ID

41000

Beschrijving

Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia; ODM derived from: https://clinicaltrials.gov/show/NCT01441518

Link

https://clinicaltrials.gov/show/NCT01441518

Trefwoorden

Versies (1)
  1. 10-06-20 10-06-20 -
Houder van rechten

See clinicaltrials.gov

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10 juni 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Gestational Diabetes Mellitus NCT01441518

Engels

Eligibility Gestational Diabetes Mellitus NCT01441518

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. patients should have one of the four criteria as following:
Beschrijving

Gestational Diabetes | Pre-Gestational Diabetes | Hyperglycemia Gestational Mild | Criteria Quantity Fulfill

Datatype

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2]
C3828492
UMLS CUI [3,1]
C0020456
UMLS CUI [3,2]
C0439671
UMLS CUI [3,3]
C2945599
UMLS CUI [4,1]
C0243161
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1550543
patients with positive screening for gdm presenting a ttg of 75 g and one of the values below:
Beschrijving

Gestational Diabetes | Glucose tolerance test

Datatype

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2]
C0017741
fasting glucose ≥ 92;
Beschrijving

Glucose measurement, fasting

Datatype

boolean

Alias
UMLS CUI [1]
C0202045
1h ≥ 180; or
Beschrijving

Fasting Glucose measurement Hour Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0202045
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1265611
2h ≥ 153 will be considered gestational diabetes mellitus (gdm) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. if the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or
Beschrijving

Fasting Glucose measurement Hour Quantity | Gestational Diabetes | Diet therapy | Exercise | Blood Glucose Profile Abnormal | Home care of patient | Hospital care

Datatype

boolean

Alias
UMLS CUI [1,1]
C0202045
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0085207
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5,1]
C0005802
UMLS CUI [5,2]
C1979963
UMLS CUI [5,3]
C0205161
UMLS CUI [6]
C0204977
UMLS CUI [7]
C0259945
patients with pre gestational diabetes mellitus type 1 or 2; or
Beschrijving

Pre-Gestational Insulin-Dependent Diabetes Mellitus | Pre-Gestational Non-Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C3828492
UMLS CUI [1,2]
C0011854
UMLS CUI [2,1]
C3828492
UMLS CUI [2,2]
C0011860
patients with positive screening for gdm and presenting normal ttg of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/
Beschrijving

Gestational Diabetes | Glucose tolerance test Normal | Blood Glucose Profile Abnormal | Fasting Glucose measurement Hour Quantity | Fasting Glucose measurement Postprandial

Datatype

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2,1]
C0017741
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0005802
UMLS CUI [3,2]
C1979963
UMLS CUI [3,3]
C0205161
UMLS CUI [4,1]
C0202045
UMLS CUI [4,2]
C0439227
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0202045
UMLS CUI [5,2]
C0376674
( rudge et al,1990).
Beschrijving

ID.8

Datatype

boolean

normal ttg and an abnormal glycemic profile will be considered as mild gestational hyperglycemia
Beschrijving

Glucose tolerance test Normal | Blood Glucose Profile Abnormal | Hyperglycemia Gestational Mild

Datatype

boolean

Alias
UMLS CUI [1,1]
C0017741
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0005802
UMLS CUI [2,2]
C1979963
UMLS CUI [2,3]
C0205161
UMLS CUI [3,1]
C0020456
UMLS CUI [3,2]
C0439671
UMLS CUI [3,3]
C2945599
patient provided written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
twin pregnancy diagnosed until the date of randomization or;
Beschrijving

Pregnancy, Twin

Datatype

boolean

Alias
UMLS CUI [1]
C0152150
fetal malformation diagnosed until the date of randomization.
Beschrijving

Fetal malformation

Datatype

boolean

Alias
UMLS CUI [1]
C0000768
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Similar models

Eligibility Gestational Diabetes Mellitus NCT01441518

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gestational Diabetes | Pre-Gestational Diabetes | Hyperglycemia Gestational Mild | Criteria Quantity Fulfill
Item
patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. patients should have one of the four criteria as following:
boolean
C0085207 (UMLS CUI [1])
C3828492 (UMLS CUI [2])
C0020456 (UMLS CUI [3,1])
C0439671 (UMLS CUI [3,2])
C2945599 (UMLS CUI [3,3])
C0243161 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1550543 (UMLS CUI [4,3])
Gestational Diabetes | Glucose tolerance test
Item
patients with positive screening for gdm presenting a ttg of 75 g and one of the values below:
boolean
C0085207 (UMLS CUI [1])
C0017741 (UMLS CUI [2])
Glucose measurement, fasting
Item
fasting glucose ≥ 92;
boolean
C0202045 (UMLS CUI [1])
Fasting Glucose measurement Hour Quantity
Item
1h ≥ 180; or
boolean
C0202045 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Fasting Glucose measurement Hour Quantity | Gestational Diabetes | Diet therapy | Exercise | Blood Glucose Profile Abnormal | Home care of patient | Hospital care
Item
2h ≥ 153 will be considered gestational diabetes mellitus (gdm) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. if the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or
boolean
C0202045 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0085207 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0005802 (UMLS CUI [5,1])
C1979963 (UMLS CUI [5,2])
C0205161 (UMLS CUI [5,3])
C0204977 (UMLS CUI [6])
C0259945 (UMLS CUI [7])
Pre-Gestational Insulin-Dependent Diabetes Mellitus | Pre-Gestational Non-Insulin-Dependent Diabetes Mellitus
Item
patients with pre gestational diabetes mellitus type 1 or 2; or
boolean
C3828492 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C3828492 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Gestational Diabetes | Glucose tolerance test Normal | Blood Glucose Profile Abnormal | Fasting Glucose measurement Hour Quantity | Fasting Glucose measurement Postprandial
Item
patients with positive screening for gdm and presenting normal ttg of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/
boolean
C0085207 (UMLS CUI [1])
C0017741 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0005802 (UMLS CUI [3,1])
C1979963 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
C0202045 (UMLS CUI [4,1])
C0439227 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0202045 (UMLS CUI [5,1])
C0376674 (UMLS CUI [5,2])
ID.8
Item
( rudge et al,1990).
boolean
Glucose tolerance test Normal | Blood Glucose Profile Abnormal | Hyperglycemia Gestational Mild
Item
normal ttg and an abnormal glycemic profile will be considered as mild gestational hyperglycemia
boolean
C0017741 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0005802 (UMLS CUI [2,1])
C1979963 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C0020456 (UMLS CUI [3,1])
C0439671 (UMLS CUI [3,2])
C2945599 (UMLS CUI [3,3])
Informed Consent
Item
patient provided written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy, Twin
Item
twin pregnancy diagnosed until the date of randomization or;
boolean
C0152150 (UMLS CUI [1])
Fetal malformation
Item
fetal malformation diagnosed until the date of randomization.
boolean
C0000768 (UMLS CUI [1])
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