Table 3. Randomized Controlled Trials of GDM Treatment

Author,
Year,
(Total N)
Glycemic level
of participants
Random-
ization
GDM
Diagnosis
Inclusion
Glycemic
Separation
During Study
% Stillbirth
(Stat Sig)
Birth
weight >
4,000 g
(Stat Sig)
% Large for
Gesta-
tional Age
(Stat Sig)
Neonatal Outcomes % Total
Cesarean
Delivery
(Stat Sig)
% Brachial
Plexus
Injury
(Stat Sig)
%
Clavicular
Fracture
(Stat Sig)
%
Hypoglycemia
(Stat Sig)
%
Hyperbili-
rubinemia
(Stat Sig)
%
Hypocalcemia
(Stat Sig)
Li et al.,
198781
(N =158)
Low
A: Controls:
No treatment
(n = 73)
B: Treatment;
diet,
monitoring
(n = 85)
GDM by NDDG65 criteria and normal or impaired glucose tolerance by WHO64 criteria NR NR A: 7
B: 4
(NS)
A: 22
B: 18
(NS)
A: 0
B: 0
(NS)
A: 0
B: 0
(NS)
No difference NR NR A: 26
B: 27
(NS)
Buchanan et al.,
199483
(N = 59)
Low
A: Diet
(n = 29)
B: Diet and
twice-daily
insulin
(n = 30)
GDM and fasting blood glucose <105 mg/dL; fetal ultrasound AC >75th percentile 5.4 - 10.8 mg/dL
mean glucose difference in mixed-meal tolerance test
NR NR A: 45
B: 13
(P <0.02)
A: 0
B: 0
(NS)
A: 0
B: 0
(NS)
A: 18
B: 14
(NS)
(lab diagnosis)
NR NR A: 14-21
B: 43
(P <0.05)
Garner et al.,
199720
(N = 300)
Low
A: Routine care
(n = 150)
B: Strict glycemic control and tertiary care
(n = 149)
Hatem and Dennis, 1987104 criteria.
Controls treated with insulin if fasting blood glucose >140 mg/dL or 1-hr postprandial value >200 mg/dL
(n = 16)
Lower in treated
group by
5 - 9 mg/dL
1 hr postprandial
A: 0
B: 0
(NS)
A: 18.7
B: 16.1
(NS)
NR A: 0
B: 0
(NS)
A: 0
B: 0
(NS)
A: 8.7
B: 14.1
(NS)
A: 6.6
B: 5.4
(NS)
A: 30
B: 40.9
(P = 0.048)
A: 18.6
B: 20.1
(NS)
Bancroft et al., 200080
(N = 68)
Low
A: Diet and no diabetic monitoring
(n = 36)
B: Diet and intensive diabetic monitoring
(n = 32)
WHO64 criteria.
Fasting blood glucose <126 mg/dL;
2-hr 75 g = 140-200 mg/dL
HbA1c:
0.2% - 0.7%
difference
A: 0
B: 0
(NS)
NR A: 7
B: 8
(NS)
NR NR NR NR NR A; 31
B: 31
(NS)
Persson et al., 198560
(N = 202)
High
A: Diet, add insulin for high glucose
(n = 105)
B: Diet and insulin
(n = 97)
Impaired glucose tolerance No difference A: 0
B: 0
(NS)
NR A: 13
B: 11
(NS)
NR NR A: 0
B: 5
(NS)
A: 20
B: 20
(NS)
A: 6.7
B: 12.5
(NS)
NR
Langer et al., 198982
(N = 272)
High
A: Controls: No treatment
(n = 146)
B: Treatment: Diet and/or insulin
(n = 126)
NDDG65 criteria
One abnormal value on 3-hr glucose tolerance test
B: Goal of glucose <95 mg/dL
24 mg/dL difference in mean capillary blood glucose NR NR A: 26
B: 6
(P <0.05)
NR NR A: 13
B: 2
(P <0.02)
(lab diagnosis)
A: 14
B: 6
(NS)
(lab diagnosis)
NR A: 11
B: 10
(NS)
Nachum et al.,
199958
(N = 274)
High
A: Diet and twice daily insulin
(n=136)
B: Diet and 4 times daily insulin
(n=138)
NDDG65 criteria 3.4 mg/dL difference in mean blood glucose;
0.3% in HbA1c
A: 0.7
B: 0
(NS)
A: 19
B: 16
(NS)
A: 30
B: 26
(NS)
A: 2.2
B: 1.4
(NS)
A: 0
B: 0
(NS)
A: 5.9
B: 0.7
(P = 0.02)
(lab diagnosis)
A: 21
B: 11
(NS)
A: 0
B: 0.7
(NS)
(lab diagnosis)
A; 28
B: 28
(NS)
Kjos et al., 200129
(N = 96)
High
A: Standard: Insulin
(n = 48)
B: Experimental Insulin only if fetal AC is = 70th percentile
(n = 48)
Fasting plasma glucose >105 and <120 mg/dL Mean fasting plasma glucose:
88.1 (B) 84.9 (A)
3.2 mg/dL difference
No difference
(only one reported)
A: 4.2
B: 6.3
(NS)
A: 6.3
B: 8.3
(NS)
No difference
(small number)
No difference
(small number)
A: 10.4
B: 10.4
(NS)
A: 2
B: 4
(NS)
NR A: 14.6
B: 33.3
P = 0.03
(Greater % of women with previous cesarean delivery in Group B)
de Veciana et al., 199559
(N = 66)
Insulin-Dependent
GDM
Very high
A: Preprandial monitoring
(n = 33)
B: Postprandial monitoring
(n = 33)
NDDG65 criteria
Fasting plasma glucose >105
mg/dL or 1-hr >140 mg/dL
1.6% difference in HbA1c A: 3
B: 0
(NS)
A: 36
B: 9
(P = 0.01)
A: 42
B: 12
(P = 0.01)
A: 0
B: 0
(NS)
A: 3
B: 3
(NS)
A: 21
B: 3
(P = 0.05)
A: 12
B: 9
(NS)
NR A: 39
(CPD: 3)
B: 24
(CPD: 12)
(P 0.04)

Note: AC indicates abdominal circumference; CPD, cephalopelvic disproportion; GDM, gestational diabetes mellitus; NDDG, National Diabetes Data Group; NR, not reported; NS, not statistically significant; Stat Sig, statistical significance; WHO, World Health Organization.

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