Amaefule, Chiamaka Esther ORCID: 0000-0003-3864-2642, Bolou, Angeliki ORCID: 0000-0002-8606-2805, Drymoussi, Zoe, Gonzalez Carreras, Francisco Jose ORCID: 0000-0002-3043-7495, Pardo Llorente, Maria del Carmen, Lanz, Doris ORCID: 0000-0001-9879-3069, Dodds, Julie, Sweeney, Lorna, Pizzo, Elena, D’Amico, Maria, Thomas, Amy, Heighway, James, Daru, Jahnavi ORCID: 0000-0001-5816-2609, Sobhy, Soha, Robson, John, Sanghi, Anita, Zamora, Javier, Harden, Angela, Hitman, Graham, Khan, Khalid, Pérez, Teresa, Huda, Mohammed SB and Thangaratinam, Shakila (2020) Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, doubleblind feasibility trial — Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA). BMJ Open, 10 (5):e036198. ISSN 2044-6055 (Online) (doi:https://doi.org/10.1136/bmjopen-2019-036198)

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Abstract

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.

Item Type:	Article
Additional Information:	© 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. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Uncontrolled Keywords:	metformin, pregnancy, gestational diabetes mellitus, type 2 diabetes, protocol, pilot trial, feasibility study, randomised controlled trials
Faculty / School / Research Centre / Research Group:	Faculty of Education, Health & Human Sciences Faculty of Education, Health & Human Sciences > School of Health Sciences (HEA)
Last Modified:	07 Oct 2021 21:02
URI:	http://gala.gre.ac.uk/id/eprint/28321

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