Treatment of gestational diabetes mellitus diagnosed early in pregnancy

Date

2023

Authors

Simmons, David
Immanuel, Jincy
Hague, William M.
Teede, Helena
Nolan, Christopher J.
Peek, Michael J.
Flack, Jeff R.
McLean, Mark
Wong, Vincent
Hibbert, Emily

Journal Title

Journal ISSN

Volume Title

Publisher

Massachusetts Medical Society

Abstract

BACKGROUND: Whether treatment of gestational diabetes before 20 weeks’ gestation improves maternal and infant health is unclear.


METHODS: We randomly assigned, in a 1:1 ratio, women between 4 weeks’ and 19 weeks 6 days’ gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes (World Health Organization 2013 criteria) to receive immediate treatment for gestational diabetes or deferred or no treatment, depending on the results of a repeat oral glucose-tolerance test [OGTT] at 24 to 28 weeks’ gestation (control). The trial included three primary outcomes: a composite of adverse neonatal outcomes (birth at <37 weeks’ gestation, birth trauma, birth weight of ≥4500 g, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia), pregnancy-related hypertension (preeclampsia, eclampsia, or gestational hypertension), and neonatal lean body mass.


RESULTS: A total of 802 women underwent randomization; 406 were assigned to the immediate-treatment group and 396 to the control group; follow-up data were available for 793 women (98.9%). An initial OGTT was performed at a mean (±SD) gestation of 15.6±2.5 weeks. An adverse neonatal outcome event occurred in 94 of 378 women (24.9%) in the immediate-treatment group and in 113 of 370 women (30.5%) in the control group (adjusted risk difference, −5.6 percentage points; 95% confidence interval [CI], −10.1 to −1.2). Pregnancy-related hypertension occurred in 40 of 378 women (10.6%) in the immediate-treatment group and in 37 of 372 women (9.9%) in the control group (adjusted risk difference, 0.7 percentage points; 95% CI, −1.6 to 2.9). The mean neonatal lean body mass was 2.86 kg in the immediate-treatment group and 2.91 kg in the control group (adjusted mean difference, −0.04 kg; 95% CI, −0.09 to 0.02). No between-group differences were observed with respect to serious adverse events associated with screening and treatment.


CONCLUSIONS: Immediate treatment of gestational diabetes before 20 weeks’ gestation led to a modestly lower incidence of a composite of adverse neonatal outcomes than no immediate treatment; no material differences were observed for pregnancy-related hypertension or neonatal lean body mass.

Description

Article originally published in New England Journal of Medicine, 388(23), 2132–2144. English. Published online 2023. https://doi.org/10.1056/nejmoa2214956
Article has been deposited under 6 month embargo required by the publisher. PDF will be available on 12/9/23.

Keywords

Complications in pregnancy, Diabetes, Adverse neonatal outcomes

Citation

This is a published version of an article that is available at: https://doi.org/10.1056/nejmoa2214956. Recommended citation: Simmons, D., Immanuel, J., Hague, W. M., Teede, H., Nolan, C. J., Peek, M. J., Flack, J. R., McLean, M., Wong, V., Hibbert, E., Kautzky-Willer, A., Harreiter, J., Backman, H., Gianatti, E., Sweeting, A., Mohan, V., Enticott, J., & Cheung, N. W. (2023). Treatment of gestational diabetes mellitus diagnosed early in pregnancy. New England Journal of Medicine, 388(23), 2132–2144. This item has been deposited in accordance with publisher copyright and licensing terms and with the author’s permission.

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