Glycemic Control After Antenatal Corticosteroids in Women With Pregestational Diabetes
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal
corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have
type 2 diabetes mellitus (T2DM). Since the initial discovery of ACS for neonatal benefit in
1972, more than 40 randomized controlled trials have been performed evaluating its efficacy.
However, none of these trials have included women with T2DM. While ACS have been shown to
reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS
(maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS
in women with T2DM. Before neonatal benefit of ACS can be evaluated in this population, the
first step is to optimize maternal glycemic control after ACS. Previous studies evaluating
maternal hyperglycemia after ACS have been limited by small sample size, retrospective study
design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a
randomized clinical trial provides a unique opportunity to overcome these challenges. Our
long-term goal is to improve maternal and child health among women with T2DM as an
independently funded clinical researcher. The research objectives of this proposal are to
test the efficacy of three treatment strategies at achieving maternal glycemic control after
ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our
central hypothesis is that treatment with a continuous insulin infusion will improve maternal
glycemic control, which is key to improving neonatal outcomes, but at the cost of less
patient satisfaction and more health resource utilization. This hypothesis will be tested by
pursuing the following specific aims: 1) Test the efficacy of three treatment strategies
(addition of sliding scale insulin, up-titration of home insulin, and continuous insulin
infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association
between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims
will determine the optimal strategy to achieve maternal glycemic control after ACS and inform
a larger, multicenter trial to improve neonatal outcomes among women with T2DM and threatened
PTB.