OMAhA: Optimising health outcomes by using Metformin to reduce risk of diabetes After pregnancy: a feasibility study for a randomised, blinded, placebo-controlled trial
Up to 50% of women affected by Gestational Diabetes (GDM) will progress to type 2 diabetes in the next five years. The proportion of women diagnosed with GDM is on the increase, and if GDM or type 2 diabetes continue to go undiagnosed and untreated, there is an increased risk of a number of maternal and fetal complications.
Current guidelines recommend that women diagnosed with GDM are followed up after birth, however only a fifth of all women with GDM undergo postnatal screening for type 2 diabetes. Metformin is an established treatment for type 2 diabetes during pregnancy and in the postnatal period, and for GDM. It is a safe, cheap and easy medicine to administer, and importantly, has been effective in reducing the rate of type 2 diabetes in general populations at risk of type 2 diabetes.
Metformin has not previously been used by postnatal women, with a diagnosis of gestational diabetes. Previous research shows the promising role of metformin in reducing the risk of type 2 diabetes by up to 50%, with a potential benefit persisting after 10 years.
In order to evaluate the effectiveness of administering metformin to women in the postnatal period, to reduce the risk of type 2 diabetes, the current study will ask the following main questions:
- What are the rates of recruitment and randomisation?
- What proportion of those randomised complete the study?
- What are the reasons for participation and non-participation?
Study start: October 2018
Study Duration: 18 Months
- The Royal London Hospital
- Whipps Cross University Hospital
- Newham University Hospital
Recruitment Target: 200