A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study.
OBJECTIVE
The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes lessened the risk of fetal macrosomia, birth trauma, neonatal hypoglycemia, 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 adverse outcomes in the control group that received routine obstetric care.


METHODS
The study was a prospective randomized controlled trial comparing fetal-neonatal and maternal outcomes in 300 women with gestational diabetes. Women randomized to the treatment arm were managed by strict glycemic control and tertiary level obstetric care, and women in the control arm received routine obstetric care.


RESULTS
Three hundred women with gestational diabetes mellitus were studied. There was no difference in maternal age, weight, or length of gestation between groups. The treatment mean birth weight was 3437 +/- 575 gm compared with 3544 +/- 601 gm in the control group, a difference of 107 gm (not significant). Macrosomia rates were similar. There was no birth trauma 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 preprandial and postprandial glucose levels by 32 weeks' gestation, which continued to term.


CONCLUSIONS
This pilot study suggests that intensive treatment of gestational diabetes mellitus may have little effect on birth weight, birth trauma, operative delivery, or neonatal metabolic disorders. It has demonstrated the safety of proceeding to a multicenter trial of sufficient sample size to confirm these findings.
Garner
P
P
Department of Obstetrics and Gynecology, University of Ottawa, Ottawa Civic Hospital, Ontario, Canada.
Okun
N
N
Keely
E
E
Wells
G
G
Perkins
S
S
Sylvain
J
J
Belcher
J
J
D000328:Adult; D001720:Birth Injuries / Q000453:epidemiology / Q000517:prevention & control; D001724:Birth Weight / Q000502:physiology; D001786:Blood Glucose / Q000032:analysis*; D003131:Combined Modality Therapy; D016640:Diabetes, Gestational / Q000097:blood* / Q000628:therapy*; D004035:Diet Therapy / Q000592:standards; D005260:Female; D005320:Fetal Macrosomia / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology / Q000517:prevention & control; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000453:epidemiology / Q000517:prevention & control; D007328:Insulin / Q000627:therapeutic use; D010865:Pilot Projects; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care / Q000379:methods* / Q000592:standards*; D012307:Risk Factors
D001786:Blood Glucose; D007328:Insulin