases (2017–19) [&lt;span&gt;1&lt;/span&gt;]. There are around 56 800 new breast cancer cases in the UK every year (2017–19) [&lt;span&gt;1&lt;/span&gt;]. Of these, 9% occur in women at or under 44 years of age [&lt;span&gt;1&lt;/span&gt;]. Survival rates have improved significantly in recent decades. In women diagnosed under the age of 39 years, 85% are alive more than 5 years after their diagnosis [&lt;span&gt;1&lt;/span&gt;] leading many women to now consider pregnancy as an option after cancer.&lt;/p&gt;&lt;p&gt;A new breast cancer diagnosis complicates about 1 in 3000 pregnancies [&lt;span&gt;2&lt;/span&gt;]. With advancing maternal age at pregnancy [&lt;span&gt;3&lt;/span&gt;] it is likely that the incidence of breast cancer during pregnancy will increase.&lt;/p&gt;&lt;p&gt;Clinical care of people who are pregnant with breast cancer should follow the principles of care for all pregnant women with medical disorders: the clinician's duty of care is first towards the woman and then to the fetus. This principle was outlined in the 2021 MBRRACE report which states that clinicians should ‘Treat women who may become pregnant, are pregnant, or who have recently been pregnant the same as a non-pregnant person unless there is a very clear reason not to’ [&lt;span&gt;4&lt;/span&gt;]. For pregnant women with breast cancer a care plan should first be established by surgeons and oncologists, as if the woman was not pregnant. This plan can then be adapted with a multidisciplinary team (MDT) that should also include obstetricians, fetal and neonatal specialists. This team should balance potential treatment for the woman and her fetus with potential compromise for pregnancy outcome. These treatment options must be discussed with the woman.&lt;/p&gt;&lt;p&gt;As breast cancer during pregnancy is relatively rare and heterogeneous in its presentation, recommendations for care are guided by international registries rather than clinical trials. Treatment decisions are therefore limited to the best available evidence, which is often not definitive. In the absence of evidence of harm or safety in pregn","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 12","pages":"e194-e228"},"PeriodicalIF":4.3,"publicationDate":"2025-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18270","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144977370","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":"Inequalities in Preterm Birth in England: A Retrospective National Cohort Study Focusing on Deprivation and Ethnicity, Using Routinely Collected Maternity Hospital Data","authors":"Iona Hindes,&nbsp;Buthaina Ibrahim,&nbsp;Jennifer Jardine,&nbsp;Dominik Zenner,&nbsp;Stamatina Iliodromiti","doi":"10.1111/1471-0528.18331","DOIUrl":"10.1111/1471-0528.18331","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To quantify the interplay between socioeconomic and ethnic inequalities in preterm birth rates in England from 2018 to 2021.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Design</h3>\u0000 \u0000 <p>A retrospective cohort study using electronic health data.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting</h3>\u0000 \u0000 <p>English hospitals.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Population</h3>\u0000 \u0000 <p>1537 595 women aged 13–55 with a singleton livebirth (April 2018–March 2021) at 24–42 gestational weeks were included.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Multivariate Poisson regression was used to estimate the rate of preterm birth in each ethnic and deprivation group, adjusted rate ratios between groups, and associations. A post hoc calculation identified the rate of preterm birth for each ethnic group at each level of deprivation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main Outcome Measures</h3>\u0000 \u0000 <p>Preterm birth (birth at less than 37 gestational weeks).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The rate of preterm birth was 6.30% (95% CI: 6.22–6.37) in women living in the most deprived areas, compared to a rate of 5.05% (95% CI: 4.96–5.14) among women in the least deprived areas. White women had a preterm birth rate of 5.74% (95% CI: 5.70–5.78), whereas South Asian and Black women had higher rates of preterm birth at 6.09% (95% CI: 5.98–6.21) and 5.89% (95% CI: 5.70–6.09), respectively. Deprivation interacted with ethnicity and attenuated the differences in the rate of preterm birth across all ethnicity groups (<i>p</i> &lt; 0.001). In areas of high deprivation, preterm birth rates were similar across ethnicity groups, whereas in the least deprived areas, South Asian and Black women had higher rates.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Deprivation and ethnicity remain key drivers of inequalities in preterm birth. Prevention strategies need to address socioenvironmental and structural determinants of preterm birth in areas of high deprivation and minority ethnicity groups.</p>\u0000 </section>\u0000 </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 12","pages":"1866-1874"},"PeriodicalIF":4.3,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18331","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144899540","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":"Four Year Clinical and Cost Effectiveness of Vaginal Pessary Self-Management Versus Clinic-Based Care for Pelvic Organ Prolapse (TOPSY): Long Term Follow-Up of a Randomised Controlled Superiority Trial","authors":"Carol Bugge,&nbsp;Rohna Kearney,&nbsp;Catherine Best,&nbsp;Kirsteen Goodman,&nbsp;Sarkis Manoukian,&nbsp;Lynn Melone,&nbsp;Melanie Dembinsky,&nbsp;Helen Mason,&nbsp;Andrew Elders,&nbsp;Margaret Graham,&nbsp;Wael Agur,&nbsp;Suzanne Breeman,&nbsp;Jane Culverhouse,&nbsp;Lucy Dwyer,&nbsp;Mark Forrest,&nbsp;Karen Guerrero,&nbsp;Christine Hemming,&nbsp;Aethele Khunda,&nbsp;Angela Kucher,&nbsp;Doreen McClurg,&nbsp;John Norrie,&nbsp;Ranee Thakar,&nbsp;Suzanne Hagen","doi":"10.1111/1471-0528.18333","DOIUrl":"10.1111/1471-0528.18333","url":null,"abstract":"&lt;div&gt;\u0000 \u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Objective&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;To compare long-term clinical and cost-effectiveness of pessary self-management (SM) with clinic-based care (CBC) for pelvic floor-specific quality of life (QoL).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Design&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Four-year questionnaire follow-up of trial participants.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Setting&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;UK pessary clinics.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Sample&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Responders at 4 years aged ≥ 18 years at recruitment, using a pessary (except Shelf, Gellhorn or Cube) which had been retained ≥ 2 weeks. Exclusions: limited manual dexterity; cognitive deficit; pregnancy; requiring non-English SM teaching.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Methods&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received routine appointments. Allocation was by remote web-based application, minimised on age, user type (new/existing) and centre with no blinding. Participants were invited to opt into a 4-year follow-up. The primary analysis was intention to treat.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Outcome Measures&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;The primary outcomes were pelvic floor-specific QoL (PFIQ-7) and incremental net monetary benefit (INB) 4 years post-randomisation. Secondary outcomes included complications and prolapse symptoms.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Results&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Of 340 women randomised, 186 (55%) responded at 4 years (86/169 [51%] SM, 100/171 [58%] CBC). There was no statistically significant group difference in PFIQ-7 at 4 years (mean SM 32.9 vs. CBC 31.4, adjusted mean difference [AMD] SM-CBC 4.86, 95% CI −6.41 to 16.12). There was a statistically non-significant lower percentage of pessary complications for SM (SM 17.7% vs. CBC 22.0%, AMD 3.01 CI −0.58 to 6.61). At 4-years, SM was cost-effective (INB £2240). There was one potentially related serious adverse event (SM group).&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Conclusions&lt;/h3&gt;\u0000 \u0000 &lt;p&gt;Pessary self-management is an effective and cost-effective long-term option for women with prolapse.&lt;/p&gt;\u0000 &lt;/section&gt;\u0000 \u0000 &lt;section&gt;\u0000 \u0000 &lt;h3&gt; Trial Registration&lt;/h3&gt;\u0000 ","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 12","pages":"1762-1771"},"PeriodicalIF":4.3,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://obgyn.onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18333","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144884241","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}