Metformin in obese non-diabetic pregnant women Version 1.0

• Research type

  Research Study

• Full title

  Does metformin improve pregnancy outcomes (onset of maternal GDM, hypertension, PET, macrosomia, shoulder dystocia, admission to SCBU) in obese non-diabetic women?

• IRAS ID

  7506

• Sponsor organisation

  Epsom & St Helier University Hospitals NHS Trust

• Eudract number

  2008-005892-83

• ISRCTN Number

  N/A

• Research summary

  Lay Description of Research:Obesity in Pregnancy has been identified by the Confidential Enquiry intoMaternal & Child Health (CEMACH) (2008-2011) as a major health risk. Thereis substantial evidence that obesity in pregnancy contributes to increasedmorbidity and mortality for both mother and baby. CEMACH found thatapproximately ?? 35% of women who diedhad a BMI of 30 or greater ?? 30% of themothers who had a stillbirth or a neonatal death were obese. Obese women spendan average of 4.83 more days in hospital and the increased levels ofcomplications in pregnancy and interventions in labour represent a 5-foldincrease in cost of antenatal care. The costs associated with newborns are alsoincreased, as in babies born to obese mothers there is a 3.5 fold increase inadmission to Neonatal Intensive Care Unit (NICU). Audit data for our populationshowed that 12% of women have a BMI >30 and 7% with morbid obesity. A recentstudy of 120,251 pregnant, obese women showed that limited or no weight gain inobese pregnant women has favourable pregnancy outcomes. The diabetes drug,Metformin, improves insulin sensitivity and causes weight reduction. It doescross the placenta, and retrospective data has shown no serious adverse events.The Metformin in gestational diabetes (MiG) study preliminary data (MiG 2007)suggested that Metformin is safe with no evidence of increase in birth defectsand maternal complications. NICE has recently approved the use of Metformin inpregnant diabetic women. Three small randomised controlled trials evaluatedmetformin for the treatment of obesity among non-pregnant adolescents showedreductions in BMI and weight. There is an urgent need for a large scalecontrolled trial of metformin in adult obese pregnant women. We aim to assesswhether metformin will achieve less weight gain and avoid complications inobese women.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  08/H0806/80

• Date of REC Opinion

  19 Nov 2008

• REC opinion

  Further Information Favourable Opinion