A planned randomized clinical trial of treatment for mild gestational diabetes mellitus

Pregnancy plasma glucose levels exceeding the American Diabetes Association thresholds, but below the National Diabetes Data Group thresholds for gestational diabetes mellitus, are related to the risk of neonatal macrosomia, hypoglycaemia and hyperbilirubinaemia

“…It is possible that infants of women assigned to the intervention (treatment for maternal hyperglycaemia) group were also more likely to receive perinatal interventions as suggested by the higher proportion of induced delivery and admission to the nursery unit observed in this group. Another trial [24] is assessing the benefit of tight glycaemic control on perinatal complications among 950 women with at least two glucose levels (other than fasting levels) meeting or exceeding the ADA thresholds [9] during the 100-g OGTT. In that trial, if a substantial number of women meeting the ADA criteria [9], but not those of the NDDG [5], were to be enrolled, an analysis restricted to these women would help in gauging the size of the benefit of treating pregnant women with relatively mild hyperglycaemia.…”

The National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network Randomized Clinical Trial in Progress

“…Screening for GDM is recommended for most pregnant women, yet it is unknown whether there is a benefit to the identification and treatment of mild carbohydrate intolerance during pregnancy (3,4). The present report is an update of our previous description of a current ongoing randomized treatment trial for mild GDM (5). A randomized clinical trial of women with mild GDM (fasting glucose Ͻ95 mg/dl) is being undertaken that compares perinatal outcomes in those receiving diet therapy and insulin as required versus those randomized to no specific treatment.…”

“…STUDY DESIGN -We have previously reported the design of this clinical trial (5). The study aims to address the primary research question, "Do women with a singleton pregnancy diagnosed with mild gestational diabetes between 24 and 29 weeks of gestation receiving diet modification and performing selfmonitoring of blood glucose have a reduction in the incidence of neonatal morbidity and mortality, as compared with standard obstetrical care?"…”

Jottings

“…With only 5 perinatal deaths among 1030 births in the ACHOIS trial, is this enough evidence to justify a policy of screening for gestational diabetes and intensive treatment? Another clinical trial is ongoing in this area, 5 and perhaps only a meta-analysis of these and other randomised trial evidence will offer sufficient data on individual component outcomes to draw confident inferences about the balance between a possible reduction in perinatal deaths and the currently much stronger evidence of an increase in induced labour and admission to a neonatal nursery.…”