Bolou, Angeliki ORCID: 0000-0002-8606-2805 , Drymoussi, Zoe ORCID: 0000-0001-6683-9114 , Lanz, Doris, Amaefule, Chiamaka Esther, Gonzalez Carreras, Francisco Jose, Pardo Llorente, Maria del Carmen, Dodds, Julie, Pizzo, Elena, Thomas, Amy, Heighway, James, Harden, Angela, Sanghi, Anita, Hitman, Graham, Zamora, Javier ORCID: 0000-0003-4901-588X , Pérez, Teresa ORCID: 0000-0003-0439-8952 , Huda, Mohammed S B and Thangaratinam, Shakila (2023) Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study. BMJ Open, 13 (11):e073813. pp. 1-18. ISSN 2044-6055 (Online) (doi:https://doi.org/10.1136/bmjopen-2023-073813)

Preview

PDF (Publisher VoR) 45044_BOLOU_Metformin_in_the_prevention_of_type_2_ diabetes_after_gestational_diabetes_in_postnatal_women.pdf - Published Version Available under License Creative Commons Attribution Non-commercial. Download (1MB) | Preview

Abstract

Objective: To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.
Design: A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.
Setting: Three inner-city UK National Health Service hospitals in London.
Participants: Pregnant women with gestational diabetes treated with medication.
Interventions: 2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.
Primary outcome measures: Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.
Secondary outcome measures: Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.
Results: Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.
Conclusions: It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

Item Type:	Article
Uncontrolled Keywords:	diabetes in pregnancy; diabetes; preventive medicine; public health; metformin; pilot study
Subjects:	R Medicine > R Medicine (General) R Medicine > RG Gynecology and obstetrics R Medicine > RS Pharmacy and materia medica
Faculty / School / Research Centre / Research Group:	Faculty of Education, Health & Human Sciences Faculty of Education, Health & Human Sciences > Institute for Lifecourse Development Faculty of Education, Health & Human Sciences > Institute for Lifecourse Development > Centre for Chronic Illness and Ageing Faculty of Education, Health & Human Sciences > School of Health Sciences (HEA)
Last Modified:	21 Dec 2023 11:11
URI:	http://gala.gre.ac.uk/id/eprint/45044

Actions (login required)

View Item

Downloads