ID

39331

Description

Early Intervention for Gestational Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01171456

Link

https://clinicaltrials.gov/show/NCT01171456

Keywords

Versions (1)
  1. 12/20/19 12/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Gestational Diabetes Mellitus NCT01171456

English

Eligibility Gestational Diabetes Mellitus NCT01171456

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women delivered >37 weeks gestation in the intermountain healthcare urban central region within the last 18 months to ascertain those at risk for gdm in their next pregnancy because of:
Description

Duration of gestation | At risk Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0460089
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0085207
a history of gestational diabetes in their immediately prior pregnancy
Description

History of gestational diabetes mellitus | Relationship Pregnancy preceding

Data type

boolean

Alias
UMLS CUI [1]
C2183115
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332152
a family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
Description

Family history of diabetes mellitus type 2

Data type

boolean

Alias
UMLS CUI [1]
C2316287
delivery of an infant > 4000 gms.
Description

Delivery | infant weight

Data type

boolean

Alias
UMLS CUI [1]
C0011209
UMLS CUI [2]
C0745274
b.m.i. > 30 six months postpartum
Description

Body mass index Postpartum

Data type

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0086839
hemoglobin a1c > 6.1% six months postpartum
Description

Hemoglobin A1c measurement Postpartum

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0086839
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-conception exclusion criteria will include any of the following:
Description

Exclusion Criteria Preconception

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2982736
history of >1 miscarriage or fetal demise
Description

Spontaneous abortion Quantity | Fetal Death

Data type

boolean

Alias
UMLS CUI [1,1]
C0000786
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0015927
no contraindication to metformin (prior metformin intolerance, metabolic acidosis, gi disease)
Description

Medical contraindication Metformin | Intolerance to Metformin | Metabolic acidosis | Gastrointestinal Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025598
UMLS CUI [3]
C0220981
UMLS CUI [4]
C0017178
hypertension (bp >135/85)
Description

Hypertensive disease | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005824
no other endocrine, metabolic, renal, or autommune medical disorders
Description

Endocrine System Diseases | Metabolic Diseases | Kidney Diseases | Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0025517
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0004364
prior preterm birth
Description

Premature Birth Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0151526
UMLS CUI [1,2]
C0205156
prior delivery complicated by shoulder dystocia
Description

Complication of delivery Shoulder girdle dystocia

Data type

boolean

Alias
UMLS CUI [1,1]
C0852962
UMLS CUI [1,2]
C0269825
prior delivery complicated by neonatal palsy
Description

Complication of delivery Palsy Neonatal

Data type

boolean

Alias
UMLS CUI [1,1]
C0852962
UMLS CUI [1,2]
C3887651
UMLS CUI [1,3]
C2939425
multifetal pregnancy, including first-trimester embryonic demise of one or more
Description

Multiple Pregnancy | EMBRYONIC DEMISE First Trimester

Data type

boolean

Alias
UMLS CUI [1]
C0032989
UMLS CUI [2,1]
C0743473
UMLS CUI [2,2]
C0032979
uterine malformations
Description

Malformation, uterus

Data type

boolean

Alias
UMLS CUI [1]
C1411635
illicit drug or alcohol abuse during current pregnancy
Description

Illicit medication use During Pregnancy | Alcohol abuse During Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0032961
UMLS CUI [2,1]
C0085762
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0032961
intent to deliver elsewhere
Description

Intent Delivery Area Other

Data type

boolean

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0011209
UMLS CUI [1,3]
C0017446
UMLS CUI [1,4]
C0205394
non-availability for prospective specimen/data collection
Description

Patient unavailable Tissue specimen | Patient unavailable Data Collection

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C1292533
UMLS CUI [2,1]
C1301818
UMLS CUI [2,2]
C0010995
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Similar models

Eligibility Gestational Diabetes Mellitus NCT01171456

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Duration of gestation | At risk Gestational Diabetes
Item
women delivered >37 weeks gestation in the intermountain healthcare urban central region within the last 18 months to ascertain those at risk for gdm in their next pregnancy because of:
boolean
C0460089 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
History of gestational diabetes mellitus | Relationship Pregnancy preceding
Item
a history of gestational diabetes in their immediately prior pregnancy
boolean
C2183115 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Family history of diabetes mellitus type 2
Item
a family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
boolean
C2316287 (UMLS CUI [1])
Delivery | infant weight
Item
delivery of an infant > 4000 gms.
boolean
C0011209 (UMLS CUI [1])
C0745274 (UMLS CUI [2])
Body mass index Postpartum
Item
b.m.i. > 30 six months postpartum
boolean
C1305855 (UMLS CUI [1,1])
C0086839 (UMLS CUI [1,2])
Hemoglobin A1c measurement Postpartum
Item
hemoglobin a1c > 6.1% six months postpartum
boolean
C0474680 (UMLS CUI [1,1])
C0086839 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Preconception
Item
pre-conception exclusion criteria will include any of the following:
boolean
C0680251 (UMLS CUI [1,1])
C2982736 (UMLS CUI [1,2])
Spontaneous abortion Quantity | Fetal Death
Item
history of >1 miscarriage or fetal demise
boolean
C0000786 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0015927 (UMLS CUI [2])
Medical contraindication Metformin | Intolerance to Metformin | Metabolic acidosis | Gastrointestinal Diseases
Item
no contraindication to metformin (prior metformin intolerance, metabolic acidosis, gi disease)
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0220981 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
Hypertensive disease | Blood pressure determination
Item
hypertension (bp >135/85)
boolean
C0020538 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Endocrine System Diseases | Metabolic Diseases | Kidney Diseases | Autoimmune Diseases
Item
no other endocrine, metabolic, renal, or autommune medical disorders
boolean
C0014130 (UMLS CUI [1])
C0025517 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0004364 (UMLS CUI [4])
Premature Birth Previous
Item
prior preterm birth
boolean
C0151526 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Complication of delivery Shoulder girdle dystocia
Item
prior delivery complicated by shoulder dystocia
boolean
C0852962 (UMLS CUI [1,1])
C0269825 (UMLS CUI [1,2])
Complication of delivery Palsy Neonatal
Item
prior delivery complicated by neonatal palsy
boolean
C0852962 (UMLS CUI [1,1])
C3887651 (UMLS CUI [1,2])
C2939425 (UMLS CUI [1,3])
Multiple Pregnancy | EMBRYONIC DEMISE First Trimester
Item
multifetal pregnancy, including first-trimester embryonic demise of one or more
boolean
C0032989 (UMLS CUI [1])
C0743473 (UMLS CUI [2,1])
C0032979 (UMLS CUI [2,2])
Malformation, uterus
Item
uterine malformations
boolean
C1411635 (UMLS CUI [1])
Illicit medication use During Pregnancy | Alcohol abuse During Pregnancy
Item
illicit drug or alcohol abuse during current pregnancy
boolean
C0281875 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0085762 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0032961 (UMLS CUI [2,3])
Intent Delivery Area Other
Item
intent to deliver elsewhere
boolean
C1283828 (UMLS CUI [1,1])
C0011209 (UMLS CUI [1,2])
C0017446 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Patient unavailable Tissue specimen | Patient unavailable Data Collection
Item
non-availability for prospective specimen/data collection
boolean
C1301818 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C1301818 (UMLS CUI [2,1])
C0010995 (UMLS CUI [2,2])
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