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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

Por: Bolou · A. · Drymoussi · Z. · Lanz · D. · Amaefule · C. E. · Gonzalez Carreras · F. J. · Pardo Llorente · M. d. C. · Dodds · J. · Pizzo · E. · Thomas · A. · Heighway · J. · Harden · A. · Sanghi · A. · Hitman · G. · Zamora · J. · Perez · T. · Huda · M. S. B. · Thangaratinam · S.
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.

Trial registration number

ISRCTN20930880.

Satisfacción de los pacientes de la vía rápida de cáncer de pulmón

Objetivo principal: Conocer la satisfacción de los usuarios del circuito de diagnóstico rápido de cáncer de pulmón. Metodología: Estudio prospectivo de cohortes que incluye todos los pacientes estudiados en consulta de cáncer de pulmón entre 1 de noviembre del 2016 hasta 31 de octubre del 2017, diagnosticados de neoplasia. Para conocer la satisfacción, la recogida de datos se realizó mediante cues-tionario en la última visita a la consulta de cáncer de pulmón. Resultados principales: Se estudiaron 566 pacientes con sospecha de malignidad, con diagnóstico final de neoplasia en 127 (84,7%) y con enfermedad metastásica en 29 (15,3%). Participaron 158 pacientes. La satisfacción fue alta (“excelente” y “muy bien”) en 85,4% pacientes. Conclusiones: Los resultados obtenidos muestran alto índice de satisfacción de los pacientes con la atención recibida y esto es un indicador de calidad del proceso.

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