TY - JOUR
T1 - Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women
T2 - a protocol for a randomised, placebo-controlled, double-blind feasibility trial—Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA)
AU - Amaefule, Chiamaka Esther
AU - Bolou, Angeliki
AU - Drymoussi, Zoe
AU - Gonzalez Carreras, Francisco Jose
AU - Pardo Llorente, Maria Del Carmen
AU - Lanz, Doris
AU - Dodds, Julie
AU - Sweeney, Lorna
AU - Pizzo, Elena
AU - D'Amico, Maria
AU - Thomas, Amy
AU - Heighway, James
AU - Daru, Jahnavi
AU - Sobhy, Soha
AU - Robson, John
AU - Sanghi, Anita
AU - Zamora, Javier
AU - Harden, Angela
AU - Hitman, Graham
AU - Khan, Khalid
AU - Pérez, Teresa
AU - Huda, Mohammed Sb
AU - Thangaratinam, Shakila
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/5/17
Y1 - 2020/5/17
N2 - INTRODUCTION: Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.METHODS AND ANALYSIS: Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.ETHICS AND DISSEMINATION: The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.TRIAL REGISTRATION NUMBER: ISRCTN20930880.
AB - INTRODUCTION: Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial.METHODS AND ANALYSIS: Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1 year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs.ETHICS AND DISSEMINATION: The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms.TRIAL REGISTRATION NUMBER: ISRCTN20930880.
KW - Diabetes Mellitus, Type 2/prevention & control
KW - Diabetes, Gestational/prevention & control
KW - Feasibility Studies
KW - Female
KW - Humans
KW - London
KW - Metformin/therapeutic use
KW - Multicenter Studies as Topic
KW - Outcome Assessment, Health Care
KW - Pregnancy
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
U2 - 10.1136/bmjopen-2019-036198
DO - 10.1136/bmjopen-2019-036198
M3 - Article
C2 - 32423937
SN - 2044-6055
VL - 10
SP - e036198
JO - BMJ open
JF - BMJ open
IS - 5
ER -