Trials最新文献

{"title":"Distribution of trial registry numbers within full-text of PubMed Central articles: implications for linking trials to publications and indexing trial publication types.","authors":"Arthur M Holt, Ang Michael Troy, Neil R Smalheiser","doi":"10.1186/s13063-025-08741-w","DOIUrl":"10.1186/s13063-025-08741-w","url":null,"abstract":"<p><strong>Background: </strong>Linking registered clinical trials with their published results continues to be a challenge. A variety of natural language processing (NLP)-based and machine learning-based models have been developed to assist users in identifying these connections. To date, however, no system has attempted to detect mentions of registry numbers within the full-text of articles.</p><p><strong>Methods: </strong>Articles from the PubMed Central full-text Open Access dataset were scanned for mentions of ClinicalTrials.gov and international clinical trial registry identifiers. We analyzed the distribution of trial registry numbers within sections of the articles and characterized their publication type indexing and other metrics.</p><p><strong>Results: </strong>Registry numbers mentioned in article metadata (e.g., the abstract) or in the Methods section of full-text are highly predictive of clinical trial articles. When a clinical trial article mentioned ClinicalTrials.gov identifier numbers (NCT) only in the Methods section, in every case examined, it was reporting clinical outcomes from that registered trial, and thus can reliably be used to link that trial to that publication. Conversely, registry numbers mentioned in Tables arise almost entirely from reviews (including systematic reviews and meta-analyses). Registry numbers mentioned in other full-text sections have relatively little predictive value for linking trials to their publications. Clinical trial articles that mention CONSORT or SPIRIT guidelines have a higher rate of mentioning registry numbers in article metadata, and hence are more easily linked to their underlying trials, than articles overall.</p><p><strong>Conclusions: </strong>The appearance and location of trial registry numbers within the full-text of biomedical articles provide valuable features for connecting clinical trials to their publications. They also potentially provide information to assist automated tools in assigning publication types to articles.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"34"},"PeriodicalIF":2.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the effectiveness and the feasibility of a group-based treatment for self-stigma in people with mental disorders in routine mental health services in North-East Italy: study protocol for a pragmatic multisite randomized controlled trial.","authors":"Antonio Lasalvia, Luca Bodini, Doriana Cristofalo, Veronica Fin, Philip T Yanos, Chiara Bonetto","doi":"10.1186/s13063-025-08739-4","DOIUrl":"10.1186/s13063-025-08739-4","url":null,"abstract":"<p><strong>Background: </strong>Self-stigma refers to the process whereby individuals with mental disorders internalize negative societal attitudes and misconceptions about mental health conditions, potentially affecting their sense of self-worth and identity. This internalization can significantly impact various aspects of life, including treatment engagement, personal relationships, and overall well-being. Narrative Enhancement and Cognitive Therapy (NECT) was developed in the United States to counteract self-stigma and has been supported by multiple randomized controlled trials. However, NECT has not yet been implemented in Italy or within a public mental health system grounded in community psychiatry. This study aims to evaluate the efficacy and feasibility of the Italian version of the NECT within the public mental health sector in a large part of North-East Italy.</p><p><strong>Methods and analysis: </strong>This pragmatic, multisite, superiority, randomized, wait-list controlled trial with two parallel arms will recruit over four hundred patients with severe mental disorders from 26 public community-based mental health centers in North-East Italy. The experimental intervention, NECT, consists of 20 group-based sessions to reduce self-stigma. The study will assess NECT's impact on several psychological dimensions, including self-stigma levels (primary outcome), self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma stress (secondary outcomes). Feasibility will be evaluated by collecting data on participant adherence and treatment implementation, including eligibility screening, participation rates, intervention completion, exposure levels, and reasons for dropout.</p><p><strong>Discussion: </strong>The findings of this research are expected to contribute to the understanding of effective treatments for patients with mental disorders, particularly those burdened by high levels of self-stigma, and to improve their recovery outcomes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov; Identifier: NCT06567145.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"35"},"PeriodicalIF":2.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143075623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery: a prospective, single-center, randomized controlled study.","authors":"Xiaojian Jia, Jingjin Wu, Caiyou Ding, Yanbo Lou","doi":"10.1186/s13063-025-08746-5","DOIUrl":"10.1186/s13063-025-08746-5","url":null,"abstract":"<p><strong>Background: </strong>Thoracic aortic pathologies involving the aortic arch are a great challenge for vascular surgeons. Maintaining the patency of supra-aortic branches while excluding the aortic lesion remains difficult. Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations provides a feasible and effective approach for this type of disease. The main purpose of this trial is to assess the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.</p><p><strong>Methods: </strong>This is a prospective, single-center, randomized controlled study. A total of 170 eligible patients will be recruited from The Fourth Affiliated Hospital, Zhejiang University School of Medicine in China and randomized on a 1:1 basis either to the group A (extracorporeal fenestration) or the group B (in situ fenestration). The primary outcome will be the all-cause mortality (30 days). The secondary outcomes will include incidence of secondary intervention (30 days, 6 months, 1 year), incidence of endoleak (30 days, 6 months, 1 year), incidence of major adverse events (MAE) (i.e., immediate procedural success and complications) (30 days, 6 months, 1 year), immediate technical success rate, and all-cause mortality (6 months, 1 year).</p><p><strong>Discussion: </strong>Suppose extracorporeal fenestration non-inferior to in situ fenestration in patients with aortic disease involving the left subclavian artery. This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery, which is expected to provide a reference for Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06256757. Registered on February 5, 2024. https://clinicaltrials.gov/study/NCT06256757 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"33"},"PeriodicalIF":2.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11783856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical analysis plan for a pragmatic randomised controlled trial comparing enhanced acceptance and commitment therapy plus ( +) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN) trial.","authors":"Clare Robinson, Trudie Chalder, Paul McCrone, Olivier Quintin, Evdoxia Gkaintatzi, Imran Khan, Stephanie J C Taylor","doi":"10.1186/s13063-025-08734-9","DOIUrl":"10.1186/s13063-025-08734-9","url":null,"abstract":"<p><strong>Background: </strong>The aim of the SURECAN trial is to evaluate a person-centred intervention, based on Acceptance and Commitment Therapy (ACT Plus ( +)), for people who have completed treatment for cancer with curative intent, but are experiencing poor quality of life. We present the statistical analysis plan for assessing the effectiveness and cost-effectiveness of the intervention in improving quality of life 1 year post randomisation.</p><p><strong>Methods and design: </strong>SURECAN is a multi-centre, pragmatic, two-arm, partially clustered randomised controlled superiority trial comparing the effectiveness of ACT + added to usual care with usual aftercare. The target sample size is 344 (172 per arm), randomised centrally in a 1:1 ratio.</p><p><strong>Results: </strong>The primary outcome is the total score of the Functional Assessment of Cancer Therapy scale-General (FACT-G) at 52 weeks, analysed using a partially nested mixed-effects model with heteroskedastic error terms. Secondary outcomes include scores at 16 and 52 weeks: FACT-G subscales; Fear of Cancer Recurrence Inventory (FCR4); positive and negative Impact of Cancer scales (IOCv2); Hospital Anxiety and Depression scale (HADS); Chalder Fatigue Scale (CFQ); and physical activity, measured on a modified version of the Godin scale. Health economic analyses will determine the incremental cost-effectiveness ratio (ICER) in terms of quality-adjusted life years (QALYs) derived from the Euroqol 5-Dimension 5-Level (EQ-5D-5L) compared to usual care at 52 weeks.</p><p><strong>Discussion: </strong>This manuscript is the statistical analysis plan (SAP) and economic evaluation for the SURECAN trial. Any exploratory or post hoc analyses will be identified as such in the respective analysis report.</p><p><strong>Trial registration: </strong>The trial was prospectively registered.</p><p><strong>Isrctn: </strong>ISRCTN67900293. Registered on 09 December 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"32"},"PeriodicalIF":2.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780776/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The PROPHECI trial: a phase II, double-blind, placebo-controlled, randomized clinical trial for the treatment of pseudoxanthoma elasticum with oral pyrophosphate.","authors":"Laetitia Clotaire, Isabelle Rubera, Christophe Duranton, Jocelyn Gal, Emmanuel Chamorey, Hélène Humeau, Samir Yamani, Christine Chiaverini, Serge Willoteaux, Bernard Padovani, Laurie Mourozeau, Adam Mainguy, Stéphanie Baillif, Ludovic Martin, Georges Leftheriotis","doi":"10.1186/s13063-024-08666-w","DOIUrl":"10.1186/s13063-024-08666-w","url":null,"abstract":"<p><strong>Background: </strong>/aims. Pseudoxanthoma Elasticum (PXE, OMIM 264800) is an autosomal, recessive, metabolic disorder characterized by progressive ectopic calcification in the skin, the vasculature and Bruch's membrane. Variants in the ABCC6 gene are associated with low plasma pyrophosphate (PPi) concentration. There is currently no reference treatment for this chronic debilitating disease.</p><p><strong>Methods: </strong>PROPHECI (PyROphosPHate supplementation to fight ECtopIc calcification in PseudoXanthoma Elasticum) is the first phase II, randomized, double-blind, placebo-controlled clinical trial (NTC 04868578) to evaluate the efficacy and safety of a daily oral PPi salt supplementation to attenuate and/or stabilize the progression of ectopic calcification in PXE patients. The primary endpoint is the change in arterial calcification volume quantified by non-contrast CT scan between baseline and 12 months of treatment. Secondary endpoints include the safety and efficacy of daily oral PPi administration on ocular and skin lesions and the evaluation of patients' quality of life.</p><p><strong>Discussion: </strong>The PROPHECI trial aims to provide safety and efficacy data on the use of daily oral PPi to reduce or stabilize ectopic calcification in PXE. It also aims to validate the best markers to include in the design of future trials for the treatment of PXE and other parent diseases.</p><p><strong>Trial registration: </strong>Trial registration number: NCT04868578. References can be found on the ClinicalTrials.gov website: https://clinicaltrials.gov/study/NCT04868578?cond=Pseudoxanthoma%20Elasticum&intr=pyrophosphate&rank=2.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"30"},"PeriodicalIF":2.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776210/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic exercise protocol for the prevention of anterior cruciate ligament injuries in female soccer players with dynamic knee valgus (RCT).","authors":"Amanda Coves García, Emilio José Poveda Pagán","doi":"10.1186/s13063-025-08736-7","DOIUrl":"10.1186/s13063-025-08736-7","url":null,"abstract":"<p><strong>Background: </strong>Women's football has experienced exponential growth over the last 10 years. Its popularity is associated with an increase in ACL injuries. They constitute a major current problem as they account for 43% of the injury burden during the sports season. Despite the existing training programs, no uniform criteria have been established to design a precise intervention protocol, with specific tasks linked to women's football, nor has it been proposed to optimize the current programs.</p><p><strong>Methods: </strong>Randomized, double-blind, single-center clinical trial protocol scheduled for the 2025-2026 women's football season. There will be 2 groups: a group that will follow a specific ACL injury prevention protocol and a control group. The intervention period will last 12 weeks. Measurements will be taken at 3 time points. The biomechanics of the lower limbs, the jump-landing dynamics, and the pre- and post-training satisfaction of the players will be evaluated. Image capture and processing systems will be used as well as tests such as the DVJ and the LESS scoring system, among others.</p><p><strong>Discussion: </strong>This protocol aims to be one of the first to implement an ACL injury prevention program for women footballers with DKV. Despite the scarcity of research in this area, studies support beneficial effects at a preventive level.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06083818. Registered on 03 October 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"29"},"PeriodicalIF":2.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776326/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator.","authors":"Sayeri Lala, Niraj K Jha","doi":"10.1186/s13063-024-08661-1","DOIUrl":"10.1186/s13063-024-08661-1","url":null,"abstract":"<p><strong>Background: </strong>Phase-3 clinical trials provide the highest level of evidence on drug safety and effectiveness needed for market approval by implementing large randomized controlled trials (RCTs). However, 30-40% of these trials fail mainly because such studies have inadequate sample sizes, stemming from the inability to obtain accurate initial estimates of average treatment effect parameters.</p><p><strong>Methods: </strong>To remove this obstacle from the drug development cycle, we present a new algorithm called Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator (TAD-SIE) that powers a parallel-group trial, a standard RCT design, by leveraging a state-of-the-art hypothesis testing strategy and a novel trend-adaptive design (TAD). Specifically, TAD-SIE uses synthetic intervention (SI) to estimate individual treatment effects and thereby simulate a cross-over design, which makes it easier for a trial to reach target power within trial constraints (e.g., sample size limits). To estimate sample sizes, TAD-SIE implements a new TAD tailored to SI given that using it violates assumptions under standard TADs. In addition, our TAD overcomes the ineffectiveness of standard TADs by allowing sample sizes to be increased across iterations without any condition while controlling significance level with futility stopping. Our TAD also introduces a hyperparameter that enables trial designers to trade off between accuracy and efficiency (sample size and number of iterations) of the solution.</p><p><strong>Results: </strong>On a real-world Phase-3 clinical RCT (i.e., a two-arm parallel-group superiority trial with an equal number of subjects per arm), TAD-SIE obtains operating points ranging between 63% to 84% power and 3% to 6% significance level in contrast to baseline algorithms that get at best 49% power and 6% significance level.</p><p><strong>Conclusion: </strong>TAD-SIE is a superior TAD that can be used to reach typical target operating points but only for trials with rapidly measurable primary outcomes due to its sequential nature. The framework is useful to practitioners interested in leveraging the SI algorithm for their study design.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"31"},"PeriodicalIF":2.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11780961/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety outcome trials in four mainline medical journals 30 years apart: a narrative review and the need for the transparency of informed consents.","authors":"Sinem Nihal Esatoglu, Ayse Ozdede, Yesim Ozguler, Koray Tascilar, Hasan Yazici","doi":"10.1186/s13063-025-08732-x","DOIUrl":"10.1186/s13063-025-08732-x","url":null,"abstract":"<p><strong>Background: </strong>It was our impression that safety outcome trials were getting more frequent, raising ethical issues mainly related to patient autonomy. We and others had also proposed this autonomy would be best served if wording of the informed consents would be in the public domain.</p><p><strong>Methods: </strong>Initially two observers and an arbiter tabulated the main aims of randomized controlled trials (RCTs) published in 1990-1991 vs. 2019-2020 as efficacy, safety, or undecided in four mainline medical journals, from the websites. A pragmatic design as well as other salient features was also tabulated. After noting too many trials were categorized as undecided, two additional independent observers and the arbiter did a reassessment.</p><p><strong>Results: </strong>In our reassessment of 889 RCTs, 309 in earlier and 580 in the later time period, 828 (93%) were categorized as efficacy and 47 (5%) as a safety trial. We were undecided in 14 (2%) trials. The proportion of safety outcome trials between the two time periods were similar [14/309 (5%) vs. 33/580 (6%)] while RCTs of any category conducted in the critical care settings notably increased in time [12/309 (4%) vs. 52/580 (9%) OR 2.4; 1.3-4.6]. Death was a primary outcome measure in 0/14 among the earlier and 16/33 (49%) among the later safety outcome trials. Stroke in 9 and myocardial infarction in 8 safety outcome trials were additional primary outcome measures in the same group. There were 2 pragmatic trials in the earlier and 93 in the later period.</p><p><strong>Conclusion: </strong>Although we did not observe a differential increase among the safety outcome trials of all categories, those in critical care settings had significantly increased in time. So did the safety outcome trials with primary outcome measures like death, myocardial infarction, and stroke as well as randomized controlled trials with a pragmatic design. These raise the issue of autonomy related to how clearly the sought-after safety through designing empirical studies primarily to quantitate harm had been worded to the trial participants in plain language. We maintain this issue cannot be adequately addressed unless the informed consent forms, especially for safety outcome trials, are in the public domain.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"28"},"PeriodicalIF":2.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11763130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143042371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A single-site randomized controlled trial of partner navigation to HCV treatment for people who inject drugs: a study protocol for the You're Empowered for Treatment Initiation (YETI) partner trial.","authors":"Meghan D Morris, Judy Y Tan, Claire C McDonell, Maia Scarpetta, Tiffany N Nguyen, Jennifer C Price, Torsten B Neilands","doi":"10.1186/s13063-024-08662-0","DOIUrl":"10.1186/s13063-024-08662-0","url":null,"abstract":"<p><strong>Background: </strong>Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors.</p><p><strong>Methods: </strong>The You're Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models.</p><p><strong>Discussion: </strong>This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06179498. Registered on December 22, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"26"},"PeriodicalIF":2.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of early versus late artificial rupture of membranes during oxytocin induction of labour on the incidence of chorioamnionitis: a randomised controlled trial (ARM trial).","authors":"Meghan G Hill, Michelle R Wise, Emmanuelle Pauleau, Beatrice Treadwell, Lynn Sadler","doi":"10.1186/s13063-025-08722-z","DOIUrl":"10.1186/s13063-025-08722-z","url":null,"abstract":"<p><strong>Background: </strong>The approach to induction of labour differs internationally, with timing of amniotomy being controversial. Some institutions favour performing artificial rupture of membranes prior to commencement of oxytocin infusion, with the belief that the labour will progress more efficiently. In other institutions, the approach recommended is for oxytocin infusion with intact amniotic membranes until the person has reached the active phase of labour, citing risk of infection with early amniotomy. Current evidence is inconclusive. We are performing a randomised controlled trial assessing whether delaying amniotomy until the active phase of labour can decrease the rate of chorioamnionitis.</p><p><strong>Methods: </strong>This is a randomised controlled trial at a single centre in New Zealand. Pregnant people undergoing induction of labour at ≥ 37 weeks gestational age with intact membranes and a singleton gestation are eligible for the trial. Participants are randomised to 'Early' amniotomy, at the commencement of oxytocin infusion, or to 'Late' amniotomy, when they have reached a cervical dilation of 6 or more centimetres or when they have been receiving oxytocin infusion for 12 h. The primary outcome of the trial is chorioamnionitis. To detect a decrease in chorioamnionitis from 9 to 3% with a power of 80% and a 95% CI, we will require 488 participants in total, randomised in a 1:1 ratio.</p><p><strong>Discussion: </strong>If delaying amniotomy reduces the rate of chorioamnionitis, this is important to inform future practice. Chorioamnionitis entails risk to both the pregnant person and the fetus and is an important contributor to neonatal sepsis, neonatal intensive care unit admission, maternal sepsis, caesarean, wound infection and postoperative infective complications. Conversely, if the rate of chorioamnionitis is not affected by timing of amniotomy, this will allow for safe individualization of care.</p><p><strong>Trial registration: </strong>The trial is registered on the Australian and New Zealand Clinical Trials Registry, anzctr.org.au. Full registry title is 'Impact of early versus late artificial rupture of membranes during oxytocin induction of labour on the incidence of chorioamnionitis: A randomised controlled trial'.</p><p><strong>Trial id: </strong>ACTRN12621000405819. Date registered 14 April 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"27"},"PeriodicalIF":2.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11752794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}