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If A9=0 no (mother does not have epilepsy)
fields A30, A31, A32 should be left empty

If A11=1 yes
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please enter same information also in A34

If A18 = 1 yes
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Add specifications in comments field A35
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If A24 =1 (one previous malformed child)
Add specifications in A25

Enter same information in A33 (choose 03 for female or 04 for male) and complete field A33bis

If A28 = 1 (induced abortion due to foetal malformations)
Add specifications in A29

Enter same information in A33 (choose 03 for female, 04 for male or 05 sibling if sex is unknown) and complete also A33bis


In A33 and A34 enter information related only to the baby’s close family (father, mother, brothers and sisters). Information related to grandparents, uncles, aunts, cousins etc. should be put only in comments field A35
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This field can be used for entering any additional information that you need to report
In case of termination of pregnancy

always enter the date in B4
NOTE: If the abortion date is unavailable but you are certain that abortion occurred before enrolment, enter 1 day before notification date (A05-1). If abortion occurred after enrolment, enter 1 day after notification date (A05+1). Otherwise, enter 0
Term date is calculated counting 40 weeks from the first day of last menstruation
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Pregnancy duration is calculated from the first day of last menstruation (A6) to the date of notification of the pregnancy (A5). This field is automatically entered by the software
If B15 =1 yes
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Add specifications in comments field B30

In case of other maternal diseases occurring in the 1st trimester, please specify in B16
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and enter drugs taken (if any) in B26 using their generic name
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NOTE: If therapy start date is unknown but you know for certain that your patient was on AED at conception, you should enter the date of the last menstrual period (same as field A6)
If A9=0 no (mother does not have epilepsy)
fields B27, B28, B29 should be left empty unless the patient has become epileptic

In case of termination of pregnancy

always enter the date in C4
NOTE: If the abortion date is unavailable but you are certain that termination of pregnancy occurred before enrolment, enter 1 day before notification date (A05-1). If abortion occurred after enrolment, enter 1 day after notification date (A05+1). Otherwise, enter 0
In case of other maternal diseases occurring in the 2nd trimester, please specify in C10
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and enter drugs taken (if any) in C17 using their generic name
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This field should be filled in only in case AED treatment has changed as compared to the 1st trimester (B21). Otherwise leave it empty. If any changes in dose or number of administrations have occurred, fill in C12 fully
If A9=0 no (mother is not epileptic)
fields C18, C19, C20 should be left empty unless the patient has become epileptic

If ultrasound was performed
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In C22 enter the date of the first ultrasound performed after week 10. Subsequent ultrasounds can be reported in comments field C30
If result was abnormal, enter details in C23. If normal, leave C23 blank
NOTE: if ultrasound date is unavailable but you know for certain that ultrasound was performed after the patient was enrolled, you should enter one day after the “date of first notification to the reporting physician” (field A5 + 1)
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Please provide a value in micrograms/ml.
If other units of measure are used, specify in comments fields C30
If no result is available, but test was carried out, specify whether result was normal or abnormal by choosing 1 or 2 respectively
If C29 = 1 yes
Add details in C30

In case of other maternal diseases occurring in the 3rd trimester, please specify in D5, and enter drugs taken (if any) in D12 using their generic name
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This field should be filled in only in case AED treatment has changed from the 2nd trimester (C12). Otherwise leave it empty. If any changes in dose or number of administrations have occurred, fill in D7 fully
If A9=0 no (mother is not epileptic)
fields D13, D14, D15, D22 should be left empty unless the patient has become epileptic

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If D16 = 1 yes
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Add details in comments field D33

If D28 = 1 yes
Enter date in D29 and details in D30

In case of malformation or chromosome abnormalities
Enter date at diagnosis and all the necessary specifications in D32

If D31 = 0 no, leave D32 blank
NOTE: specifications entered in D32 will be submitted to the Outcome Classification Commission. Please provide detailed information
If E4 =1 yes, specify cause in E5

If E4 =0 no, leave E5 blank
In case of malformation or chromosome abnormalities
Fill in also E7 and E8 in details

If E6 =0 no, leave E7 and E8 blank
If E9 = 1 yes, fill in also E10
