Prevention of gestational diabetes in pregnant women with obesity: protocol for a pilot randomised controlled trial.
Gestational diabetes
Lifestyle intervention
Maternal obesity
Metformin
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
25 Mar 2022
25 Mar 2022
Historique:
received:
21
09
2021
accepted:
03
03
2022
entrez:
26
3
2022
pubmed:
27
3
2022
medline:
27
3
2022
Statut:
epublish
Résumé
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. Women aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥ 30kg/m 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. 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 .
Sections du résumé
BACKGROUND
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
METHODS
Women aged 18 years or older with a singleton pregnancy and body mass index (BMI) ≥ 30kg/m
DISCUSSION
CONCLUSIONS
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
BACKGROUND
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 .
Identifiants
pubmed: 35337389
doi: 10.1186/s40814-022-01021-3
pii: 10.1186/s40814-022-01021-3
pmc: PMC8948450
doi:
Types de publication
Journal Article
Langues
eng
Pagination
70Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Informations de copyright
© 2022. The Author(s).
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