CDE Detailed Report

Disease: Headache
Sub-Domain: General Health History
CRF: Pregnancy Outcome

Displaying 1 - 38 of 38
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
C16060 Weight delivery mother unit of measure WgtDelMotherUoM Units for the measurement of the participant's/subject's weight at the time she gave birth Units for the measurement of the participant's/subject's weight at the time she gave birth Mother's weight at the time of birth: lb;kg Pounds;Kilograms Alphanumeric

Choose one unit

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

Single Pre-Defined Value Selected

C18000 Congenital anomalies child specification text CongAnmlChildSpecTxt Text specifying any congenital anomalies of the participant/subject Text specifying any congenital anomalies of the participant/subject If Yes, specify: Alphanumeric No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

C16046 Pregnancy labor delivery complication indicator PregLabDelCompInd Indicator of whether there were complications during labor/delivery Indicator of whether there were complications during labor/delivery Did the participant/subject experience any complications during labor/delivery? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If yes, explain the labor/delivery complication.

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

Single Pre-Defined Value Selected

C16062 Pregnancy fetal diagnostic test performed indicator PregFetDignstcTestPerfmInd Indicates whether there were any abnormal fetal diagnostic tests performed during the pregnancy Indicates whether there were any abnormal fetal diagnostic tests performed during the pregnancy Any abnormal fetal diagnostic tests performed during pregnacy? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

C18001 Newborn complication child specification text NewbrnCompChldSpecTxt Text specifying other newborn complications Text specifying other newborn complications If Yes, specify: Alphanumeric No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

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 performed. Date pregnancy outcome obtained: 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.).

ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm Adult;Pediatric Exploratory 3.00 2013-07-24 21:00:23.88 Pregnancy Outcome General Health History Participant History and Family History

Free-Form Entry

C16048 Tocolytic agents required during preterm labor indicator ToclytcAgntReqDrnPretermLabInd Indicator of whether medications used to suppress premature labor were required during preterm labor Indicator of whether medications used to suppress premature labor were required during preterm labor Did the participant/subject require tocolytic agents during preterm labor? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If yes, explain the agent(s) administered.

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

Single Pre-Defined Value Selected

C16063 Pregnancy fetal diagnostic test date PregFetDignstcTestDate Date the fetal diagnostic testing was performed during the pregnancy Date the fetal diagnostic testing was performed during the pregnancy Date(s) of testing 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.).

ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History

Free-Form Entry

C18002 Placenta umbilical cord abnormality specification text PlcntaUmblclCrdAbnrmlySpecTxt Text describing placenta or umbilical cord abnormalities Text describing placenta or umbilical cord abnormalities If Yes, specify: Alphanumeric No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

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) Outcome date 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.).

ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History

Free-Form Entry

C16049 Birth child date and time BrthChildDateTime Date of birth of participant/subject's most recent live birth Date of birth of participant/subject's most recent live birth Birth date: 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.).

ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html) Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History

Free-Form Entry

C16064 Pregnancy fetal diagnostic test result PregFetDignstcTestReslt Results of the fetal diagnostic testing performed during the pregnancy Results of the fetal diagnostic testing performed during the pregnancy Results of Fetal Diagnositc Testing Alphanumeric

Answer this question if abnormal fetal diagnostic tests performed

No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

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 Other, specify: Alphanumeric

Choose only one

No references available Adult;Pediatric Exploratory 3.00 2013-07-25 08:54:08.2 Pregnancy Outcome General Health History Participant History and Family History 4000

Free-Form Entry

C11078 Delivery mode type DeliveryModeTyp Type of delivery mode of the neonate Type of delivery mode of the neonate Delivery type? (Choose only one) Spontaneous;Induced, specify reason Spontaneous;Induced, specify reason Alphanumeric

Choose only one

No references available Adult;Pediatric Exploratory 3.00 2013-07-25 08:54:08.2 Pregnancy Outcome General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16050 Phenotypic sex child type PhenotypSexChildTyp Sex of the participant/subject's child based on physical examination Sex of the participant/subject's child based on physical examination Birth sex: Female;Male;Unknown Female;Male;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

C16065 Congenital anomaly child indicator CongAnmlChldInd Indicates whether there were congenital anomalies in the participant's/subject's child Indicates whether there were congenital anomalies in the participant's/subject's child Were there any congenital anomalies? Yes, specify;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If YES, explain the anomalies

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

Single Pre-Defined Value Selected

C55935 Weight birth child unit of measure WgtChildBirthUoM Measure of the weight of the participant/subject's child at birth Measure of the weight of the participant/subject's child at birth Birth weight: ounces;grams ounces;grams Alphanumeric

Record in g or oz

No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome 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 Delivery route? (Choose only one) Vaginal;Caesarean;Unknown Vaginal;Caesarean;Unknown Alphanumeric

Choose only one

No references available Adult;Pediatric Exploratory 3.00 2013-07-25 08:54:08.2 Pregnancy Outcome General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16051 Birth weight child value WgtChildVal Value of the weight of the participant/subject's child at birth Value of the weight of the participant/subject's child at birth Birth weight: Numeric Values

Record in g or oz

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

Free-Form Entry

C16067 Newborn complication child indicator NewbrnCompChldInd Indicates whether there were other newborn complications experienced by the participant's/subject's child Indicates whether there were other newborn complications experienced by the participant's/subject's child Were there other newborn complications? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If YES, explain the complications

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

Single Pre-Defined Value Selected

C55936 Length birth child unit of measure LngthChildBirthUoM Measure of the length of the participant/subject's child at birth Measure of the length of the participant/subject's child at birth Birth length: in;cm Inches;Centimeters Alphanumeric

Record in inches or centimeters

No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome 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 Breech;Cephalic;Unknown Breech;Cephalic;Unknown Alphanumeric

Choose one

No references available Adult;Pediatric Exploratory 3.00 2013-07-25 08:54:08.2 Pregnancy Outcome General Health History Participant History and Family History

Single Pre-Defined Value Selected

C16053 Birth length child value LngthChildVal Value of the length of the participant's/subject's child at birth Value of the length of the participant's/subject's child at birth Birth length: Numeric Values

Record in inches or centimeters

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

Free-Form Entry

C16069 Placenta umbilical cord abnormality indicator PlcntaUmblclCrdAbnrmlyInd Indicates whether the participant/subject experienced any abnormalities of placenta or umbilical cord Indicates whether the participant/subject experienced any abnormalities of placenta or umbilical cord Did the newborn experience any abnormalities of placenta or umbilical cord? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. If YES, explain the abnormalities

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

Single Pre-Defined Value Selected

C55937 Birth weight mother value WgtBrthMthrVal Value of the weight of the participant/subject at birth Value of the weight of the participant/subject at birth Mother's weight at the time of birth: Numeric Values

Choose one unit

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

Free-Form Entry

C11081 Delivery caesarean timing status DeliveryCaesareanTimingStatus Status of the caesarean delivery Status of the caesarean delivery Timing of cesarean Emergency;Elective Emergency;Elective Alphanumeric

Choose one. Answer only if Cesarean was the delivery route.

No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome 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 What the child delivered full-term? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one

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

Single Pre-Defined Value Selected

C16169 Pregnancy outcome type PregOutcmeTyp Type of outcome of the pregnancy experienced by the participant/subject Type of outcome of the pregnancy experienced by the participant/subject Pregnancy outcome Elective termination;Spontaneous abortion;Fetal death/stillbirth;Unknown;Therapeutic abortion or elective termination;Miscarriage;Still birth;Currently pregnant;Live birth Elective termination;Spontaneous abortion (< 20 weeks);Fetal death/stillbirth (> 20 weeks);Unknown;Therapeutic abortion or elective termination;Spontaneous abortion (<20 weeks);Fetal death/stillbirth (>20 weeks);Currently pregnant;Live birth Alphanumeric

Choose one. Answer for the female participant/subject only (not the partner). Only answered if No was answered for "Was the outcome of the participant's/subject's most recent pregnancy a live born infant?". Complete this question, outcome date, and was the fetus normal and then stop completing the form.

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

Single Pre-Defined Value Selected

C16037 Pregnancy most recent live born infant indicator PregMostRecntLveBornInfantInd Indicates whether the outcome of the participant/subject's most recent pregnancy was a live born infant? Indicates whether the outcome of the participant/subject's most recent pregnancy was a live born infant? Was the outcome of the participant/subject's most recent pregnancy a live born infant? Yes;No;Unknown Yes;No;Unknown Alphanumeric

If 'Yes' is answered, skip to question 3. If 'No' is answered, then complete questions 2a-1c only. If 'Unknown' answered, then Stop.

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

Single Pre-Defined Value Selected

C16056 Gestational age child value GestAgeChldVal Time elapsed between the first day of the last normal menstrual period and the day the participant/subject delivered the neonate Time elapsed between the first day of the last normal menstrual period and the day the participant/subject delivered the neonate Indicate gestational age GA (weeks): Numeric Values

Record the gestational age of the child in weeks

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

Free-Form Entry

week
C17997 Pregnancy fetus not normal description text PregFetusNotNormDescriptTxt Description of the abnormal pregnancy fetus Description of the abnormal pregnancy fetus No, describe Alphanumeric No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

C16040 Pregnancy fetus normal indicator PregFtusNormInd Indicates whether the fetus was normal Indicates whether the fetus was normal Was the fetus normal? Yes;No, describe;Unknown Yes;No, describe;Unknown Alphanumeric

Only answered if No was answered for "Was the outcome of the participant's/subject's most recent pregnancy a live born infant?", and only complete this question, outcome date, and pregnancy outcome, the end form.

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

Single Pre-Defined Value Selected

C16057 Activity pulse grimace appearance respiration five minute child score APGARFveMinChldScore Assessment of a newborn which is 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. This score describes the participant's/subject's child. Activity pulse grimace appearance respiration (APGAR) Assessment of a newborn which is 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. 5-minute APGAR score: Numeric Values

Record the score (0 - 10 points, inclusive)

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

Free-Form Entry

C17998 Pregnancy labor delivery complication specification text PregLabDelCompSpecTxt Text about the participant/subject's experience with any complications during labor/delivery Text about the participant/subject's experience with any complications during labor/delivery If Yes, specify: Alphanumeric No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

C16042 Delivery mode induced reason DeliveryModeInduceRsn Type of induced delivery that occurred during the live infant birth Type of induced delivery that occurred during the live infant birth Induced; specify reason: (Choose all that apply) Hemorrhage and placental complications;Hypertension, preeclampsia or eclampsia;Rupture of membranes-premature, prolonged;Maternal conditions complicating pregnancy/delivery;Fetal conditions complicating pregnancy/delivery;Malposition and malpresentation of fetus;Late pregnancy;Prior uterine surgery;Other, specify;Unknown Hemorrhage and placental complications;Hypertension, preeclampsia or eclampsia;Rupture of membranes-premature, prolonged;Maternal conditions complicating pregnancy/delivery;Fetal conditions complicating pregnancy/delivery;Malposition and malpresentation of fetus;Late pregnancy;Prior uterine surgery;Other, specify;Unknown Alphanumeric

Choose all that apply

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

Multiple Pre-Defined Values Selected

C16058 Activity pulse grimace appearance respiration ten minute child score APGARTenMinChldScore Assessment of a newborn which is 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. This score describes the participant's/subject's child. Activity pulse grimace appearance respiration (APGAR) Assessment of a newborn which is 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. 10-minute APGAR score: Numeric Values

Record the score (0 - 10 points, inclusive)

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

Free-Form Entry

C17999 Tocolytic agents required during preterm specification text ToclytcAgntReqDrnPretermLabTxt Text specifying the tocolytic agents the participant/subject required during preterm labor Text specifying the tocolytic agents the participant/subject required during preterm labor If Yes, specify: Alphanumeric No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

C16044 Delivery cesarean section reason DelCesSctnRsn Reason for the Cesarean section Reason for the Cesarean section Specify reason Alphanumeric

Answer only if Cesarean was the delivery route.

No references available Adult;Pediatric Exploratory 3.00 2013-07-16 14:01:43.01 Pregnancy Outcome General Health History Participant History and Family History 255

Free-Form Entry

CSV