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Kimberlee A McKay, M.D. Avera Medical Group Ob/GYN Gestational Diabetes: An Update on Testing

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Page 1: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

Kimberlee A McKay, M.D.

Avera Medical Group Ob/GYN

Gestational Diabetes: An Update on

Testing

Page 2: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

Gestational Diabetes

Increased risks of: Still Birth

Hydramnios

Should Dystocia

Prolonged Labor

Preeclampsia

Macrosomia

Habitual Abortions

Page 3: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

Gestational Diabetes :

“Carbohydrate intolerance that begins or

is first recognized during pregnancy.”

Page 4: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

The Beatles

Go-Go boots

Gestational Diabetes

1960s

Page 5: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

Positive 1-hour GTT:•140 mg/dl or higher

•Sensitivity of 80%

•15% of your patients may require 3-hr OGTT

•130 mg/dl or higher

•Sensitivity of 90%

•23% of your patients may require 3-hr OGTT

ACOG Practice Bulletin No. 30

Gestational Diabetes

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ACOG Diagnostic Criteria for GDM: 2 or

more thresholds must be exceeded

Serum Glucose by

Carpenter /Coustan

Conversion

Serum Glucose

level by National

Diabetes Data

Group

Conversion

Fasting 95 mg/dl 105 mg/dl

1-hour 180 mg/dl 190 mg/dl

2-hour 155 mg/dl 165 mg/dl

3-hour 140 mg/dl 145 mg/dl

Gestational Diabetes. ACOG Practice Bulletin No. 30. American

College of Obstetricians and Gynecologists. Obstet Gynecol 2001;

98:535-38

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“Although a number of comparative studies of various treatments are available, there is little

information regarding the effectiveness of treatment versus no treatment.”

ACOG Practice Bulletin No. 30

Gestational Diabetes

American College of Obstetricians and Gynecologists. Obstet

Gynecol 2001; 98:535-38

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RCT to determine whether treating GDM affected perinataloutcomes

At the time, usual practice was no treatment in some centers

1000 pregnant women across 18centers in Australia and 2 centers in the UK

Positive 2 hour OGTT (FBS>99 mg/dl and 2-hour BS<198 mg/dl

ACHOIS Trial

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of treatment of

gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in

pregnant women (ACHOIS) trial group. NEJM 2005; 352: 2477-86

Page 9: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

ACHOIS Trial: 1000 patients

n=510

Positive 2-hour OGTT

Usual care

n=490

Positive 2-hour OGTT

Intervention

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of

treatment of gestational diabetes mellitus on pregnancy outcomes. Australian

carbohydrated intolerance study in pregnant women (ACHOIS) trial group. NEJM

2005; 352: 2477-86

Page 10: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

ACHOIS Trial: Outcome Measures

Primary Secondary

Maternal •Cesarean Delivery

•Need for labor induction

•#PN visits

•Mode of delivery

•Wt. Gain

•Antenatal Admits

•PIH

Neonatal •Perinatal complications

•Admission to NICU

•Jaundice requiring Photo therapy

•Gestational age

•Birth Weight

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of treatment of

gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study

in pregnant women (ACHOIS) trial group. NEJM 2005; 352: 2477-86

Page 11: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

ACHOIS Trial: Neonatal Outcomes

Primary

Intervention

#(%) of

n=506

Routine Care

#(%) of n=534 RR

Death 7(1) 24(4) 0.32

Stillbirth 0 5(1)

Neonatal death0 3(<1)

Shoulder

Dystocia 7 (1) 16(3) 0.45

Bone

Fracture0 1(<1)

Nerve Palsy 0 3(1)

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of treatment of gestational

diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women

(ACHOIS) trial group. NEJM 2005; 352: 2477-86

Page 12: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

ACHOIS Trial: Neonatal Outcomes

SecondaryIntervention

n=506

Routine

n=524P-value

Birth Weight3335+/-551

gms

3482+/-660

gms<.0001

LGA 63(13%) 115 (22%) <.0001

EFW>4 kg 49 (10%) 110 (21%) <.0001

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of

treatment of gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated

intolerance study in pregnant women (ACHOIS) trial group. NEJM 2005; 352: 2477-86

Page 13: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

ACHOIS Trial: Maternal Outcomes

Primary Intervention

# (%) n=490

Routine

# (%) n=510

RR

Induction 189 (39) 150(29) 1.31

C/S Total 152 (31) 164(32) 0.96

C/S Emergent 80 (16) 103 (20) 0.81

C/S Elective 72 (15) 61 (12) 1.23

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of treatment of

gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study

in pregnant women (ACHOIS) trial group. NEJM 2005; 352: 2477-86

Page 14: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

ACHOIS: Conclusions

Routine Care Group Increased risk of macrosomia and LGA

Increased risk of perinatal outcomes (shoulder dystocia, birth trauma)

Intervention Group Increased risk of labor induction

Increased risk of NICU Admission

Decreased neonatal body weight

Crowther, CA. Hiller JE. Moss JR. McPhee AJ, Jeffries WS, Robinson JJ. Effects of

treatment of gestational diabetes mellitus on pregnancy outcomes. Australian

carbohydrated intolerance study in pregnant women (ACHOIS) trial group. NEJM 2005;

352: 2477-86

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US Preventive Task Force 2008

“The USPTF concludes that the current evidence is

insufficient to asses the benefits and harms of screening

for GDM either before or after 24 weeks gestation.”

Screening for gestational diabetes mellitus: Us Preentitive

Services Task Force recommendations statement. Ann Intern Med

2008;148 (10): 759-65

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HAPO Study 2008

25,000 patients in 9 countries

75-g OGTT from 24-32 WGA

Looked at maternal glucose values as a continuum

to see what levels may be associated with an

increased risk of adverse perinatal outcomes.

The HAPO study cooperative research group.

Hyperglycemia and adverse pregnancy outcomes. NEJM

2008; 358(19): 1991-2001

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HAPO Study

Primary Outcomes Birth weight > 90%ile

Primary cesarean delivery

Clinical neonatal hypoglycemia

Cord-blood serum C-peptide level > 90%ile

Secondary Outcomes Premature delivery

Shoulder dystocia or birth injury

NICU admissions

Hyperbilirubinemia

PreecampsiaThe HAPO study cooperative research group. Hyperglycemia and adverse pregnancy

outcomes. NEJM 2008; 358(19): 1991-2001

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HAPO Study

Glc >200

• = Overt Diabetes

• Unblindedfrom study

Glc >105

• GDM

• Unblindedfrom study

Glc= 2 abnomalvalues

• Mild hyperglycemia

The HAPO study cooperative research group. Hyperglycemia and adverse pregnancy

outcomes. NEJM 2008; 358(19): 1991-2001

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HAPO Study

Plasma glucose levels were divided in to 7 categories

Adjusted Odds Ratios were calculated for both primary and

secondary outcomes

Then they made some really complicated graphs that I am not

going to reproduce because, let’s face it, I am just not that

smart.

The HAPO study cooperative research group. Hyperglycemia and

adverse pregnancy outcomes. NEJM 2008; 358(19): 1991-2001

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HAPO Study: Birth weight>90th%ile

FBS OR 1-hr OR 2-hr OR

1 1.0 1.0 1.0

2 1.37 1.21 1.11

3 1.72 1.65 1.51

4 1.95 2.27 2.15 (126-139)

5 2.73 (90-94) 2.66 (172-193) 2.10

6 3.0 3.5 2.68

7 5.01 4.49 4.46

The HAPO study cooperative research group. Hyperglycemia and adverse pregnancy

outcomes. NEJM 2008; 358(19): 1991-2001

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HAPO Study: Cord-blood serum C-

peptide >90%ile

FBS OR 1-hr OR 2-hr OR

1 1.0 1.0 1.0

2 1.41 1.07 1.06

3 1.75 1.62 1.44

4 2.36 (85-89) 1.95 (156-171) 1.72 (140-157)

5 3.62 2.76 (172-193) 2.21 (140-157)

6 4.46 2.91 2.86

7 7.65 4.65 3.48

The HAPO study cooperative research group. Hyperglycemia and adverse

pregnancy outcomes. NEJM 2008; 358(19): 1991-2001

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HAPO Study: Secondary outcomes

Positive associationsPreeclampsia

Shoulder dystocia

Birth Injury

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HAPO Study: Conclusions

“Our results indicated strong, continuous

associations of maternal glucose levels below those

diagnostic of diabetes with increased birth weight

and increased cord-blood serum C-peptide levels.”

The HAPO study cooperative research group. Hyperglycemia and

adverse pregnancy outcomes. NEJM 2008; 358(19): 1991-2001

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Carpenter-Coustan criteria Vs. National

Diabetes Data Group Thresholds

2009 retrospective cohort study of patients in California

delivering from 1988-2001

14, 500 patients 753 (5.1%) patients meeting criteria for GDM by both NDDG and C-C criteria.

480 (3.3%) by NDDG

272 (1.9%) by C-C

Hypothesized that using the C-C criteria would decrease

undesirable perinatal complications.

Cheng, WC, Block-Kurbisch, I. and Caughey, A. Carpenter-Coustan Criteria

Compared with the National Diabetes Data Group Thresholds for Gestational

Diabetes Mlitus. Obstet and Gynecol. 2009; 114(2)326-332

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273 (1.9 %)

LGA (5.1%)

Macrosomia (4.0%)

Shoulder dystocia (3.3%)

Birth Trauma(4.4%)

Operative Vaginal delivery (18.8%)

C-section (22.7%)

Post Partum Hemorrhage (26.7%)

Neonatal Hypoglycemia (1.8%)

480 (3.3%)

LGA (2.9%)

Macrosomia (1.0%)

Shoulder Dystocia (1.1%)

Birth Trauma (2.7%)

Operative Vaginal Delivery (14.3%)

C-Section (26.1%)

Post Partum Hemorrhage (31.9%)

Neonatal Hypoglycemia (4.4%)

Cheng, WC, Block-Kurbisch, I. and Caughey, A. Carpenter-Coustan Criteria

Compared with the National Diabetes Data Group Thresholds for Gestational

Diabetes Millitus. Obstet and Gynecol. 2009; 114(2)326-332

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Carpenter-Coustan criteria Vs. National

Diabetes Data Group Thresholds

Suggested that NDDG threshold was missing a subgroup of

women who had mild hyperglycemia

Suggested that treatment of this subgroup of patients may lower

the risk of complications

Cheng, WC, Block-Kurbisch, I. and Caughey, A. Carpenter-Coustan

Criteria Compared with the National Diabetes Data Group Thresholds

for Gestational Diabetes Millitus. Obstet and Gynecol. 2009; 114(2)326-

332

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IADPSG 2010

Made considerable changes to recommendations for screening

based primarily on the HAPO Study. Goal:

Achieve international consensus

Translate the HAPO data as it relates to improving perinatal morbidity

Page 28: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

IADPSG Recommendations 2010

Fasting Plasma

Glucose>92 mg/dl

1-Hour Plasma Glucose > 180 mg/dl

2-Hour plasma Glucose > 153 mg/dl

**One or more values must be exceeded.

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IADAPSG Screening

Recommendations

First prenatal visit

Measure FPG, A1C, or random plasma glucose on all or only high-risk women

1. If results indicate overt diabetes

Treatment and follow-up as for preexisting diabetes

2. If results not diagnostic of overt diabetes:

--and fasting plasma glucose ≥92 mg/dl but <126 mg/dl,

diagnose as GDM.

--and fasting plasma glucose <92 mg/dl, test for GDM from

24 to 28 weeks' gestation with a 75-g OGTT

Page 30: Gestational Diabetes: An Update on Testing Diabetes - Dr...gestational diabetes mellitus on pregnancy outcomes. Australian carbohydrated intolerance study in pregnant women (ACHOIS)

IADAPSG Screening

Recommendations

24–28 weeks' gestation: diagnosis of GDM

2-h 75-g OGTT: perform after overnight fast on all women not previously found to have overt diabetes or GDM during testing earlier in this pregnancy

1. Overt diabetes if fasting plasma glucose 126 mg/dl

2. GDM if one or more values equals or exceeds thresholds

3. Normal if all values on OGTT less than thresholds

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No evidence that these changes will lead to clinically significant improvements in maternal and neonatal outcomes.

Could significantly increase costs without improving perinatal, neonatal and maternal outcomes.

DO NOT recommend changing from the current 2-step process until more research is available.

ACOG Committee Opinion No. 504

Screening and Diagnosis of Gestational Diabetes Mellitus. Committee

Opinion Number 504. ACOG. Obstet Gynecol 2011; 118: 751-53

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Why do we care (clinical

relevance)?

• Fewer shoulder dystocias

• Fewer NICU admissions

• Decreased childhood and potentially adult obesity

• Less “Birth Trauma.”

• More inductions

• More interventions

• Potentially increased cost

• More patients who will be forced to eat a healthy and balanced diet