دورية أكاديمية
أعرض في EDS

RidStress 2 randomised controlled trial protocol: an Australian phase III clinical trial of intrapartum sildenafil citrate or placebo to reduce emergency caesarean birth for fetal distress in women with small or suboptimally grown infants at term (≥37 weeks).

التفاصيل البيبلوغرافية
العنوان: RidStress 2 randomised controlled trial protocol: an Australian phase III clinical trial of intrapartum sildenafil citrate or placebo to reduce emergency caesarean birth for fetal distress in women with small or suboptimally grown infants at term (≥37 weeks).
المؤلفون: Triggs T; Mater Research Institute The University of Queensland, South Brisbane, Queensland, Australia.; Women's and Newborn Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.; The University of Queensland Faculty of Medicine, Herston, Queensland, Australia., Badawi N; Cerebral Palsy Alliance, Forestville, New South Wales, Australia.; The University of Sydney, Sydney, New South Wales, Australia., Crawford K; Mater Research Institute The University of Queensland, South Brisbane, Queensland, Australia., Liley H; Mater Research Institute The University of Queensland, South Brisbane, Queensland, Australia.; Neonatal Critical Care Unit, Mater Mothers' Hospital, Brisbane, Queensland, Australia., Lehner C; Women's and Newborn Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.; The University of Queensland Faculty of Medicine, Herston, Queensland, Australia., Nugent R; Obstetrics and Gynaecology, Sunshine Coast University Hospital, Sunshine Coast, Queensland, Australia., Kristensen K; Maternal Fetal Medicine Unit, Gold Coast University Hospital, Southport, Queensland, Australia., da Silva Costa F; Maternal Fetal Medicine Unit, Gold Coast University Hospital, Southport, Queensland, Australia., Tarnow-Mordi W; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.; NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia., Kumar S; Mater Research Institute The University of Queensland, South Brisbane, Queensland, Australia sailesh.kumar@mater.uq.edu.au.; Women's and Newborn Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.; The University of Queensland Faculty of Medicine, Herston, Queensland, Australia.; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.; NHMRC Clinical Trials Centre, Camperdown, New South Wales, Australia.
المصدر: BMJ open [BMJ Open] 2024 Sep 25; Vol. 14 (9), pp. e082945. Date of Electronic Publication: 2024 Sep 25.
نوع المنشور: Journal Article; Clinical Trial Protocol
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Sildenafil Citrate*/therapeutic use , Sildenafil Citrate*/administration & dosage , Fetal Distress* , Cesarean Section*, Humans ; Female ; Pregnancy ; Double-Blind Method ; Infant, Newborn ; Australia ; Randomized Controlled Trials as Topic ; Clinical Trials, Phase III as Topic ; Adult
مستخلص: Introduction: Small for gestational age (SGA) infants are at increased risk of fetal distress in labour requiring emergency operative birth (by caesarean section (CS), vacuum or forceps). We have previously shown that maternal oral sildenafil citrate (SC) in labour halves the need for operative birth for suspected fetal distress in women with appropriately grown term infants.
Methods and Analysis: RidStress 2 is a phase III randomised, double-blinded, placebo-controlled trial of 660 women with an SGA or suboptimally grown fetus (estimated fetal weight or abdominal circumference<10th centile for gestational age) planning a vaginal birth at term. The trial will determine whether oral intrapartum SC (50 mg eight hourly) reduces the relative risk of emergency CS for fetal distress compared with placebo. The primary outcome is CS for fetal distress, and the secondary outcomes are any operative birth for fetal distress, cost-effectiveness of SC treatment and 2-year childhood neurodevelopmental outcomes. To detect a 33% reduction in the primary outcome from 30% to 20% for an alpha of 0.05 and power of 80% with 10% dropout, requires approximately 660 women (330 in each arm). This sample size will also yield >90% power to detect a similar reduction for the secondary outcome of any operative birth (CS or instrumental vaginal birth) for fetal distress.
Ethics and Dissemination: Ethics approval was granted by the Mater Misericordiae Limited Human Research Ethics Committee (EC00332) on 11 September 2020. We plan to disseminate the results of this randomised controlled trial through presentations at scientific meetings and peer-reviewed journals, adhering to all relevant reporting guidelines.
Trial Registration Number: RidStress 2 is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000354886, 29/03/2021) and the Therapeutic Goods Association of Australia (date registered: 16 March 2021).
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: Clinical Trial; Fetal medicine; Neonatology; Perinatology; Primary Prevention
المشرفين على المادة: BW9B0ZE037 (Sildenafil Citrate)
تواريخ الأحداث: Date Created: 20240925 Date Completed: 20240925 Latest Revision: 20240927
رمز التحديث: 20240927
DOI: 10.1136/bmjopen-2023-082945
PMID: 39322593
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2023-082945