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Efficacy of metformin in pregnant obese women : a randomised controlled trial

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Chiswick, C. A., Reynolds, R. M., Denison, F. C., Whyte, Sonia, Drake, A. J., Newby, D. (David), Walker, B. R. , Forbes, S., Murray, G. D., Quenby, Siobhan, Wray, Susan and Norman, Jane E. (2015) Efficacy of metformin in pregnant obese women : a randomised controlled trial. British Medical Journal, 5 (1). e006854. doi:10.1136/bmjopen-2014-006854

Research output not available from this repository, contact author.
Official URL: http://bmjopen.bmj.com/content/5/1/e006854.abstrac...

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Abstract

Introduction Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications.

Methods and analysis The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m2) pregnant women from 16 weeks’ gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks’ gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks’ gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK.

Ethics and dissemination The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals.

Item Type: Journal Article
Subjects: R Medicine > RG Gynecology and obstetrics
Divisions: Faculty of Medicine > Warwick Medical School > Biomedical Sciences > Translational & Experimental Medicine > Reproductive Health ( - until July 2016)
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Pregnancy -- Complications, Metformin, Overweight women
Journal or Publication Title: British Medical Journal
Publisher: BMJ Group
ISSN: 0959-8146
Official Date: 15 July 2015
Dates:
DateEvent
15 July 2015Published
30 October 2014Accepted
8 October 2014Submitted
Volume: 5
Number: 1
Number of Pages: 10
Article Number: e006854
DOI: 10.1136/bmjopen-2014-006854
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: National Institute for Health Research (Great Britain) (NIHR), Medical Research Council (Great Britain) (MRC), Scotland. Chief Scientist Office (CSO), National Institute for Social Care and Health Research (Wales) (NISCHR), Northern Ireland. Public Health Agency. HSC Research & Development Division
Grant number: 08/246/09 (NIHR)

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