Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
Screening e diagnosi de diabete gestazionalenella pratica clinica:
Sempre valide le linee guida ?
Graziano Di Cianni Direttore UOC Diabetologia e Mal.
Metabolismo – ASL Toscana Nordovest “rete clinica diabetologica”
Dichiarazione Conflitti di Interesse
Il sottoscritto dott. Graziano Di Cianni
Dichiara Di aver avuto negli ultimi due anni i rapporti anche di finanziamento con i seguenti soggetti portatori di interessi commerciali in campo sanitario:
Eli Lilly, Novonordisk, SanofiMerck, Jansen, Novartis,
Mediolanum, Astrazeneca,TakedaJonshon & Jonson, Roche Diagnostics, Menarini
GDM Screening
1964O’Sullivan e Mahan
definisconoi criteri per il DG
1979NDDG modifica
i criteri proposti daO’Sullivan
201020001990198019701960
1980OMS
Propone criteri per il DG
1982Carpenter e Coustan
propongono una revisionedei criteri di O’Sullivan
1996EASD propone
nuovi criteriper il DG
2010IADPSG propone
nuovi criteri basatisullo studio HAPO
2013OMS
adottai criteri IADPSG
2011ADA approvaI Criteri IADPSG
1985OMS
rivede i criteri per il DGabbassando le soglie diagnostiche
a digiuno e a 2h1999OMS
rivede i criteri per il DGabbassando la soglie diagnostica
a digiuno
ADA: American Diabetes Association; EASD: European Association for the Study of Diabetes; IADPSG: International Association of theDiabetes and Pregnancy Study Groups; NDDG: National Diabetes Data Group; OMS: Organizzazione Mondiale della Sanità
Settembre 2011ISS-SID-AMD
stabiliscono unoscreening selettivo
• In March 2010, the International Association of Diabetes and Pregnancy Study Groups(IADPSG) recommendations were accepted in Italy.
• The use of these criteria resulted in higher rate of GDM.• As a consequence, the Italian Public Health Authority, in September 2011, issued more
restrictive guidelines
CURRENT PROTOCOLS FOR THE DIAGNOSIS OF GDM
IADPSGWHOAACEFIGO
Universal screening24-28 weeks
75grOGTT
ACOG Universalscreening24-28 weeks
50 gOGCT
100 gr OGTTIn positive cases
CDA Universal screening24-28 weeks
50 gOGCT
75 gr In positive cases
NICEADIPS
Selectivescreening At soon aspossible
75 grOGTT
Negative and at high risk75 grOGTT
ADA (2015) Declare one o two step proach is accetable
Screening for and diagnosis of GDM
ACOG and NIH still support the two-step approach with universal screening
ADA concludes that… IADPSG criteria may be the preferred approach
WHO 2013 vs VHO 1999 GDM +45%GDM by FPG 1 % vs 65%
GDM by 2h OGTT 97% vs 19%
WHO 1999 non consente la diagnosi di GDM (FPG) in donne obese che spesso sviluppano ipertensione; WHO 2013 esclude donne (2hOGTT) in cui il trattamento per GDM risulta efficace
High Risk (16th-18th weeks)OGTT according HAPO study
Medium Risk (24th-28th weeks)OGTT according HAPO study
Personal history of GDM Pre-pregnancy BMI ≥ 30 Kg/m2
FPG at the first visit 100-125mg/dl
Age ≥ 35 years Pre-pregnancy BMI ≥ 25 Kg/m2
Previous macrosomia Family history of diabetes Family from areas with a high
prevalence of diabetes
If OGTT is normal, women with these riskfactors must repeat the OGTT between24th and 28th gestational weeks
National Guidelines for GDM Screening in Italy (2011)Selective Screening
according risk factors
National Guidelines for GDM Screening in Italy (2011)
mg/dl mmol/lbasal 92 5.11-h 180 10.02-h 153 8.5
OGTT 75 g
According HAPO Study
Alla 1° visita FPG o RPG
Fattori di rischio
FPG ≥126mg/dl oRBG ≥200mg/dl o
HbA1c ≥6.5%
FPG 100-125mg/dl
o fattori di rischio
FPG<100 mg/dl + fattori di rischio
Diabete pregravidico
trattamento
OGTT 75g glucosio
Fra la 16 e 18°sett. gestazionale
OGTT 75g glucosio
Fra la 24 e 28°sett. gestazionale
National Guidelines for GDM Screening in Italy (2011)
BassoRischio Medio rischio Alto
ISS No screeening 24-28 settimane, - eta ≥35 anni - Sovrappesomacrosomia fetale in una gravidanza precedente- GDM in gravidanza precedente - anamnesi familiare DM 2Etnia ad elevata prevalenza
A 16-18 settimane : - Pregresso GDM- Obesità- Glicemia precedentemente/o all’inizio della gravidanza, di fra 100 e 125 mg/dl
ADA2010
No screeningGruppo etnico a bassa prevalenzaFamiliarità negativaAnamnesi ostetrica negativa per eventi sfavorevoliAnamesi negativa per intolleranza glucidicaEtà < 25 aaNormopeso
24-28 settimaneCaratteristiche intermedie
Appena possibile:Familiarità positivaPregressa GDMObesitàGlicosuria marcata nella gravidanza in corsoPregresso neonato macrosoma/LGAPCOS
NICE 2015
24-28 settimaneObesitàPregressa macrosomiaPregresso GDMFamiliarità per DM2Etnia ad elevato rischio
Appena possibilePregresso GDMGlicosuria nella gravidanza in corso
Stratificazione del rischio
Pregnancy outcomes after IADPSG recommendation
GDMn=2026
GDM ex NGTn=112
NGTn=1815
Delivery (g.w.) 38.6 ± 2.1 38.3 ± 2.9 38.7 ± 2.8Cesarean section(%) 41 * 43.6 * 31.1 *Fetal morbidity (%) 9.8 16.5 7.2Macrosomia (%) 9.2 10.8 7.9Birthweight (g) 3346 ± 519 3326 ± 590 3348 ± 478Babies’ length (cm) 49.2 ± 2.4 48.5 ± 3 49.4 ± 2.2Ponderal index (g/cm3) 2.81 ± 0.41 ** 2.95 ± 0.61 ** 2.77 ± 0.34 **LGA (%) 19.5 18.1 15SGA(%) 2.9 2.8 3.2
* p<0,005 ** p< 0,0001
Lapolla A Diabet Med,2011
«Overt Diabetes»:7.7%
GDM Prevalence 10.9% ( 25% greater as compared to the one determined with the old criteria10 years ago)
Early screening for high risk women is not applied
30% low-risk women with OGTT positive for GDM
Level of implementation of guidelines on screening and diagnosis of gestational diabetes: a national survey.
B. Pintaudi et al. (2015)Diabetes Research and Clinical Practice
REGIONE TOSCANA - PERCORSO ASSISTENZIALE DIABETE GESTAZIONALE
This is a retrospective study based on two administrative sources
A database of certificate of care and delivery (CEDAP) including informationabout pregnancy, delivery newborn and parentsA regional flux dataset of lab prescription including all prescriptions of OGTTperformed since the 16th gestational week from the 12 local health care units ofTuscany
All women who delivered in Tuscany in the year 2014 were identified by CEDAPand their data after excluding those with pregestational diabetes, were linkedto the regional flux of all specialists’ visit including prescription of OGTTperformed since the 16th week of gestation.
All pregnant women were classified as eligible and not eligible according toNGL.
In the two groups, for each stratum, a logistic regression was performed toevaluate the chance of being tested by the OGTT, after adjusting for maternalage, marital status, education degree, ancestry, employment status, parity,smoking habit, pregestational BMI, first visit setting.
METHODS
Women tested before 16th week: 94
22730 pregnant women
Total group of women who delivered in 2015 (n. 23270)
Medium-High risk women (Eligible for screening test) n. 12840 (56.4%)Low risk women (Non eligible for screening test) n. 9890 (43.5%)
Eligible10,015 (55.6%)
OGTT18006 (79.2%)
Women with pre-gestational diabetes: 446
No OGTT4724 (20.8%)
Not Eligible7,991 (44.4%)
Eligible2,825 (59.8%)
Not Eligible1,899 (40.2%)
Chance of being testes by the OGTT Logistic regression analysis
0
20
40
60
80
100
120
Eligible women Not eligible women
Late screeningEarly screening
3,95% 1,98%
TIME OF SCREENING TEST
STIMA DELLA PREVALENZA DEL DIABETE GESTAZIONALEDefinizione dell’algoritmo diagnostico
Donne che effettuano curva OGTT (flussi Spa)
+ almeno una delle seguenti condizioni
•Donne che effettuano terapia insulinica (flussi Spf e Fed)*•Donne che effettuano una visita diabetologica (flussi Spa)*•Donne che effettuano una terapia educazionale per diabete (flussi Spa)*•Donne che effettuano OGTT entro 6 mesi dal parto (flussi Spa)
* Data di erogazione prima del parto
VALIDATION OF GDM DIAGNOSIS
Total Cases with GDM, captured by algorithm
2000 (11.11%)
Group of eligible women who performed OGTT
n. 10015
Group of non eligible women who performed OGTT
n. 7991
GDM captured by algorithm1439 (14.37%)
GDM captured by algorithm561 (7%)
Fig. 2
GDM DIAGNOSIS
Prevalenza del Diabete GestazionalePer le donne che hanno effettuato screening eleggibili e non eleggibili
N. casi con GDM2000
(11,36%)
Elegibili 1439(14,37%)
Non Elegibili 561(7,02%)
Diabete Gestazionale in Trattamento Insulinico
N. casi611
(30,5%)
Elegibili 465(32,3%)
Non Elegibili 146(26 %)
Donne a basso Rischio per GDM che Non avrebbero dovuto eseguire lo screening secondo le Linee Guida Nazionali
•10816 Donne Non Eleggibili
•7991 Eseguono lo screening per GDM
•561 Diagnosi di GDM
•146 In trattamento Insulinico
Epoca del Parto in donne sottoposte a screening con e senza con GDM
< 32 settimane(%)
32-36 sett.(%)
≥ 37 sett.(%)
Donne con GDM
Eleggibili 0,6 11,5 88
Non Eleggibili
0,4 8,4 91,3
Donne no GDM
Eleggibili 1,0 7,2 91,7
Non Eleggibili
0,5 5,3 94,2
Spontaneo(%)
Operativo*(%)
Taglio Cesareo**(%)
Donne con GDM
Eleggibili 61,4 4,9 33,8
Non Eleggibili
64 5,7 30,4
Donne no GDM
Eleggibili 63,9 5,4 30,7
Non Eleggibili 72,9 5,8 21,2
*Parto Operativo = con uso di Forcipe o Ventosa**Taglio Cesareo d’elezione + in travaglio+ in urgenza
Modalità del Parto in donne sottoposte a screening con e senza con GDM
Maternal and fetal complications in women with gestational and pregestational diabetes
• 85075 parti 2012 – 2016 (identificati da CeDAP)In donne che hanno eseguito OGTT
– NGT (Normale OGTT) 76922– GDM (ldentificate mediante Algoritmo) 8153
– Pre-GDM (database regionale) 476* (solo 2 anni)
Pre-GDM and GDM vs NGT
Macrosomia
Pre – GDMGDM
IRR: 2.00 (CI 1.54-2.58) p < 0.001IRR: 0.89 (CI 0.81-0.98) p =0.02
Caesarean Section
Pre - GDM IRR: 1.28 (CI 1.05 – 1.57) p<0.001
GDM IRR: 1.11 (CI 1.05 – 1.17) p=0.02
Neonatal Distress (Apgar<7)
Pre – GDMGDM
IRR : 1,59 (CI 0.80-3.16) nsIRR: 1.12 (CI 0,92 -1.39) ns
Reduced risk of Macrosomia in GDM women: this suggest an effective prevention of this complication in our population
CONCLUSIONS
• In Tuscany glucose metabolism is being tested in aboutthe 80% of pregnancies
• Adhesion to guidelines is very low, with a large numberof women not elegible who have been tested
• Rate of GDM, calculated by a validate algorithm issimilar to the one found in other populations
• Insulin therapy is required in quite a third of GDM, including a significant number of not eligible women
This study represents an example of how significantinformation cam be obtained from administrativedatasets.
Only universal glucose screening in pregnancies seems to be effective to adequately capture all GDM cases.
CONCLUSIONS
Grazie per l’attenzione