Abstract | INTRODUCTION: 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/m(2)) 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. TRIAL REGISTRATION NUMBER: ISRCTN51279843.
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Authors | Carolyn A Chiswick, Rebecca M Reynolds, Fiona C Denison, Sonia A Whyte, Amanda J Drake, David E Newby, Brian R Walker, Shareen Forbes, Gordon D Murray, Siobhan Quenby, Susan Wray, Jane E Norman |
Journal | BMJ open
(BMJ Open)
Vol. 5
Issue 1
Pg. e006854
(Jan 14 2015)
ISSN: 2044-6055 [Electronic] England |
PMID | 25588785
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions. |
Chemical References |
- Blood Glucose
- Hypoglycemic Agents
- Insulin
- Metformin
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Topics |
- Adolescent
- Adult
- Birth Weight
- Blood Glucose
(metabolism)
- Clinical Protocols
- Diabetes, Gestational
(blood)
- Double-Blind Method
- Female
- Fetal Development
(drug effects)
- Glucose Tolerance Test
- Humans
- Hyperglycemia
(blood, complications, prevention & control)
- Hypoglycemic Agents
(therapeutic use)
- Infant, Newborn
- Insulin
(blood)
- Insulin Resistance
- Metformin
(pharmacology, therapeutic use)
- Obesity
(complications)
- Pregnancy
- Pregnancy Complications
(blood, drug therapy, prevention & control)
- Pregnancy Outcome
- Prenatal Care
- Research Design
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