ID

35881

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02036619

Nyckelord

Versioner (1)
  1. 2019-04-01 2019-04-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Gestational Diabetes NCT02036619

Engelsk

Eligibility Gestational Diabetes NCT02036619

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Gender | Age

Datatyp

boolean

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

Singleton Pregnancy

Datatyp

boolean

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

Gestational Age

Datatyp

boolean

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

Delivery Planned Hospital Study Site

Datatyp

boolean

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

Exclusion Criteria

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
multiple pregnancy
Beskrivning

Multiple Pregnancy

Datatyp

boolean

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

Diabetes Mellitus | Metformin

Datatyp

boolean

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

Adrenal Cortex Hormones chronic

Datatyp

boolean

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

Signs Spontaneous abortion

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Bariatric Surgery

Datatyp

boolean

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

Delivery Planned Center Other

Datatyp

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…)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0184661
UMLS CUI [4,1]
C0023676
UMLS CUI [4,2]
C0184661
Tillbaka till toppen

Similar models

Eligibility Gestational Diabetes NCT02036619

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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