Metformin for women who are obese during pregnancy for improving maternal and infant outcomes

Eames, Amanda J; Grivell, Rosalie M; Deussen, Andrea R; Hague, William; Dodd, Jodie M

doi:10.1002/14651858.cd010564

Cited by 3 publications

(2 citation statements)

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“…Obese pregnant women are significantly more insulin resistant and hyperglycaemic than are pregnant women of a normal weight, 11 and several large studies, including the Camden study 12 and the HAPO study, 13 show a positive association between high glucose concentrations and macrosomia, even at glucose concentrations regarded as normal during pregnancy. Additionally, a Cochrane review protocol 14 has outlined additional potential benefits on mother and baby of metformin in obese pregnant women.…”

Section: Introductionmentioning

confidence: 99%

Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): a randomised, double-blind, placebo-controlled trial

Chiswick¹,

Reynolds²,

Denison³

et al. 2015

The Lancet Diabetes & Endocrinology

225

215

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SummaryBackgroundMaternal obesity is associated with increased birthweight, and obesity and premature mortality in adult offspring. The mechanism by which maternal obesity leads to these outcomes is not well understood, but maternal hyperglycaemia and insulin resistance are both implicated. We aimed to establish whether the insulin sensitising drug metformin improves maternal and fetal outcomes in obese pregnant women without diabetes.MethodsWe did this randomised, double-blind, placebo-controlled trial in antenatal clinics at 15 National Health Service hospitals in the UK. Pregnant women (aged ≥16 years) between 12 and 16 weeks' gestation who had a BMI of 30 kg/m2 or more and normal glucose tolerance were randomly assigned (1:1), via a web-based computer-generated block randomisation procedure (block size of two to four), to receive oral metformin 500 mg (increasing to a maximum of 2500 mg) or matched placebo daily from between 12 and 16 weeks' gestation until delivery of the baby. Randomisation was stratified by study site and BMI band (30–39 vs ≥40 kg/m2). Participants, caregivers, and study personnel were masked to treatment assignment. The primary outcome was Z score corresponding to the gestational age, parity, and sex-standardised birthweight percentile of liveborn babies delivered at 24 weeks or more of gestation. We did analysis by modified intention to treat. This trial is registered, ISRCTN number 51279843.FindingsBetween Feb 3, 2011, and Jan 16, 2014, inclusive, we randomly assigned 449 women to either placebo (n=223) or metformin (n=226), of whom 434 (97%) were included in the final modified intention-to-treat analysis. Mean birthweight at delivery was 3463 g (SD 660) in the placebo group and 3462 g (548) in the metformin group. The estimated effect size of metformin on the primary outcome was non-significant (adjusted mean difference −0·029, 95% CI −0·217 to 0·158; p=0·7597). The difference in the number of women reporting the combined adverse outcome of miscarriage, termination of pregnancy, stillbirth, or neonatal death in the metformin group (n=7) versus the placebo group (n=2) was not significant (odds ratio 3·60, 95% CI 0·74–17·50; p=0·11).InterpretationMetformin has no significant effect on birthweight percentile in obese pregnant women. Further follow-up of babies born to mothers in the EMPOWaR study will identify longer-term outcomes of metformin in this population; in the meantime, metformin should not be used to improve pregnancy outcomes in obese women without diabetes.FundingThe Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research partnership.

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Section: Introductionmentioning

confidence: 99%

Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): a randomised, double-blind, placebo-controlled trial

Chiswick¹,

Reynolds²,

Denison³

et al. 2015

The Lancet Diabetes & Endocrinology

225

215

View full text Add to dashboard Cite

show abstract

“…This, in turn, would result in a reduction in future life risk of obesity and metabolic syndrome in the offspring. A Cochrane review 11 has outlined additional potential benefits of metformin on mother and child in normally glucose-tolerant obese pregnant women. In contrast, EMPOWaR (Effect of metformin on maternal and fetal outcomes in obese pregnant women) 12 , a multicentre, randomized, double-blind, placebo-controlled trial, concluded that metformin did not have a role in reducing the birth weight of offspring of obese pregnant women, possibly indicating that this was mediated through a pathway other than insulin resistance.…”

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confidence: 99%