Prophylactic metformin after antenatal corticosteroids (PROMAC): A double blind randomized controlled trial

Hong, Jesrine Gek Shan and Tan, Peng Chiong and Kamarudin, Maherah and Omar, Siti Zawiah (2021) Prophylactic metformin after antenatal corticosteroids (PROMAC): A double blind randomized controlled trial. BMC Pregnancy and Childbirth, 21 (1). ISSN 1471-2393, DOI

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Background: Antenatal corticosteroids (ACS) are increasingly used to improve prematurity-related neonatal outcome. A recognized and common adverse effect from administration of antenatal corticosteroid is maternal hyperglycemia. Even normal pregnancy is characterized by relative insulin resistance and glucose intolerance. Treatment of maternal hyperglycemia after ACS might be indicated due to the higher risk of neonatal acidosis which may coincide with premature birth. Metformin is increasingly used to manage diabetes mellitus during pregnancy as it is effective and more patient friendly. There is no data on prophylactic metformin to maintain euglycemia following antenatal corticosteroids administration. Methods: A double blind randomized trial. 103 women scheduled to receive two doses of 12-mg intramuscular dexamethasone 12-hour apart were separately randomized to take prophylactic metformin or placebo after stratification according to their gestational diabetes (GDM) status. First oral dose of allocated study drug was taken at enrolment and continued 500 mg twice daily for 72 hours if not delivered. Six-point blood sugar profiles were obtained each day (pre- and two-hour post breakfast, lunch and dinner) for up to three consecutive days. A hyperglycemic episode is defined as capillary glucose fasting/pre-meal >= 5.3 mmol/L or two-hour post prandial/meal >= 6.7 mmol/L. Primary outcome was hyperglycemic episodes on Day-1 (first six blood sugar profile points) following antenatal corticosteroids. Results: Number of hyperglycemic episodes on the first day were not significantly different (meanstandard deviation) 3.91.4 (metformin) vs. 4.1 +/- 1.6 (placebo) p=0.64. Hyperglycemic episodes markedly reduced on second day in both arms to 0.9 +/- 1.0 (metformin) vs. 1.2 +/- 1.0 (placebo) p=0.15 and further reduced to 0.6 +/- 1.0 (metformin) vs. 0.7 +/- 1.0 (placebo) p=0.67 on third day. Hypoglycemic episodes during the 3-day study period were few and all other secondary outcomes were not significantly different. Conclusions: In euglycemic and diet controllable gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1. The magnitude of Day-1 hyperglycemia is generally low. Prophylactic metformin does not reduce antenatal corticosteroids' hyperglycemic effect.

Item Type: Article
Funders: Department of Obstetrics and Gynecology, University of Malaya
Uncontrolled Keywords: Antenatal corticosteroids; Blood sugar profile; Gestational diabetes; Hyperglycemia; Metformin; Premature labor
Subjects: R Medicine > R Medicine (General)
R Medicine > RG Gynecology and obstetrics
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 01 Apr 2022 03:23
Last Modified: 01 Apr 2022 03:23

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