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https://hdl.handle.net/2440/52562
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Type: | Journal article |
Title: | Metformin versus insulin for the treatment of gestational diabetes |
Author: | Rowan, J. Hague, W. Gao, W. Battin, M. Moore, M. |
Citation: | New England Journal of Medicine, 2008; 358(19):2003-2016 |
Publisher: | Massachusetts Medical Soc |
Issue Date: | 2008 |
ISSN: | 0028-4793 1533-4406 |
Statement of Responsibility: | Janet A. Rowan, William M. Hague, Wanzhen Gao, Malcolm R. Battin, M. Peter Moore |
Abstract: | Background: Metformin is a logical treatment for women with gestational diabetes mellitus, but randomized trials to assess the efficacy and safety of its use for this condition are lacking. Methods: We randomly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin (with supplemental insulin if required) or insulin. The primary outcome was a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity. The trial was designed to rule out a 33% increase (from 30% to 40%) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin. Secondary outcomes included neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance, and acceptability of treatment. Results: Of the 363 women assigned to metformin, 92.6% continued to receive metformin until delivery and 46.3% received supplemental insulin. The rate of the primary composite outcome was 32.0% in the group assigned to metformin and 32.2% in the insulin group (relative risk, 0.99; 95% confidence interval, 0.80 to 1.23). More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again (76.6% vs. 27.2%, P<0.001). The rates of other secondary outcomes did not differ significantly between the groups. There were no serious adverse events associated with the use of metformin. Conclusions: In women with gestational diabetes mellitus, metformin (alone or with supplemental insulin) is not associated with increased perinatal complications as compared with insulin. The women preferred metformin to insulin treatment. (Australian New Zealand Clinical Trials Registry number, 12605000311651.) |
Keywords: | MiG Trial Investigators Humans Diabetes, Gestational Premature Birth Pregnancy Complications, Cardiovascular Jaundice, Neonatal Hypoglycemia Metformin Insulin Hypoglycemic Agents Pregnancy Outcome Drug Therapy, Combination Gestational Age Pregnancy Adult Infant, Newborn Patient Satisfaction Female |
DOI: | 10.1056/NEJMoa0707193 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/250403 |
Published version: | http://dx.doi.org/10.1056/nejmoa0707193 |
Appears in Collections: | Aurora harvest Obstetrics and Gynaecology publications |
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