ID

24061

Description

Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00474045

Link

https://clinicaltrials.gov/show/NCT00474045

Keywords

Versions (1)
  1. 7/24/17 7/24/17 -
Uploaded on

July 24, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00474045

English

Eligibility Diabetes NCT00474045

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00474045
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes treated with insulin for at least 12 months
Description

Insulin regime Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011854
planning to become pregnant and have a screening hba1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
Description

Pregnancy, Planned | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2]
C0019018
pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a hba1c lesser than or equal to 8.0% when pregnancy is confirmed
Description

Pregnancy Week Quantity | Fetus Living Singleton Intrauterine | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0015965
UMLS CUI [2,2]
C0376558
UMLS CUI [2,3]
C1313913
UMLS CUI [2,4]
C0694756
UMLS CUI [3]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to the trial product(s) or related products
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Product Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1514468
UMLS CUI [2,3]
C0439849
untreated hyperthyroidism or hypothyroidism
Description

Hyperthyroidism untreated | Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0020676
known or suspected abuse of alcohol or narcotics
Description

Alcohol abuse | Narcotic Abuse | Alcohol abuse Suspected | Narcotic Abuse Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0524661
UMLS CUI [3,1]
C0085762
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0524661
UMLS CUI [4,2]
C0750491
cardiac problems
Description

cardiac problem

Data type

boolean

Alias
UMLS CUI [1]
C0262402
impaired kidney function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
history of severe hyperemesis gravidarum
Description

Severe hyperemesis gravidarum

Data type

boolean

Alias
UMLS CUI [1]
C0544566
treatment with in-vitro fertilisation or other medical infertility treatment
Description

Fertilization in Vitro | Infertility therapy

Data type

boolean

Alias
UMLS CUI [1]
C0015915
UMLS CUI [2]
C0200070
impaired liver function
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
proliferative retinopathy or maculopathy requiring acute treatment
Description

Proliferative retinopathy | Maculopathy Treatment required for

Data type

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
known to be hiv (human immunodeficiency virus) positive, hepatitis b or hepatitis c positive
Description

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
any concomitant medication contraindicated in pregnancy
Description

Medical contraindication Pharmaceutical Preparation | Phase Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0205390
UMLS CUI [2,2]
C0032961
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Similar models

Eligibility Diabetes NCT00474045

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00474045
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin regime Insulin-Dependent Diabetes Mellitus
Item
type 1 diabetes treated with insulin for at least 12 months
boolean
C0557978 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Pregnancy, Planned | Glycosylated hemoglobin A
Item
planning to become pregnant and have a screening hba1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
boolean
C0032992 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Pregnancy Week Quantity | Fetus Living Singleton Intrauterine | Glycosylated hemoglobin A
Item
pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a hba1c lesser than or equal to 8.0% when pregnancy is confirmed
boolean
C0032961 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0015965 (UMLS CUI [2,1])
C0376558 (UMLS CUI [2,2])
C1313913 (UMLS CUI [2,3])
C0694756 (UMLS CUI [2,4])
C0019018 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Product Related
Item
known or suspected hypersensitivity to the trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Hyperthyroidism untreated | Hypothyroidism
Item
untreated hyperthyroidism or hypothyroidism
boolean
C0020550 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0020676 (UMLS CUI [2])
Alcohol abuse | Narcotic Abuse | Alcohol abuse Suspected | Narcotic Abuse Suspected
Item
known or suspected abuse of alcohol or narcotics
boolean
C0085762 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
C0085762 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0524661 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
cardiac problem
Item
cardiac problems
boolean
C0262402 (UMLS CUI [1])
Renal Insufficiency
Item
impaired kidney function
boolean
C1565489 (UMLS CUI [1])
Severe hyperemesis gravidarum
Item
history of severe hyperemesis gravidarum
boolean
C0544566 (UMLS CUI [1])
Fertilization in Vitro | Infertility therapy
Item
treatment with in-vitro fertilisation or other medical infertility treatment
boolean
C0015915 (UMLS CUI [1])
C0200070 (UMLS CUI [2])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Proliferative retinopathy | Maculopathy Treatment required for
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
known to be hiv (human immunodeficiency virus) positive, hepatitis b or hepatitis c positive
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Medical contraindication Pharmaceutical Preparation | Phase Pregnancy
Item
any concomitant medication contraindicated in pregnancy
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205390 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
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