Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Protocol Identifier
Item
Protocol Identifier
text
C4331034 (UMLS CUI [1])
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Who is pregnant? Subject or Subject's Partner?
text
C0032961 (UMLS CUI [1,1])
C1997894 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
Code List
Who is pregnant? Subject or Subject's Partner?
CL Item
Subject (Subject)
CL Item
Subject's Partner (Subject's Partner)
Mother's Date of Birth
Item
Mother's Date of Birth
date
C0026591 (UMLS CUI [1,1])
C0421451 (UMLS CUI [1,2])
Date of last menstrual period
Item
Date of last menstrual period
date
C0425932 (UMLS CUI [1])
Estimated date of delivery
Item
Estimated date of delivery
date
C1287845 (UMLS CUI [1])
Item
Was the mother using a method of contraception?
text
C0420837 (UMLS CUI [1])
Code List
Was the mother using a method of contraception?
Method of Contraception
Item
If Yes, specify
text
C0700589 (UMLS CUI [1])
Item
Type of Conception
text
C2598844 (UMLS CUI [1])
Code List
Type of Conception
CL Item
Normal (includes use of fertility drugs) (Normal (includes use of fertility drugs))
CL Item
IVF (in vitro fertilisation) (IVF (in vitro fertilisation))
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures (e.g., ultrasound, amniocentesis and chorionic villi sampling, including dates of tests and procedures).
text
C0022885 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0430022 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
Number of Previous Pre-term pregnancies
Item
Number of Previous Pre-term pregnancies
integer
C0422807 (UMLS CUI [1,1])
C1547235 (UMLS CUI [1,2])
Number of Previous Full-term pregnancies
Item
Number of Previous Full-term pregnancies
integer
C0422807 (UMLS CUI [1,1])
C3814420 (UMLS CUI [1,2])
Number of normal births
Item
Number of normal births
integer
C3665337 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Stillbirths
Item
Number of Stillbirths
integer
C0595939 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of children born with defects
Item
Number of children born with defects
integer
C0000768 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Details of birth defects in children
Item
Record details of children born with defects
text
C1522508 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Number of Spontaneous abortions
Item
Number of Spontaneous abortions
integer
C0000786 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of Elective Abortions
Item
Number of Elective Abortions
integer
C0269439 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of other pregnancies/births
Item
Number of other pregnancies/births
integer
C0422807 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Are there any additional factors that may have an impact on the outcome of this pregnancy?
text
C0035648 (UMLS CUI [1,1])
C0747843 (UMLS CUI [1,2])
Code List
Are there any additional factors that may have an impact on the outcome of this pregnancy?
additional risk factors for this pregnancy, specify
Item
If yes, specify
text
C0035648 (UMLS CUI [1,1])
C0747843 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Father's Relevant Medical/Family History
Item
Father's Relevant Medical/Family History
text
C0262926 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0015671 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route
Item
Route of Admin. or Formulation
text
C0013153 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Ongoing Medication
Item
Ongoing Medication
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study as a result of this pregnancy?
text
C0422727 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
Code List
Was the subject withdrawn from the study as a result of this pregnancy?
Name
Item
Name
text
C2826892 (UMLS CUI [1])
Title
Item
Title
text
C3888414 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Speciality
Item
Speciality
text
C0037778 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Address
Item
Address
text
C1442065 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
City
Item
City or State/Province
text
C0008848 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Zip Code
Item
Post or Zip Code
text
C0421454 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Telephone No
Item
Telephone No
integer
C1515258 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Fax No
Item
Fax No
integer
C1549619 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature confirming that the data on these pages are accurate and complete
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator’s name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])