ID

35880

Descrição

Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation; ODM derived from: https://clinicaltrials.gov/show/NCT01839448

Link

https://clinicaltrials.gov/show/NCT01839448

Palavras-chave

Versões (1)
  1. 31/03/2019 31/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

31 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Gestational Diabetes NCT01839448

Inglês

Eligibility Gestational Diabetes NCT01839448

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient must have given her informed and signed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
the patient must be insured or beneficiary of a health insurance plan
Descrição

Patient is insured Health insurance plan | Insurance Beneficiary Health insurance plan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1548651
UMLS CUI [1,2]
C0679933
UMLS CUI [2,1]
C3853043
UMLS CUI [2,2]
C0679933
the patient is available for 10 months of follow-up
Descrição

Patient Available Follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
the patient is pregnant and consulting before 24 weeks of amenorrhea and has at least one of the following risk factors: age > 35 years; body mass index > 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
Descrição

Pregnancy | Consultation Before Amenorrhea | Risk factors Quantity | Age | Body mass index | Family history of diabetes mellitus type 2 | Gestational Diabetes | Macrosomia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0009818
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0002453
UMLS CUI [3,1]
C0035648
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0001779
UMLS CUI [5]
C1305855
UMLS CUI [6]
C2316287
UMLS CUI [7]
C0085207
UMLS CUI [8]
C0158915
the patient has a fasting blood glucose level >= 0.92 g/l before 24 weeks of amenorrhea or a fasting blood glucose level < 0.92 g/l before 24 weeks of amenorrhea and an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at t0 < 0.92 g/l; t60 < 1.80 g/l; t120 < 1.53 g/l).
Descrição

Fasting blood glucose measurement | Status pre- Amenorrhea | Oral Glucose Tolerance Test Abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0002453
UMLS CUI [3,1]
C0029161
UMLS CUI [3,2]
C0205161
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient is participating in another study
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
the patient is in an exclusion period determined by a previous study
Descrição

Study Subject Participation Status | Exclusion Period

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C1948053
the patient is under judicial protection, under tutorship or curatorship
Descrição

Guardianship

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0870627
the patient refuses to sign the consent
Descrição

Informed Consent Refused

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
it is impossible to correctly inform the patient
Descrição

Patient Information Unsuccessful

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1955348
UMLS CUI [1,2]
C1272705
the patient cannot read french
Descrição

Lacking Able to read French language

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0586740
UMLS CUI [1,3]
C0376246
the patient has a known history of type 2 diabetes
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
the patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level > 1.26 g/l)
Descrição

Non-Insulin-Dependent Diabetes Mellitus During Pregnancy | Fasting blood glucose measurement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0032961
UMLS CUI [2]
C0428568
the patient has a contra-indication for a treatment necessary for this study
Descrição

Medical contraindication Investigational Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0949266
the patient is taking chronic or intermittent oral or inhaled corticosteroids, or a
Descrição

Adrenal Cortex Hormones Oral chronic | Adrenal Cortex Hormones Oral Intermittent | Adrenal Cortex Hormones by Inhalation chronic | Adrenal Cortex Hormones by Inhalation Intermittent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205267
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
UMLS CUI [3,3]
C0205191
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205535
UMLS CUI [4,3]
C0205267
β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.
Descrição

Agonist Disease Previous | Disease Newly Diagnosed During Pregnancy | Glucose measurement, fasting | Oral Glucose Tolerance Test

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2987634
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1518321
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0032961
UMLS CUI [3]
C0202045
UMLS CUI [4]
C0029161
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Similar models

Eligibility Gestational Diabetes NCT01839448

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
the patient must have given her informed and signed consent
boolean
C0021430 (UMLS CUI [1])
Patient is insured Health insurance plan | Insurance Beneficiary Health insurance plan
Item
the patient must be insured or beneficiary of a health insurance plan
boolean
C1548651 (UMLS CUI [1,1])
C0679933 (UMLS CUI [1,2])
C3853043 (UMLS CUI [2,1])
C0679933 (UMLS CUI [2,2])
Patient Available Follow-up
Item
the patient is available for 10 months of follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Pregnancy | Consultation Before Amenorrhea | Risk factors Quantity | Age | Body mass index | Family history of diabetes mellitus type 2 | Gestational Diabetes | Macrosomia
Item
the patient is pregnant and consulting before 24 weeks of amenorrhea and has at least one of the following risk factors: age > 35 years; body mass index > 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
boolean
C0032961 (UMLS CUI [1])
C0009818 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0002453 (UMLS CUI [2,3])
C0035648 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C1305855 (UMLS CUI [5])
C2316287 (UMLS CUI [6])
C0085207 (UMLS CUI [7])
C0158915 (UMLS CUI [8])
Fasting blood glucose measurement | Status pre- Amenorrhea | Oral Glucose Tolerance Test Abnormal
Item
the patient has a fasting blood glucose level >= 0.92 g/l before 24 weeks of amenorrhea or a fasting blood glucose level < 0.92 g/l before 24 weeks of amenorrhea and an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at t0 < 0.92 g/l; t60 < 1.80 g/l; t120 < 1.53 g/l).
boolean
C0428568 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0002453 (UMLS CUI [2,2])
C0029161 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
the patient is participating in another study
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status | Exclusion Period
Item
the patient is in an exclusion period determined by a previous study
boolean
C2348568 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
Guardianship
Item
the patient is under judicial protection, under tutorship or curatorship
boolean
C0870627 (UMLS CUI [1])
Informed Consent Refused
Item
the patient refuses to sign the consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Patient Information Unsuccessful
Item
it is impossible to correctly inform the patient
boolean
C1955348 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Lacking Able to read French language
Item
the patient cannot read french
boolean
C0332268 (UMLS CUI [1,1])
C0586740 (UMLS CUI [1,2])
C0376246 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent
Item
the patient has a known history of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus During Pregnancy | Fasting blood glucose measurement
Item
the patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level > 1.26 g/l)
boolean
C0011860 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0428568 (UMLS CUI [2])
Medical contraindication Investigational Therapy
Item
the patient has a contra-indication for a treatment necessary for this study
boolean
C1301624 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
Adrenal Cortex Hormones Oral chronic | Adrenal Cortex Hormones Oral Intermittent | Adrenal Cortex Hormones by Inhalation chronic | Adrenal Cortex Hormones by Inhalation Intermittent
Item
the patient is taking chronic or intermittent oral or inhaled corticosteroids, or a
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205267 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C0001617 (UMLS CUI [4,1])
C0205535 (UMLS CUI [4,2])
C0205267 (UMLS CUI [4,3])
Agonist Disease Previous | Disease Newly Diagnosed During Pregnancy | Glucose measurement, fasting | Oral Glucose Tolerance Test
Item
β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.
boolean
C2987634 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0032961 (UMLS CUI [2,4])
C0202045 (UMLS CUI [3])
C0029161 (UMLS CUI [4])
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