دورية أكاديمية

Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial

التفاصيل البيبلوغرافية
العنوان: Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial
المؤلفون: Ola F. Quotah, Glen Nishku, Jessamine Hunt, Paul T. Seed, Carolyn Gill, Anna Brockbank, Omoyele Fafowora, Ilektra Vasiloudi, Opeoluwa Olusoga, Ellie Cheek, Jannelle Phillips, Katarzyna G. Nowak, Lucilla Poston, Sara L. White, Angela C. Flynn
المصدر: Pilot and Feasibility Studies, Vol 8, Iss 1, Pp 1-9 (2022)
بيانات النشر: BMC, 2022.
سنة النشر: 2022
المجموعة: LCC:Medicine (General)
مصطلحات موضوعية: Gestational diabetes, Maternal obesity, Lifestyle intervention, Metformin, Medicine (General), R5-920
الوصف: Abstract Background Obesity in pregnancy increases the risk of gestational diabetes mellitus (GDM) and associated adverse outcomes. Despite metabolic differences, all pregnant women with obesity are considered to have the same risk of developing GDM. Improved risk stratification is required to enable targeted intervention in women with obesity who would benefit the most. The aim of this study is to identify pregnant women with obesity at higher risk of developing GDM and, in a pilot randomised controlled trial (RCT), test feasibility and assess the efficacy of a lifestyle intervention and/or metformin to improve glycaemic control. Methods Women aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥ 30kg/m2 will be recruited from one maternity unit in London, UK. The risk of GDM will be assessed using a multivariable GDM prediction model combining maternal age, mid-arm circumference, systolic blood pressure, glucose, triglycerides and HbA1c. Women identified at a higher risk of developing GDM will be randomly allocated to one of two intervention groups (lifestyle advice with or without metformin) or standard antenatal care. The primary feasibility outcomes are study recruitment, retention rate and intervention adherence and to collect information needed for the sample size calculation for the definitive trial. A process evaluation will assess the acceptability of study processes and procedures to women. Secondary patient-centred outcomes include a reduction in mean glucose/24h of 0.5mmol/l as assessed by continuous glucose monitoring and changes in a targeted maternal metabolome, dietary intake and physical activity. A sample of 60 high-risk women is required. Discussion Early risk stratification of GDM in pregnant women with obesity and targeted intervention using lifestyle advice with or without metformin could improve glucose tolerance compared to standard antenatal care. The results from this feasibility study will inform a larger adequately powered RCT should the intervention show trends for potential effectiveness. Trial registration This study has been approved by the NHS Research Ethics Committee (UK IRAS integrated research application system; reference 18/LO/1500). EudraCT number 2018-000003-16 .
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 2055-5784
18427723
العلاقة: https://doaj.org/toc/2055-5784Test
DOI: 10.1186/s40814-022-01021-3
الوصول الحر: https://doaj.org/article/c362be02ef464f5db712bde18427723bTest
رقم الانضمام: edsdoj.362be02ef464f5db712bde18427723b
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:20555784
18427723
DOI:10.1186/s40814-022-01021-3