ID

35881

Description

The Belgian Diabetes in Pregnancy Study: BEDIP-N Study; ODM derived from: https://clinicaltrials.gov/show/NCT02036619

Link

https://clinicaltrials.gov/show/NCT02036619

Keywords

Versions (1)
  1. 4/1/19 4/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 1, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Gestational Diabetes NCT02036619

English

Eligibility Gestational Diabetes NCT02036619

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women between 18-45 years,
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
singleton pregnancy
Description

Singleton Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C1313913
UMLS CUI [1,2]
C0032961
between 6-13 weeks of pregnancy
Description

Gestational Age

Data type

boolean

Alias
UMLS CUI [1]
C0017504
the delivery has to be planned in the hospital where the study is performed.
Description

Delivery Planned Hospital Study Site

Data type

boolean

Alias
UMLS CUI [1,1]
C0011209
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0019994
UMLS CUI [1,4]
C2347790
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
< 18 years or > 45 year
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
multiple pregnancy
Description

Multiple Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032989
known diabetes or taking metformin
Description

Diabetes Mellitus | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0025598
chronic treatment with corticoids
Description

Adrenal Cortex Hormones chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
signs of a miscarriage
Description

Signs Spontaneous abortion

Data type

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0000786
chronic medical condition: uncontrolled hypertension, severe heart disease, severe chronic liver disease, severe chronic kidney disease, chronic infection (such as hiv or hepatitis)
Description

Medical condition chronic | Uncontrolled hypertension | Heart Disease Severe | Chronic liver disease Severe | Chronic Kidney Disease Severe | Chronic infectious disease | HIV Infection | Hepatitis

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0341439
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C1561643
UMLS CUI [5,2]
C0205082
UMLS CUI [6]
C0151317
UMLS CUI [7]
C0019693
UMLS CUI [8]
C0019158
bariatric surgery
Description

Bariatric Surgery

Data type

boolean

Alias
UMLS CUI [1]
C1456587
delivery is planned in another center than the screening
Description

Delivery Planned Center Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0011209
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1552416
UMLS CUI [1,4]
C0205394
a normal follow up and treatment during pregnancy will not be possible (due to incompliance, psychiatric problems, severe communication problems…)
Description

Follow-up Unsuccessful | Therapeutic procedure Unsuccessful | Compliance behavior Lacking | Psychiatric problem | Communication problem Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1272705
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0332268
UMLS CUI [4]
C1306597
UMLS CUI [5,1]
C0481701
UMLS CUI [5,2]
C0205082
participating in another study with any medication or intervention ( including life style intervention) up to 90 days before the start of the study
Description

Study Subject Participation Status | Investigational New Drugs | Intervention | Life Style Intervention

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0184661
UMLS CUI [4,1]
C0023676
UMLS CUI [4,2]
C0184661
Back to the top of the page

Similar models

Eligibility Gestational Diabetes NCT02036619

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women between 18-45 years,
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Singleton Pregnancy
Item
singleton pregnancy
boolean
C1313913 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Gestational Age
Item
between 6-13 weeks of pregnancy
boolean
C0017504 (UMLS CUI [1])
Delivery Planned Hospital Study Site
Item
the delivery has to be planned in the hospital where the study is performed.
boolean
C0011209 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,3])
C2347790 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Age
Item
< 18 years or > 45 year
boolean
C0001779 (UMLS CUI [1])
Multiple Pregnancy
Item
multiple pregnancy
boolean
C0032989 (UMLS CUI [1])
Diabetes Mellitus | Metformin
Item
known diabetes or taking metformin
boolean
C0011849 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Adrenal Cortex Hormones chronic
Item
chronic treatment with corticoids
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Signs Spontaneous abortion
Item
signs of a miscarriage
boolean
C0311392 (UMLS CUI [1,1])
C0000786 (UMLS CUI [1,2])
Medical condition chronic | Uncontrolled hypertension | Heart Disease Severe | Chronic liver disease Severe | Chronic Kidney Disease Severe | Chronic infectious disease | HIV Infection | Hepatitis
Item
chronic medical condition: uncontrolled hypertension, severe heart disease, severe chronic liver disease, severe chronic kidney disease, chronic infection (such as hiv or hepatitis)
boolean
C3843040 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2])
C0018799 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0341439 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1561643 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0151317 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
C0019158 (UMLS CUI [8])
Bariatric Surgery
Item
bariatric surgery
boolean
C1456587 (UMLS CUI [1])
Delivery Planned Center Other
Item
delivery is planned in another center than the screening
boolean
C0011209 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1552416 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Follow-up Unsuccessful | Therapeutic procedure Unsuccessful | Compliance behavior Lacking | Psychiatric problem | Communication problem Severe
Item
a normal follow up and treatment during pregnancy will not be possible (due to incompliance, psychiatric problems, severe communication problems…)
boolean
C3274571 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C1306597 (UMLS CUI [4])
C0481701 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Study Subject Participation Status | Investigational New Drugs | Intervention | Life Style Intervention
Item
participating in another study with any medication or intervention ( including life style intervention) up to 90 days before the start of the study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0184661 (UMLS CUI [3])
C0023676 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial