A RANDOMIZED CONTROLLED TRIAL OF STRICT GLYCEMIC CONTROL AND TERTIARYLEVEL OBSTETRIC CARE VERSUS ROUTINE OBSTETRIC CARE IN THE MANAGEMENT OF GESTATIONAL DIABETES - A PILOT-STUDY

OBJECTIVES: The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes le ssened the risk of fetal macrosomia, birth trauma, neonatal hypoglycem ia, and operative delivery. The aim of the pilot study was to prepare for a multicenter trial by assessing patient acceptance of the study, by determining realistic accrual rates, and by detecting any major adv erse outcomes in the control group that received routine obstetric car e. STUDY DESIGN: The study was a prospective randomized controlled tri al comparing fetal-neonatal and maternal outcomes in 300 women with ge stational diabetes. Women randomized to the treatment arm were managed by strict glycemic control and tertiary level obstetric care, and wom en in the control arm received routine obstetric care. RESULTS: Three hundred women with gestational diabetes mellitus were studied. There w as no difference in maternal age, weight, or length of gestation betwe en groups. The treatment mean birth weight was 3437 +/- 575 gm compare d with 3544 +/- 601 gm in the control group, a difference of 107 gm (n ot significant). Macrosomia rates were similar. There was no birth tra uma in either group. The frequency of neonatal hypoglycemia and other metabolic complications was the same. The mode of delivery also showed similar patterns. The treatment group had significantly lower prepran dial and postprandial glucose levels by 32 weeks' gestation; which con tinued to term. CONCLUSION: This pilot study suggests that intensive t reatment of gestational diabetes mellitus may have little effect on bi rth weight, birth trauma, operative delivery, or neonatal metabolic di sorders. It has demonstrated the safety of proceeding to a multicenter trial of sufficient sample size to confirm these findings.