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Pregnancy form
Clinical trial report
Trial number
Case number
Spontaneous report
Product name
1. Event
Pregnancy
Partner pregnancy
2. Patient
Patient initials
Patient date of birth
Patient age
Case report form number(CRF)
Last menstrual period date
Expected delivery date
3. Family history of pregnancies
Year
Has the patient any history of previous pregnancies?
Yes
No
Number of live births
Number of multiple births?
Number of still births? (>22 wks)
Number of premature births? (<36 wks)
Number of spontaneous abortions
Number of therapeutic abortions
Number of congenital abnormalities
Is this pregnancy as a result of infertility treatment?
Yes
No
Is the plan to continue with this pregnancy?
Yes
No
Unknown
If NO or UNKNOWN current plan for this pregnancy?
Are there any risks associated with this pregnancy?
Yes
No
If yes what are the risks?
Smoking
Alcohol
Metabolic disorders
Other (please specify below)
Besides from the pregnancy, has any adverse event been reported for this patient?
Yes
No
If yes, was it a serious adverse event?
Yes
No
If yes, please specify
4. Medications
A. At the time of pregnancy
Product name
Dose
Route
Indication
Start date
Stop date
B. At the time of conception (concurrent medications)
Product name
Dose
Route
Indication
Start date
Stop date
5. Medical history
A. Disease(s)
Start date
Stop date
B. Maternal complications experienced during previous pregnancies
Start date
Stop date
6. Reporter
Name of reporter
Address of reporter
Contact telephone number
Contact email address
Date of report
7. For clinical trials
Name of principal investigator
Centre number
Submit