Gestational Diabetes Mellitus: Original Research
Glyburide in Women With Mild
Gestational Diabetes
A Randomized Controlled Trial
Brian M. Casey, MD, Elaine L. Duryea, MD, Mina Abbassi-Ghanavati, MD, Carmen M. Tudela,
Stephan A. Shivvers, MD, Donald D. McIntire, PhD, and Kenneth J. Leveno, MD
OBJECTIVE: To evaluate whether the addition of glybur-
ide to diet therapy modifies pregnancy outcomes in
women with mild gestational diabetes.
METHODS: Women with at least two abnormal values
on a 3-hour, 100-g oral glucose tolerance test according
to National Diabetes Data Group criteria and fasting
values less than 105 mg/dL between 24 and 30 weeks
of gestation were randomized to blinded glyburide or
placebo study drug. All women were placed on
a 35-kcal/kg diet and recorded four times daily capillary
glucose measurements. The study drug was titrated
based on weekly maternal capillary glucose values with
targets of less than 95 mg/dL (5.3 mmol/L) and 120 mg/dL
(6.7 mmol/L) for fasting and 2-hour postprandial glucose
measurements, respectively. The primary study outcome
was a 200-g birth weight decrement in neonates of
women treated with glyburide. The sample size estimate
for this outcome was 334 total randomized women with
a one-to-one allocation.
RESULTS: A total of 395 women were enrolled at a single
center between September 2008 and October 2012.
Women treated with glyburide had a significantly greater
decline in fasting glucose values over the course of
therapy. However, there was no difference in the primary
study outcome. Specifically, the mean birth weight was
33 g lower in the group treated with glyburide (P5.52).
Although not powered to examine all outcomes
From the Department of Obstetrics and Gynecology, University of Texas
Southwestern Medical Center, Dallas, Texas.
Presented at the 34th Annual Meeting of the Society of Maternal-Fetal Medicine,
February 38, 2014, New Orleans, Louisiana.
Corresponding author: Brian M. Casey, MD, Department of Obstetrics and
Gynecology, University of Texas Southwestern Medical Center at Dallas, 5323
Harry Hines Boulevard, Dallas, TX; e-mail: brian.casey@utsouthwestern.edu.
Financial Disclosure
The authors did not report any potential conflicts of interest.
2015 by The American College of Obstetricians and Gynecologists. Published
by Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0029-7844/15
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and Gynecologists. Published by Wolters Kluwer Health, Inc.
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MD,
associated with gestational diabetes, treatment with gly-
buride did not affect need for operative delivery, shoulder
dystocia, clavicular fracture, Erbs palsy, or neonatal hypo-
glycemia. Four women in each group required insulin.
CONCLUSION: The addition of glyburide to diet ther-
apy significantly improved maternal glycemic control
over time when compared with placebo. However,
adding glyburide to diet did not decrease birth weight
or improve maternal or neonatal outcomes in women
with mild gestational diabetes.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov,
www.clinicaltrials.gov, NCT00744965.
(Obstet Gynecol 2015;126:3039)
DOI: 10.1097/AOG.0000000000000967
LEVEL OF EVIDENCE: I
G
estational diabetes, which complicates 56% of
pregnancies in the United States, is associated
with numerous maternal and neonatal complications.1
Treatment of gestational diabetes decreases the rate of
many of these morbidities and is usually comprised of
diet modification with initiation of pharmacotherapy
as needed to maintain a fasting glucose at or less than
95 mg/dL (5.3 mmol/L) and 2-hour postprandial
plasma glucose levels below 120 mg/dL (6.7 mmol/L).2,3
Treatment with insulin has traditionally been consid-
ered the standard; however, the use of oral hypogly-
cemics such as glyburide has become widespread after
studies demonstrating its efficacy in pregnancy.4,5 In
fact, glyburide has become the most commonly used
pharmacotherapy for gestational diabetes in some
populations,6 with the American College of Obstetri-
cians and Gynecologists acknowledging that glybur-
ide is an appropriate first-line agent for glycemic
control.1
The Hyperglycemia and Adverse Pregnancy Out-
come Study demonstrated that the risk for outcomes
such as large-for-gestational-age (LGA) birth weight
OBSTETRICS & GYNECOLOGY 303
and neonatal hypoglycemia were increased at mater-
nal glucose levels below those typically used for the
diagnosis of gestational diabetes.7 Indeed, a random-
ized multicenter trial demonstrated a reduction in
maternal and neonatal complications with diet modi-
fication for the treatment of mild gestational diabetes.8
The objective of this study now reported was to eval-
uate if the addition of glyburide to diet therapy im-
proves pregnancy outcomes in women with mild
gestational diabetes.
MATERIALS AND METHODS
This was a randomized placebo-controlled trial of
glyburide therapy in women with diet-treated mild
gestational diabetes. The study was approved by the
University of Texas Southwestern Medical Center
institutional review board and was locally funded by
the Department of Obstetrics and Gynecology.
Women without a diagnosis of overt diabetes mellitus
receiving prenatal care at our institution undergo
universal screening with a 50-g 1-hour oral glucose
challenge test between 24 and 28 weeks of gestation. If
the 1-hour value is 140 mg/dL (7.8 mmol/L) or
greater, a 100-g 3-hour diagnostic oral glucose toler-
ance test is performed. Women were considered
eligible for this study if they had a singleton preg-
nancy and underwent testing between 24 and 30
weeks of gestation. Eligible women were diagnosed
to have mild gestational diabetes with a fasting
glucose level below 105 mg/dL (5.8 mmol/L) in the
setting of at least two elevated values on the 3-hour
glucose tolerance test according to National Diabetes
Data Group criteria of 1-hour, 2-hour, and 3-hour
plasma glucose levels of 105 mg/dL (5.8 mmol/L),
190 mg/dL (10.6 mmol/L), 165 mg/dL (9.2 mmol/L),
and 145 mg/dL (8.1 mmol/L), respectively.9 Exclu-
sion criteria included pregestational diabetes, abnor-
mal gestational diabetes testing before 24 weeks of
gestation, multiple gestation, known major fetal
anomaly or fetal demise, renal disease with serum
creatinine greater than 1.0 mg/dL, known liver dis-
ease, known allergy to glyburide, or maternal or fetal
conditions likely to require imminent delivery such as
preeclampsia, preterm rupture of membranes, pre-
term labor, or intrauterine fetal growth restriction.
All women identified with mild gestational diabetes
during the study period received standardized nutri-
tional education and recommendations for dietary
therapy. Counseling included instructions regarding
food types to avoid and a goal to limit caloric intake
to 35 kcal/kg. They were instructed to check their
capillary blood glucose measurements four times
dailyfasting and 2 hours after each meal using
304 Casey et al Glyburide for Mild Gestational Diabetes
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memory-based glucose meters, which were down-
loaded to a study database. Eligible women were ap-
proached and consented by research nurses with the
assistance of the authors. Study participants self-
monitored diet intake and submitted weekly diet logs,
which were reviewed. Women were allocated accord-
ing to a predetermined randomization schedule to
receive either placebo or glyburide encapsulated to
look identical to placebo. Eligible patients were ran-
domly assigned in a one-to-one ratio to glyburide or
placebo using a computer-generated randomization
schedule with treatment assigned under a scheme of
permuted blocks of sizes four, six, eight, and 10. The
schedule was generated using SAS PROC PLAN and
provided to our investigational drug pharmacy for
masking, allocation, and assignment. The study drug
was dispensed by our investigational drug service and
distributed to the patients by a research nurse. The
starting dose for therapy was 2.5 mg daily with weekly
titration according to the protocol shown in Table 1 to
a maximum of 20 mg per day based on evaluation of
maternal capillary glucose values. If the maximum
dose of study drug was reached without achieving
target glucose values of less than 95 mg/dL (5.3
mmol/L) and 120 mg/dL (6.7 mmol/L) for fasting
and 2-hour postprandial glucose measurements,
respectively, insulin was initiated. Antenatal testing
was not performed routinely in the study group unless
insulin therapy was required but was reserved for
standard obstetric indications as was induction of
labor.
The primary outcome chosen was a 200-g birth
weight decrement in neonates of mothers treated with
glyburide and was based on an a priori sample size
analysis. This was based on a prior study that
demonstrated a 239-g difference in birth weight
attributable to the use of insulin compared with diet
in women with mild gestational diabetes (Casey BM,
Lo JY, McIntire DD, Leveno KJ. Insulin therapy in
Table 1. Dosage Algorithm for Study Drug
According to Maternal Glycemic Control
Capillary Blood Glucose Current Dose
Level (mg/dL) Dose Modification
Hyperglycemia defined as 95 2.5 mg daily Increase to
or greater fasting or 120 or 5 mg or more 5 mg daily
greater postprandial in daily Increase by
more than 50% of values 5 mg daily
Hypoglycemia defined as less 5 mg or less Decrease by
than 60 with symptoms daily 2.5 mg daily
occurring 3 or more times More than Decrease by
in 1 wk 5 mg daily 5 mg daily
OBSTETRICS & GYNECOLOGY
women with class A1 gestational diabetes [abstract
#635]. 48th annual meeting of the Society for Gyne-
cologic Investigation, Toronto, Ontario, Canada,
2001). Assuming an 80% power to detect a 200-g
decrease in birth weight, a total sample size of 334
eligible women was estimated. Mean capillary blood
glucose levels were examined for trend over time,
starting from the day of enrollment.
Secondary pregnancy outcomes included the
need for insulin therapy, the presence of chorioam-
nionitis, diagnosis of pregnancy-induced hyperten-
sion, need for operative delivery, shoulder dystocia,
and third- or fourth-degree perineal lacerations. Insu-
lin therapy was initiated if the woman was receiving
the maximum dose of the study drug and her capillary
blood glucose level regularly exceeded a fasting level
of 95 mg/dL (5.3 mmol/L) or 2-hour postprandial of
120 mg/dL (6.7 mmol/L). Chorioamnionitis was
diagnosed clinically based on the presence of a mater-
nal fever greater than or equal to 38.0C with or with-
out maternal or fetal tachycardia. Pregnancy-induced
hypertension was defined as a persistent systolic blood
pressure greater than 140 mm Hg or diastolic blood
pressure greater than 90 mm Hg. Severe pregnancy-
induced hypertension was defined to include: protein-
uria greater than 2 g in 24 hours or greater than or
equal to 2+ on dipstick, blood pressure greater than
160 mm Hg systolic or 110 mm Hg diastolic, serum
creatinine greater than 1.0 mg/dL, platelets less than
100,000/mm3, aspartate aminotransferase greater
than 90 units/L, or symptoms such as persistent head-
ache, scotomata, or epigastric pain. Shoulder dystocia
was identified if performance of maneuvers such as
McRoberts and suprapubic pressure to accomplish
delivery of the anterior shoulder were documented
in the medical record. Secondary neonatal outcomes
included birth weight, small and LGA based on the
10th and 90th birth weight percentiles, respectively,
using published birth weight curves from our popula-
tion,10 admission to the neonatal intensive care unit,
fractured clavicle, Erbs palsy, hyperbilirubinemia,
active treatment of hypoglycemia, and umbilical
artery blood pH less than or equal to 7.0.
Data analysis included Pearson x2 or Fishers exact
test for categorical data as appropriate, Students t test
for continuous data, and Wilcoxon rank-sum. P values
,.05 were considered significant. To estimate the
decline of the mean glucose in each study group over
time, a mixed-effect model was used. This regression
model was mixed because the treatment group was
fixed and the days from enrollment were considered
a random effect. The interaction between the treatment
effect and the number of days from enrollment was
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used to evaluate whether the rate of decline was differ-
ent between the two study arms. A value of less than
0.10 was considered significant for interaction. Logistic
regression was used to generate unadjusted and
adjusted odds ratios for the effect of maternal weight
gain on birth weight. This trial is registered with
Clinicaltrials.gov; the trial number is NCT00744965.
RESULTS
Between September 2008 and October 2012, 98% of
the 48,088 women who delivered viable neonates at
Parkland Hospital received prenatal care with our
institution, 3,126 (6.5%) of whom were diagnosed with
gestational diabetes. A total of 395 women were
eligible and enrolled in this trial. Twenty of these
women were lost to follow-up. Thus, a total of 375
randomized women were delivered at our hospital
with 189 women treated with glyburide and 186
women treated with placebo (Fig. 1). As shown in
Table 2, maternal demographics did not differ
between the two study groups. The addition of gly-
buride therapy as compared with placebo significantly
improved maternal glycemic profiles over the study
period, depicted in Figure 2. Average fasting glucose
levels in women given glyburide decreased by 7 mg/dL
(0.4 mmol/L) during treatment compared with 3 mg/dL
(0.2 mmol/L) in women given placebo. The mean
fasting glucose value during the last 3 weeks of study
participation in women receiving glyburide (84610
mg/dL) was lower than those receiving placebo
(87611 mg/dL; P..001). Additionally, 34 women
receiving glyburide therapy (18%) had a mean fasting
glucose value less than or equal to 75 mg/dL (4.2
mmol/L) compared with only 15 women (8%) receiv-
ing placebo (P,.01). The difference in the cumulative
distribution of these mean fasting glucose levels is
illustrated in Figure 3.
Shown in Table 3 are pregnancy outcomes ac-
cording to treatment group. Mean maternal weight
gain after study enrollment was 16 pounds and did
not differ between the treatment arms. Eight women
overall were treated with insulin for persistent hyper-
glycemia and were equally distributed between the
study groups. There was no difference in gestational
age at delivery (3961 week) or incidence of labor
induction23% in those women treated with glybur-
ide and 18% in those receiving placebo. One woman
in the placebo arm underwent primary cesarean deliv-
ery for an estimated fetal weight of more than 4,500 g.
The rates of pregnancy-induced hypertension (13%
compared with 10%) and severe pregnancy-induced
hypertension (8% compared with 6%) were similar
between women receiving glyburide and placebo,
Casey et al Glyburide for Mild Gestational Diabetes 305
 Women with mild
gestational diabetes
during the study period
Not enrolled (n=2,731)
(n=3,126)
Did not meet inclusion
criteria: 2,107
Not screened for
eligibility: 404
Declined to participate:
Randomized
220
(n=395)

Allocated to glyburide Allocated to placebo Fig. 1. Flow diagram of eligibility,

Did not deliver at
(n=198) (n=197)
Did not deliver at
enrollment, and follow-up for
study institution or study institution or 3,126 women with gestational
lost to follow-up lost to follow-up diabetes during the study period.
(n=9) (n=11)
Analyzed Analyzed Casey. Glyburide for Mild Gestational
(n=189) (n=186) Diabetes. Obstet Gynecol 2015.

respectively. The rate of operative vaginal delivery,
cesarean delivery, and third- or fourth-degree perineal
laceration was not different between the groups.
Shoulder dystocia occurred in only one delivery,
and this was in a woman randomized to placebo.
Neonatal outcomes are listed in Table 4. The pri-
mary outcome for the study, a decrement in birth
weight of 200 g, was not found. Mean birth weight
was 33 g lower in neonates born to women treated
with glyburide compared with those treated with pla-
cebo (P5.52). The number of neonates classified as
small or LGA also did not differ between the groups.
No other neonatal outcomes evaluated, including
admission to an intensive care unit, clavicular fracture,
brachial plexus palsy, umbilical artery blood pH of
7.0 or less, or stillbirth, were found to be different
between the glyburide and placebo groups. Notably,
hyperbilirubinemia and hypoglycemia were uncom-
mon in the neonates and unrelated to maternal treat-
ment with glyburide. Three stillbirths occurred in the
study population with two in the placebo arm and one
to a woman receiving glyburide. All stillbirths
occurred at term with appropriate-for-gestational-age
birth weights in women with excellent glycemic

Table 2. Demographic Characteristics of Women 92

With Mild Gestational Diabetes Treated 90
With Glyburide Compared With Placebo
Fasting capillary blood
glucose level (mg/dL)

88
Glyburide Placebo 86
Characteristic (n5189) (n5186) P
84
Age (y) 31.366 31.266 .9
82
Race .7
Hispanic 177 (93) 173 (93) 80
White 6 (3) 7 (3)
Black 3 (2) 1 (1) 78
0 20 40 60 80 100 120
Other 3 (2) 5 (3)
Multiparous 151 (80) 155 (83) .4 Days from enrollment
Prepregnancy BMI (kg/m2) 29.064.8 28.965.3 .8 Glyburide, mean
Gestational age at 2662 2661 .8 Glyburide, 95% confidence interval
enrollment (wk) Placebo, mean
50-g glucose screen result 174622 172623 .5 Placebo, 95% confidence interval
(mg/dL)
100-g GTT values (mg/dL) Fig. 2. Mean (95% confidence interval) fasting capillary
Fasting 8869 89611 .6 blood glucose level according to days from enrollment in
1h 205623 201621 .1 women treated with glyburide compared with those treated
2h 186623 185621 .8 with placebo. The difference between mean fasting glucose
3h 140630 140630 1.0 levels among study groups is considered significant
(P5.07).
BMI, body mass index; GTT, glucose tolerance test.
Data are mean6standard deviation or n (%) unless otherwise Casey. Glyburide for Mild Gestational Diabetes. Obstet Gynecol
specified. 2015.

306 Casey et al Glyburide for Mild Gestational Diabetes OBSTETRICS & GYNECOLOGY

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 100 Table 4. Neonatal Outcomes in Women Treated
With Glyburide Compared With Placebo
80
Cumulative percentage

Glyburide Placebo
60 Outcome (n5189) (n5186) P

40
Birth weight (g) 3,3226481 3,3556521 .5
SGA* 18 (10) 16 (9) .8
LGA* 20 (11) 22 (12) .7
20 Birth weight 4,000 g or 13 (7) 18 (10) .3
greater
0 Fractured clavicle 3 (2) 4 (2) .7
50 60 70 80 90 100 110 120 130
Erbs palsy 0 1 (1) .5
Mean fasting glucose level over the
last three observations (mg/dL)
Intensive care admission 13 (6) 11 (5) .7
Umbilical artery blood pH 1 (1) 0 1.0
Glyburide, cumulative percentage 7.0 or less
Placebo, cumulative percentage Hyperbilirubinemia 6 (3) 3 (2) .5
Fig. 3. Cumulative frequency distribution of the mean Hypoglycemia 4 (2) 2 (1) .7
fasting capillary blood glucose levels from the last three Stillbirth 1 (5/1,000) 2 (11/1,000) .6
prenatal visits for women treated with glyburide compared Neonatal death 0 0
with those treated with placebo. Wilcoxon rank-sum test, SGA, small for gestational age; LGA, large for gestational age.
P,.001. Data are mean6standard deviation or n (%) unless otherwise spec-
Casey. Glyburide for Mild Gestational Diabetes. Obstet Gynecol ified.
2015. * SGA defined as birth weight less than the 10th percentile for age;
LGA defined as birth weight greater than the 90th percentile.

control. Autopsy was elected in two and declined in a birth weight greater than 4,000 g for each 5-pound
one patient with all determined to be unexplained. increase in total pregnancy weight gain was 1.27
Of note, maternal weight gain correlated with (1.111.45, P,.001). This did not change with perfor-
birth weight greater than 4,000 g. The odds ratio for mance of multivariate analysis to adjust for treatment
arm and demographic characteristics with an adjusted
odds ratio of 1.32 (1.151.52, P..001) for each 5-
Table 3. Pregnancy Outcomes for Women With pound increase in weight gain. Put another way, the
Mild Gestational Diabetes Treated With
average maternal weight gain was 27.4615.4 pounds
Glyburide Compared With Placebo
for women delivering a neonate greater than 4,000 g,
Glyburide Placebo whereas those women delivering a neonate less than
Outcome (n5189) (n5186) P 4,000 g had an average pregnancy weight gain of
18.3612.6 pounds (P,.001).
Weight gain after enrollment (lb) 16610 16611 1.0
Insulin required 4 (2) 4 (2) 1.0
Gestational age at delivery (wk) 3962 3961 .9 DISCUSSION
Labor induction 42 (23) 35 (18) .4 In women with mild gestational diabetes, the addition
Chorioamnioitis 7 (4) 11 (6) .3
of glyburide to diet therapy significantly improved
Pregnancy hypertension 24 (13) 19 (10) .5
Severe pregnancy 15 (8) 12 (6) .6 maternal glycemic control when compared with
hypertension placebo plus diet therapy. However, the addition of
Route of delivery glyburide did not result in a significant decrease in
Spontaneous vaginal 116 (61) 112 (60) .8 birth weight or improve pregnancy outcomes typi-
Operative vaginal 3 (2) 7 (4) .2
cally associated with gestational diabetes, although
Cesarean 70 (37) 67 (36) .8
Repeat 37 (20) 45 (24) .3 this study was not powered to examine rare occur-
Dystocia 13 (7) 6 (3) .1 rences such as shoulder dystocia. Furthermore, the
Nonreassuring fetal status 9 (5) 8 (4) .8 use of glyburide in these women did not reduce the
Malpresentation 8 (4) 6 (3) .6 need for insulin therapy. Overall, the findings in this
Other 3 (2) 2 (1) 1.0
study suggest that the addition of glyburide to dietary
Shoulder dystocia 0 1 (1) .5
3rd- or 4th-degree perineal 1 (1) 5 (3) .1 treatment in women with mild gestational diabetes
laceration offers no additional benefit.
Data are mean6standard deviation or n (%) unless otherwise When OSullivan and Mahan11 first detailed the
specified. use of the 100-g glucose tolerance test to diagnose

VOL. 126, NO. 2, AUGUST 2015 Casey et al Glyburide for Mild Gestational Diabetes 307

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diabetes in pregnancy, their goal was the identification
of women at risk for diabetic complications later in
life. Years later, gestational diabetes was noted to be
associated with an increased likelihood of fetal death
in women with fasting hyperglycemia, which could be
reduced with treatment.12,13 Subsequently the perina-
tal focal point shifted to avoidance of difficult deliver-
ies and resultant birth trauma secondary to
macrosomia, a condition that affects women with ges-
tational diabetes but normal fasting glucose values.
The treatment of mild gestational diabetes with diet
therapy reduces birth weight.8 Our purpose was to
study whether women with mild gestational diabetes
would benefit from the addition of pharmacologic
therapy to diet. Given the contemporary focus in ges-
tational diabetes management on a reduction in birth
weight, we hypothesized that the addition of glyburide
to dietary therapy in women with mild hyperglycemia
would be associated with a decrease in birth weight.
However, in the trial now reported, despite the
improvement in glycemic profiles in women given
glyburide, no reduction in birth weight was found.
The most plausible explanation is that glycemic con-
trol is an imperfect target to achieve a reduction in
birth weight and that dietary modification in women
with mild gestational diabetes sufficiently optimizes
glycemic control. Put another way, a therapeutic
limit has likely been reached and further intervention
seems unnecessary in this group of women.
Excessive maternal weight gain during preg-
nancy has been strongly associated with LGA neo-
nates, even more so than gestational diabetes.14
Indeed, we found in our study population that birth
weight greater than 4,000 g was associated with
a greater maternal weight gain in pregnancy.
Hawkins et al15 demonstrated that routine use of
glucometers in women with mild gestational diabetes
resulted in a reduction in maternal weight gain. In
the currently reported study, all women received
glucometers as well as diet logs and extensive dietary
counseling. We believe that there was no difference
in birth weight between the treatment groups
because there was no difference in maternal weight
gain. The overall prevalence of LGA neonates in the
study cohort was 1112%. This represents a lower
than expected rate of LGA birth weight, particularly
because the women in our study were overweight
and at a decidedly high risk for LGA neonates. It
stands to reason that maternal weight gain was opti-
mized in both study groups through diet intervention
and thus was not further reduced through the use of
glyburide. This was true despite a demonstrable
improvement in glycemic profile.
308 Casey et al Glyburide for Mild Gestational Diabetes
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This randomized trial does have a few limita-
tions. First, the study was performed in a largely
Hispanic population at a single institution and thus
may not be generalizable to the U.S. population as
a whole. Second, the sample size of 395 women
limits our ability to analyze the effect of glyburide on
uncommon pregnancy outcomes such as shoulder
dystocia. Although no differences in maternal or
neonatal outcomes were found between groups, the
study was underpowered for outcomes other than
birth weight difference. That said, assuming a 1%
shoulder dystocia rate in women with mild gesta-
tional diabetes treated with diet, a study of the
addition of glyburide to detect a halving of this rate
with 80% power would require a sample size of more
than 9,000 women. Therefore, although no conclu-
sions can be drawn regarding the effect of glyburide
on these outcomes, an appropriately sized study is
probably not feasible.
The International Association of the Diabetes
and Pregnancy Study Groups has proposed a one-
step screening approach that is predicted to more
than double the number of women diagnosed with
gestational diabetes. The majority of these newly
diagnosed women would qualify as having mild
gestational diabetes.16,17 Because the identification
and treatment of women with gestational diabetes
in the United States is already a costly endeavor,
estimated to have required $636 million in 2007,
a further increase in the number of women diag-
nosed would consume a large amount of resources.17
Although a change in screening practice was deemed
unwarranted in a recent statement by the National
Institutes of Health, it is still a point of dissent and
will continue to evoke discussion and further study.18
The currently reported trial demonstrates that diet
therapy alone, when coupled with regular glucose
monitoring, is the optimal treatment regimen for
women with mild gestational diabetes and represents
a therapeutic limit beyond which further improve-
ment of the glycemic profile does not result in better
pregnancy outcomes.
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