Screening & Diagnosis

Original guidelines for diagnosis of GDM were largely an extension of those developed for non-gestational diabetes and were aimed at identifying women at risk for the subsequent development of diabetes after pregnancy. (O'Sullivan & Mahan, 1964).

Lack of data connecting maternal hyperglycemia with adverse maternal and fetal outcome

ACHOIS (2005) : treating mild hyperglycemia (glucose intolerance) in pregnant women leads to reduction in the composite endpoint of perinatal death, shoulder dystocia, bone fracture and nerve palsy

Landon et al (2009) : similarly demonstrated a reduction in macrosomia, shoulder dystocia, cesarean delivery, and hypertensive disorders with treatment.

HAPO (2008) a prospective, blinded, multinational observational study a continuous association between rising maternal glucose concentrations and large for gestational age, pre-eclampsia, and primary cesarean section. positive association between maternal hyperglycemia and neonatal hypoglycemia, cord blood serum c-peptide, premature delivery, intensive neonatal care, and hyperbilirubinemia

1. Treatment of GDM will improve perinatal outcome (not perinatal mortality) 2. Glucose levels for diagnosis of GDM (after GTT) are lower than previously thought.

Screening methods: selective vs universal Screening protocol : timing Classification of diagnosis Diagnostic threshold

Organization
ACOG (2001) American College of Obstetricians and Gynecologists

Screening
Risk assessment or perform universal screening at 2428 wks. Low risk patients may be excluded from screening. Screen with 50-g 1-h GCT. Positive if 1-h > 7.2 mmol/l (130 mg/dl) or 7.8 mmol/l (140 mg/dl) Diagnose with 100-g OGTT.

SOGC (2002) Society of Each of the following approaches is acceptable: Obstetricians and Routine screening at 2428 wks with 50-g GCT, using Gynaecologists of Canada threshold of 7.8 mmol/l (140 mg/dl) except in low risk patients. Non-screening is also acceptable. Consider the recommendations given by the Fourth International Workshop-Conference for screening women at high riskfor GDM early in pregnancy and again at 2428 wks if initial results are negative

Organization
5th International Workshop-Conference on Gestational Diabetes Mellitus (2007)

Screening
Risk assessment should be performed at the rst prenatal visit. Low risk women do not require any routine testing. High risk women should undergo screening as soon as possible (as below). All other women should have screening at 2428 wks. Screening can be done as 50-g GCT followed by diagnostic OGTT if abnormal. Abnormal if 1-h 7.8 mmol/l (140 mg/dl) Or proceed directly to a diagnostic OGTT.

Organization
USPSTF (2008) U.S. Preventive Services Task Force

Screening
No recommendation made for routine screening due to insufcient evidence. Until there is better evidence, clinicians should discussion screening with patients and make case-by-base decisions. If a decision is made to screen for gestational diabetes, they cite most screening is done between 24 and 28 wks and the 50-g GCT is the most common test used in the United States followed by the 100-g OGTT for conrmation. Perform risk assessment at the initial visit. Women with any risk factors should be offered testing for GDM. If a woman has had GDM in a prior pregnancy, she should be offered SMBG at 1618 wks and repeat OGTT at 28 wks if initial testing is normal. Women without risk factors should be offered an OGTT at 2428 wks. Screen using the 75-g OGTT

NICE UK (2008) National Institute for Health and Clinical Excellence, United Kingdom

Organization ADA (2010) American Diabetes Association

Screening Risk assessment should take place at the rst prenatal visit. Do not screen low risk women.
Screen high-risk women at the initial visit to identify pre-gestational diabetes.

If negative at rst visit, high risk women should be retested at 24 and 28 wks. Women of average risk should be universally screened between 24 and 28 wks.
Initial screening: -hemoglobin A1c by NGSP-certied, standardized method, fasting plasma glucose, 1 step 75-g OGTT with 2-h glucose level, or random plasma glucose in a patient with classic symptoms of hyperglycemia 2-step approach: Perform a 50-g glucose challenge test and if 1-h plasma or serum glucose move on to either the 100-g OGTT or the 75g OGTT for diagnosis. 1-step approach: 75-g OGTT; this approach may be cost-effective in high-risk>130 mg/dL or > 140 mg/dl, populations

Pregnant women should be screened if they have any of the following risk factors: BMI >27kg/m Previous macrosomic baby weighing 4kg or above Previous gestational diabetes mellitus (GDM) First-degree relative with diabetes Bad obstetric history Glycosuria at the first prenatal visit Current obstetric problems (essential hypertension, pregnancy induced hypertension, polyhydramnios and current use of steroids) Age above 25

Screening is done using the 75g OGTT and performed at least once at >24 weeks of gestation Screening at an earlier stage of gestation depends on the degree of suspicion and at the physicians/obstetricians request.

Screen for risk factor(s)

MGTT after 12-14 weeks or as soon as risk identified Repeat test at 28-30 weeks of gestation

Screen for risk factor(s) absent present 75gm OGTT Normal

Gestational Diabetes mellitus

positive
negative 75 gm OGTT At or after 28-30 weeks of gestation

positive

negative

Selective vs Universal

Organisation
ACOG (2001) American College of Obstetricians and Gynecologists SOGC (2002) Society of Obstetricians and Gynaecologists of Canada 5th International Workshop-Conference on Gestational Diabetes Mellitus (2007) USPSTF (2008) U.S. Preventive Services Task Force NICE UK (2008) National Institute for Health and Clinical Excellence, United Kingdom ADA (2010) American Diabetes Association CPG Management of Type 2 DM 2009 Perinatal Care Manual

Selective
X X *

Universal
X/

At booking Measure FPG, HbA1C, or random plasma glucose on all or only women high-risk
> 7.0 mmol/l >5.1 mmol/l but <7.0 mmol/l
Gestational Diabetes

<5.1 mmol

Overt Diabetes in Pregnancy

75-g OGTT at 24 to 28 weeks gestation

Selective screening: risk assessment OGTT upon identification of risk factor

 GDM complicates approx 7% of all pregnancies in US (Nicholson W, 2009) NICE (2008) = average prevalence in England and Wales is approximately 3.5%

Study
Fuziah Paimin et al, 2011 (unpub) Idris N et al, 2009

Prevalance

19.4% 18.4% 24.9% 12.5%

Shamsuddin K, 2001

Chan S, 1993

Idris N et al (2009), screening of GDM as recommended by Malaysian CPG 2009/ADA will result in 90% of patient being screened

Screen for risk factor(s) absent present 75gm OGTT Normal

Gestational Diabetes mellitus

positive
negative 75 gm OGTT At or after 24-28 weeks of gestation

positive

negative

Timing

OGTT should be prescribed once risk factors identified

If at risk repeat GTT.

Organization
ADIPS (1998) The Australasian Diabetes in Pregnancy Society WHO (1999) World Health Organization
ACOG (2001) American College of Obstetricians and Gynecologists SOGC (2002) Society of Obstetricians and Gynaecologists of Canada Japan (2002) The Committee of the Japan Diabetes Society

Screening design
Screen at 2630 wks.

If high risk, screen in rst trimester. All others, screen at 2428 wks.
Risk assessment or perform universal screening at 2428 wks. Routine screening at 2428 wks with 50-g GCT

Screen all at 2428 wks.

Organization
Austrian (2004)

Screening design
Screen all at 2428 wks.

Joslin Diabetes Center (2005)

Screen average-risk women at 2428 wks.

AACE (2007) American Association of Clinical Endocrinologists

Screen low-risk women at 2428 wks.

NICE UK (2008) National Institute for Health and Clinical Excellence, United Kingdom
ADA (2010) American Diabetes Association

Women without risk factors should be offered an OGTT at 2428 wks.

High risk women should be retested at 24 and 28 wks Average risk should be universally screened between 24 and 28 wks

Screen for risk factor(s) absent present 75gm OGTT Normal

Gestational Diabetes mellitus

positive
negative 75 gm OGTT At or after 24-28 weeks of gestation

positive

negative

PPVs for risk factors : First-degree relative with type 2 diabetes 6.7%, First-degree relative with type 1 diabetes 15%, Previous macrosomic baby (more than 4500 g) 12.2% Glycosuria in current pregnancy 50% Macrosomia in current pregnancy 40% Polyhydramnios in current pregnancy 40%

Griffin ME, Coffey M, Johnson H, et al. Universal vs. risk factor-based screening for gestational diabetes mellitus: detection rates, gestation at diagnosis and outcome. Diabetic Medicine 2000;17(1):2632

OR for GDM Previous gestational diabetes (OR 23.6, 95% CI 11.6 to 48.0) Previous macrosomic baby (OR 5.59, 95% CI 2.68 to 11.7) Family history of diabetes (OR 2.74, CI 1.47 to 5.11) Age 25 years or more (OR 3.37, 95% CI 1.45 to 7.85)

Ostlund I and Hanson U. Occurrence of gestational diabetes mellitus and the value of different screening indicators for the oral glucose tolerance test. Acta Obstetricia et Gynecologica Scandinavica 2003;82(2):1038

Prescribe 75 gm OGTT in presence of (any of the following risk factors)

BMI >27kg/m Previous macrosomic baby weighing 4kg or above Previous gestational diabetes mellitus (GDM) First-degree relative with diabetes Bad obstetric history (recurrent miscarriages, unexplained stillbirth, diabetic related birth defect)* Glycosuria at the first prenatal visit Current obstetric problems (essential hypertension, pregnancy induced hypertension, polyhydramnios and current use of steroids) Age above 25

The International Workshop-Conferences on GDM (2007) have defined the condition as any degree of glucose intolerance with onset or first recognition during pregnancy
While this facilites screening and diagnosis, management of undetected glucose intolerance antedated the pregnancy might be misjudged.

Current practice
1. Gestational diabetes mellitus diagnosed in pregnancy 2. Established DM diagnosed before pregnancy *DM diagnosed in pregnancy *GDM managed as established DM

Increased risk of congenital anomalies in offspring (Schaefer et al, 1997). Risk of diabetes complications (nephropathy and retinopathy) requiring treatment during pregnancy (Omori & Jovanovic, 2005). Need for rapid treatment and close follow-up during pregnancy to ensure prompt restoration of normal glycemia (Bartha et al, 2000; Maegawa et al, 2003). Need to ensure conrmation and appropriate treatment of diabetes after pregnancy.

 Increasing prevalence of T2DM in Malaysia younger female (in reproductive age group)higher risk of overt diabetes in pregnancy
In Metabolic Study In Malaysia (May 2010) prevalence of T2DM in Malaysia (based on OGTT) is 22.3%

Classification of diabetes mellitus in pregnancy 1. Established diabetes mellitus 2. Overt diabetes in pregnancy (1st diagnosed in pregnancy, but probably pre-pregnancy DM) 3. Gestational diabetes mellitus

Venous plasma glucose level (mmol/l) Time

Normal <5.6 <7.8 Diabetes mellitus >5.6 >7.8

Fasting 2 hours

IADPSG, 2010

Overt diabetes in pregnancy = fasting plasma glucose > 7 mmol/L Gestational diabetes mellitus = at least one of the following
FPG = > 5.1 mmol/L 1 hour PG = > 10.0 mmo/L 2 hours PG = > 8.5 mmol/L

75 gm oral glucose tolerance test

3 days of normal diet Fasting for at least 8 hours before the test 75gm glucose in 250 mls water to be finished in 10-15 minutes Rest during the 2 hours (of test procedure)

75 gm OGTT

Overt DM

Antenatal booking & all visits

GDM

Normal

.. 75 gm OGTT Overt DM

24-28 weeks gestation

GDM Normal

1. Screen the high risk women for diabetes in pregnancy at the first and every antenatal encounters 2. Women at risk should undergo a 75 gm OGTT and plasma venous glucose testing at 0 (fasting state), 1 and 2 hours post glucose load 3. Any one of the abnormal readings can be used in the diagnosis (of gestational diabetes mellitus) 4. Overt diabetes in pregnancy is diagnosed base on fasting plasma glucose 5. Those at risk and tested negative (for diabetes in pregnancy) on the initial encounter, should be re-tested at 24-28 weeks of gestation

Dr Norhayati Yahaya Dr Nurain Mohd Noor Prof Mohd Shukri Othman Dr Iskandar Firzada Osman Dr Khatijah Abd Rahman AP Dr. Che Anuar Che Yaakob Dr Zahar Azuar Zakaria Dr Jusoh Senik Dr Kamilah Mohamed Dr Yazeed Zainal Abidin Dr Nik Norashikin Nik AbdulRahman Dr Jumizah Abd Kadir

1. 2. 3. 4.

Detection rate Cost Human resource Training

Schaefer UM, Songster G, Xiang A, Berkowitz K, Buchanan TA, Kjos SL. Congenital malformations in offspring of women with hyperglycemia rst detected during pregnancy. Am J Obstet Gynecol 1997;177:11651171 Omori Y, Jovanovic L. Proposal for the reconsideration of the denition of gestational diabetes. Diabetes Care 2005; 28:2592 2593 Bartha JL, Martinez-Del-Fresno P, CominoDelgado R. Gestational diabetes mellitus diagnosed during early pregnancy. Am J Obstet Gynecol 2000;182:346 350

Maegawa Y, Sugiyama T, Kusaka H, Mitao M, Toyoda N. Screening tests for gestational diabetes in Japan in the 1st and 2nd trimester of pregnancy. Diabetes Res Clin Pract 2003;62:47

 Ostlund I and Hanson U. Occurrence of gestational diabetes mellitus and the value of different screening indicators for the oral glucose tolerance test. Acta Obstetricia et Gynecologica Scandinavica 2003;82(2):1038
Griffin ME, Coffey M, Johnson H, et al. Universal vs. risk factor-based screening for gestational diabetes mellitus: detection rates, gestation at diagnosis and outcome. Diabetic Medicine 2000;17(1):2632 Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med 2009; 361(14): 13391348.

 Nicholson W, Bolen S, Witkop CT, Neale D, Wilson L, Bass E. Benefits and risks of oral diabetes agent compared with insulin in women with gestational diabetes: a systematic review. Obstet Gynaecol 2009; 113:193-205 Crowther CA, Hiller JE, Moss JR, et al.; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. New England Journal of Medicine 2005;352(24):247786. O'Sullivan JB & Mahan CM. Criteria for the oral glucose tolerance test in pregnancy. Diabetes 1964; 13: 278285

 HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 1991-2002; 2008: 358 International Association of Diabetes and Pregnancy Study Groups. International Association of Diabetes and Pregnancy Study Groups recommendations on the diagnosis and classication of hyperglycemia in pregnancy. Diabetes Care 2010; 33(3): 676682
N Idris, CH Che Hatikah, MZ Murizah, MN Rushdan. Universal Versus Selective Screening For Detection Of Gestational Diabetes Mellitus In A Malaysian Population, Malaysian Family Physician 2009; Volume 4, Number 2

 Shamsuddin K, Mahdy ZA, Rafiaah SI, Jamil MA. Risk Factor screening for abnormal glucose tolerance in pregnancy. International Journal of Gynecology and Obstetric 2001;75:27-32
Chan S. Prevalence of GDM in Malaysia. ASGODIP Report: ASEAN, 7th Congress of ASEAN Federation of Endocrine Society, 1993 Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med 2009; 361(14): 13391348