CDE Detailed Report

Disease: Spinal Muscular Atrophy
Sub-Domain: General Health History
CRF: Prenatal and Perinatal History - SMA

Displaying 1 - 24 of 24
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C12616 Pregnant prior history miscarry count PregPriorHistMiscarryCt Count of prior miscarriages (spontaneous abortions) that the participant/subject's mother has had Count of prior miscarriages (spontaneous abortions) that the participant/subject's mother has had Number of miscarriages Numeric Values

Record as an integer the number of spontaneous abortions/miscarriages. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

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

Free-Form Entry

0 30
C21620 Gestational age value range GestatnlAgeValRange Range of time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. Range of time elapsed in weeks between the first day of the last normal menstrual period and the day of delivery of the participant/subject. Gestational age (GA) <35 weeks;35-37 weeks;38-41 weeks;>41 weeks <35 weeks;35-37 weeks;38-41 weeks;>41 weeks Alphanumeric

Record the gestation age in weeks and days. This is a pediatric-specific element.

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

Single Pre-Defined Value Selected

3192017
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

Record as an integer the number of times the participant/subject (female) has been pregnant. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

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

Free-Form Entry

1 99
C12617 Pregnant prior history medical terminate count PregPriorHistMedTrmnatCt Count of prior medical terminations (abortions) that the participant/subject's mother has had Count of prior medical terminations (abortions) that the participant/subject's mother has had Number of medical terminations of prior pregnancy Numeric Values

Record as an integer the number of medical terminations/abortions. History can be obtained from participant/ subject, family member, friend, or chart/ medical record

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

Free-Form Entry

0 30
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 Was there a history of any of the following during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery? Oligohydramnios;Polydramnios;Decreased fetal movement;Absence of fetal movement;Second stage of labor more than two hours;Intervention(s) for neonate breathing problems during labor or while giving birth;Any interventions for breathing problems at birth;Any oxygen during neonatal period;Hypotonia (floppiness) Oligohydramnios;Polydramnios;Decreased fetal movement;Absence of fetal movement;Second stage of labor more than two hours;Intervention(s) for neonate breathing problems during labor or while giving birth;Any interventions for breathing problems at birth;Any oxygen during neonatal period;Hypotonia (floppiness) Alphanumeric

For each pregnancy condition record whether the mother experienced it using the element "Pregnancy condition maternal indicator".

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

Multiple Pre-Defined Values Selected

C12625 Respiratory intervention neonatal problem type RespIntervntnNeonatlProbTyp Type of intervention for breathing problems at or soon after the participant/subject's delivery Type of intervention for breathing problems at or soon after the participant/subject's delivery If yes, type Oxygen by nose or mask;Nasal CPAP;Intubation/Ventilation (tube down to lungs/on ventilator);Other, specify Oxygen by nose or mask;Nasal CPAP;Intubation/Ventilation (tube down to lungs/on ventilator);Other, specify Alphanumeric

Choose all that apply

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

Multiple Pre-Defined Values Selected

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 Was there a history of any of the following during the prenatal period (i.e., during time mother pregnant), at the time of delivery, or soon after delivery? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for each pregnancy or delivery risk factor

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

Single Pre-Defined Value Selected

C12627 Respiratory intervention neonatal oxygen required indicator RespIntervntnNeonatlO2ReqInd Whether oxygen was needed during the neonatal period (i.e., first 28 days of life) Whether oxygen was needed during the neonatal period (i.e., first 28 days of life) NULL Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

No references available Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Prenatal and Perinatal History - SMA 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;Induced, specify reason;Unknown Spontaneous;Induced;Induced, specify reason;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

C12628 Neonatal intensive care unit stay indicator NICUStayInd Indicator whether the participant/subject had to stay in the neonatal intensive care unit (NICU) Indicator whether the participant/subject had to stay in the neonatal intensive care unit (NICU) Any neonatal intensive care unit (NICU) stay Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

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 Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Prenatal and Perinatal History - SMA General Health History Participant History and Family History

Single Pre-Defined Value Selected

C12629 Neonatal intensive care unit stay duration NICUStayDur Duration of the participant/subject's stay in the neonatal intensive care unit (NICU) Duration of the participant/subject's stay in the neonatal intensive care unit (NICU) If Yes, length of NICU stay? <=48 hours;>48 hours and <1 week;>=1 week <=48 hours;>48 hours and <1 week;>=1 week Alphanumeric

Only answered if Yes is answered for "Any NICU stay?"

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

Single Pre-Defined Value Selected

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 Breech;Cephalic;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

C12631 Deliver condition hypotonia grade DelivrConditnHypotoniaGrade Grade of any hypotonia (floppiness) that was present at or soon after the participant/subject's delivery Grade of any hypotonia (floppiness) that was present at or soon after the participant/subject's delivery If Yes, hypotonia is Mild;Moderate;Severe;Unknown Mild;Moderate;Severe;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

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 3.00 2013-07-25 08:54:08.2 Prenatal and Perinatal History - SMA General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17983 Caesarean delivery timing type CaesarDelivTimingTyp Type of timing conditions under which Caesarean delivery was decided upon Type of timing conditions under which Caesarean delivery was decided upon If yes, timing of the Caesarean Emergency;Elective Emergency;Elective Alphanumeric No references available Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Prenatal and Perinatal History - SMA General Health History Participant History and Family History

Single Pre-Defined Value Selected

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 responsiveness. 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. This is a pediatric-specific element.

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

Single Pre-Defined Value Selected

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 condition maternal indicator".

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

Free-Form Entry

C12614 Pregnant more than once maternal indicator PregPriorHistInd Indicator of whether the mother of the participant/subject has a history of other pregnancies (both term and not to term) besides the pregnancy with the participant/subject Indicator of whether the mother of the participant/subject has been pregnant before Mother's pregnancy history: prior pregnancy (both term and not to term) ? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Yes = History reported and/or confirmed in medical record; No = History reported as negative and/or confirmed as negative in medical record; Unknown = History reported as unknown or medical record unclear about history If No or Unknown, go to Pregnancy or delivery risk factor type

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

Single Pre-Defined Value Selected

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 Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Prenatal and Perinatal History - SMA General Health History Participant History and Family History 4000

Free-Form Entry

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 responsiveness. 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

Only collected if needed. Record the APGAR score (0 - 10 points, inclusive) assessed at 10 minutes. This is a pediatric-specific element.

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

Single Pre-Defined Value Selected

3181701
C12615 Delivery or pregnancy termination maternal last date and time PregDelvMscryTrmnLstYrDateTime Date and time (if applicable and known) of the participant's/subject's mother's last delivery, miscarriage or medical termination Year in which the participant/subject's mother's most recent prior pregnancy ended whether delivered miscarried or medically terminated Year of last delivery/miscarriage/medical termination 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 Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Prenatal and Perinatal History - SMA General Health History Participant History and Family History

Free-Form Entry

C18864 Respiratory intervention neonatal problem other text RespIntervntnNeonatlProbOTH The free-text field related to 'Respiratory intervention neonatal problem type' specifying other text. Type of intervention for breathing problems at or soon after the participant/subject's delivery The free-text field related to 'Respiratory intervention neonatal problem type' specifying other text. Type of intervention for breathing problems at or soon after the participant/subject's delivery Other, specify Alphanumeric

Choose all that apply

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

Free-Form Entry

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 responsiveness. 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. This is a pediatric-specific element.

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

Single Pre-Defined Value Selected

2738533
CSV