RULES FOR CRFs COMPLETION

TRIMESTER RANGES

Pregnancy is divided into three trimester periods which information should be respectively reported in subform B (first trimester), subform C (second trimester) and subform D (third trimester).

The trimester ranges are provided on the top of each subform (B-C-D), and they are automatically calculated by the system, based on the last menstruation date that is entered in field A06.

Always remember that each subform should be filled in at the end of the trimester to which it refers, and kindly make sure that all information reported in specific subform (B, C or D) really belong to the ranges that appear on the top of that subform.

DATES FORMAT

Any date should be provided in the format: dd-mm-yyyy (with two digits for the day, two digits for the month and four digits for the year).  If the date is incomplete, use ‘xx’ to comply with the format (i.e. March 2005 should be reported as xx-­03-­2005).

DECIMAL NUMBERS

Numbers that should be expressed with decimal parts should always be entered using commas instead of the conventional dots.

Actually, the EURAP software does not recognize dots (.) but only commas (,), and therefore automatically remove dots when presents, resulting in false data (for example 47.7  becomes 477). Hence, to avoid this inconvenience, always remember to use commas “,“.

NOTE: this rule should be applied while completing fields C26, C28, D26, D27 and all therapy fields referring to AED total daily dose and largest single dose.

TWIN PREGNANCY

If  patient is pregnant with twins, you should create a record for each baby. In case of a triplet pregnancy, you should create three different records, one for each baby… etc.

Field A07 : REPORTING PHYSICIAN’S NAME

Field A07 should mention only the name of Reporting Physician, without the use of any title such as Pr., Dr., Mr.,….etc.

Field A09: PATIENT’S EPILEPSY

In field A09 it should be stated whether patient has epilepsy or not, regardless if she takes AEDs or not. Therefore, enter YES if patient has epilepsy. Otherwise, enter NO and fill in also field A10.

If A09 is 0= no (mother is not epileptic), fields A30, A31 and A32  should be left empty.

Note: if patient is not epileptic, all fields regarding seizures and status epilepticus in subforms B-C and D should be left empty.

Field A12: FAMILY NAME (FIRST 3 LETTERS)

Field A12 should always report only patient’s maiden name, regardless of her civil status.

Field A11: PROBAND’S FATHER EPILEPSY

If proband’s father is epileptic, the same information should be reported in field A34 by entering code “02=proband’s father”.

Field A18: IONISING RADIATION EXPOSURE

Ionising radiation in field A18 refers to any exposure that occurred during the three months before pregnancy; both therapeutic and professional exposure should be reported. If answer is YES, use the comment field to specify type of radiation, date of exposure, frequencies and the part of the body involved (note that MRI or RMN is not considered as ionising radiation exposure).

Fields from A19 to A29: PATIENT’S OBSTETRIC HISTORY

Patient’s obstetric history is basically retrieved from the number of patient’s previous deliveries (field A20) + the number of patient’s previous abortions (fields A26+A27+A28).

  • Field A19: number of current pregnancy (gravida).
    this field should report the number of patient’s current gravidity, (1st pregnancy, 2nd pregnancy, 3rd pregnancy…etc.), referring to the ongoing pregnancy.
  • Field A20: number of previous deliveries.
    this field should report the total number of patient’s previous deliveries, including previous stillbirths (A21), previous neonatal deaths (A22), previous not malformed offsprings (A23) and previous malformed offsprings (A24). Therefore, none of these fields can be left empty, since the number reported in field A20 should be the sum of numbers entered in A21+ A22+ A23+ A24. In case patient had one previous twin pregnancy, you will experience the only case when patient’s previous obstetric history presents some apparent inconsistencies, but it will be sufficient to specify in comments field A35 that patient had a previous twin pregnancy.
  • Field A21: number of previous stillbirths.
    this field should report the patient’s previous stillbirths, intended as those pregnancies that ended spontaneously after first trimester of pregnancy (intrauterine deaths).
  • Field A22: number of previous neonatal deaths.
    this field should report the patient’s previous neonatal deaths, intended as those pregnancies in which foetus or baby was born alive, but died after birth.
  • Field A23: number of previous not malformed offsprings.
    this field should report the patient’s previous deliveries of any not malformed child, including also any offspring with chromosomal abnormalities.
  • Field A24: number of previous malformed offsprings.
    this field should report the patient’s previous deliveries of any foetus or child born with a major congenital malformation, which should be further specified in field A25.
  • Field A26: number of previous spontaneous abortions.
    this field should report the patient’s previous spontaneous abortions, intended as those pregnancies losses that occured spontaneously within first trimester of pregnancy.
  • Field A27: number of previous induced abortions not due to foetal malformations.
    this field should report the patient’s previous induced abortions not due to foetal malformations, intended as those pregnancies interruptions that were induced either for maternal social reasons, for maternal medical reasons, for foetal chromosomal abnormalities, or for any other foetal reason not due to major malformations.
  • Field A28: number of previous induced abortions due to foetal malformations.
    this field should report the patient’s previous induced abortions due to foetal malformations, intended as those pregnancies interruptions that were due to major congenital malformations detected on foetus by any prenatal screening. The foetal malformation should be specified in field A29.

Field A33: FAMILY HISTORY OF CONGENITAL MALFORMATIONS

Field A33 refers only to proband’s father, proband’s mother and proband’s siblings. Other proband’s relatives with malformations should be only reported in comments A35 as additional information.

Moreover, please note that fields A33 should be filled in for each proband’s close relative involved, for instance if proband has two brothers with malformations, field A33 should be filled in twice, as in the example 04-04-00 here below.

Whereas, if proband’s father has a congenital malformation, field A33 will be 02-00-00 and field A35 should report the malformation.

Field A33bis:  AED TREATMENT DURING PATIENT’S PREVIOUS PREGNANCIES WITH MALFORMED OUTCOMES

Field A33bis should be filled in exclusively in case patient had some previous pregnancies with malformed outcomes. Otherwise field A33bis should be always left empty.

Therefore, since field A33bis should report information on AED TREATMENT of those previous pregnancies which offsprings (either aborted or delivered) presented some major congenital malformations, it clearly refers to patient’s previous offsprings reported in field A24 and/or in field A28. Therefore field A33bis should be left empty if A24=0 and A28=0.

 Moreover, field A33bis should be filled in only for the same number of previous malformed outcomes reported in field A33.

Field A34: FAMILY HISTORY OF EPILEPSY

Field A34 refers only to proband’s father, proband’s brothers and proband’s sisters. Other proband’s relatives with epilepsy should be only reported in comments A35 as additional information.

Field B06: POST MORTEM EXAMINATION

Field B06 should be filled in only in case an abortion occurs (either spontaneous or induced), thus it should be left empty when answers at fields B03 and B05 are both 0=NO.

Please note that field post-mortem examination is the same field in subform B (field B06) and in subform C (field C06), therefore the above rule is valid also for subform C.

Field B15: IONISING RADIATION EXPOSURE

Ionising radiation refers to any exposure that occurred during the 1st trimester of pregnancy; both therapeutic and professional exposure should be reported. If answer is YES, use the comment field to specify type of radiation, date of exposure, frequencies and the part of the body involved (note that MRI or RMN is not considered as ionising radiation exposure).

Field B18: FOLIC ACID STARTDATE

It was established that a correct consumption of folic acid would be those cases where patient started folic acid at least 3 months prior to conception, and for duration up to at least 3 months after conception. Therefore, it is important for us to know whether patient assumed folic acid at least 3 months prior to conception or not.

Field B19: FOLIC ACID END DATE

Field B19 should be filled in only in case folic acid intake was stopped during pregnancy. Otherwise it should be left empty.

Field C06: POST MORTEM EXAMINATION

Field C06 should be filled in only in case a stillbirth or an induced abortion occurs and it should be left empty if answers at fields C03 and C05 are both 0=NO.

Please note that field post-mortem examination is the same field in subform B (field B06) and in subform C (field C06), therefore the above rule is valid also for subform B.

Field C21, C22: MALFORMATION DIRECTED ULTRASOUND

Field C21 refers primarily to malformation directed ultrasound; however, if  patient has not performed one, field C21 can be entered with any other ultrasound performed during pregnancy. In such case, the most significant ultrasound must be reported, or, if normal, enter the first ultrasound.

Information about results of malformation directed ultrasound should be reported in field C21 by choosing the appropriate answer among those available when you click inside the field.

Of course, in case a malformation directed ultrasound was performed (regardless of its findings), you should always provide the date of ultrasound in field C22. Therefore field C22 should be always filled in except when answer in field C21 is 0=not performed or 8=not ascertained.

Moreover, in case you cannot obtain exact ultrasound date but you know approximately when it was performed, there is conventional rule that you can apply to provide an estimated date:

  • if ultrasound date is unavailable but you are certain that ultrasound was performed before enrolment, enter 1 day before notification date (field A05 – 1day).
  • If ultrasound was performed after enrolment, enter 1 day after notification date (field A05 + 1day).
  • Otherwise, enter 0.

 Field D28: PERINATAL DEATH OF PROBAND

Proband’s death or foetal death that occurs within the 28th week of pregnancy up to 7 days after delivery should be reported here.

If field D28 is “YES”, specify date of proband’s death in field D29 and the cause of proband’s death in field D30.

Field D31, D32: CONGENITAL MALFORMATIONS

Field D31 refers to proband’s anomalies diagnosed within the first week of life.

If field D31=yes (i.e answer to D31 is one among codes 1, 2 or 3), provide details of all proband’s congenital anomalies or malformations (including date at diagnosis) in field D32.

NOTE: Same malformation cannot be entered in both subforms D & E. In subform D should be entered only anomalies detected within the first week of life.

Field E04: DEATH DURING 1ST YEAR OF LIFE

Proband’s death that occurs after the 1st week of life should be reported here.

If field E04 is “YES”, specify the date and the cause of proband’s death in field E05

Field E06: CONGENITAL MALFORMATION DETECTED POSTNATALLY

This field refers to proband’s anomalies diagnosed after the first week of life.

If field E06=yes (i.e answer to E06 is one among codes 1, 2 or 3), provide details of all proband’s congenital anomalies or malformations in field E07 and baby’s age in moths at time of detection in field E08.

NOTE: Same malformation cannot be entered in both subforms D & E. In subform E should be entered only anomalies detected after the first week of life.

Field E09, E10: HOSPITAL AMMISSION DURING 1ST YEAR OF LIFE

Field E09 and E10 should exclusively report those baby’s hospitalizations that have occurred  after the neonatal period ( 1st week of life). Otherwise hospitalizations referring to 1st week of life should be reported only in subform D.

If field E09=yes, specify the number of hospitalizations and also the reasons in field E10.

 

 

AED THERAPY DURING PREGNANCY (Fields from B21 to B25bis, from C12 to C16bis, from D07 to D11bis)

AED therapy during pregnancy is one of the main endpoint of the EURAP study so, you should always provide complete information and add more details as possible according to the following rules:

  • The same AED cannot be entered twice, in different fields. Actually, the AED fields should be intended as “rows”, and once an AED is entered in a “row”, the same “row” should be kept exclusively for such AED, in all the other sub-forms of the record.
  • The AED fields (B21-B25, C12-C16, D07-D11) should always report the situation at the beginning of the corresponding trimester, regardless of changes that occurred later during that specific trimester. Total daily dose, largest single dose and number of administrations should be indeed entered, as they were on the first day of the trimester in question (always use commas instead of the conventional dots to report an AED dose with decimal parts).
  • Changes of AED doses during the trimester should be reported either in fields B25bis, C16bis, D11bis (according to the trimester that you are reporting), and if available, further details about the AED scheme may be specified in the comment field (B30, C30 or D33).
  • When an AED is interrupted during a trimester and do not re-start during that same trimester, you should provide AED end date in the appropriate field (thus enter YES in either B25bis or C16bis or D11bis, depending on the trimester).
  • When an AED is interrupted during a trimester and re-started within that same trimester, you should not enter the AED end date, since it should be registered just as a change of dose during the trimester (thus enter YES in either B25bis or C16bis or D11bis, depending on the trimester).
  • When an AED starts during a trimester, all data should be provided, regardless if the AED started at the very beginning of the trimester or not. Hence, in this case you should enter AED generic name (choose a code among the list), AED total daily dose, AED largest single dose, AED N° of administrations and AED start date).

Please find here below detailed rules on how AED therapy fields should be completed for each trimester.

FIRST TRIMESTER (see trimester ranges on the top of SUBFORM B)

  1. For each AED, you should provide AED generic name, total daily dose, largest single dose and number of administrations that patient was taking at the beginning of 1st trimester of pregnancy (namely, at conception).
  2. For each AED, you should provide AED start date, which refers to the date when patient started to take such AED in her life. In most cases, AED start date precedes the first day of last menstruation.
  3. AED end date should be filled in only in case patient really stopped that AED during 1st trimester and did not restart it within the same 1st Consequently, AED end date should be left empty if AED was stopped and restarted during 1st trimester, or if AED did not stopped at all during the 1st trimester.
  4. Answer to field B25bis should be NO if AED therapy was kept unchanged for the whole trimester; otherwise you should put YES if any AED dose changed during 1st trimester of pregnancy, or if an AED started or was interrupted during 1st trimester.

SECOND TRIMESTER (see trimester ranges on the top of SUBFORM C)

  1. For each AED that is still in use during 2nd trimester, you should provide AED generic name, total daily dose and number of administrations that patient was taking at the beginning of 2nd trimester of pregnancy.
  2. AED start date should be left empty, unless patient started the AED during 2nd trimester for the first time, or when the AED was discontinued during 1st trimester and then restarted during the 2nd trimester of pregnancy.
  3. AED end date should be left empty, unless patient really stopped that AED during 2nd trimester and did not restart it within the same 2nd trimester.
  4. Answer to field C16bis should be NO if AED therapy was kept unchanged for the whole trimester; otherwise you should put YES if any AED dose changed during 2nd trimester of pregnancy, or if an AED started or was interrupted during 2nd trimester.

THIRD TRIMESTER (see trimester ranges on the top of SUBFORM D)

  1. For each AED that is still in use during 3rd trimester, you should provide AED generic name, total daily dose and number of administrations that patient was taking at the beginning of 3rd trimester of pregnancy.
  2. AED start date should be left empty, unless patient started the AED during 3rd trimester for the first time, or when the AED was discontinued in a previous trimester and then restarted during the 3rd trimester of pregnancy.
  3. AED end date should be left empty, unless patient really stopped that AED during 3rd trimester and did not restart it within the same 3rd trimester.
  4. Answer to field D11bis should be NO if AED therapy was kept unchanged for the whole trimester; otherwise you should put YES if any AED dose changed during 3rd trimester of pregnancy, or if an AED started or was interrupted during 3rd trimester.

Examples of AED therapy fields completion