Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): a randomised, double-blind, placebo-controlled trial
Open accessAbstract
BACKGROUND: Maternal 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. METHODS: We 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/m(2) 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/m(2)). 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. FINDINGS: Between 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). INTERPRETATION: Metformin 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. FUNDING: The Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council and National Institute for Health Research partnership.
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In the Fetal Medicine Foundation trial, women had a higher BMI (>35 kg/m2 vs. >30 kg/m2) than in the EMPOWaR trial.
“In the Fetal Medicine Foundation trial, women had a higher BMI (>35 kg/m2 vs. >30 kg/m2), were treated with a higher starting and maximum dose of metformin, and were more compliant than women in the EMPOWaR trial(95, 96).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the EMPOWaR trial, only 67% of women fulfilled the compliance criterion.
“By contrast, in the EMPOWaR trial, compliance was defined as ingestion of at least one tablet for at least 29% of the days between randomization and delivery, and only 67% of women fulfilled this criterion(95).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the EMPOWaR trial, metformin had no significant effect on maternal weight gain during gestation.
“In this trial, metformin had no significant effect on birth weight, maternal weight gain during gestation, preeclampsia, or combined adverse pregnancy outcomes, including miscarriage, termination of pregnancy, or fetal or neonatal death(95).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the EMPOWaR trial, metformin had no significant effect on preeclampsia.
“In this trial, metformin had no significant effect on birth weight, maternal weight gain during gestation, preeclampsia, or combined adverse pregnancy outcomes, including miscarriage, termination of pregnancy, or fetal or neonatal death(95).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the Fetal Medicine Foundation trial, women were more compliant than women in the EMPOWaR trial.
“In the Fetal Medicine Foundation trial, women had a higher BMI (>35 kg/m2 vs. >30 kg/m2), were treated with a higher starting and maximum dose of metformin, and were more compliant than women in the EMPOWaR trial(95, 96).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the EMPOWaR trial, metformin had no significant effect on combined adverse pregnancy outcomes, including miscarriage, termination of pregnancy, or fetal or neonatal death.
“In this trial, metformin had no significant effect on birth weight, maternal weight gain during gestation, preeclampsia, or combined adverse pregnancy outcomes, including miscarriage, termination of pregnancy, or fetal or neonatal death(95).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
Only 13% (443/3329) of eligible patients consented to participate in the EMPOWaR study.
“It is also noteworthy that only 13% (443/3329) of eligible patients consented to participate in the EMPOWaR study, whereas 47% (400/844) of eligible women were recruited to the Fetal Medicine Foundation study, making the latter group more representative of women who meet the study’s eligibility criteria and to whom the study’s results apply.”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the Fetal Medicine Foundation trial, women were treated with a higher starting and maximum dose of metformin than in the EMPOWaR trial.
“In the Fetal Medicine Foundation trial, women had a higher BMI (>35 kg/m2 vs. >30 kg/m2), were treated with a higher starting and maximum dose of metformin, and were more compliant than women in the EMPOWaR trial(95, 96).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the EMPOWaR trial, compliance was defined as ingestion of at least one tablet for at least 29% of the days between randomization and delivery.
“By contrast, in the EMPOWaR trial, compliance was defined as ingestion of at least one tablet for at least 29% of the days between randomization and delivery, and only 67% of women fulfilled this criterion(95).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
In the EMPOWaR trial, metformin had no significant effect on birth weight.
“In this trial, metformin had no significant effect on birth weight, maternal weight gain during gestation, preeclampsia, or combined adverse pregnancy outcomes, including miscarriage, termination of pregnancy, or fetal or neonatal death(95).”
From Metformin, the Aspirin of the 21st Century: Its Role in Gestational Diabetes Mellitus, Prevention of Preeclampsia and Cancer, and the Promotion of Longevity (2017) · cites this paper as [95]
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- Authors
- Chiswick, C., Reynolds, R. M., Denison, F., Drake, A. J., Forbes, S., Newby, D. E., Walker, B. R., Quenby, S., Wray, S., Weeks, A., Lashen, H., Rodriguez, A., Murray, G., Whyte, S., & Norman, J. E.
- Affiliations
- MRC Centre for Reproductive Health (GB)
- British Heart Foundation Centre for Cardiovascular Science (GB)
- Edinburgh Royal Infirmary (GB)
- University of Warwick (GB)
- Liverpool Women's Hospital (GB)
- Jessop Hospital (GB)
- University of Edinburgh (GB)
- Corresponding author
- Norman, Jane E
- ORCID
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2015-10
- Volume
- 3
- Issue
- 10
- Pages
- 778-786
- ISSN
- 2213-8587 (ISSN-L)
- PMC
- PMC4673088
- OpenAlex
- W2144199745
- Cited by
- 260
- References
- 36
- Citations by year
- 2026: 12 · 2025: 20 · 2024: 15 · 2023: 21 · 2022: 21 · 2021: 27 · 2020: 28 · 2019: 28 · 2018: 33 · 2017: 22 · 2016: 27 · 2015: 6
- FWCI
- 33.38
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Explore Bristol Research (publishedVersion)
- Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, cc-by)
- Bristol Research (University of Bristol) (submittedVersion, cc-by)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- Wellcome Trust (103782)
- National Institute for Health and Care Research (08/246/09)
- Medical Research Council (MC_G1002463)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Birth, Development, and Health
- Keywords
- metformin, maternal obesity, pregnancy, birth weight, insulin resistance, miscarriage, stillbirth, preterm birth, gestational diabetes mellitus, maternal hyperglycemia, placental growth factor, placental insufficiency, fetal growth restriction, placental DNA methylation, epigenetics
- MeSH terms
- Abortion, Spontaneous, Adult, Double-Blind Method, Female, Fetal Macrosomia, Humans, Hypoglycemic Agents, Metformin, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Diabetes, Gestational, Stillbirth, Young Adult, Obesity, Abdominal
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