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The relation between FTO gene variants and pregnancy outcomes will be examined. Secondary outcomes include maternal and neonatal outcomes, body composition scores, patient satisfaction and infant development at 2 years. The primary outcome will be the birth weight centile (z score). This is a randomised, multicentre, double blind, placebo-controlled trial.Assuming power 90%, significance level 5% and 2-sided testing, we will recruit 425 subjects per arm of the trial.This will allow the detection of a difference in mean centile (z-score) of 0.21 standard deviations.Īll women will undergo oral glucose tolerance testing at booking and at 28 wks those found to have GDM at 28 weeks will commence home glucose monitoring and will receive metformin if glucose values are outside target range. Genetic studies will investigate whether patients with polymorphisms of the candidate fat gene, FTO gene, differ in their response to metformin and whether this is associated with favourable pregnancy outcomes. The study will also seek to determine whether metformin will improve body fat distribution as measured by bioimpedance during pregnancy with particular emphasis on metabolic active visceral fat.
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The aim of this study is to test the hypothesis that management of obese non-diabetic pregnant women with standardised life-style intervention (diet and physical activity) plus metformin will lead to improved maternal and perinatal outcomes compared with life-style intervention alone. By improving insulin sensitivity and enhancing GLP-1 release, metformin is associated with weight reduction by approximately 5.8% with no serious adverse events. Results from various studies have concluded that limited or no weight gain during pregnancy in obese women results in more favourable pregnancy outcomes. There is a 5-fold increase in costs of antenatal care. Obesity increases the risk of miscarriages, GDM, pregnancy-induced hypertension/PET, Caesarean sections, deep venous thrombosis, puerperal sepsis and LGA babies.
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Obesity in Pregnancy has been identified by the Confidential Enquiry into Maternal and Child Health report (2007) as a major health risk to mother and baby: We anticipate babies will also have better birth weights, will be easier to deliver naturally, will not need to go to special care baby units and will be healthier. We are hoping to show that it will benefit these women by causing less weight gain, less high blood pressure, and less diabetes. We now wish to examine its potential for obese women who do not have diabetes. We have a lot of experience using metformin to treat women with diabetes in pregnancy where it is greatly beneficial. It works by improving the body's sensitivity to insulin which is important as resistance to insulin is common in obesity. Metformin has the great advantage of not causing weight gain and often leads to a small amount of weight loss. Fortunately it is relatively cheap and taken as a tablet with meals. Studies in pregnant PCOS women and women with diabetes in pregnancy have shown it to be safe and effective. The drug metformin has been used for years in the treatment of diabetes and more recently for polycystic ovary syndrome (PCOS). This was shown in a very large study of more than 120, 000 obese women. If obese women gain little or even no weight during pregnancy, the outcome of the pregnancy is known to be improved. Unfortunately these measures are often insufficient to produce significant improvements in weight. Traditionally, obesity is treated by lifestyle measures encouraging healthy eating and increasing physical activity. Babies of obese mothers are more than 3 times as likely to need admission to the Neonatal Intensive Care Unit. When all deaths in women during pregnancy are analysed, obesity comes out as the most common risk factor. We know from a recent large national enquiry into all maternal and child deaths in the UK, known as CEMACH, that obesity is a major risk both for the mother and her child. Of particular concern is that more young people including children are being recognised as being overweight or obese. Obesity is on the rise in all developed countries.