Toggle Main Menu Toggle Search

Open Access padlockePrints

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

Lookup NU author(s): Professor Brian Walker

Downloads

Full text for this publication is not currently held within this repository. Alternative links are provided below where available.


Abstract

© 2015, BMJ Publishing Group. All rights reserved.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 pee-rreviewed journals. Trial registration number: ISRCTN51279843.


Publication metadata

Author(s): Chiswick CA, Reynolds RM, Denison FC, Whyte SA, Drake AJ, Newby DE, Walker BR, Forbes S, Murray GD, Quenby S, Wray S, Norman JE

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2015

Volume: 5

Issue: 1

Print publication date: 01/01/2015

Online publication date: 14/01/2015

Acceptance date: 31/10/2014

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjopen-2014-006854

DOI: 10.1136/bmjopen-2014-006854

PubMed id: 25588785


Altmetrics

Altmetrics provided by Altmetric


Share