Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Identification number, Randomization
Item
Randomization Number
integer
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Pregnancy, Mother, Date of birth
Item
Mother's date of birth
date
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0421451 (UMLS CUI [1,3])
Pregnancy, Mother, Date of last menstrual period
Item
Date of last menstrual period
date
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0425932 (UMLS CUI [1,3])
Pregnancy, Mother, Estimated date of delivery
Item
Estimated date of delivery
date
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C1287845 (UMLS CUI [1,3])
Pregnancy, Mother, Contraceptive method
Item
Was the mother using a method of contraception?
boolean
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Pregnancy, Mother, Contraceptive method
Item
ff Yes, specify
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Item
Type of conception, check one
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C2598844 (UMLS CUI [1,3])
Code List
Type of conception, check one
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilisation) (2)
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C0199171 (UMLS CUI [1,4])
Code List
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
Pregnancy, Mother, Number of Previous Pregnancies
Item
Number of previous pregnancies (specify: Pre-term, Full-term, Normal births, Stillbirths, Children born with defects, Spontaneous abortions, Elective abortions, Other)
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0422807 (UMLS CUI [1,3])
Pregnancy, Mother, Congenital Abnormality, number of children
Item
Record details of children born with defects
text
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,3])
C2229974 (UMLS CUI [1,4])
Pregnancy, Mother, Risk factors, Pregnancy Outcome
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
boolean
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0032972 (UMLS CUI [1,4])
Pregnancy, Mother, Risk factors, Pregnancy Outcome
Item
ff Yes, specify
boolean
C0032961 (UMLS CUI [1,1])
C0026591 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C0032972 (UMLS CUI [1,4])
Pregnancy, Father, Medical History
Item
Father's Relevant Medical/Family History (Include habitual exposures such as alcohol/substance abuse, chronic illnesses, familial birth defects/genetic/ chromosomal disorders and medication use}
text
C0032961 (UMLS CUI [1,1])
C0015671 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Drug exposure during pregnancy, Medication name
Item
Drug Name
text
C0877161 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Drug exposure during pregnancy, Drug Administration Routes
Item
Route of Administration or Formulation
text
C0877161 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Drug exposure during pregnancy, Daily Dose, Total
Item
Total Daily Dose
text
C0877161 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Drug exposure during pregnancy, Unit of Measure
Item
Units
text
C0877161 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Drug exposure during pregnancy, Start Date, Before, Clinical Trial Period
Item
Started Pre-Study
boolean
C0877161 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Drug exposure during pregnancy, Start Date
Item
Start Date
date
C0877161 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Drug exposure during pregnancy, End Date
Item
Stop Date
date
C0877161 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Drug exposure during pregnancy, Continuous
Item
Ongoing Medication
boolean
C0877161 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Drug exposure during pregnancy, Indication
Item
Reason for Medication
text
C0877161 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pregnancy, Withdraw
Item
Was the subject withdrawn from the study as a result of this pregnancy?
boolean
C0032961 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Investigator Name
Item
Name
text
C2826892 (UMLS CUI [1])
Clinical Investigators, Title
Item
Title
text
C0008961 (UMLS CUI [1,1])
C3888414 (UMLS CUI [1,2])
Clinical Investigators, Medical Specialities
Item
Speciality
text
C0008961 (UMLS CUI [1,1])
C0037778 (UMLS CUI [1,2])
Clinical Investigators, Address
Item
Address
text
C0008961 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
Clinical Investigators, Cities, State/Province
Item
City or State/Province
text
C0008961 (UMLS CUI [1,1])
C0008848 (UMLS CUI [1,2])
C1547742 (UMLS CUI [1,3])
Clinical Investigators, Country
Item
Country
text
C0008961 (UMLS CUI [1,1])
C0454664 (UMLS CUI [1,2])
Clinical Investigators, Postal Code
Item
Post or Zip Code
text
C0008961 (UMLS CUI [1,1])
C1514254 (UMLS CUI [1,2])
Clinical Investigators, Telephone Number
Item
Telephone No
integer
C0008961 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Clinical Investigators, Fax Number
Item
Fax No
integer
C0008961 (UMLS CUI [1,1])
C1549619 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
nvestigator Name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])