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Oral Concurrent Session 2 - Diabetes

Oral Concurrent Sessions

(29) Permissive Glucose Control Versus Usual Care for Diabetes in Labor: An Equivalence Randomized Control Trial

Tuesday, February 13, 2024

2:30 PM – 2:45 PM

Location: Potomac Ballroom C, Ballroom Level

Primary & Presenting Author(s)

Ghamar Bitar, MD

McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States

Coauthor(s)

RS

Rafael Santos, PhD

McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
CP

Claudia Pedroza, PhD

McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth)
Houston, TX, United States
Sarah Nazeer, MD (she/her/hers)

Maternal-Fetal Medicine Fellow
McGovern Medical School at UTHealth Houston
Houston, TX, United States
Suneet P. Chauhan, MD

Professor
University of Texas-Houston Medical School
Houston, TX, United States
SB

Sean C. Blackwell, MD

Professor
Children's Memorial Hermann Hospital
Houston, TX, United States
Baha M. Sibai, MD

Professor
Hermann Memorial Hospital
Houston, TX, United States
Michal Fishel Bartal, MD (she/her/hers)

Maternal Fetal Medicine Faculty
McGovern Medical School at UTHealth Houston, Sheba Medical Center, Tel Hashomer, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel
Houston, TX, United States

Objective: There is limited high quality data to determine best practices for maternal blood glucose (BG) management during labor. We compared permissive control (target maternal BG 70–180mg/dL) to usual care (BG 70–110mg/dL) among laboring individuals with diabetes (DM).

Study Design: We performed a multi-site equivalence RCT (NCT05553275) for individuals with DM (pregestational or gestational) at ≥ 34 weeks in labor. Individuals were randomly allocated to usual care or permissive control. Capillary BG monitoring was performed in latent and active labor every 4 and 2 hours, respectively. Insulin drip was initiated if maternal BG exceeded the upper bounds of the allocated target. Primary outcome was neonatal heel stick BG within two hours of birth. For usual care, we assumed a mean neonatal BG of 50 ± 10 mg/dL (standard deviation). To ensure that use of permissive control did not increase or decrease the mean neonatal BG > 10 mg/dL (two-tailed, α= 0.05, β= 0.2), 96 participants total were required. We calculated relative risk (RR) and 95% confidence intervals (CI) in an intention-to-treat analysis. A Bayesian analysis was preplanned to estimate the probability of equivalence with a neutral informative prior.

Results: Of 6,628 deliveries (10/2022 - 6/2023), 280 (4.2%) met eligibility criteria, and 96 (34.3%) agreed and were randomized, with similar baseline characteristics between groups. 17% of individuals in the usual care required an insulin drip compared to none in permissive care. There was equivalence in the primary outcome between usual and permissive care (57.9 vs. 57.1 mg/dL, mean difference [MD] -0.72, 95% CI -8.87,7.43). Bayesian analysis indicated 89% posterior probability of MD not being greater than ±10 mg/dL and 99% probability of the MD not being more than 10 mg/dL lower (95% credible interval -3.5,13.2). There was no difference in other neonatal or maternal outcomes (Table).

Conclusion: In this RCT, while almost 1 in 6 individuals with DM required an insulin drip during usual maternal BG care in labor, permissive BG care was associated with equivalent neonatal BG when compared to usual care.