INTERVENTION STUDIES in GDM 관동의대제일병원산부인과 김문영
ISSUE Is it time to treat for mild GDM? Can the treatment of mild GDM prevent fetal death? Can the treatment of mild GDM prevent fetal over-growth? Justification of routine treatment of mild GDM Justification of universal screening for GMD
Intervention Studies & Related Articles Effect of treatment of GDM on pregnancy outcome (ACHOIS, Australian CHO intolerance study) Crowther CA et al 2005 A multicenter, randomized trial of treatment for mild GDM (NICDH, National institute child health human development) Landon MB et al 2009 A planned randomized clinical trial of treatment of mild GDM Landon MB et al 2002 Can the findings of recent randomized trials of treatment or no treatment of gestational diabetes be used for changing current treatment approaches? Moore TR 2010
Introduction Mild GDM 75gm or 100gm OGTT 로 GDM 진단받은경우 FBS <95mg/dl in 100gm OGTT FBS <99mg/dl in 75gm OGTT & 2hr 140-198mg/dl Mild GDM - metabolic heterogenecity? from a major health problem to a diagnosis still looking a disease Randomized clinical trial
Primary Pregnancy Outcome ACHOIS Perinatal death Shoulder dystocia Bone fracture Nerve palsy Admission NICU Jaundice requiring phototherapy NICHD Still birth or neonatal death Hypoglycemia Hyper-bilirubinemia Neonatal insulinemia Brachial palsy Fracture:clavicle,humerus,skull Induction of labor C/S
Secondary Pregnancy Outcome GA at delivery ACHOIS Birth wt : macrosomia, LGA, SGA NICHD Birth wt : macrosomia, LGA, SGA Admission of NICU RDS Wt.gain during pregnancy No of antenatal admission PIH C/S Induction of labor Shoulder dystocia Wt. gain during pregnancy PIH
Primary Clinical Outcomes in ACHOIS Crowther CA et al NEJM 2005;352:2477 2486
Secondary Clinical Outcomes in ACHOIS Crowther CA et al NEJM 2005;352:2477 2486
Primary Perinatal Outcome in NICHD Landon MB et al NEJM 2009;361:1396 1398
Secondary Neonatal Outcome in NICHD Landon MB et al NEJM 2009;361:1396 1398
Maternal Outcome in NICHD Landon MB et al NEJM 2009;361:1396 1398
Comparison of Two Studies Study criteria Insulin Tx criteria Significant adverse outcome ACHOIS 16-30wks single & twin 50gm OGTT >140 and 75gm OGTT (24-34wks) FBS <99 & 2hr 140-198 <35wks FBS>99, 2hr>126 >35wks FBS>99, 2hr>144 Random >162 Any serious perinatal Cx Perinatal death Shoulder dystocia Bone fracture Nerve palsy Macrosomia 24-30wks single NICHD 50gm OGTT 135-200 and 100gm OGTT (+) & FBS<95 FBS>95 2hr>120 Random >160 Macrosomia C/S Shoulder dystocia Difference Primary outcome: Mortality Secondary outcome: Morbidity PIH
No recommendation d/t insufficient evidence. Harms of screening include short-term anxiety in some women with positive screening results Inconvenience to many women and medical practices because most positive screening test results are probably false positive. Until there is better evidence, clinicians should discuss screening for GDM with their patients and make case-bycase decisions. Ann Intern Med. 2008;148:759-765.
Prospective studies are needed to assess health outcomes in women with various glucose levels adjusted for obesity to help understand what level of glucose constitutes an important risk to the mother or fetus. Additional randomized trials are needed to compare health outcomes of lowering glucose with the health outcomes of not intervening in GDM. More definitive data are required regarding screening strategies for GDM including glucose load in timing. Ann Intern Med. 2008;148:759-765.
It is now time to consider how screening of the pregnant population can be performed in a timely and efficient manner how care of women with GDM can be better organized to provide in the maximum benefit in reducing the fetal and neonatal adiposity.
Discussion Points Fetal surveillance protocol in mild GDM Evaluation of risk of perinatal mortality & morbidity Shoulder dystocia ACHOIS primary outcome NICHD secondary outcome Serious birth injury Perinatal death
Fetal Surveillance Test for GDM Well controlled GDM (class A 1 ) Kick count from 28 wks NST from 40 wks US for fetal growth every 4 wks Delivery no later than 40 wks Insulin required without vasculopathy (class A 2 ) Kick count from 26-28 wks NST from 32 wks If necessary CST, BPP US for fetal growth every 4 wks Delivery no later than 40 wks
Shoulder Dystocia Incidence : 0.6-1.4% Brachial plexopathy : 2/3 of injury Half of brachial plexo-pathy from shoulder dystocia 88% resolved by 1yr of life Clavicle fracture : 38% Humeral fracture : 17% McRoberts maneuver Woods screw maneuver
Changing the Study View Fetal macrosomia shoulder dystocia-birth trauma high relation Macrosomia & shoulder dystocia : significant outcome in both studies evaluation of complication of birth trauma Only diet control group vs no treatment group of GDM
In treatment group of GDM, significantly reduced risk for perinatal morbidity Metabolic Cx, hypebilirubinemia, hypoglycemia, respiratory complication, shoulder dystocia, macrosomia, LGA, still birth, C/S
OGCT negative / OGCT positive, OGTT negative / OGCT OAV / GDM Definition of metabolic SD GDM or OAV or hyperinsulinemia : any one BP >140/90, TG >2SD, low HDL, BMI>30, waist >2SD: Metabolic SD in mid trimester can predictor macrosomia
Conclusion GDM, it is time to treat. ACHOIS trial Glycemic control in the form of dietary advice, blood glucose monitoring, and insulin therapy reduced the rate of serious perinatal complication without increasing the rate of C/S. NICHD trial Although Tx of mild GDM did not significant reduced the frequency of stillbirth or perinatal death, it did reduce the risks of fetal overgrowth, shoulder dystocia, cesarean section, and hypertensive disorders.
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Case : Previous GDM with macrosomia 38 yrs old, Ht 160cm, Wt 52kg, BMI 21.1, Wt gain 16.5kg OBGY history G6 P2 L2 A3 NSVD 3.4kg(1992), NSVD 3.44kg(2007) Past history GDM(2007) 50gm OGTT 156 100gm OGTT 82/161/159/157 Present illness 50gm OGTT 181 100gm OGTT 81/141/171/117 at 25wks 69/140/121/117 at 28wks
Case (to be continued) Vacuum assisted vaginal delivery at 39 +6 wks Male / 4090gm / Apgar 1-6, 5-8 Postpartum 1&1/2 hr later BP 60/40, PR 110/min
The Point in this case Category in Mild GDM?? If the GDM was diagnosed in this case, the macrosomia would be prevented -?? If the macrosomia was not developed, the If the macrosomia was not developed, the obstetrical complication would be prevented -??
GDM 총산모군 Total delivery 603 LGA 22(3.64) GA at delivery(median) 38.5 SGA 69(11.44) PIH 25(4.15) Labor induction 45(7.46) V/D 298(49.5) Neonatal death 2 c/sec 294(48.76) NICU 입원 32(5.31) vacuum 11(1.82) hypoglycemia 5(0.83) Still birth 1 hyperbilirubinemia 145(24.05) Birth Wt 3175 Neonatal hyperinsulinemia TTN 153(25.4) RDS 13(2.16) Brachial palsy 0 Fracture(clavicle, humerus) Adverse NST 28(4.64) 0 1
GDM A1 Total delivery 537 LGA 19(3.54) GA at delivery(median) 38.5 SGA 64(11.92) PIH 23(4.28) Labor induction 43(8.00) V/D 263(48.97) Neonatal death 2 c/sec 263(48.97) NICU 입원 29(5.40) vacuum 11(2.05) hypoglycemia 5(0.93) Still birth 1 hyperbilirubinemia 127(23.65) Birth Wt 3107 Neonatal hyperinsulinemia TTN 141(26.26) RDS 11(2.05) Brachial palsy 0 Fracture(clavicle, humerus) Adverse NST 25(4.66) 0 1
Insulin Tx Total delivery 66 LGA 3(4.55) GA at delivery(median) 38.3 SGA 4(6.06) PIH 2(3.03) Labor induction 3(4.55) V/D 35(53.03) Neonatal death 0 c/sec 31(46.97) NICU 입원 3(4.55) vacuum 0 hypoglycemia 1(1.51) Still birth 0 hyperbilirubinemia 16(24.24) Birth Wt 3175 Neonatal hyperinsulinemia TTN 10(15.15) RDS 2(3.03) Brachial palsy 0 Fracture(clavicle, humerus) Adverse NST 3(4.55) 0 0