Trecia A Wouldes1, Malcolm Battin2, Suzette Coat3, Elaine C Rush4, William M Hague5, Janet A Rowan6. 1. Department of Psychological Medicine, Faculty of Medical and Health Sciences, Auckland, New Zealand. 2. New Born Services, Auckland City Hospital, Auckland, New Zealand. 3. Robinson Research Institute, The University of Adelaide, North Adelaide, South Australia. 4. Centre for Child Health Research, Auckland University of Technology, Auckland, New Zealand. 5. Department of Obstetrics, Women and Children's Hospital, University of Adelaide, North Adelaide, South Australia. 6. Department of Obstetrics, National Women's Health, Auckland City Hospital, Auckland, New Zealand.
Abstract
OBJECTIVE:Gestational diabetes mellitus (GDM) is a common complication of pregnancy and is increasingly being treated with metformin that crosses the placenta rather than insulin, which does not. This study seeks to examine the neurodevelopment of offspring of women treated with metformin or insulin for GDM. DESIGN: We performed a prospective follow-up study of children whose mothers had been randomly assigned at 20-33 weeks gestation to treatment withmetformin or insulin for GDM. Of the 211 children followed up at 2 years, 128 were from Auckland, New Zealand (64 metformin vs 64 insulin), and 83 from Adelaide, Australia (39 metformin vs 49 insulin). Neurodevelopment was examined with the Bayley Scales of Infant Development V.2 mental development index (MDI) and psychomotor development index (PDI). Clinical and demographic background characteristics were obtained at enrolment, birth and follow-up. RESULTS: No significant differences were found between treatment groups in clinical or demographic characteristics. The MDI and PDI composite scores were tested with general linear models. No significant differences were found between metformin and insulin, respectively, in New Zealand (MDI, M=83.6 vs 86.9 and PDI, M=83.4 vs M=85.2) or Australia (MDI, M=102.5 vs M=98.4 and PDI, M=105.6 vs M=99.9) and no interactions observed. The differences in neurodevelopmental outcomes between the Auckland and Adelaide cohorts were explained by parental ethnicity, infant birth weight >4000 g, neonatal hypoglycaemia, maternal glycaemia and smoking in the household. CONCLUSIONS: This study provides additional data supporting the safety of metformin in the treatment of GDM. TRIAL REGISTRATION NUMBER: ACTRN 12605000311651. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
RCT Entities:
OBJECTIVE:Gestational diabetes mellitus (GDM) is a common complication of pregnancy and is increasingly being treated with metformin that crosses the placenta rather than insulin, which does not. This study seeks to examine the neurodevelopment of offspring of women treated with metformin or insulin for GDM. DESIGN: We performed a prospective follow-up study of children whose mothers had been randomly assigned at 20-33 weeks gestation to treatment with metformin or insulin for GDM. Of the 211 children followed up at 2 years, 128 were from Auckland, New Zealand (64 metformin vs 64 insulin), and 83 from Adelaide, Australia (39 metformin vs 49 insulin). Neurodevelopment was examined with the Bayley Scales of Infant Development V.2 mental development index (MDI) and psychomotor development index (PDI). Clinical and demographic background characteristics were obtained at enrolment, birth and follow-up. RESULTS: No significant differences were found between treatment groups in clinical or demographic characteristics. The MDI and PDI composite scores were tested with general linear models. No significant differences were found between metformin and insulin, respectively, in New Zealand (MDI, M=83.6 vs 86.9 and PDI, M=83.4 vs M=85.2) or Australia (MDI, M=102.5 vs M=98.4 and PDI, M=105.6 vs M=99.9) and no interactions observed. The differences in neurodevelopmental outcomes between the Auckland and Adelaide cohorts were explained by parental ethnicity, infant birth weight >4000 g, neonatal hypoglycaemia, maternal glycaemia and smoking in the household. CONCLUSIONS: This study provides additional data supporting the safety of metformin in the treatment of GDM. TRIAL REGISTRATION NUMBER: ACTRN 12605000311651. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
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Keywords:
Gestational Diabetes Mellitus; Metformin; Neurodevelopment; Outcomes research
Authors: Suzanne N Landi; Sarah Radke; Stephanie M Engel; Kim Boggess; Til Stürmer; Anna S Howe; Michele Jonsson Funk Journal: JAMA Pediatr Date: 2019-02-01 Impact factor: 16.193
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