Jerrie S Refuerzo1, Rose Gowen2, Claudia Pedroza3, Maria Hutchinson1, Sean C Blackwell1, Susan Ramin4. 1. Division of Maternal Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Texas Health Science Center at Houston, Houston, Texas. 2. Department of Obstetrics, Gynecology and Reproductive Sciences, University of Texas Health Science Center at Brownsville, Brownsville, Texas. 3. Center for Clinical Research and Evidence-Based Medicine, University of Texas Health Science Center at Houston, Houston, Texas. 4. Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas.
Abstract
OBJECTIVE: Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. STUDY DESIGN: A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c < 7% at delivery. Maternal and neonatal outcomes were compared between groups. RESULTS: In this study, 8 women received metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. CONCLUSION: In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
RCT Entities:
OBJECTIVE: Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM. STUDY DESIGN: A pilot randomized, controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy. The primary outcome was glycemic control measured with hemoglobin A1c < 7% at delivery. Maternal and neonatal outcomes were compared between groups. RESULTS: In this study, 8 women received metformin and 11 received insulin. All women in both groups achieved glycemic control by delivery (HgbA1c: metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92%). There were similar rates of cesarean delivery, birth weights, neonatal intensive care unit admissions, respiratory distress syndrome, and neonatal dextrose treatment between groups. There was one case of fetal macrosomia in the insulin group, one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy. CONCLUSION: In this pilot study, glycemic control was achieved in women who received metformin and insulin. Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Authors: O Kgosidialwa; D Bogdanet; A M Egan; P M O'Shea; C Newman; T P Griffin; C McDonagh; C O'Shea; L Carmody; S D Cooray; E Anastasiou; E Wender-Ozegowska; C Clarson; A Spadola; F Alvarado; E Noctor; E Dempsey; A Napoli; C Crowther; S Galjaard; M R Loeken; Mja Maresh; P Gillespie; H de Valk; A Agostini; L Biesty; D Devane; F Dunne Journal: BJOG Date: 2021-08-03 Impact factor: 7.331