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Gestational DiabetesGestational DiabetesUpdate in Diagnosis and Update in Diagnosis and ManagementManagement
Objectives
Review basic physiology of gestational diabetes Review fetal and maternal implications Review current recommendations for screening
for GDM Review 3 important studies published within last
5 years that are driving current recommendations
Review recommendations from the 5th International Workshop-Conference on Gestational Diabetes Mellitus
Review use of insulin analogs in pregnancy Review use of oral antihyperglycemic agents in
pregnancy
Brief overviewBrief overview
Defined as carbohydrate intolerance that Defined as carbohydrate intolerance that begins or is first recognized during begins or is first recognized during pregnancypregnancy
Important because it impacts maternal Important because it impacts maternal health care both during and after health care both during and after pregnancypregnancy
Incidence varies, but most often reported Incidence varies, but most often reported as 5-7% of pregnant women; may be as 5-7% of pregnant women; may be greater in some high-risk populationsgreater in some high-risk populations
Insu
lin
R
esis
tan
ce
Insu
lin
Ou
tpu
t
12 24 36
Gestational Age (weeks)
Normal pregnancy
Brief overviewBrief overview
Insu
lin
R
esis
tan
ce
Insu
lin
Ou
tpu
t
12 24 36
Gestational Age (weeks)
Gestational diabetes
Brief overviewBrief overview
Brief overviewBrief overview
Underlying risk factors include Underlying risk factors include increased maternal age, obesity, increased maternal age, obesity, h/o GDM in prior pregnancy, h/o h/o GDM in prior pregnancy, h/o large babieslarge babies
Increased risk for development of Increased risk for development of hypertensive disorders, cesarean hypertensive disorders, cesarean delivery, and developing diabetes delivery, and developing diabetes later in lifelater in life
Maternal hyperglycemia
Fetal hyperglycemia
Fetal hyperinsulinemia
Pederson Hypothesis
(1952)
Brief overviewBrief overview
Brief overviewBrief overview
Fetal risks include adverse events Fetal risks include adverse events related to macrosomia, ie, related to macrosomia, ie, shoulder dystocia and birth shoulder dystocia and birth injuries, neonatal hypoglycemia injuries, neonatal hypoglycemia and hyperbilirubinemiaand hyperbilirubinemia
As rates of obesity increase, so do As rates of obesity increase, so do the rates of type 2 diabetes and the rates of type 2 diabetes and GDMGDM
Current recommendations for screening for GDM Depends on who you ask!!
– ADA– ACOG– WHO– 4th International Workshop-Conference on
GDM– National Diabetes Data Group– United States Preventive Services Task Force– 5th International Workshop-Conference on
GDM
Current recommendations for screening for GDM Do risk assessment at first visit, with
no screening for low risk– Low-risk ethnicity (Caucasian, European)– Age < 25– BMI < 25– No known diabetes in first degree relative– No h/o glucose intolerance– No h/o obstetric complications usually
associated with GDM4th International Workshop-Conference on Gestational
Diabetes Mellitus, ADA, ACOG
Current recommendations for screening for GDM High risk patients should be
screened as early as possible and repeated at 24-28 weeks if screening negative– Strong family history of diabetes– Prior history of GDM– Morbid obesity– Other manifestations of glucose
intolerance 4th International Workshop-Conference on Gestational
Diabetes Mellitus, ADA, ACOG
Patients of intermediate risk should be screened at 24 to 28 weeks
Recommended screening is 2-step approach, with 50-g 1-hr GCT followed by 2-hr or 3-hr 100-g OGTT
Threshold value for 1-hr GCT is 130 or 140 – either is acceptable
Threshold values for 3-hr OGTT are 95, 180, 155, 140, respectively; 2 values must be abnormal to diagnose GDM
4th International Workshop-Conference on Gestational
Diabetes Mellitus, ADA, ACOG
Current recommendations for screening for GDM
WHO advocates universal screening utilizing a one-step 2-hr 75-g OGTT
Patient is diagnosed with GDM if fasting > 126 or 2-hr > 140
5th International Workshop-Conference on Gestational Diabetes Mellitus did not change recommendations set forth by 4th International Workshop-Conference on Gestational Diabetes Mellitus
Current recommendations for screening for GDM
Effect of Treatment of Gestational Diabetes Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. Crowther, Mellitus on Pregnancy Outcomes. Crowther, CA et al. NEJM, June 2005.CA et al. NEJM, June 2005.
Hypothesis: Treatment of women Hypothesis: Treatment of women with GDM will reduce the risk of with GDM will reduce the risk of perinatal complicationsperinatal complications
Prospective, randomized study of Prospective, randomized study of 1,000 women with GDM (490 in 1,000 women with GDM (490 in intervention group, 510 in intervention group, 510 in routine-care group)routine-care group)
*Often referred to as Australian Carbohydrate Intoleranc Study (ACHOIS)
Eligible women had the following:Eligible women had the following:– Singleton or twin pregnancySingleton or twin pregnancy– One or more risk factors for GDM or One or more risk factors for GDM or
positive 50-g glucose challenge test positive 50-g glucose challenge test ((>> 140) 140)
– 75-g glucose-tolerance test at 24-34 75-g glucose-tolerance test at 24-34 weeks with fasting glucose < 140 weeks with fasting glucose < 140 and glucose at 2 hours was 140-and glucose at 2 hours was 140-198*198*
Effect of Treatment of Gestational Diabetes Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. Crowther, Mellitus on Pregnancy Outcomes. Crowther, CA et al. NEJM, June 2005.CA et al. NEJM, June 2005.
*When study was initiated, women meeting this criteria were classified as having glucose intolerance of pregnancy by WHO, but in 1998 WHO classified any glucose level above normal as indicative of GDM
Intervention group:Intervention group:– Individualized dietary adviceIndividualized dietary advice– Self-monitored blood glucose levels 4x/daySelf-monitored blood glucose levels 4x/day– Insulin therapy for FBS > 99 or 2-hr Insulin therapy for FBS > 99 or 2-hr
postprandial > 126postprandial > 126
Effect of Treatment of Gestational Diabetes Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. Crowther, Mellitus on Pregnancy Outcomes. Crowther, CA et al. NEJM, June 2005.CA et al. NEJM, June 2005.
Routine-care group:Routine-care group:– Providers unaware of diagnosis of glucose Providers unaware of diagnosis of glucose
intoleranceintolerance
– Care c/w clinical care in whichCare c/w clinical care in which screening screening for GDM is not availablefor GDM is not available
Effect of Treatment of Gestational Diabetes Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. Crowther, Mellitus on Pregnancy Outcomes. Crowther, CA et al. NEJM, June 2005.CA et al. NEJM, June 2005.
OutcomeOutcome InterventioIntervention Groupn Group
Routine-Routine-Care Care GroupGroup
Adjusted P Adjusted P valuevalue
InfantsInfants
Total NumberTotal Number 506506 524524
Serious Serious perinatal perinatal complicationscomplications
7 (1%)7 (1%) 23 (4%)23 (4%) 0.040.04
WomenWomen
Total NumberTotal Number 490490 510510
Labor inductionLabor induction 189 (39%)189 (39%) 150 (29%)150 (29%) <0.001<0.001
Cesarean Cesarean deliverydelivery
152 (31%)152 (31%) 164 (32%)164 (32%) 0.730.73
Treatment of women with GDM Treatment of women with GDM (glucose intolerance) reduced the rate (glucose intolerance) reduced the rate of serious perinatal complications from of serious perinatal complications from 4% to 1%4% to 1%
Number needed to treat to prevent Number needed to treat to prevent serious complication was 34serious complication was 34
Benefits were associated with Benefits were associated with increased rate of labor induction, but increased rate of labor induction, but not an increased rate of C/Snot an increased rate of C/S
Effect of Treatment of Gestational Diabetes Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. Crowther, Mellitus on Pregnancy Outcomes. Crowther, CA et al. NEJM, June 2005.CA et al. NEJM, June 2005.
Conclusions
Hyperglycemia and Adverse Pregnancy Hyperglycemia and Adverse Pregnancy Outcomes (HAPO). NEJM. May, 2008.Outcomes (HAPO). NEJM. May, 2008.
Hypothesis: maternal Hypothesis: maternal hyperglycemia less severe than hyperglycemia less severe than overt DM will still increase risk for overt DM will still increase risk for adverse pregnancy outcomesadverse pregnancy outcomes
25,505 pregnant women at 15 25,505 pregnant women at 15 centers in 9 countries underwent centers in 9 countries underwent 75-g oral glucose-tolerance 75-g oral glucose-tolerance testing at 24-32 weeks gestationtesting at 24-32 weeks gestation
Data remained blinded if FBS Data remained blinded if FBS << 105 105 and 2-hr glucose was and 2-hr glucose was << 200 200
Only women whose data were blinded Only women whose data were blinded and who did not undergo any and who did not undergo any additional glucose testing outside the additional glucose testing outside the HAPO study were included for analysisHAPO study were included for analysis
Primary outcomes were BW > 90Primary outcomes were BW > 90thth percentile, primary C/S, clinically percentile, primary C/S, clinically diagnosed hypoglycemia, and cord-diagnosed hypoglycemia, and cord-blood serum C-peptide > 90blood serum C-peptide > 90thth percentile (fetal hyperinsulinemia)percentile (fetal hyperinsulinemia)
Hyperglycemia and Adverse Pregnancy Hyperglycemia and Adverse Pregnancy Outcomes (HAPO). NEJM. May, 2008.Outcomes (HAPO). NEJM. May, 2008.
Secondary outcomes were Secondary outcomes were delivery before 37 weeks, delivery before 37 weeks, shoulder dystocia or birth injury, shoulder dystocia or birth injury, need for NICU, need for NICU, hyperbilirubinemia, and hyperbilirubinemia, and preeclampsiapreeclampsia
Hyperglycemia and Adverse Pregnancy Hyperglycemia and Adverse Pregnancy Outcomes (HAPO). NEJM. May, 2008.Outcomes (HAPO). NEJM. May, 2008.
2-2-hrhr
<90<90 91-91-108108
109-109-125125
126-126-139139
140-140-157157
158-158-177177
>17>1788
1-1-hrhr
<10<1055
106-106-132132
133-133-155155
156-156-171171
172-172-193193
194-194-211211
>21>2122
FBFBSS
<75<75 75-75-7979
80-80-8484
85-85-8989
90-90-9494
95-95-9999
>10>1000
11 22 33 44 55 66 77
Glucose categories defined:
Hyperglycemia and Adverse Pregnancy Hyperglycemia and Adverse Pregnancy Outcomes (HAPO). NEJM. May, 2008.Outcomes (HAPO). NEJM. May, 2008.
Birth weight > 90Birth weight > 90thth percentile percentile
0
5
10
15
20
25
30
1 2 3 4 5 6 7
Fasting1-hr glu2-hr glu
Frequency
(%
)
Glucose category
HAPO. NEJM. May 2008: Frequency of primary outcomes across the Glucose Categories
HAPO. NEJM. May 2008: Frequency of primary outcomes across the Glucose Categories
0
5
10
15
20
25
30
35
1 2 3 4 5 6 7
Fasting1-hr glu2-hr gluFr
equency
(%
)
Glucose category
Cord-Blood Serum C-Peptide > 90Cord-Blood Serum C-Peptide > 90thth PercentilePercentile
0
5
10
15
20
25
30
35
1 2 3 4 5 6 7
Fasting1-hr glu2-hr glu
Frequency
(%
)
Glucose category
Primary Cesarean SectionPrimary Cesarean Section
HAPO. NEJM. May 2008: Frequency of primary outcomes across the Glucose Categories
00.5
11.5
22.5
33.5
44.5
5
1 2 3 4 5 6 7
Fasting1-hr glu2-hr gluFr
equency
(%
)
Glucose category
Clinical Neonatal HypoglycemiaClinical Neonatal Hypoglycemia
HAPO. NEJM. May 2008: Frequency of primary outcomes across the Glucose Categories
HAPO. NEJM. May 2008: Frequency of primary outcomes across the Glucose Categories
With increasing maternal glucose levels, With increasing maternal glucose levels, the frequency of each primary outcome the frequency of each primary outcome increased, although less so for clinical increased, although less so for clinical neonatal hypoglycemia than for the othersneonatal hypoglycemia than for the others
Secondary outcomes of preeclampsia, Secondary outcomes of preeclampsia, shoulder dystocia or birth injury, shoulder dystocia or birth injury, premature delivery, NICU admit, and premature delivery, NICU admit, and hyperbilirubinemia also showed significant hyperbilirubinemia also showed significant positive associations with maternal positive associations with maternal glycemiaglycemia
Hyperglycemia and Adverse Pregnancy Hyperglycemia and Adverse Pregnancy Outcomes (HAPO). NEJM, May, 2008.Outcomes (HAPO). NEJM, May, 2008.
Conclusions
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007Diabetes Mellitus. Diabetes Care. July 2007
Efforts at diagnosis and management of GDM Efforts at diagnosis and management of GDM are supported (preferably with onset of are supported (preferably with onset of treatment by 30 weeks gestation)treatment by 30 weeks gestation)
Identification and intensive management of Identification and intensive management of GDM is associated with a decrease in mortality GDM is associated with a decrease in mortality and morbidity in infantsand morbidity in infants
With appropriate therapy, the likelihood of With appropriate therapy, the likelihood of IUFD is not detectably higher than in the IUFD is not detectably higher than in the general populationgeneral population
Morbidity, however, can be increased and will Morbidity, however, can be increased and will likely remain an issue until optimal likely remain an issue until optimal management of the altered intrauterine management of the altered intrauterine environment is understood and appropriate environment is understood and appropriate interventions are implementedinterventions are implemented
Maternal glycemiaMaternal glycemia– Target glucose concentrations:Target glucose concentrations:
FBS < 96FBS < 96 1 hr PP < 1401 hr PP < 140 2 hr PP < 1202 hr PP < 120
– Daily SMBG using meters appears to Daily SMBG using meters appears to be superior to less frequent be superior to less frequent monitoring in the clinicmonitoring in the clinic
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Goals and surveillance
Assessment of fetal response Assessment of fetal response utilizing ultrasound measurements, utilizing ultrasound measurements, particularly of fetal abdomen, in particularly of fetal abdomen, in second and early third trimesters second and early third trimesters can provide useful informationcan provide useful information
Less intensified management may Less intensified management may be allowed with normal growth be allowed with normal growth (fetal AC < 75(fetal AC < 75thth percentile for GA) percentile for GA)
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Goals and surveillance
Medical nutrition therapy remains Medical nutrition therapy remains cornerstone of treatment for GDM; cornerstone of treatment for GDM; however, relatively little however, relatively little information available to allow information available to allow evidence-based recommendations evidence-based recommendations regarding specific nutritional regarding specific nutritional approaches such as total calories approaches such as total calories and nutrient distribution to the and nutrient distribution to the management of GDMmanagement of GDM
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
MNT and physical activity
MNT best prescribed by registered dieticianMNT best prescribed by registered dietician Food plans should be culturally appropriateFood plans should be culturally appropriate Adjust amount and type of carbohydrate to Adjust amount and type of carbohydrate to
achieve target for PP glucose achieve target for PP glucose concentrationsconcentrations
No data on optimal weight gain for women No data on optimal weight gain for women with GDMwith GDM
Physical activity of 30 min/day is Physical activity of 30 min/day is recommended for individuals capable of recommended for individuals capable of participatingparticipating
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
MNT and physical activity
Insulin remains cornerstone in Insulin remains cornerstone in treatment of patients who fail to treatment of patients who fail to maintain glycemic goals with MNTmaintain glycemic goals with MNT
Insulin analogs offer advantages Insulin analogs offer advantages of improved glucose control with of improved glucose control with immunogenic rates similar to immunogenic rates similar to human insulinhuman insulin
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Intensified medical therapy
Rapid-acting insulin analogs (RAIA)Rapid-acting insulin analogs (RAIA)– Lispro (Humalog) and Aspart (Novolog)Lispro (Humalog) and Aspart (Novolog)– Achieve more rapid insulin peak and have Achieve more rapid insulin peak and have
been shown to provide better post-been shown to provide better post-prandial glucose controlprandial glucose control
– Multiple studies have demonstrated Multiple studies have demonstrated improved PP glucose control with RAIA vs improved PP glucose control with RAIA vs human regular insulin with no increased human regular insulin with no increased risk of complications, such as retinopathy risk of complications, such as retinopathy or teratogenic effector teratogenic effect
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Intensified medical therapy
Long-acting insulin analogsLong-acting insulin analogs– Glargine (Lantus) and Detemir Glargine (Lantus) and Detemir
(Levomir)(Levomir)– Lantus provides peak-less duration of Lantus provides peak-less duration of
action around 24 hrs, translating to action around 24 hrs, translating to less glucose variability and lower risk less glucose variability and lower risk of nocturnal hypoglycemiaof nocturnal hypoglycemia
– Levomir also with peak-less but less Levomir also with peak-less but less longer duration of action, about 12 hrs; longer duration of action, about 12 hrs; provides similar benefits as Lantusprovides similar benefits as Lantus
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Intensified medical therapy
Long-acting insulin analogs: safetyLong-acting insulin analogs: safety– Currently classified as Category C by FDACurrently classified as Category C by FDA
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus. fetus.
Compares to NPH which is Category B and is onlybasal insulin that has received FDA approval for Compares to NPH which is Category B and is onlybasal insulin that has received FDA approval for treating GDM specificallytreating GDM specifically
– Review article Nov 2007: “long-acting Review article Nov 2007: “long-acting insulin analogs do not yet have sufficient insulin analogs do not yet have sufficient safety evaluation in clinical studies to safety evaluation in clinical studies to warrant their use during pregnancy”warrant their use during pregnancy”
– Recent placental perfusion study Recent placental perfusion study published in Mar 2010 showed Lantus does published in Mar 2010 showed Lantus does not cross the human placentanot cross the human placenta
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Intensified medical therapy
Oral antihyperglycemic agentsOral antihyperglycemic agents– Glyburide acts by promoting Glyburide acts by promoting
production of insulin in the pancreasproduction of insulin in the pancreas– Langer, et al. NEJM 2000: Langer, et al. NEJM 2000:
Randomized, prospective study Randomized, prospective study comparing glyburide and insulin in comparing glyburide and insulin in women with GDMwomen with GDM
– Conclusion: Conclusion: In women with GDM, In women with GDM, glyburide is a clinically effective glyburide is a clinically effective alternative to insulin therapy.alternative to insulin therapy.
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Intensified medical therapy
Oral antihyperglycemic agentsOral antihyperglycemic agents– Metformin is thought to act by inhibiting Metformin is thought to act by inhibiting
liver’s production of glucose; appears to liver’s production of glucose; appears to increase insulin sensitivity/reduce insulin increase insulin sensitivity/reduce insulin resistanceresistance
– Rowan, et al. NEJM 2008: Randomized, Rowan, et al. NEJM 2008: Randomized, prospective study comparing metformin and prospective study comparing metformin and insulin in GDMinsulin in GDM
– Conclusion: Conclusion: In women with GDM, metformin In women with GDM, metformin (alone or with supplemental insulin) is not (alone or with supplemental insulin) is not associated with increased perinatal associated with increased perinatal complications as compared with insulin. The complications as compared with insulin. The women preferred metformin to insulin women preferred metformin to insulin treatment.treatment.
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Intensified medical therapy
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Obstetric management
Fetal surveillanceFetal surveillance– Ultrasound screening for congenital Ultrasound screening for congenital
anomalies recommended for women with anomalies recommended for women with GDM who present with A1C > 7.0% or FPG GDM who present with A1C > 7.0% or FPG > 120> 120
– Data insufficient to determine whether Data insufficient to determine whether surveillance beyond self-monitoring of fetal surveillance beyond self-monitoring of fetal movements is indicated in women with movements is indicated in women with GDM who continue to meet targets of GDM who continue to meet targets of glycemic control with MNT regimens alone glycemic control with MNT regimens alone and in whom fetal growth is normaland in whom fetal growth is normal
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Obstetric management Maternal surveillanceMaternal surveillance
– Risk for PTD may be increased with untreated GDMRisk for PTD may be increased with untreated GDM– Use of steroids to enhance fetal lung maturity Use of steroids to enhance fetal lung maturity
should not be withheld because of GDM but should not be withheld because of GDM but intensified monitoring of glucose levels is indicated intensified monitoring of glucose levels is indicated with possible need for (increased) insulinwith possible need for (increased) insulin
– Risk for hypertensive disorders increased with GDMRisk for hypertensive disorders increased with GDM– Blood glucose monitoring should be continued Blood glucose monitoring should be continued
during labor with insulin or glyburide as necessary during labor with insulin or glyburide as necessary to correct maternal hyperglycemiato correct maternal hyperglycemia
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Obstetric management
Timing and route of deliveryTiming and route of delivery– No data supporting delivery of No data supporting delivery of
women with GDM prior to 38 weeks women with GDM prior to 38 weeks in absence of objective evidence of in absence of objective evidence of maternal or fetal compromisematernal or fetal compromise
– Lung maturity amnio not indicated Lung maturity amnio not indicated in well-controlled patients who have in well-controlled patients who have indications for induction or C/S as indications for induction or C/S as long as reasonable certainty of long as reasonable certainty of datesdates
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Obstetric management
Timing and route of deliveryTiming and route of delivery– Delivery of LGA fetus in setting of Delivery of LGA fetus in setting of
GDM is associated with increased GDM is associated with increased risk of birth injury compared with risk of birth injury compared with nondiabetic populationnondiabetic population
– Strategies to reduce this risk include Strategies to reduce this risk include liberal policy toward C/S; however, liberal policy toward C/S; however, no controlled trials available to no controlled trials available to support this approachsupport this approach
Summary and Recommendations of the Fifth Summary and Recommendations of the Fifth International Workshop-Conference on Gestational International Workshop-Conference on Gestational Diabetes Mellitus. Diabetes Care. July 2007.Diabetes Mellitus. Diabetes Care. July 2007.
Post partum/long term
Studies show that after GDM, 35-Studies show that after GDM, 35-60% of women develop Type 2 60% of women develop Type 2 diabetes within 10 yearsdiabetes within 10 years
Glucose tolerance testing should Glucose tolerance testing should be performed 6-12 weeks after be performed 6-12 weeks after delivery in GDM women who do delivery in GDM women who do not have diabetes immediately PPnot have diabetes immediately PP
Optimal testing frequency for Optimal testing frequency for diabetes long term has not been diabetes long term has not been establishedestablished
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Hypothesis: Treatment of mild GDM Hypothesis: Treatment of mild GDM improves pregnancy outcomes.improves pregnancy outcomes.
Prospective, randomized study of 958 Prospective, randomized study of 958 women (485 in treatment group, and women (485 in treatment group, and 473 in control group)473 in control group)
Treatment group received nutritional Treatment group received nutritional counseling, diet therapy, and insulin if counseling, diet therapy, and insulin if requiredrequired
Control group received usual prenatal Control group received usual prenatal carecare
Eligible women had the following:Eligible women had the following:– Abnormal 1-hr 50-g glucose Abnormal 1-hr 50-g glucose
challenge with glucose between challenge with glucose between 135-200135-200
– Abnormal 3-hr GTT with FBS < 95 Abnormal 3-hr GTT with FBS < 95 and 2 of 3 glucose measurements and 2 of 3 glucose measurements that exceeded thresholds for 1-hr that exceeded thresholds for 1-hr (180), 2-hr (155), or 3-hr (140)(180), 2-hr (155), or 3-hr (140)
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Primary outcome was composite Primary outcome was composite outcome that included perinatal outcome that included perinatal mortality, hypoglycemia, mortality, hypoglycemia, hyperbilirubinemia, neonatal hyperbilirubinemia, neonatal hyperinsulinemia, and birth hyperinsulinemia, and birth traumatrauma
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Neonatal secondary outcomes Neonatal secondary outcomes included BW > 4000 gm, LGA, included BW > 4000 gm, LGA, SGA, NICU admit, and RDSSGA, NICU admit, and RDS
Maternal secondary outcomes Maternal secondary outcomes included weight gain, gestational included weight gain, gestational HTN, preeclampsia, cesarean HTN, preeclampsia, cesarean delivery, labor induction, and delivery, labor induction, and shoulder dystociashoulder dystocia
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Outcome Outcome variablevariable
Treatment Treatment Group Group (N=485)(N=485)
Control Control Group (N = Group (N = 473)473)
P valueP value
GA at birth GA at birth (wk)(wk)
39.039.0 38.938.9 0.870.87
Composite Composite end pointend point
32.4%32.4% 37%37% 0.140.14
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Neonatal Neonatal Secondary Secondary Outcome Outcome VariableVariable
Treatment Treatment Group Group (N=485)(N=485)
Control Group Control Group (N=473)(N=473)
P valueP value
Birth weight Birth weight 3302 gm3302 gm 3408 gm3408 gm <0.001<0.001
BW > 4000 gmBW > 4000 gm 5.9%5.9% 14.3%14.3% <0.001<0.001
LGALGA 7.1%7.1% 14.5%14.5% <0.001<0.001
Preterm deliveryPreterm delivery 9.4%9.4% 11.6%11.6% 0.270.27
SGASGA 7.5%7.5% 6.4%6.4% 0.490.49
NICU admitNICU admit 9.0%9.0% 11.6%11.6% 0.190.19
RDSRDS 1.9%1.9% 2.9%2.9% 0.330.33
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Maternal Maternal Secondary Secondary Outcome Outcome VariableVariable
Treatment Treatment Group Group (N=476)(N=476)
Control Control Group Group (N=455)(N=455)
P valueP value
Induction of laborInduction of labor 27.3%27.3% 26.8%26.8% 0.860.86
Cesarean deliveryCesarean delivery 26.9%26.9% 33.8%33.8% 0.020.02
Shoulder dystociaShoulder dystocia 1.5%1.5% 4.0%4.0% 0.020.02
Preeclampsia/HTNPreeclampsia/HTN 8.6%8.6% 13.613.6 0.010.01
BMI at deliveryBMI at delivery 31.331.3 32.332.3 <0.001<0.001
Weight gain (kg)Weight gain (kg) 2.82.8 5.05.0 <0.001<0.001
Although treatment of mild GDM Although treatment of mild GDM did not reduce the frequency of did not reduce the frequency of the composite primary outcome, the composite primary outcome, it did lower the risks of fetal it did lower the risks of fetal overgrowth, shoulder dystocia, overgrowth, shoulder dystocia, cesarean delivery, and cesarean delivery, and preeclampsiapreeclampsia
A Multicenter, Randomized Trial of Treatment A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. Landon, MB, et for Mild Gestational Diabetes. Landon, MB, et al. NEJM, Oct 2009.al. NEJM, Oct 2009.
Conclusions
Summary
Screening/diagnosis– No new guidelines at present– WHO endorses universal screening
with single step, arguing that the 2-step process introduces additional barrier to care
– Discussions continue around use of fasting, random glucose, or A1C at initial visit, but no consensus at present
Measure of glycemia Threshold
Fasting glucose > 126 mg/dl
A1C > 6.5%
Random glucose > 200 mg/dl
To diagnose overt diabetes (preexisting) in pregnancy
Summary
International Association of Diabetes and Pregnancy Study
Groups, 2009
Summary
Glucose measure Glucose threshold
FPG 92 mg/dl
1-hr plasma glucose
180 mg/dl
2-hr plasma glucose
153 mg/dl
Diagnosis of GDM (75-g OGTT)
*One or more of these values must be met or exceeded for diagnosis of GDM
International Association of Diabetes and Pregnancy Study
Groups, 2009
Summary
First prenatal visit– Measure FPG, A1C, or random glucose on all or only
high-risk women If results indicate overt diabetes as per Table 1, treat
and f/u as for preexisting diabetes If results are not diagnostic of overt diabetes and FPG
> 92 but < 126, diagnose as GDM; if FPG < 92, test for GDM at 24-28 weeks
24-28 weeks– 2-hr 75-g OGTT after overnight fast on all women not
previously found to have overt diabetes or GDM– Overt diabetes if FPG > 126– GDM if one or more values equals or exceeds
thresholds– Normal if all values on OGTT less than thresholds
International Association of Diabetes and Pregnancy Study
Groups, 2009
Summary
Medical management of GDM includes following:– Nutritional therapy– Exercise– Self-monitoring of glucose at home– If diet and exercise fail, oral hyperglycemic
agent or insulin Glyburide “preferred” but metformin safe Short-acting insulin analogs should be standard,
and long-acting analogs not far behind, if not already here
– Goal: Euglycemia!!
SummarySummary
2-hr2-hr <90<90 91-91-108108
109-109-125125
126-126-139139
140-140-157157
158-158-177177
>178>178
1-hr1-hr <105<105 106-106-132132
133-133-155155
156-156-171171
172-172-193193
194-194-211211
>212>212
FBSFBS <75<75 75-7975-79 80-8480-84 85-8985-89 90-9490-94 95-9995-99 >100>100
11 22 33 44 55 66 77
Summary
Fetal surveillance with GDM– Increased surveillance of fetal well-being
suggested if oral agent or insulin necessary, or abnormal fetal growth evident on ultrasound
– Optimal timing of delivery remains uncertain, but would consider delivery by 39 weeks if evidence of poor glucose control and/or abnormal fetal growth noted
– Allow usual indications for delivery management if diet controlled with normal growth and well-being
Summary
Postpartum management– Assess fasting and/or 2-hr PP in first day or
two after delivery – no further treatment necessary if normal (majority of GDM)
– If fasting and/or 2-hr PP abnormal, continue oral agent or insulin
– Screen for Type 2 diabetes at 6-week postpartum visit
– Council patients regarding dietary and behavioral changes necessary to minimize risk of developing overt diabetes later in life
Summary
Time Test PurposePost-delivery (1-3 d) Fasting or random glucose Detect persistent, overt
diabetes
Postpartum visit 75-g 2-h OGTT PP classification of glucose metabolism per ADA
1 year postpatum 75-g 2-h OGTT Assess glucose metabolism
Annually Fasting plasma glucose Assess glucose metabolism
Tri-annually 75-g 2-h OGTT Assess glucose metabolism
Prepregnancy 75-g 2-h OGTT Assess glucose metabolism
Metabolic assessments after GDM
5th Annual Workshop-Conference on GDM