INTERVENTION STUDIES in GDM

INTERVENTION STUDIES

in GDM

관동의대 제일병원 산부인과

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 � 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 OGTT로 GDM 진단 받은 경우

� FBS <95mg/dl in 100gm OGTT 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 NICHD

Perinatal death

Shoulder dystocia

Bone fracture

Nerve palsy

Still birth or neonatal death

Hypoglycemia

Hyper-bilirubinemia

Neonatal insulinemiaNerve palsy

Admission NICU

Jaundice requiring phototherapy

Induction of labor

C/S

Neonatal insulinemia

Brachial palsy

Fracture:clavicle,humerus,skull

Secondary Pregnancy Outcome

ACHOIS NICHD

GA at delivery

Birth wt : macrosomia, LGA, SGA

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


Maternal Outcome in NICHD


Comparison of Two Studies

ACHOIS NICHD

Study criteria 16-30wks single & twin

50gm OGTT >140 and

75gm OGTT (24-34wks)

FBS <99 & 2hr 140 -198

24-30wks single

50gm OGTT 135-200 and

100gm OGTT (+) & FBS<95

Insulin Tx

criteria

<35wks FBS>99, 2hr>126

>35wks FBS>99, 2hr>144

FBS>95

2hr>120 criteria >35wks FBS>99, 2hr>144

Random >162

2hr>120

Random >160

Significant

adverse

outcome

Any serious perinatal Cx

Perinatal death

Shoulder dystocia

Bone fracture

Nerve palsy

Macrosomia

Macrosomia

C/S

Shoulder dystocia

PIH

Difference Primary outcome: Mortality Secondary outcome: Morbidity

� 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 � 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-by-

case 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.

Ann Intern Med. 2008;148:759-765.

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.

� It is now time to consider

� how screening of the pregnant population can be

performed in a timely and efficient manner 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� ACHOIS primary outcome

� NICHD secondary outcome

� Serious birth injury

� Perinatal death

Fetal Surveillance Test for GDM

Well controlled GDM

(class A1)

Insulin required without

vasculopathy (class A2)

Kick count from 28 wks Kick count from 26-28 wks

NST from 40 wks NST from 32 wksNST from 40 wks NST from 32 wks

If necessary CST, BPP

US for fetal growth

every 4 wks

US for fetal growth

every 4 wks

Delivery no later than 40 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 � 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 studiesoutcome 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 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.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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Thank you for your attention !

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� 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 총 산모군

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)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

0

TTN 153(25.4) RDS 13(2.16)

Brachial palsy 0 Fracture(clavicle, humerus)

1

Adverse NST 28(4.64)

GDM A1



38.5 SGA 64(11.92)



c/sec 263(48.97) NICU 입원 29(5.40)

vacuum 11(2.05) hypoglycemia 5(0.93)



0

TTN 141(26.26) RDS 11(2.05)


1

Adverse NST 25(4.66)

Insulin Tx



38.3 SGA 4(6.06)



c/sec 31(46.97) NICU 입원 3(4.55)c/sec 31(46.97) NICU 입원 3(4.55)

vacuum 0 hypoglycemia 1(1.51)



0

TTN 10(15.15) RDS 2(3.03)


0

Adverse NST 3(4.55)

INTERVENTION STUDIES in GDM

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