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Glycemic control following two regimens of antenatal corticosteroids in mild gestational diabetes: a randomized controlled trial

  • Maternal-Fetal Medicine
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

To compare 3 consecutive days of hyperglycemic response following antenatal dexamethasone regimens of 12-mg or 6-mg doses 12 hourly in diet-controlled gestational diabetes.

Methods

A randomized controlled trial was carried out in a university hospital in Malaysia. Women with lifestyle-controlled gestational diabetes scheduled to receive clinically indicated antenatal corticosteroids (dexamethasone) were randomized to 12-mg 12 hourly for one day (2 × 12-mg) or 6-mg 12-hourly for two days (4 × 6-mg). 6-point (pre and 2-h postprandial) daily self-monitoring of capillary blood sugar profile for up to 3 consecutive days was started after the first dexamethasone injection. Hyperglycemia is defined as blood glucose pre-meal ≥ 5.3 or 2 h postprandial ≥ 6.7 mmol/L. The primary outcome was a number of hyperglycemic episodes in Day-1 (first 6 BSP points). A sample size of 30 per group (N = 60) was planned.

Results

Median [interquartile range] hyperglycemic episodes 4 [2.5–5] vs. 4 [3–5] p = 0.3 in the first day, 3 [2–4] vs. 1 [0–3] p = 0.01 on the second day, 0 [0–1] vs. 0 [0–1] p = 0.6 on the third day and over the entire 3 trial days 7 [6–9] vs. 6 [4–8] p = 0.17 for 6-mg vs. 12-mg arms, respectively. 2/30 (7%) in each arm received an anti-glycemic agent during the 3-day trial period (capillary glucose exceeded 11 mmol/L). Mean birth weight (2.89 vs. 2.49 kg p < 0.01) and gestational age at delivery (37.7 vs. 36.6 weeks p = 0.03) were higher and median delivery blood loss (300 vs. 400 ml p = 0.02) was lower in the 12-mg arm; all other secondary outcomes were not significantly different.

Conclusion

In gestational diabetes, 2 × 12-mg could be preferred over 4 × 6-mg dexamethasone as hyperglycemic episodes were fewer on Day-2, fewer injections were needed and the regimen was completed sooner.

Clinical trial registration

http://www.isrctn.com/ISRCTN16613220.

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Data availability

All data generated or analyzed during this study are included in this published article and the datasets used are available from the corresponding author on reasonable request and subject to approval of our ethics board.

Code availability

Not applicable.

Abbreviations

ACS:

Antenatal corticosteroids

GDM:

Gestational diabetes mellitus

IADPSG:

International Association of Diabetes and Pregnancy Study Groups

UK:

United Kingdom

USA:

United States of America

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Acknowledgements

We thank the women who participated in the trial and all care providers in our medical center for their contribution to this trial.

Funding

This study was funded internally by the Department of Obstetrics and Gynecology, University Malaya.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia

    Nuraini Sukarna, Peng Chiong Tan, Jesrine Gek Shan Hong, Sofiah Sulaiman & Siti Zawiah Omar

Authors
  1. Nuraini Sukarna
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  2. Peng Chiong Tan
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  3. Jesrine Gek Shan Hong
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  4. Sofiah Sulaiman
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  5. Siti Zawiah Omar
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Contributions

NS: Project development (main), data collection (main), data analysis and interpretation (support), manuscript drafting and amendments (support). PCT: Project development (main), data analysis and interpretation (main), manuscript drafting and editing (main). JGSH: Project development (main), manuscript review and editing (main). SS: Data interpretation (support), manuscript review and amendments (support). SZO: Data interpretation (support), manuscript review and amendments (support). All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jesrine Gek Shan Hong.

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Conflict of interest

All authors have no conflict of interest to declare that are relevant to the content of this manuscript.

Ethics approval

This study was approved by Medical Ethics Committee of University Malaya Medical Center (Date of approval: Feb 3 2016, Reference number: 2018–13–3) and registered in ISRCTN registry (http://www.isrctn.com/ISRCTN16613220). The study was conducted in compliance with the principles of the Declaration of Helsinki.

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Informed consent was obtained from all individual participants included in the study.

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Not applicable.

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Sukarna, N., Tan, P.C., Hong, J.G.S. et al. Glycemic control following two regimens of antenatal corticosteroids in mild gestational diabetes: a randomized controlled trial. Arch Gynecol Obstet 304, 345–353 (2021). https://doi.org/10.1007/s00404-020-05950-3

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  • DOI: https://doi.org/10.1007/s00404-020-05950-3

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