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Treatment of gestational diabetes improves the health of both mother and child, but diagnostic criteria remain unclear.
We randomly assigned women between 24 and 32 weeks of gestation in a 1:1 ratio to assess gestational diabetes mellitus using lower or higher blood glucose diagnostic criteria. Lower blood glucose is a fasting blood glucose level of at least 92 mg/dL (≥5.1 mmol/L), a 1-hour blood glucose level of at least 180 mg/dL (≥10.0 mmol/L ) or at least 153 mg. /dl (≥10.0 mmol/l. 8.5 mmol per liter) at the 2-hour level. Higher blood glucose levels are fasting blood glucose levels of at least 99 mg/dL (≥ 5.5 mmol/L) or 2-hour levels of at least 162 mg/dL (≥ 9.0 mmol/L). The primary outcome was children who were overweight for gestational age (defined as greater than 90% of birth weight according to the Fenton-World Health Organization criteria). The secondary outcome was maternal and child health.
A total of 4061 women were randomized. Gestational diabetes was diagnosed in 310 of 2022 women (15.3%) in the hypoglycemic criteria group and in 124 of 2039 women (6.1%) in the hyperglycemic criteria group. Of 2,019 babies born to women in the standard hypoglycemic group, 178 (8.8%) were large for gestational age, and of 2,031 babies born to women in the standard hyperglycemic group, 181 (8.9%) were large for gestational age (Adjusted relative risk 0.98; 95% CI 0.80 to 1.19; p=0.82). Induction of labor, medical attention, medication, and neonatal hypoglycemia were more common in the standard hypoglycemia group than in the standard hyperglycemia group. Results for other secondary outcomes were similar in the two study groups, and there were no significant differences between groups in adverse events. Among the two groups of women with blood glucose test results between lower and higher blood sugar levels, mothers and babies had more good health benefits, including fewer babies large for gestational age.
Diagnosis of gestational diabetes mellitus using lower glycemic index criteria did not reduce the risk of having babies with higher birth weight for gestational age compared to using higher glycemic index criteria. (Funded by the New Zealand Health Research Council and others; New Zealand clinical trial registry number GEMS Australia, ACTRN12615000290594.)
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Supported by a 3-year New Zealand Health Research Council Project Grant (ID14/104) and funding from the Manukau Tupu County Health Foundation, the Liggins Institute Charitable Foundation and the New Zealand Diabetes Research Association.
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The data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
We thank all the women and babies who participated in this trial, the midwives and medical staff who counseled eligible women, and the staff who conducted the trial at each center.
From the Liggins Institutes (CAC, DS, CJM), Obstetrics and Gynecology (LMEM) and School of Population Health (RE), University of Auckland, New Zealand, and Osteoporosis and Bone Biology, Garvan Institute for Medical Research, Sydney (TT).
Dr. Crowther can be contacted at [email protected] or at the Liggins Institute at the University of Auckland. 503, level 2, 85 Park Rd., Auckland 1142, New Zealand.
Post time: Aug-19-2022