ID

35881

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02036619

Trefwoorden

Versies (1)
  1. 01-04-19 01-04-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 april 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Gestational Diabetes NCT02036619

Engels

Eligibility Gestational Diabetes NCT02036619

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Gender | Age

Datatype

boolean

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

Singleton Pregnancy

Datatype

boolean

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

Gestational Age

Datatype

boolean

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

Delivery Planned Hospital Study Site

Datatype

boolean

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

Exclusion Criteria

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
multiple pregnancy
Beschrijving

Multiple Pregnancy

Datatype

boolean

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

Diabetes Mellitus | Metformin

Datatype

boolean

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

Adrenal Cortex Hormones chronic

Datatype

boolean

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

Signs Spontaneous abortion

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Bariatric Surgery

Datatype

boolean

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

Delivery Planned Center Other

Datatype

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…)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0184661
UMLS CUI [4,1]
C0023676
UMLS CUI [4,2]
C0184661
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Similar models

Eligibility Gestational Diabetes NCT02036619

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

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