.png)
Late-Breaking Research Presentation Session 4
Late-breaking Research Sessions
Expedited Sessions
Optimal management of type 2 diabetes mellitus in pregnancy is uncertain. Our objective was to estimate the effect of metformin added to insulin for maternal type 2 diabetes treatment on composite adverse neonatal outcome.
Study Design:
In this multicenter trial, we randomly assigned patients with pre-gestational type 2 diabetes or diabetes diagnosed < 22 weeks’ gestation to insulin/placebo or insulin/metformin until delivery. The primary outcome was a composite of perinatal death or severe neonatal complications; principal secondary outcomes were maternal hypoglycemia and neonatal fat mass at birth. Pre-specified subgroup analyses included patients with BMI > 30 kg/m2 and pre-gestational diabetes. Logistic regression controlling for site, timing of diabetes diagnosis, BMI, and gestational age at enrollment estimated the adjusted odds ratio (aOR) and 95% CI of composite adverse neonatal outcome.
Results:
397 were randomized to insulin/placebo and 397 to insulin/metformin. The primary outcome occurred in 71% of infants in the insulin/placebo group and 69% in the insulin/metformin group [relative risk 0.96; 95% CI 0.82-1.12]. Frequency of maternal hypoglycemia was similar between groups. Compared to insulin/placebo, the insulin/metformin group had lower odds of delivery of a large for gestational age (LGA) infant [aOR 0.66, 95%CI 0.50-0.92], but no significance difference in cesarean delivery. There were no significant differences in composite adverse neonatal outcome in subgroup analyses for BMI > 30 kg/m2 or pre-gestational diabetes. There were also no significant differences in maternal/neonatal adverse events or delivery of an SGA infant.
Conclusion: Adding metformin to insulin to treat type 2 diabetes in pregnancy did not reduce composite adverse neonatal outcome, reduce maternal hypoglycemia, or infant fat mass. Metformin reduced frequency of an LGA infant without effecting mode of delivery. While the addition of metformin did not demonstrate a decrease in adverse composite neonatal outcome, the reduction in LGA suggests additional studies are needed to measure long term infant metabolic outcomes.
Kim Boggess, MD
Professor
University of North Carolina
Chapel Hill, North Carolina, United States
Alison Marquis, PhD
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Jerrie Refuerzo, MD
Associate Professor
University of Texas Health Science Center at Houston
Houston, Texas, United States
Noelia Zork, MD
New York Presbyterian-Columbia University Medical Center
New York, New York, United States
Ashley N. Battarbee, MD, MSCR (she/her/hers)
Assistant Professor
University of Alabama at Birmingham
Birmingham, AL, United States
Kacey Eichelberger, MD
Chair, Department of Obstetrics & Gynecology
USC School of Medicine Greenville
Greenville, South Carolina, United States
Gladys A. Ramos, MD
Clinica Professor
University of California
San Diego, California, United States
Gayle Olson, MD, MPH
Professor
University of Texas Medical Branch
Galveston, Texas, United States
Celeste Durnwald, MD (she/her/hers)
Associate Professor
Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
.jpg "Mark B. Landon, MD photo")
Mark B. Landon, MD
Richard L. Meiling Professor and Chair, Obstetrics and Gynecology
The Ohio State University
Columbus, Ohio, United States
Kjersti M. Aagaard, MD,PhD
Professor and Vice Chair of Research Department of Obstetrics and Gynecology, Division of MFM
Texas Children's and Baylor College of Medicine
Houston, Texas, United States
Kedra Wallace, PhD
University of Mississippi Medical Center
Rockford, Illinois, United States
Christina Scifres, MD
Indiana University School of Medicine
Indianapolis, Indiana, United States
Todd J. Rosen, MD
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Wadia Mulla, MD
Temple University Hospital
Philadelphia, Pennsylvania, United States
Amy M. Valent, DO (she/her/hers)
Assistant Professor of Obstetrics and Gynecology
Oregon Health and Science University
Portland, Oregon, United States
Sherri Longo, MD
Maternal-Fetal Medicine Physician
Ochsner Medical center
New Orleans, Louisiana, United States