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GESTATIONAL
DIABETES
Evidence For Universal Screening
Laura Andersen & Danielle Major Galasso

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99 Topics - Objectives

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Background

Gestational diabetes mellitus (GDM) is associated with

adverse maternal and fetal outcomes

Screening is recommended but the best screening

method (glucose load, blood glucose level cut-off, etc)
remains controversial

According to the WHO definition for an acceptable

screening programme, GDM does not fulfill the criteria

The recommendations outlined in the CDA guidelines

are Grade C level of evidence at best

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CDA Guidelines

All pregnant women should be screened for GDM at 24

28 weeks of gestation [Grade C, Level 3]

If there is a high risk of GDM based on multiple clinical

factors, screening should be offered at any stage in the
pregnancy [Grade D, Consensus]

If the initial screening is performed before 24 weeks of

gestation and is negative, re-screen between 24 and 28
weeks of gestation [Grade D, Consensus]

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CDA Guidelines

Risk factors:

Previous GDM

Pre-diabetes

High risk population/ethnicity

Age > 35 years

BMI > 30

History of PCOS/acanthosis nigracans

Corticosteroid use

History of macrosomic infant/current macrosomia

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CDA Guidelines

The preferred approach for the screening and

diagnosis of GDM is the following [Grade D,
Consensus]:

Screening for GDM should be conducted using the 50

g GCT administered in the nonfasting state with PG
glucose measured 1 hour later [Grade D, Level 4]

PG 7.8 mmol/L at 1 hour will be considered a

positive screen and will be an indication to proceed to
the 75 g OGTT [Grade C, Level 2]

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CDA Guidelines

PG 11.1 mmol/L can be considered diagnostic of

gestational diabetes and does not require a 75 g OGTT
for confirmation [Grade C, Level 3]

If the GCT screen is positive, a 75 g OGTT should be

performed as the diagnostic test for GDM using the
following criteria 1 of the following values:

Fasting 5.3 mmol/L

1 hour 10.6 mmol/L

2 hours 9.0 mmol/L [Grade B, Level 1]

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Griffin, et al. 2000

Universal versus risk-factor based screening for gestation diabetes

mellitus: detection rates, gestation at diagnosis, and outcome.
Diabetic Medicine. 17: 26-32.

Aim: prospective, randomized study aimed to compare differences

in outcomes in either universally screened groups versus risk-based
screening groups

Methods:

Study conducted over 24-month period in Dublin, Ireland

Subjects were randomized at booking on the basis of which day they

came to clinic

If 1 > more risk factor was present, women were allocated to risk-based
group and underwent a 100g OGTT at 32 weeks GA

Other women were allocated to the universal group who were screened
with a 1-hr 50g GCT at 26-28 weeks GA

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Griffin, et al. 2000

Methods cont:

Subjects diagnosed with GDM were reviewed by an OB and

endocrinology q2weeks until 36 weeks, then weekly
thereafter

All subjects were instructed on appropriate diabetics diets

or treated with insulin if indicated

SVD was awaited until 42 weeks

Fetal outcome data was recorded (gestational age, fetal

hypoglycemia, hyperbilirubinemia, birth weight)

Students t-test was used to statisitcally compare groups

and p < 0.05

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Griffin, et al. 2000

Results:

1853 subjects were analyzed in the risk-based group and

1889 in the universal group

Study found a prevalence of 2.7% in the universal group

compared to a prevalence of 1.45%

Gestational age at diagnosis was significantly earlier in the

universal group (30 weeks vs. 33 weeks, p < 0.05)

Almost all the differences in adverse outcomes between

GDM and non-GDM patients were statistically significant

+Griffin, et al. 2000

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Griffin, et al. 2000

Bottom line:

Universal screening is superior to risk-factor based

screening in the detection of GDM in low-risk,
Caucasian population

Validity:

Randomized

Patient demographics were equal in both groups

Sample of patients at similar point in course of disease

Objective and un-biased outcome criteria were used

Will these results change my practice?

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HAPO group, 2008

Hyperglycemia and adverse pregnancy outcomes

Prospective observational study

Aim: to clarify risks adverse outcomes associated with

various degrees maternal glucose intolerance less severe
than over DM

Methods

Participants all pregnant women in the centres (international),

excluding:

Age <16, uncertain dates, inability to complete OGTT by 32wks

GA, multiple preg, fertility treatment, dx DM during or prior to
current preg, HIV or Hep B/C

75gm OGTT 24-32 weeks and random BG 34-37 weeks

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HAPO group, 2008

Methods contd

Women, caregivers and HAPO staff (except lab personnel) blinded

to OGTT and random BG unless glucose level diagnostic of DM,
safety reasons (hyper- or hypoglycemia)

Only data from women who remained blinded included in study

Infant cord-blood samples at delivery (C-peptide and BG)

Collected data on prenatal care, timing of delivery, neonatal care

Outcomes

Primary BW >90th %ile, C/S, clinical neonatal hypoglycemia,

fetal hyperinsulinemia (C-peptide >90th %ile)

Secondary premature delivery (<37wks), shoulder dystocia,

need for intensive neonatal care, hyperbilli, preeclampsia

Statistical analysis: multiple logistic regressions (incl model

controlling for potential confounders)

Glucose as
categorical
variable
and
primary
outcomes

Glucose as continuous variable and primary & secondary outcomes

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HAPO group, 2008

Results (contd)

Did not have power to look at perinatal death as primary

outcome

130 perinatal deaths

Unadjusted analyses showed no increase in risk of death

with glucose levels

Bottom Line: strong, continuous relationship

between maternal glucose levels below dx
criteria for DM with increased BW and cord blood
serum C-peptide levels

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HAPO group, 2008

Validity

Randomized? N/A

Patient characteristics similar at baseline? N/A

Blinding?

Groups were treated equally? N/A

Will these results change my practice

Threshold glucose levels in GDM guidelines based on OR

2.0 for primary outcome from this study

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Crowther et al, 2005

ACHOIS study; RCT

Aim: to assess whether txt for GDM would reduce

oerinata complications and to assess whether the
effects of treatment on maternal outcome, mood, and
QOL

Methods

Population: singleton or twin preg 16-30wks GA, attended

antenatal clinics, had one or more RF for GDM or positive
50gm GCT, and had 75gm OGTT at 24-34 wks GA w 1hr BG
<7.8 and 2hr BG 7.8-11.0 (glucose intolerance)

Randomization: central, number generator into blocks

Blinded

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Crowther et al, 2005

Methods (contd)

Interventions

Intervention group received ongoing care by OB;

interventions included dietary advice, instructions on SMBG
(QID until within target range), and insulin if appropriate

Replicated clinical care in which universal screening and

treatment for GDM available

Routine care group replicated clinical care in which

screening for GDM not available

Primary outcomes

Infants: composite measure serious perinatal complications,

admission neonatal nursery, and jaundice w phototherapy

Women: IOL, C/S, health status, psychological outcomes

Secondary outcomes: infants and women

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Crowther et al, 2005

Methods (contd)

Statistics

Intention to treat

Adjusted for confounders

Primary outcomes: RR, NNT, NNH for binary outcomes;

ANOVA for continuous variables

Power calculation

(SF-36 = measure of
maternal health
status)

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Crowther et al, 2005

Bottom line: treatment of GDM reduced rate of

serious perinatal morbidity and may also
improve womens health-related QOL

Validity

Randomized

Patient characteristics similar at baseline

Controlled for differences

Blinding

Groups were treated equally

Will these results change my practice

Informed CDA guideline for universal GDM screening

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Landon, et al. 2009

A multi-centre, randomized trial of treatment for mild

gestational diabetes. New England Journal of Medicine.
361: 1339-48.

Aim: to determine if treatment of mild gestational

diabetes improves pregnancy outcomes (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])

The primary outcome was a composite of stillbirth or

perinatal death and neonatal complications, including
hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and
birth trauma

Secondary outcomes included birth weight greater than

4000g, LGA, SGA, admission to NICU, or respiratory distress
syndrome

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Landon, et al. 2009

Methods:

Included women 24-31 weeks GA with mild GDM

Randomly assigned to usual pre-natal care (control group) or or

dietary intervention, self-monitoring of blood glucose, and insulin
therapy, if necessary (treatment group)

Women completed a fasting, 3-hr 100g OGTT

Exclusion criteria:

preexisting diabetes

an abnormal result on a glucose screening test before 24 weeks

of gestation

prior gestational diabetes

a history of stillbirth

multifetal gestation, asthma, or chronic hypertension

if they were taking corticosteroids

if there was a known fetal anomaly

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Landon, et al. 2009

Methods contd:

Statistical analysis:

Authors reviewed literature to determine the event rates for

each of the primary outcomes defined in women with and
without treatment for GDM

With sample size of n = 950, they needed at least 80%

power to show at 30% difference between groups with a
type 1 error of 5% (2-sided)

Analysis conducted according to intention-to-treat principle

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Landon, et al. 2009

Results:

There was no statistically significant differences in primary

outcome measures (perinatal and neonatal factors)

The mean birth weight/neonatal fat mass, and frequence of

LGA babies was significantly reduced in the treatment group
(p < 0.001)

In terms of maternal factors, c-section was significantly less

common in the treatment group (p=0.02) as well as the
incidence of shoulder dystocia (p=0.02)

Bottom Line: treatment for mild GDM did not

reduce primary perinatal outcomes but did
significantly reduce the rate of c-section, shoulder
dystocia, macrosomia/LGA, and pre-eclampsia

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Landon, et al. 2009

Validity:

Randomized using the simple urn method

Patient characteristics were similar at baseline

Blinding was achieved

Groups were not treated equally

Will these results change my practice

CDA guidelines currently recommend this:

Women with GDM should receive nutrition counseling from

a registered dietitian during pregnancy [Grade C, Level
3] and postpartum [Grade D, Consensus].
Recommendations for weight gain during pregnancy
should be based on pregravid BMI [Grade D, Consensus]

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Criteria for universal screening

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Summary

All pregnant women should

be screened for GDM at 24-28
weeks of gestation [Grade C,
Level 3 (121)].

If there is a high risk of GDM

based on multiple clinical
factors, screening should be
offered at any stage in the
pregnancy [Grade D,
Consensus]. If the initial
screening is performed before
24 weeks of gestation and is
negative, rescreen between
24 and 28 weeks of gestation.

Questions
?

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References

HAPO Study Cooperative Research Group. Hyperglycemia and

adverse preg- nancy outcomes. N Engl J Med 2008;35:1991e2002.

Crowther CA, Hiller JE, Moss JR, et al. Effect of treatment of

gestational diabetes mellitus on pregnancy outcomes. N Engl J Med
2005;352:2477e86.

Griffin et al. Universal versus risk-factor based screening for

gestation diabetes mellitus: detection rates, gestation at
diagnosis, and outcome. Diabetic Medicine. 17: 26-32

Landon et al. A multi-center, randomized trial of treatment for mild

gestational diabetes. New England Journal of Medicine. 361: 133948.

Meltzer SJ, Snyder J, Penrod JR, et al. Gestational diabetes mellitus

screening and diagnosis: a prospective randomised controlled trial
comparing costs of one-step and two-step methods. BJOG
2010;117:407e15.