ID

31520

Description

Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00678080

Link

https://clinicaltrials.gov/show/NCT00678080

Keywords

Versions (1)
  1. 8/31/18 8/31/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 31, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Pregnancy Complications NCT00678080

English

Eligibility Pregnancy Complications NCT00678080

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the onset of t2dm for less than 10 years prior to the onset of pregnancy by patient history
Description

Diabetes Mellitus, Non-Insulin-Dependent | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0032961
treatment with diet or oral hypoglycemic agents prior to pregnancy.
Description

Diet therapy | Oral hypoglycemic | Status pre- Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0359086
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0032961
pregnancies less than 20 weeks of pregnancy. this gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin a1c (primary outcome) with medical therapy prior to delivery.
Description

Pregnancy Week Quantity | Gestational Age | Prenatal care Trimester Ordinal number | Glycosylated hemoglobin A Improvement Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0017504
UMLS CUI [3,1]
C0033052
UMLS CUI [3,2]
C0032982
UMLS CUI [3,3]
C0439080
UMLS CUI [4,1]
C0019018
UMLS CUI [4,2]
C2986411
UMLS CUI [4,3]
C0332149
newly diagnosed diabetes in the first 20 weeks of pregnancy. these women likely have had diabetes prior to the onset of pregnancy. they do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dl, a 50 gram glucola result greater than 200 mg/dl or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. an abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
Description

Newly diagnosed diabetes | Pregnancy Week Quantity | Elevated fasting blood glucose | Glucola Measurement | Glucola Test Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1320655
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0439230
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C4313271
UMLS CUI [4,1]
C0119395
UMLS CUI [4,2]
C0242485
UMLS CUI [5,1]
C0119395
UMLS CUI [5,2]
C0039593
UMLS CUI [5,3]
C0205161
hemoglobin a1c <9%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
gestational age greater than 20 weeks
Description

Gestational Age Week Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0017504
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
multiple gestations (twins or more gestations)
Description

Multiple Pregnancy | Pregnancy, Twins

Data type

boolean

Alias
UMLS CUI [1]
C0032989
UMLS CUI [2]
C0152150
type 1 diabetes by patient history
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
known fetal chromosomal or structural defects
Description

Foetal chromosome abnormality | Defect Fetal structural

Data type

boolean

Alias
UMLS CUI [1]
C1535919
UMLS CUI [2,1]
C1457869
UMLS CUI [2,2]
C0521457
UMLS CUI [2,3]
C0678594
contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
Description

Medical contraindication Metformin | Kidney Disease | Liver disease | Myocardial Infarction | Sepsis

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0243026
those with a hemoglobin a1c greater than 9%.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
on insulin at the start of pregnancy
Description

Insulin regime During Start Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0439659
UMLS CUI [1,4]
C0032961
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Similar models

Eligibility Pregnancy Complications NCT00678080

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Pregnancy
Item
the onset of t2dm for less than 10 years prior to the onset of pregnancy by patient history
boolean
C0011860 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Diet therapy | Oral hypoglycemic | Status pre- Pregnancy
Item
treatment with diet or oral hypoglycemic agents prior to pregnancy.
boolean
C0012159 (UMLS CUI [1])
C0359086 (UMLS CUI [2])
C0332152 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
Pregnancy Week Quantity | Gestational Age | Prenatal care Trimester Ordinal number | Glycosylated hemoglobin A Improvement Possible
Item
pregnancies less than 20 weeks of pregnancy. this gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin a1c (primary outcome) with medical therapy prior to delivery.
boolean
C0032961 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0017504 (UMLS CUI [2])
C0033052 (UMLS CUI [3,1])
C0032982 (UMLS CUI [3,2])
C0439080 (UMLS CUI [3,3])
C0019018 (UMLS CUI [4,1])
C2986411 (UMLS CUI [4,2])
C0332149 (UMLS CUI [4,3])
Newly diagnosed diabetes | Pregnancy Week Quantity | Elevated fasting blood glucose | Glucola Measurement | Glucola Test Abnormal
Item
newly diagnosed diabetes in the first 20 weeks of pregnancy. these women likely have had diabetes prior to the onset of pregnancy. they do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dl, a 50 gram glucola result greater than 200 mg/dl or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. an abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
boolean
C1320655 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0439230 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C4313271 (UMLS CUI [3])
C0119395 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C0119395 (UMLS CUI [5,1])
C0039593 (UMLS CUI [5,2])
C0205161 (UMLS CUI [5,3])
Hemoglobin A1c measurement
Item
hemoglobin a1c <9%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gestational Age Week Quantity
Item
gestational age greater than 20 weeks
boolean
C0017504 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Multiple Pregnancy | Pregnancy, Twins
Item
multiple gestations (twins or more gestations)
boolean
C0032989 (UMLS CUI [1])
C0152150 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes by patient history
boolean
C0011854 (UMLS CUI [1])
Foetal chromosome abnormality | Defect Fetal structural
Item
known fetal chromosomal or structural defects
boolean
C1535919 (UMLS CUI [1])
C1457869 (UMLS CUI [2,1])
C0521457 (UMLS CUI [2,2])
C0678594 (UMLS CUI [2,3])
Medical contraindication Metformin | Kidney Disease | Liver disease | Myocardial Infarction | Sepsis
Item
contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0243026 (UMLS CUI [5])
Hemoglobin A1c measurement
Item
those with a hemoglobin a1c greater than 9%.
boolean
C0474680 (UMLS CUI [1])
Insulin regime During Start Pregnancy
Item
on insulin at the start of pregnancy
boolean
C0557978 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,4])
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