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Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial.
Hong, Jesrine Gek Shan; Tan, Peng Chiong; Kamarudin, Maherah; Omar, Siti Zawiah.
Afiliación
  • Hong JGS; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia. jesrine@um.edu.my.
  • Tan PC; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.
  • Kamarudin M; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.
  • Omar SZ; Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, Malaysia.
BMC Pregnancy Childbirth ; 21(1): 138, 2021 Feb 15.
Article en En | MEDLINE | ID: mdl-33588801
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 (mean ± standard deviation) 3.9 ± 1.4 (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. TRIAL REGISTRATION: The trial is registered in the ISRCTN registry on May 4 2017 with trial identifier https://doi.org/10.1186/ISRCTN10156101 .
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Complicaciones del Embarazo / Atención Prenatal / Dexametasona / Glucocorticoides / Hiperglucemia / Hipoglucemiantes / Metformina Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: BMC Pregnancy Childbirth Asunto de la revista: OBSTETRICIA Año: 2021 Tipo del documento: Article País de afiliación: Malasia Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Complicaciones del Embarazo / Atención Prenatal / Dexametasona / Glucocorticoides / Hiperglucemia / Hipoglucemiantes / Metformina Tipo de estudio: Clinical_trials Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: BMC Pregnancy Childbirth Asunto de la revista: OBSTETRICIA Año: 2021 Tipo del documento: Article País de afiliación: Malasia Pais de publicación: Reino Unido