# Gestational diabetes drugs and perinatal outcomes in underserved populations

> **NIH NIH R21** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2021 · $216,250

## Abstract

PROJECT SUMMARY/ABSTRACT
Gestational diabetes mellitus (GDM) is characterized by maternal hyperglycemia leading to fetal overgrowth
and associated complications: large for gestational age (LGA), neonatal hypoglycemia, shoulder dystocia,
birth injury, and cesarean birth. While insulin has been the traditional pharmacologic intervention to maintain
euglycemia among women with GDM, there are numerous barriers to insulin use. Insulin therapy often
requires referral to specialized providers, training on administration, and multiple daily injections – all factors
that may deter effective utilization, particularly in women from racial/ethnic minorities or living in rural areas.
Disparities in diagnosis and treatment of GDM may have large public health implications; non-white women
are more than twice as likely to be diagnosed with GDM compared to white women, and black women have
higher risks for GDM-associated pregnancy and neonatal complications compared to white women. Newer
oral hypoglycemic agents, such as metformin, may be safe and effective alternatives to insulin that are
more widely accessible and acceptable in minority or resource-limited populations. The American College of
Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine continue to disagree about the
optimal pharmacological treatment for GDM. Furthermore, to date, few studies have examined how patient
sociodemographic factors - especially race/ethnicity, rural residence, and socioeconomic status - impact the
relationship between hypoglycemic medication selection and perinatal outcomes. Although the
management of GDM ideally would be informed by properly powered randomized clinical trials, the
medications of interest are already on the market and new trials are unlikely. Our multidisciplinary team of
experts in maternal-fetal medicine, health policy, pharmacoepidemiology, biostatistics, and computer
sciences have demonstrated successful collaboration to investigate medication use during pregnancy and
the postpartum period. We propose a carefully designed observational cohort study using a comprehensive
research platform of linked records including TN Medicaid claims, birth certificates and a registry of all
hospital-based encounters in TN, which will focus on relevant clinical outcomes and incorporate the
practical complexities of real-world settings. Our proposal aims to test the hypotheses that metformin use in
women with GDM is associated with a lower risk of adverse neonatal (Aim 1) and maternal (Aim 2)
outcomes compared to glyburide or insulin, especially among women from sociodemographic minority
groups. Key neonatal outcomes include large for gestational age, neonatal hypoglycemia, and NICU
admission and key maternal outcomes include cesarean birth, new hypertensive disorders of pregnancy,
and third- and fourth-degree perineal lacerations.

## Key facts

- **NIH application ID:** 10193041
- **Project number:** 1R21HD104983-01
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** CARLOS G GRIJALVA
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $216,250
- **Award type:** 1
- **Project period:** 2021-09-10 → 2023-09-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10193041

## Citation

> US National Institutes of Health, RePORTER application 10193041, Gestational diabetes drugs and perinatal outcomes in underserved populations (1R21HD104983-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10193041. Licensed CC0.

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