CDE Detailed Report
Disease: Spinal Muscular Atrophy
Subdomain Name: General Health History
CRF: Prenatal and Perinatal History - SMA
Displaying 1 - 24 of 24
Subdomain Name: General Health History
CRF: Prenatal and Perinatal History - SMA
Displaying 1 - 24 of 24
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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. 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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 |
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| 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 |
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| 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. 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 | |||||||
| 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/subjec | 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 |
