CDE Detailed Report

Disease: Stroke
Subdomain Name: General Health History
CRF: Pregnancy and Perinatal History

Displaying 1 - 29 of 29
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C59019 Birth weight measurement BirthWeightMeasr Measurement in kilograms of the weight of a neonate at birth Measurement in kilograms of the weight of a neonate at birth Birth weight Numeric Values

Recorded value of participant's/subject's measured weight at birth. This element is intended for pediatric clinical studies. Record the birth weight of the participant/ subject in kilograms (Kg)

No references available Pediatric Supplemental-Highly Recommended 1.10 2022-08-01 10:17:22.0 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

0 9000 kilograms 3201400;2179689
C58820 Pregnancy or delivery risk factor status PregDeliveryRiskFactStat The status of the participant/subject when the specific risk factor was experienced either during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery The status of the participant/subject when the specific risk factor was experienced either during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after deliver If YES, specify Prenatal;Perinatal;Postnatal Prenatal;Perinatal;Postnatal Alphanumeric

No instructions available

No references available Pediatric Supplemental-Highly Recommended 1.00 2020-05-15 11:46:12.0 Pregnancy and Perinatal History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C58821 Pregnancy or delivery risk factor illness other text PregDeliveryRiskFactIllOthrTxt The free-text field related to 'Pregnancy or delivery risk factor type' specifying other illness text. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery The free-text field related to 'Pregnancy or delivery risk factor type' specifying other illness text. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), If YES, specify illness(es) Alphanumeric

No instructions available

No references available Pediatric Supplemental-Highly Recommended 1.00 2020-05-15 12:38:41.0 Pregnancy and Perinatal History General Health History Participant History and Family History 255

Free-Form Entry

C58823 Pregnancy or delivery risk factor fetal abnormal recognize in utero text PregDlvRskFactFetlAbnRcgUtrTxt The free-text field related to 'Pregnancy or delivery risk factor type' specifying the fetal abnormality(ies) recognized in utero. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery The free-text field related to 'Pregnancy or delivery risk factor type' specifying the fetal abnormality(ies) recognized in utero. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., d If YES, specify abnormality(ies) Alphanumeric

No instructions available

No references available Pediatric Supplemental-Highly Recommended 1.00 2020-05-15 12:45:28.0 Pregnancy and Perinatal History General Health History Participant History and Family History 255

Free-Form Entry

C58824 Pregnancy or delivery risk factor maternal infection text PregDelivrRiskFactMatInfectTxt The free-text field related to 'Pregnancy or delivery risk factor type' specifying maternal infection(s). Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery The free-text field related to 'Pregnancy or delivery risk factor type' specifying maternal infection(s). Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnan If YES, specify infections(s) Alphanumeric

No instructions available

No references available Pediatric Supplemental-Highly Recommended 1.00 2020-05-15 12:50:57.0 Pregnancy and Perinatal History General Health History Participant History and Family History 255

Free-Form Entry

C58825 Intracranial aneurysm rupture delivery status IARuptDeliveryStat The element related to the time when the rupture of the brain aneurysm occurred, either before, during or after delivery The element related to the time when the rupture of the brain aneurysm occurred, either before, during or after deliver Timing of intracranial aneurysm rupture during pregnancy After delivery;Before delivery;During delivery After delivery;Before delivery;During delivery Alphanumeric

No instructions available

No references available Pediatric Exploratory 1.00 2020-05-15 12:53:46.0 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00007 Birth date BirthDate Date (and time, if applicable and known) the participant was born Date (and time, if applicable and known) the participant was born Date of delivery Date or Date & Time

No instructions available

No references available Pediatric Core 3.1 10/16/2024 8:51:14 AM Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

793
C12604 APGAR one minute score APGAR1MinScore Score of a newborn recorded at one minute from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness Score of a newborn recorded at one minute from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsivenes APGAR 1 minute score 0;1;2;3;4;5;6;7;8;9;10 0;1;2;3;4;5;6;7;8;9;10 Numeric Values

Record the APGAR score (0 - 10 points, inclusive) assessed at 1 minute.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 11:38:01.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16055 Full term delivery child indicator FullTrmDelChldInd Indicates whether the participant's/subject's child was delivered full-term Indicates whether the participant's/subject's child was delivered full-term Was the child delivered full-term (>36 weeks)? Yes;No Yes;No Alphanumeric

No instructions available

No references available Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C11078 Delivery mode type DeliveryModeTyp Type of delivery mode of the neonate Type of delivery mode of the neonate Mode of delivery of the neonate Spontaneous;Induced, specify reason;Unknown Spontaneous;Induced, specify reason;Unknown Alphanumeric

Choose one.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00724 APGAR five minute score APGARFiveMinuteScore Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness Score of a newborn recorded at five minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsivenes APGAR 5 minute score 0;1;2;3;4;5;6;7;8;9;10 0;1;2;3;4;5;6;7;8;9;10 Numeric Values

Record the APGAR score (0 - 10 points, inclusive) assessed at 5 minutes

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2738533
C11079 Neonate delivery route type NeonateDelivRteTyp Route of delivery of the neonate Route of delivery of the neonate Route of delivery of the neonate Vaginal;Caesarean;Unknown Vaginal;Caesarean;Unknown Alphanumeric

Choose one.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performe Date family history taken Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 21:00:23.88 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

C11080 Delivery modality type DeliveryModltyTyp Type of modality of the participant/subject's intrauterine orientation at delivery Type of modality of the participant/subject's intrauterine orientation at delivery Delivery modality type of the neonate Breech;Cephalic;Unknown;Other Breech;Cephalic;Unknown;Other Alphanumeric

Choose one.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10556 Pregnant ever indicator PregEverInd Indicator as to whether or not the participant/subject has every been pregnant, both term and not to term Indicator as to whether or not the participant/subject has every been pregnant, both term and not to term Prior pregnancy Yes;No;Unknown Yes;No;Unknown Alphanumeric

No instructions available

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C11081 Delivery caesarean timing status DeliveryCaesareanTimingStatus Status of the caesarean delivery Status of the caesarean delivery If caesarean, timing of the caesarean Emergency;Elective;Unknown Emergency;Elective;Unknown Alphanumeric

Choose one. Element is only applicable if "Delivery route" is answered as "Caesarean".

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10558 Delivery or pregnancy termination last date and time DeliveryPregTerminLstDateTime Date (and time if applicable and known) the female participant/subject last delivered a pregnancy or the pregnancy terminated (e.g., miscarriage, abortion) Date (and time if applicable and known) the female participant/subject last delivered a pregnancy or the pregnancy terminated (e.g., miscarriage, abortion) Year of last delivery / miscarriage/ medical termination Date or Date & Time

Enter 4-digit year (YYYY) at a minimum. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-16 14:01:43.01 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

C11083 Delivery extraction type DeliveryExtractionTyp Type of extraction used to assist with the delivery of the participant/subject Type of extraction used to assist with the delivery of the participant/subject Instrument(s) used to assist with the delivery of the participant/subject None;Vacuum;Forceps;Vacuum and Forceps;Unknown None;Vacuum;Forceps;Vacuum and Forceps;Unknown Alphanumeric

Choose one.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10559 Spontaneous miscarriage count SpontaneousMiscarriageCt Value representing the number of times the participant/subject has had miscarriages or spontaneous abortions, including all trimesters Value representing the number of times the participant/subject has had miscarriages or spontaneous abortions, including all trimesters Number of miscarriages Numeric Values

Enter integer number of spontaneous abortions/ miscarriages.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-11 15:03:49.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

0 99
C14151 Pregnancy medical terminations count PregMedTerminationCt Number of medical terminations (abortions) Number of medical terminations (abortions) Number of medical terminations Numeric Values

Enter integer number of medical terminations/ abortions.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-06-21 00:00:00.0 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

0 99
C11062 Maternal delivery age value MatrnlDelvryAgeVal Mother's age at the time she gave birth to the participant/subject Mother's age at the time she gave birth to the participant/subject Mother'?s age at the time she gave birth to the participant/subject Numeric Values

Enter the mother's age in years. Record the value as an integer.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-24 21:00:23.88 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

0 99 year
C18819 Pregnancy or delivery risk factor other text PregnDeliveryRiskFactOTH The free-text field related to 'Pregnancy or delivery risk factor type' specifying other text. Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery The free-text field related to 'Pregnancy or delivery risk factor type' specifying other text. Type of risk factor that may have been experienced during the prenatal period, at the time of delivery, or soon after delivery Other, specify Alphanumeric

For each pregnancy condition record whether the mother experienced it using the element "Pregnancy or delivery risk factor indicator".

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History 4000

Free-Form Entry

C11063 Parity maternal value ParityMaternalVal Number of live born children the participant's/subject's mother has delivered Number of live born children the participant's/subject's mother has delivered Number of live born children the participant/subject'?s mother has delivered Numeric Values

Enter integer number of live births.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-10 11:37:29.993 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

0 99
C18829 Delivery mode induced other text DeliveryModeOTH The free-text field related to 'Delivery mode type' for induced delivery mode. Type of delivery mode of the neonate The free-text field related to 'Delivery mode type' for induced delivery mode. Type of delivery mode of the neonate Induced, specify reason Alphanumeric

Choose one.

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History 4000

Free-Form Entry

C11065 Gravida maternal value GravidaMaternalVal Total number of times the participant's/subject's mother has been pregnant, regardless of whether these pregnancies were carried to term Total number of times the participant's/subject's mother has been pregnant, regardless of whether these pregnancies were carried to term Number of prior pregnancies Numeric Values

Enter integer number of times woman has been pregnant.

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Free-Form Entry

1 99
C11066 Pregnancy or delivery risk factor type PregnDeliveryRiskFactTyp Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery Type of risk factor to the participant's/subject's health that may have been experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery Did the mother experience any of the following during the prenatal period, at the time of delivery, or soon after delivery with the participant/subject Preeclampsia;Other hypertensive disorder;Oligohydramnios;Gestational diabetes;Prolonged rupture of membranes during delivery;Chorioamnionitis;Other illness(es);Decreased fetal movement;Fever during delivery of participant/subject;Meconium staining of the amniotic fluid;Intravascular catheter placed in newborn period;Placenta sent for pathology;Placental abnormalities;Fetal heart rate abnormality;Other, specify;Fetal abnormalities recognized in utero;Maternal infection;Lack of prenatal care;Maternal drug abuse Preeclampsia;Other hypertensive disorder;Oligohydramnios;Gestational diabetes;Prolonged rupture of membranes during delivery;Chorioamnionitis;Other illness(es);Decreased fetal movement;Fever during delivery of participant/subject;Meconium staining of the amniotic fluid;Intravascular catheter placed in newborn period;Placenta sent for pathology;Placental abnormalities;Fetal heart rate abnormality;Other, specify;Fetal abnormalities recognized in utero;Maternal infection;Lack of prenatal care;Maternal drug abuse Alphanumeric

For each pregnancy condition record whether the mother experienced it using the element "Pregnancy or delivery risk factor indicator".

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C00001 Gestational age value GestatnlAgeVal Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject Time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subjec Gestational age at birth Numeric Values

Gestational age at birth should be recorded in weeks and can be obtained from family or medical record/ chart. This element should be collected along with the other elements of the Sophia Classification. Recommended for Neonates ONLY (i.e., not appropriate for Children).

Govaert P, Ramenghi L, Taal R, de Vries L, Deveber G. Diagnosis of perinatal stroke I: definitions, differential diagnosis and registration. Acta Paediatr. 2009;98(10):1556-1567. Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

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0 52 week 3192017
C11067 Pregnancy or delivery risk factor indicator PregDeliveryRiskFactInd Whether the specific risk factor to the participant's/subject's health was experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery Whether the specific risk factor to the participant's/subject's health was experienced during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery Did the mother experience any of the following during the prenatal period, at the time of delivery, or soon after delivery with the participant/subject Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for each condition (see "Pregnancy or delivery risk factor type" CDE).

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00723 APGAR ten minute score APGARTenMinuteScore Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsiveness Score of a newborn recorded at ten minutes from the time of birth and expressed as a number quantifying the overall physical condition, which includes heart rate, muscle tone, respiratory effort, color, and reflex responsivenes APGAR 10 minute score 0;1;2;3;4;5;6;7;8;9;10 0;1;2;3;4;5;6;7;8;9;10 Numeric Values

Record the APGAR score (0 - 10 points, inclusive) assessed at 10 minutes

No references available Pediatric Supplemental-Highly Recommended 3.00 2013-07-25 08:54:08.2 Pregnancy and Perinatal History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3181701
CSV