Demography
Subject must discontinue study medication if pregnancy test is positive
integer
Race
text
Age
float
Date of birth
date
Weight
float
Weight units
text
Height
float
Height units
text
Medical History
Was the mother using a method of contraception?
boolean
If Yes, specify
text
select one
text
e.g., ultrasound, amniocentesis, chronic villi sampling, including dates of test and procedures
text
Known allergies
boolean
If Yes, specify
text
Alcohol intake
boolean
If Yes, specify
text
Other significant prior or co-existent medical conditions or history
boolean
If Yes, specify
text
Pregnancy Information
Start date of last menstrual period
date
Date of positive pregnancy test
date
Date of last negative pregnancy test
date
Was pregnancy terminated?
boolean
If Yes, date:
date
elective or spontaneous termination?
text
Date of expected delivery
date
If none, enter a zero
integer
if none, enter a zero
integer
Has subject experienced complications during this or previous pregnancies?
boolean
If Yes, specify below
text
Pregnancy Outcome Information
Subject ID Number
integer
Age
float
Date of Birth
date
Weight
float
Weight unit
text
Height
float
Height units
text
Child Information
Baby #
integer
Sex
text
Height
float
Height units
text
Weight
float
Weight units
text
Apgar score 1 min
integer
Apgar score 5 min
integer
Outcome of pregnancy
text
Comment
text
Date of abortion
date
Date of congenital abnormality identified/diagnosed
date
Pregnancy Outcome Details
Date of delivery
date
Length of gestation
float
select one
text
include live and stillbirth; if none enter a zero
integer
Reminder: If pregnancy outcome is serious (spontaneous abortion, congenital abnormality, stillbirth, prolonged hospitalization, etc.) please submit the SAE report.
text