Metformin in gestational diabetes mellitus: A double-blind placebo-controlled randomized trial

Tew, Min P. and Tan, Peng C. and Saaid, Rahmah and Hong, Jesrine G. S. and Omar, Siti Z. (2022) Metformin in gestational diabetes mellitus: A double-blind placebo-controlled randomized trial. International Journal of Gynecology & Obstetrics, 156 (3). pp. 508-515. ISSN 0020-7292, DOI https://doi.org/10.1002/ijgo.13718.

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Abstract

Objective To evaluate the impact of preemptive metformin on the level of glycosylated hemoglobin (HbA1c) at 36 weeks of pregnancy in women with gestational diabetes mellitus controlled by diet change (GDMA1). Methods A randomized, double-blind, placebo-controlled trial was performed in a university hospital. Women with GDMA1 were recruited at 16-30 weeks of pregnancy and randomized to oral metformin 500 mg twice daily or identical placebo tablets to delivery. Level of HbA1c was taken at recruitment and at 36 weeks of pregnancy. The primary outcome was the change in level of HbA1c at recruitment and 36 weeks of pregnancy. Results Data from 106 participants were analyzed. The level of HbA1c during pregnancy increased significantly with a mean increase of 0.20% +/- 0.31% (P < 0.001; metformin) versus 0.27% +/- 0.31% (P < 0.001; placebo). An increment of 0.07% across trial arms was not significant (P = 0.310). Mean birth weight was significantly lower in the metformin group (2.81 +/- 0.41 kg vs 2.98 +/- 0.37 kg; P = 0.030). Rates of macrosomia (>= 3.5 kg; 0/53 0%] vs 4/53 8%]; P = 0.123) and low birth weight (P = 0.102) were not significantly different. Conclusion Preemptive metformin did not prevent the level of HbA1c at 36 weeks of pregnancy from rising nor significantly reduce the increase of HbA1c. Mean birth weight was significantly lower in the metformin arm with a non-significant trend to low birth weight, which is concerning. ISRCTN: ISRCTN10845466.

Item Type: Article
Funders: Universiti Malaya
Uncontrolled Keywords: Gestational diabetes; HbA1c; Low birth weight; Macrosomia; Metformin
Subjects: R Medicine > RG Gynecology and obstetrics
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 19 Jul 2022 04:39
Last Modified: 19 Jul 2022 04:39
URI: http://eprints.um.edu.my/id/eprint/33824

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