ID

29430

Beschrijving

Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country; ODM derived from: https://clinicaltrials.gov/show/NCT01855763

Link

https://clinicaltrials.gov/show/NCT01855763

Trefwoorden

Versies (1)
  1. 23-03-18 23-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 maart 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Gestational Diabetes NCT01855763

Engels

Eligibility Gestational Diabetes NCT01855763

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pregnancies in women with pre-pregnancy diagnosis of niddm (type 2 dm) and pregnancy continued beyond the first trimester.
Beschrijving

Pregnancy | Diabetes Mellitus, Non-Insulin-Dependent | Pregnancy Trimester

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0032982
2. women with gestational diabetes mellitus who are at 20-34 weeks of gestation.
Beschrijving

Gestational Diabetes | Gestational Age

Datatype

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2]
C0017504
3. women who have glucose elevations consistent with undiagnosed diabetes in pregnancy.
Beschrijving

Blood glucose increased Consistent with Gestational Diabetes Undiagnosed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0595877
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0085207
UMLS CUI [1,4]
C1408353
4. women with impaired glucose tolerance (igt) at any gestational age of pregnancy and pregnancy continued beyond first trimester.
Beschrijving

Gender Impaired glucose tolerance | Gestational Age | Pregnancy | Pregnancy Trimester

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0271650
UMLS CUI [2]
C0017504
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0032982
5. singleton pregnancy.
Beschrijving

Pregnancy Singleton

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1313913
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who have contraindication for metformin intake.
Beschrijving

Gender | Medical contraindication Metformin

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0025598
2. a recognized fetal anomaly at 14-16 weeks ultrasound examination at the time of study entry.
Beschrijving

Fetal anomaly Ultrasonography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0266647
UMLS CUI [1,2]
C0041618
3. ruptured membranes at time of study entry.
Beschrijving

Ruptured membranes

Datatype

boolean

Alias
UMLS CUI [1]
C0233308
4. women with iddm (type 1 dm) entering pregnancy.
Beschrijving

Gender | Diabetes Mellitus, Insulin-Dependent | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0032961
5. presence of any other medical disorder like essential hypertension, renal disease, hepatic disease, hypothyroidism, cardiac disease.
Beschrijving

Comorbidity | Essential Hypertension | Kidney Disease | Liver disease | Hypothyroidism | Heart Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0085580
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0020676
UMLS CUI [6]
C0018799
6. presence of diabetic complications.
Beschrijving

Complications of Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0342257
7. patient already on sulphonylureas.
Beschrijving

Sulfonylurea

Datatype

boolean

Alias
UMLS CUI [1]
C0038766
8. multiple pregnancy.
Beschrijving

Multiple Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032989
9. gestational diabetes controlled on diet alone.
Beschrijving

Gestational Diabetes Controlled by Diet therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085207
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C0012159
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Similar models

Eligibility Gestational Diabetes NCT01855763

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy | Diabetes Mellitus, Non-Insulin-Dependent | Pregnancy Trimester
Item
1. pregnancies in women with pre-pregnancy diagnosis of niddm (type 2 dm) and pregnancy continued beyond the first trimester.
boolean
C0032961 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0032982 (UMLS CUI [3])
Gestational Diabetes | Gestational Age
Item
2. women with gestational diabetes mellitus who are at 20-34 weeks of gestation.
boolean
C0085207 (UMLS CUI [1])
C0017504 (UMLS CUI [2])
Blood glucose increased Consistent with Gestational Diabetes Undiagnosed
Item
3. women who have glucose elevations consistent with undiagnosed diabetes in pregnancy.
boolean
C0595877 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0085207 (UMLS CUI [1,3])
C1408353 (UMLS CUI [1,4])
Gender Impaired glucose tolerance | Gestational Age | Pregnancy | Pregnancy Trimester
Item
4. women with impaired glucose tolerance (igt) at any gestational age of pregnancy and pregnancy continued beyond first trimester.
boolean
C0079399 (UMLS CUI [1,1])
C0271650 (UMLS CUI [1,2])
C0017504 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0032982 (UMLS CUI [4])
Pregnancy Singleton
Item
5. singleton pregnancy.
boolean
C0032961 (UMLS CUI [1,1])
C1313913 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Gender | Medical contraindication Metformin
Item
1. women who have contraindication for metformin intake.
boolean
C0079399 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Fetal anomaly Ultrasonography
Item
2. a recognized fetal anomaly at 14-16 weeks ultrasound examination at the time of study entry.
boolean
C0266647 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
Ruptured membranes
Item
3. ruptured membranes at time of study entry.
boolean
C0233308 (UMLS CUI [1])
Gender | Diabetes Mellitus, Insulin-Dependent | Pregnancy
Item
4. women with iddm (type 1 dm) entering pregnancy.
boolean
C0079399 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
Comorbidity | Essential Hypertension | Kidney Disease | Liver disease | Hypothyroidism | Heart Disease
Item
5. presence of any other medical disorder like essential hypertension, renal disease, hepatic disease, hypothyroidism, cardiac disease.
boolean
C0009488 (UMLS CUI [1])
C0085580 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0020676 (UMLS CUI [5])
C0018799 (UMLS CUI [6])
Complications of Diabetes Mellitus
Item
6. presence of diabetic complications.
boolean
C0342257 (UMLS CUI [1])
Sulfonylurea
Item
7. patient already on sulphonylureas.
boolean
C0038766 (UMLS CUI [1])
Multiple Pregnancy
Item
8. multiple pregnancy.
boolean
C0032989 (UMLS CUI [1])
Gestational Diabetes Controlled by Diet therapy
Item
9. gestational diabetes controlled on diet alone.
boolean
C0085207 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C0012159 (UMLS CUI [1,3])
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