EMPOWaR

• Research type

  Research Study

• Full title

  Efficacy of Metformin in Pregnant Obese Women, a Randomised Controlled Trial.

• IRAS ID

  42103

• Contact name

  Jane E Norman

• Sponsor organisation

  University of Edinburgh

• Eudract number

  2009-017134-47

• ISRCTN Number

  TBC

• Research summary

  The aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies. We will use high birthweight centile as a surrogate marker for future obesity as its validity has been shown in large epidemiological studies. The problem of maternal obesity, leading to programming of future life obesity risk in the offspring, and manifest by excess birthweight, is reaching epidemic proportions. Metformin is widely used to treat gestational diabetes. It reduces insulin resistance, which is likely to be higher in obese pregnant women. We believe that metformin will likely be an effective therapy in interrupting this cycle, and improving pregnancy outcome for both baby and mother. Additionally, intervention with metformin will allow us to explore the mechanism by which obesity causes adverse pregnancy outcome. This study sets out a multidisciplinary programme for testing this hypothesis. We will randomise 400 obese pregnant women to treatment with metformin (up to 2500mg daily) or placebo. Our primary outcome is birthweight centile of the baby, and we will collect this information on all women. Additionally, we will perform nested studies on a subset of women, to determine the effects of metformin and or reducing insulin resistance on other parameters such as vascular reactivity and myometrial contractility.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/12

• Date of REC Opinion

  24 Feb 2010

• REC opinion

  Further Information Favourable Opinion