A multicenter, randomized trial of treatment for mild gestational diabetes.
BACKGROUND
It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes.


METHODS
Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus (i.e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3 mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma.


RESULTS
A total of 958 women were randomly assigned to a study group--485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively; P=0.14). There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including mean birth weight (3302 vs. 3408 g), neonatal fat mass (427 vs. 464 g), the frequency of large-for-gestational-age infants (7.1% vs. 14.5%), birth weight greater than 4000 g (5.9% vs. 14.3%), shoulder dystocia (1.5% vs. 4.0%), and cesarean delivery (26.9% vs. 33.8%). Treatment of gestational diabetes mellitus, as compared with usual care, was also associated with reduced rates of preeclampsia and gestational hypertension (combined rates for the two conditions, 8.6% vs. 13.6%; P=0.01).


CONCLUSIONS
Although treatment of mild gestational diabetes mellitus did not significantly reduce the frequency of a composite outcome that included stillbirth or perinatal death and several neonatal complications, it did reduce the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders. (ClinicalTrials.gov number, NCT00069576.)
Department of Obstetrics and Gynecology, Ohio State University, Columbus, USA. mark.landon@osumc.edu
Mark B
MB
Landon
Catherine Y
CY
Spong
Elizabeth
E
Thom
Marshall W
MW
Carpenter
Susan M
SM
Ramin
Brian
B
Casey
Ronald J
RJ
Wapner
Michael W
MW
Varner
Dwight J
DJ
Rouse
John M
JM
Thorp
Anthony
A
Sciscione
Patrick
P
Catalano
Margaret
M
Harper
George
G
Saade
Kristine Y
KY
Lain
Yoram
Y
Sorokin
Alan M
AM
Peaceman
Jorge E
JE
Tolosa
Garland B
GB
Anderson
D000328:Adult; D001724:Birth Weight; D015992:Body Mass Index; D002585:Cesarean Section / Q000706:statistics & numerical data; D003131:Combined Modality Therapy; D016640:Diabetes, Gestational / Q000097:blood / Q000178:diet therapy* / Q000188:drug therapy; D005260:Female; D005320:Fetal Macrosomia / Q000517:prevention & control; D005951:Glucose Tolerance Test; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000453:epidemiology / Q000517:prevention & control; D007328:Insulin / Q000627:therapeutic use*; D054238:Perinatal Mortality; D011247:Pregnancy; D011256:Pregnancy Outcome; D047928:Premature Birth / Q000453:epidemiology; D050497:Stillbirth / Q000453:epidemiology
D007004:Hypoglycemic Agents; D007328:Insulin