A C129604 GAIA Level 3a Postnatally Diagnosed Congenital Microcephaly GAIA Level 3a Postnatally Diagnosed Congenital Microcephaly is defined by three criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24 weeks gestational age; second, a head circumference measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to gestational age and gender using appropriate standardized reference charts for the population (e.g., WHO growth reference charts if gestational age is greater than or equal to 37 weeks and Intergrowth-21st reference charts for gestation at ages of 24-36 weeks); third, measured up to 6 weeks after birth or end of pregnancy with no apparent post-natal insult resulting in microcephaly. Level 3a Postnatally Diagnosed Congenital Microcephaly Level 3a Postnatally Diagnosed Congenital Microcephaly is defined by three criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24 weeks gestational age; second, a head circumference measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to gestational age and gender using appropriate standardized reference charts for the population (e.g., WHO growth reference charts if gestational age is greater than or equal to 37 weeks and Intergrowth-21st reference charts for gestation at ages of 24-36 weeks); third, measured up to 6 weeks after birth or end of pregnancy with no apparent post-natal insult resulting in microcephaly. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology A C129605 GAIA Level 3a Prenatally Diagnosed Congenital Microcephaly GAIA Level 3a Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain LMP with confirmatory 1st or 2nd trimester ultrasound scan, intrauterine insemination (IUI) or embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks) with femur length and abdominal circumference concordant with GA assessment; third, no additional data to confirm microcephaly (i.e., no additional prenatal US scan or confirmation of microcephaly by HC measurement at either birth or autopsy). Level 3a Prenatally Diagnosed Congenital Microcephaly Level 3a Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain LMP with confirmatory 1st or 2nd trimester ultrasound scan, intrauterine insemination (IUI) or embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks) with femur length and abdominal circumference concordant with GA assessment; third, no additional data to confirm microcephaly (i.e., no additional prenatal US scan or confirmation of microcephaly by HC measurement at either birth or autopsy). C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology A C129606 GAIA Level 5 Small for Gestational Age GAIA Level 5 Small for Gestational Age is defined by either no evidence of Small for Gestational Age (SGA) or a confirmed diagnosis other than SGA. Level 5 Small for Gestational Age Level 5 Small for Gestational Age is defined by either no evidence of Small for Gestational Age (SGA) or a confirmed diagnosis other than SGA. C128703 GAIA Small for Gestational Age Level of Diagnostic Certainty Terminology C C128729 GAIA Level 1 Neonatal Encephalopathy GAIA Level 1 Neonatal Encephalopathy is defined by four criteria: first, a newborn aged 1-28 days, and born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or the presence of seizures; third, difficulty with initiating and maintaining respiration; fourth, depression of muscle tone. Level 1 Neonatal Encephalopathy Level 1 Neonatal Encephalopathy is defined by four criteria: first, a newborn aged 1-28 days, and born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or the presence of seizures; third, difficulty with initiating and maintaining respiration; fourth, depression of muscle tone. C128699 GAIA Neonatal Encephalopathy Level of Diagnostic Certainty Terminology C C128730 GAIA Level 2 Neonatal Encephalopathy GAIA Level 2 Neonatal Encephalopathy is defined by three criteria: first, a newborn aged 1-28 days, and born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or the presence of seizures; third, either difficulty with initiating and maintaining respiration OR depression of muscle tone. Level 2 Neonatal Encephalopathy Level 2 Neonatal Encephalopathy is defined by three criteria: first, a newborn aged 1-28 days, and born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or the presence of seizures; third, either difficulty with initiating and maintaining respiration OR depression of muscle tone. C128699 GAIA Neonatal Encephalopathy Level of Diagnostic Certainty Terminology C C128731 GAIA Level 3 Neonatal Encephalopathy GAIA Level 3 Neonatal Encephalopathy is defined by two criteria: first, a newborn aged 1-28 days, and born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or the presence of seizures without difficulty initiating or maintaining respiration nor depression of muscle tone. Level 3 Neonatal Encephalopathy Level 3 Neonatal Encephalopathy is defined by two criteria: first, a newborn aged 1-28 days, and born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or the presence of seizures without difficulty initiating or maintaining respiration nor depression of muscle tone. C128699 GAIA Neonatal Encephalopathy Level of Diagnostic Certainty Terminology C C128014 GAIA Level 2a Assessment of Gestational Age GAIA Level 2a Assessment of Gestational Age is defined by the presence of at least one of the following criteria: a) Certain last menstrual period (LMP) date with second trimester scan (14 0/7 weeks to 27 6/7 weeks), (If LMP and ultrasound (U/S) do not correlate, default to U/S GA assessment); OR b) Certain LMP date with first trimester physical examination. Level 2a Assessment of Prematurity and Gestational Age Level 2a Assessment of Gestational Age is defined by the presence of at least one of the following criteria: a) Certain last menstrual period (LMP) date with second trimester scan (14 0/7 weeks to 27 6/7 weeks), (If LMP and ultrasound (U/S) do not correlate, default to U/S GA assessment); OR b) Certain LMP date with first trimester physical examination. C126855 GAIA Preterm Birth Level of Diagnostic Certainty Terminology C C128015 GAIA Level 2b Assessment of Gestational Age GAIA Level 2b Assessment of Gestational Age is defined by the following criteria: uncertain last menstrual period (LMP) date with second trimester scan (14 0/7 weeks to 27 6/7 weeks). Level 2b Assessment of Prematurity and Gestational Age Level 2b Assessment of Gestational Age is defined by the following criteria: uncertain last menstrual period (LMP) date with second trimester scan (14 0/7 weeks to 27 6/7 weeks). C126855 GAIA Preterm Birth Level of Diagnostic Certainty Terminology C C128016 GAIA Level 3a Assessment of Gestational Age GAIA Level 3a Assessment of Gestational Age is defined by the presence at least one of the following criteria: a) Certain last menstrual period (LMP) date with third trimester scan (28 0/7 weeks or more); OR b) Certain LMP date with confirmatory second trimester fundal height (FH); OR c) Certain LMP date with birth weight; OR d) Uncertain LMP date with first trimester physical examination. Level 3a Assessment of Prematurity and Gestational Age Level 3a Assessment of Gestational Age is defined by the presence at least one of the following criteria: a) Certain last menstrual period (LMP) date with third trimester scan (28 0/7 weeks or more); OR b) Certain LMP date with confirmatory second trimester fundal height (FH); OR c) Certain LMP date with birth weight; OR d) Uncertain LMP date with first trimester physical examination. C126855 GAIA Preterm Birth Level of Diagnostic Certainty Terminology C C128017 GAIA Level 3b Assessment of Gestational Age GAIA Level 3b Assessment of Gestational Age is defined by the presence of at least one of the following criteria: a) Uncertain last menstrual period (LMP) date with fundal height (FH); OR b) Uncertain LMP date with newborn physical assessment; OR c) Uncertain LMP date with birth weight. Level 3b Assessment of Prematurity and Gestational Age Level 3b Assessment of Gestational Age is defined by the presence of at least one of the following criteria: a) Uncertain last menstrual period (LMP) date with fundal height (FH); OR b) Uncertain LMP date with newborn physical assessment; OR c) Uncertain LMP date with birth weight. C126855 GAIA Preterm Birth Level of Diagnostic Certainty Terminology C C128758 GAIA Level 2a Postnatally Diagnosed Congenital Microcephaly GAIA Level 2a Postnatally Diagnosed Congenital Microcephaly is defined by three criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24 weeks gestational age (GA) based on certain last menstrual period (LMP) date with confirmatory 1st trimester or 2nd trimester ultrasound (US) scan OR intrauterine insemination (IUI) or embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile as assessed by GA and gender, using appropriate, standardized reference charts for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, one of the following requirements is met: a) the measurement is taken within the first 24 hours after birth; OR b) the measurement is taken greater than 36 hours and up to 6 weeks after birth or the end of the pregnancy with no apparent post-natal insult resulting in microcephaly. Level 2a Postnatally Diagnosed Congenital Microcephaly Level 2a Postnatally Diagnosed Congenital Microcephaly is defined by three criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24 weeks gestational age (GA) based on certain last menstrual period (LMP) date with confirmatory 1st trimester or 2nd trimester ultrasound (US) scan OR intrauterine insemination (IUI) or embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile as assessed by GA and gender, using appropriate, standardized reference charts for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, one of the following requirements is met: a) the measurement is taken within the first 24 hours after birth; OR b) the measurement is taken greater than 36 hours and up to 6 weeks after birth or the end of the pregnancy with no apparent post-natal insult resulting in microcephaly. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128759 GAIA Level 2b Postnatally Diagnosed Congenital Microcephaly GAIA Level 2b Postnatally Diagnosed Congenital Microcephaly is defined by three criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24 weeks of gestational age (GA), as assessed by uncertain last menstrual period (LMP) date with 2nd trimester ultrasound (US) scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile as assessed by GA and gender, using appropriate, standardized reference charts for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, one of the following requirements is met: a) the measurement is taken within the first 24 hours after birth or at the end of the pregnancy; OR b) the measurement is taken greater than 36 hours and up to 6 weeks after birth or the end of the pregnancy with no apparent post-natal insult resulting in microcephaly. Level 2b Postnatally Diagnosed Congenital Microcephaly Level 2b Postnatally Diagnosed Congenital Microcephaly is defined by three criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24 weeks of gestational age (GA), as assessed by uncertain last menstrual period (LMP) date with 2nd trimester ultrasound (US) scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile as assessed by GA and gender, using appropriate, standardized reference charts for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, one of the following requirements is met: a) the measurement is taken within the first 24 hours after birth or at the end of the pregnancy; OR b) the measurement is taken greater than 36 hours and up to 6 weeks after birth or the end of the pregnancy with no apparent post-natal insult resulting in microcephaly. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128760 GAIA Level 3b Postnatally Diagnosed Congenital Microcephaly GAIA Level 3b Postnatally Diagnosed Congenital Microcephaly is defined by two criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion; second, the case meets the criteria for microcephaly using the following validated algorithm: one inpatient diagnosis; OR two outpatient diagnoses; OR one outpatient diagnosis AND death in first year using the following diagnostic codes: ICD-9-CM code 742.1 or ICD-10-CM code Q02. Level 3b Postnatally Diagnosed Congenital Microcephaly Level 3b Postnatally Diagnosed Congenital Microcephaly is defined by two criteria: first, a live birth, stillbirth, or spontaneous or therapeutic abortion; second, the case meets the criteria for microcephaly using the following validated algorithm: one inpatient diagnosis; OR two outpatient diagnoses; OR one outpatient diagnosis AND death in first year using the following diagnostic codes: ICD-9-CM code 742.1 or ICD-10-CM code Q02. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128765 GAIA Level 3b Prenatally Diagnosed Congenital Microcephaly GAIA Level 3b Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain or uncertain LMP with fundal height and no confirmatory 1st or 2nd trimester ultrasound scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks) with femur length and abdominal circumference concordant with GA assessment; third, no confirmation of microcephaly with any additional prenatal US or by HC measurement at either birth or autopsy. Level 3b Prenatally Diagnosed Congenital Microcephaly Level 3b Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain or uncertain LMP with fundal height and no confirmatory 1st or 2nd trimester ultrasound scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks) with femur length and abdominal circumference concordant with GA assessment; third, no confirmation of microcephaly with any additional prenatal US or by HC measurement at either birth or autopsy. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C127992 GAIA Level 2 Neonatal Respiratory Tract Infection GAIA Level 2 Neonatal Respiratory Tract Infection is defined by two criteria: first, new or progressive or persistent infiltrate or shadowing or fluid in the intrapleural cavity or interlobar fissure on chest X-ray; second, four or more of the following requirements must be met: a) Temperature greater than or equal to 37.5 degrees C or less than 35.5 degrees C; b) Tachypnea or nasal flaring or chest indrawing or grunting; c) Desaturations or increased oxygen requirements or increased ventilator requirements or oxygen saturation less than 95%; d) Apnea; e) Increased respiratory secretions or increased suctioning requirements; f) Cough, wheeze, or crepitations; g) Increased CRP or procalcitonin. Level 2 Neonatal Respiratory Tract Infection Level 2 Neonatal Respiratory Tract Infection is defined by two criteria: first, new or progressive or persistent infiltrate or shadowing or fluid in the intrapleural cavity or interlobar fissure on chest X-ray; second, four or more of the following requirements must be met: a) Temperature greater than or equal to 37.5 degrees C or less than 35.5 degrees C; b) Tachypnea or nasal flaring or chest indrawing or grunting; c) Desaturations or increased oxygen requirements or increased ventilator requirements or oxygen saturation less than 95%; d) Apnea; e) Increased respiratory secretions or increased suctioning requirements; f) Cough, wheeze, or crepitations; g) Increased CRP or procalcitonin. C126854 GAIA Neonatal Infections Level of Diagnostic Certainty Terminology C C128710 GAIA Level 1 Ectopic Pregnancy GAIA Level 1 Ectopic Pregnancy is defined by either of the following two criteria: first, the following three requirements must be met: a) Gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm; b) B-HCG serum blood test greater than 2000 mIU/ml; c) Transvaginal ultrasound showing no intrauterine pregnancy; OR second, the following two criteria must be met: a) Gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm; b) Transvaginal ultrasound showing extrauterine pregnancy OR no products of conception found on endometrial curettage after dilation and curettage procedure. Level 1 Ectopic Pregnancy Level 1 Ectopic Pregnancy is defined by either of the following two criteria: first, the following three requirements must be met: a) Gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm; b) B-HCG serum blood test greater than 2000 mIU/ml; c) Transvaginal ultrasound showing no intrauterine pregnancy; OR second, the following two criteria must be met: a) Gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm; b) Transvaginal ultrasound showing extrauterine pregnancy OR no products of conception found on endometrial curettage after dilation and curettage procedure. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128711 GAIA Level 2 Ectopic Pregnancy GAIA Level 2 Ectopic Pregnancy is defined by three criteria: first, it does not qualify as a Level 1 Ectopic Pregnancy; second, gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm); third, at least one of the following two requirements must be met: a) Transvaginal ultrasound showing no intrauterine pregnancy; OR b) No products of conception found on endometrial curettage after dilation and curettage procedure. Level 2 Ectopic Pregnancy Level 2 Ectopic Pregnancy is defined by three criteria: first, it does not qualify as a Level 1 Ectopic Pregnancy; second, gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm); third, at least one of the following two requirements must be met: a) Transvaginal ultrasound showing no intrauterine pregnancy; OR b) No products of conception found on endometrial curettage after dilation and currettage procedure. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128712 GAIA Level 3 Ectopic Pregnancy GAIA Level 3 Ectopic Pregnancy is defined by four criteria: first, it does not qualify as either a Level 1 or a Level 2 Ectopic Pregnancy; second, gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 2-3) (Brighton Preterm Birth Gestational Age algorithm); third, a positive urine pregnancy test; fourth, no products of conception are found on endometrial curettage after a dilation and curettage procedure. Level 3 Ectopic Pregnancy Level 3 Ectopic Pregnancy is defined by four criteria: first, it does not qualify as either a Level 1 or a Level 2 Ectopic Pregnancy; second, gestational age is within the pre-defined range for the selected ectopic pregnancy definition as assessed by maternal and/or fetal parameters (Level 2-3) (Brighton Preterm Birth Gestational Age algorithm); third, a positive urine pregnancy test; fourth, no products of conception are found on endometrial curettage after a dilation and curettage procedure. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128719 GAIA Level 1 Dysfunctional Second Stage of Labor GAIA Level 1 Dysfunctional Second Stage of Labor is defined by three criteria. For nulliparous women: first, full dilation of the cervix (10 cm dilated, or no palpable cervix around the presenting part of the fetus); second, the onset of the active stage of labor (active maternal effort (i.e. pushing) or visible baby); third, at least one of the following requirements must be met: a) Greater than 2 hours of pushing; OR b) The use of an instrument (forceps or vacuum/ventouse) for the indication of dystocia; OR c) Cesarean delivery for the indication of dystocia. For multiparous women: first, full dilation of the cervix (10 cm dilated, or no palpable cervix around the presenting part of the fetus); second, the onset of the active stage of labor (active maternal effort (i.e. pushing) or visible baby); third, at least one of the following requirements must be met: a) Greater than 1 hour of pushing; OR b) The use of an instrument (forceps or vacuum/ventouse) for the indication of dystocia; OR c) Cesarean delivery for the indication of dystocia. Level 1 Dysfunctional Second Stage of Labor Level 1 Dysfunctional Second Stage of Labor is defined by three criteria. For nulliparous women: first, full dilation of the cervix (10 cm dilated, or no palpable cervix around the presenting part of the fetus); second, the onset of the active stage of labor (active maternal effort (i.e. pushing) or visible baby); third, at least one of the following requirements must be met: a) Greater than 2 hours of pushing; OR b) The use of an instrument (forceps or vacuum/ventouse) for the indication of dystocia; OR c) Cesarean delivery for the indication of dystocia. For multiparous women: first, full dilation of the cervix (10 cm dilated, or no palpable cervix around the presenting part of the fetus); second, the onset of the active stage of labor (active maternal effort (i.e. pushing) or visible baby); third, at least one of the following requirements must be met: a) Greater than 1 hour of pushing; OR b) The use of an instrument (forceps or vacuum/ventouse) for the indication of dystocia; OR c) Cesarean delivery for the indication of dystocia. C128707 GAIA Dysfunctional Bleeding Level of Diagnostic Certainty Terminology C C128720 GAIA Level 2 Dysfunctional Second Stage of Labor GAIA Level 2 Dysfunctional Second Stage of Labor is defined by two criteria. For nulliparous and multiparous women: first, full dilation of the cervix (10 cm dilated, or no palpable cervix around the presenting part of the fetus) during any phase of the second stage of labor; second, at least one of the following requirements must be met: a) No delivery within 3 hours of full dilation; OR b) The use of an instrument (forceps or vacuum/ventouse) for the indication of dystocia; OR d) Cesarean delivery for the indication of dystocia. Level 2 Dysfunctional Second Stage of Labor Level 2 Dysfunctional Second Stage of Labor is defined by two criteria. For nulliparous and multiparous women: first, full dilation of the cervix (10 cm dilated, or no palpable cervix around the presenting part of the fetus) during any phase of the second stage of labor; second, at least one of the following requirements must be met: a) No delivery within 3 hours of full dilation; OR b) The use of an instrument (forceps or vacuum/ventouse) for the indication of dystocia; OR d) Cesarean delivery for the indication of dystocia. C128707 GAIA Dysfunctional Bleeding Level of Diagnostic Certainty Terminology C C128721 GAIA Level 1a Fetal Growth Restriction GAIA Level 1a Fetal Growth Restriction is defined by two criteria: first, Level 1 evidence of pregnancy dating; second, at least one of the following requirements must be met: a) Estimated fetal weight below the third percentile using locally-accepted growth curve; OR b) Estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR a finding of oligohydramnios. Level 1a Fetal Growth Restriction Level 1a Fetal Growth Restriction is defined by two criteria: first, Level 1 evidence of pregnancy dating; second, at least one of the following requirements must be met: a) Estimated fetal weight below the third percentile using locally-accepted growth curve; OR b) Estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR a finding of oligohydramnios. C128708 GAIA Fetal Growth Restriction Level of Diagnostic Certainty Terminology C C128722 GAIA Level 1b Fetal Growth Restriction GAIA Level 1b Fetal Growth Restriction is defined by two criteria: first, Level 1 evidence of pregnancy dating; second, an estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either no findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR absence of oligohydramnios. Level 1b Fetal Growth Restriction Level 1b Fetal Growth Restriction is defined by two criteria: first, Level 1 evidence of pregnancy dating; second, an estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either no findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR absence of oligohydramnios. C128708 GAIA Fetal Growth Restriction Level of Diagnostic Certainty Terminology C C128723 GAIA Level 2a Fetal Growth Restriction GAIA Level 2a Fetal Growth Restriction is defined by two criteria: first, Level 2 evidence of pregnancy dating; second, at least one of the following requirements must be met: a) Estimated fetal weight below the third percentile using locally-accepted growth curve; OR b) Estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR a finding of oligohydramnios. Level 2a Fetal Growth Restriction Level 2a Fetal Growth Restriction is defined by two criteria: first, Level 2 evidence of pregnancy dating; second, at least one of the following requirements must be met: a) Estimated fetal weight below the third percentile using locally-accepted growth curve; OR b) Estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR a finding of oligohydramnios. C128708 GAIA Fetal Growth Restriction Level of Diagnostic Certainty Terminology C C128724 GAIA Level 2b Fetal Growth Restriction GAIA Level 2b Fetal Growth Restriction is defined by two criteria: first, Level 2 evidence of pregnancy dating; second, at least one of the following requirements must be met: a) Estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either no findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR absence of oligohydramnios. Alternatively, Level 2b may be defined by the following two criteria: first, Level 1 evidence of pregnancy dating; second, an estimated fetal weight below the tenth percentile using locally-accepted growth curve, and absence of oligohydramnios with the inability to assess umbilical artery Doppler. Level 2b Fetal Growth Restriction Level 2b Fetal Growth Restriction is defined by two criteria: first, Level 2 evidence of pregnancy dating; second, at least one of the following requirements must be met: a) Estimated fetal weight below the tenth percentile using locally-accepted growth curve AND either no findings of absent or reversed end-diastolic flow of the umbilical artery Doppler OR absence of oligohydramnios. Alternatively, Level 2b may be defined by the following two criteria: first, Level 1 evidence of pregnancy dating; second, an estimated fetal weight below the tenth percentile using locally-accepted growth curve, and absence of oligohydramnios with the inability to assess umbilical artery Doppler. C128708 GAIA Fetal Growth Restriction Level of Diagnostic Certainty Terminology C C128743 GAIA Level 2 Placenta Previa GAIA Level 2 Placenta Previa is defined by two criteria: first, painless vaginal bleeding during the second or third trimester; second, one of the following two requirements must be met: a) A pelvic exam with fullness palpable in the fornices (avoiding digital cervical exam), OR b) A speculum exam with tissue visible through an open cervical os. Level 2 Placenta Previa Level 2 Placenta Previa is defined by two criteria: first, painless vaginal bleeding during the second or third trimester; second, one of the following two requirements must be met: a) A pelvic exam with fullness palpable in the fornices (avoiding digital cervical exam), OR b) A speculum exam with tissue visible through an open cervical os. C128706 GAIA Antenatal Bleeding Level of Diagnostic Certainty Terminology C C128748 GAIA Level 1 Placental Abruption GAIA Level 1 Placental Abruption is defined by two criteria: first, vaginal bleeding during the second or third trimester in the absence of placenta previa on ultrasound; second, one of the following two requirements must be met: a) Uterine irritability (irregular, frequent uterine activity, not coalesced into clear contractions in a regular pattern) or labor; OR b) Clinical signs of hypovolemic shock or coagulopathy. Alternatively, Level 1 may be defined as placental pathology with histologic findings of a chronic abruption. Level 1 Placental Abruption Level 1 Placental Abruption is defined by two criteria: first, vaginal bleeding during the second or third trimester in the absence of placenta previa on ultrasound; second, one of the following two requirements must be met: a) Uterine irritability (irregular, frequent uterine activity, not coalesced into clear contractions in a regular pattern) or labor; OR b) Clinical signs of hypovolemic shock or coagulopathy. Alternatively, Level 1 may be defined as placental pathology with histologic findings of a chronic abruption. C128706 GAIA Antenatal Bleeding Level of Diagnostic Certainty Terminology C C128754 GAIA Level 2 Gestational Diabetes Mellitus GAIA Level 2 Gestational Diabetes Mellitus is defined by four criteria: first, at least one of the following requirements must be met: a) the absence of a previous diagnosis of diabetes while not pregnant; b) a first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol); c) a first trimester fasting blood glucose greater than or equal to 126 mg/dL (greater than 7 mmol/L); second, identification of sustained hyperglycemia during pregnancy is not due to other known causes (i.e. corticosteroids, beta-mimetics, etc.); third, gestational age with level 1 or level 2 certainty, using the GAIA definition for gestational age; fourth, the diagnosis of gestational diabetes as determined by a positive result from an international standard oral glucose tolerance test using capillary blood samples. Level 2 Gestational Diabetes Mellitus Level 2 Gestational Diabetes Mellitus is defined by four criteria: first, at least one of the following requirements must be met: a) the absence of a previous diagnosis of diabetes while not pregnant; b) a first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol); c) a first trimester fasting blood glucose greater than or equal to 126 mg/dL (greater than 7 mmol/L); second, identification of sustained hyperglycemia during pregnancy is not due to other known causes (i.e. corticosteroids, beta-mimetics, etc.); third, gestational age with level 1 or level 2 certainty, using the GAIA definition for gestational age; fourth, the diagnosis of gestational diabetes as determined by a positive result from an international standard oral glucose tolerance test using capillary blood samples. C128709 GAIA Gestational Diabetes Mellitus Level of Diagnostic Certainty Terminology C C128755 GAIA Level 3 Gestational Diabetes Mellitus GAIA Level 3 Gestational Diabetes Mellitus is defined by four criteria: first, at least one of the following requirements must be met: a) the absence of a previous diagnosis of diabetes while not pregnant; b) a first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol); c) a first trimester fasting blood glucose greater than or equal to 126 mg/dL (greater than 7 mmol/L); second, identification of sustained hyperglycemia during pregnancy is not due to other known causes (i.e. corticosteroids, beta-mimetics, etc.); third, gestational age with at least level 3 certainty, using the GAIA definition for gestational age; fourth, at least one of the following requirements must be met: a) diagnosis of gestational diabetes based on positive internationally recognized oral glucose tolerance test using venous blood or capillary blood samples; b) the diagnosis of gestational diabetes as determined by fasting plasma glucose of 5.1-6.9 mmol/l (92-125 mg/dL) using either venous or capillary blood samples. Level 3 Gestational Diabetes Mellitus Level 3 Gestational Diabetes Mellitus is defined by four criteria: first, at least one of the following requirements must be met: a) the absence of a previous diagnosis of diabetes while not pregnant; b) a first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol); c) a first trimester fasting blood glucose greater than or equal to 126 mg/dL (greater than 7 mmol/L); second, identification of sustained hyperglycemia during pregnancy is not due to other known causes (i.e. corticosteroids, beta-mimetics, etc.); third, gestational age with at least level 3 certainty, using the GAIA definition for gestational age; fourth, at least one of the following requirements must be met: a) diagnosis of gestational diabetes based on positive internationally recognized oral glucose tolerance test using venous blood or capillary blood samples; b) the diagnosis of gestational diabetes as determined by fasting plasma glucose of 5.1-6.9 mmol/l (92-125 mg/dL) using either venous or capillary blood samples. C128709 GAIA Gestational Diabetes Mellitus Level of Diagnostic Certainty Terminology C C128756 GAIA Insufficient Evidence for Diagnosis of Gestational Diabetes Mellitus GAIA Insufficient Evidence for Diagnosis of Gestational Diabetes Mellitus (GDM) is a category of individuals for whom a diagnosis of GDM cannot be made due to one of the following: a) the blood glucose cannot be measured; b) elevated postprandial blood glucose level without confirmatory fasting venous blood or capillary glucose level; c) use of Hemoglobin A1c alone, without a diagnostic oral glucose tolerance test or elevated fasting plasma glucose level; d) clinical and laboratory findings, including glucosuria, fundal height greater than dates, obesity, prior history of GDM, or family history for the diagnosis of gestational diabetes mellitus, without a diagnostic test. Insufficient Evidence for Diagnosis of Gestational Diabetes Mellitus Insufficient Evidence for Diagnosis of Gestational Diabetes Mellitus (GDM) is a category of individuals for whom a diagnosis of GDM cannot be made due to one of the following: a) the blood glucose cannot be measured; b) elevated postprandial blood glucose level without confirmatory fasting venous blood or capillary glucose level; c) use of Hemoglobin A1c alone, without a diagnostic oral glucose tolerance test or elevated fasting plasma glucose level; d) clinical and laboratory findings, including glucosuria, fundal height greater than dates, obesity, prior history of GDM, or family history for the diagnosis of gestational diabetes mellitus, without a diagnostic test. C128709 GAIA Gestational Diabetes Mellitus Level of Diagnostic Certainty Terminology C C128762 GAIA Level 1a Prenatally Diagnosed Congenital Microcephaly GAIA Level 1a Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain last menstrual period (LMP) date with confirmatory 1st trimester or 2nd trimester ultrasound (US) scan OR intrauterine insemination (IUI) or embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, confirmation of microcephaly (i.e., HC 2 SD below the mean or less than 3%) in the fetus by either at least one additional US after 24 weeks that occurs at least one week after the first US, OR confirmation of microcephaly by HC measurement with a standard tape measure at either birth or autopsy. Level 1a Prenatally Diagnosed Congenital Microcephaly Level 1a Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain last menstrual period (LMP) date with confirmatory 1st trimester or 2nd trimester ultrasound (US) scan OR intrauterine insemination (IUI) or embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, confirmation of microcephaly (i.e., HC 2 SD below the mean or less than 3%) in the fetus by either at least one additional US after 24 weeks that occurs at least one week after the first US, OR confirmation of microcephaly by HC measurement with a standard tape measure at either birth or autopsy. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128763 GAIA Level 1b Prenatally Diagnosed Congenital Microcephaly GAIA Level 1b Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on uncertain last menstrual period (LMP) date with a 2nd trimester ultrasound (US) scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, confirmation of microcephaly (i.e., HC 2 SD below the mean or less than 3%) in the fetus by either at least one additional US after 24 weeks that occurs at least one week after the first US, OR confirmation of microcephaly by HC measurement with a standard tape measure at either birth or autopsy. Level 1b Prenatally Diagnosed Congenital Microcephaly Level 1b Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on uncertain last menstrual period (LMP) date with a 2nd trimester ultrasound (US) scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, confirmation of microcephaly (i.e., HC 2 SD below the mean or less than 3%) in the fetus by either at least one additional US after 24 weeks that occurs at least one week after the first US, OR confirmation of microcephaly by HC measurement with a standard tape measure at either birth or autopsy. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128764 GAIA Level 2 Prenatally Diagnosed Congenital Microcephaly GAIA Level 2 Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain or uncertain last menstrual period (LMP) date with fundal height and no confirmatory 1st or 2nd trimester ultrasound (US) scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks) with femur length and abdominal circumference concordant with GA assessment; third, confirmation of microcephaly (i.e., HC 2 SD below the mean or less than 3%) in the fetus by either at least one additional US after 24 weeks that occurs at least one week after the first US, OR confirmation of microcephaly by HC measurement with a standard tape measure at either birth or autopsy. Level 2 Prenatally Diagnosed Congenital Microcephaly Level 2 Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain or uncertain last menstrual period (LMP) date with fundal height and no confirmatory 1st or 2nd trimester ultrasound (US) scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks) with femur length and abdominal circumference concordant with GA assessment; third, confirmation of microcephaly (i.e., HC 2 SD below the mean or less than 3%) in the fetus by either at least one additional US after 24 weeks that occurs at least one week after the first US, OR confirmation of microcephaly by HC measurement with a standard tape measure at either birth or autopsy. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128766 GAIA Level 4 Prenatally Diagnosed Congenital Microcephaly GAIA Level 4 Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain last menstrual period (LMP) date with confirmatory 1st or 2nd trimester ultrasound (US) scan, uncertain LMP with 2nd trimester US, intrauterine insemination (IUI), embryo transfer date or certain or uncertain LMP with fundal height and no confirmatory 1st or 2nd trimester US scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US scan using appropriate standardized reference charts according to GA and gender for the population (e.g., WHO growth reference charts if GA is greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA of 24-36 weeks); third, HC measurement at either birth or autopsy is in the normal range using appropriate standardized reference charts according to GA and gender for the population, which means that this is NOT a case of prenatally diagnosed congenital microcephaly. Level 4 Prenatally Diagnosed Congenital Microcephaly Level 4 Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA) based on certain last menstrual period (LMP) date with confirmatory 1st or 2nd trimester ultrasound (US) scan, uncertain LMP with 2nd trimester US, intrauterine insemination (IUI), embryo transfer date or certain or uncertain LMP with fundal height and no confirmatory 1st or 2nd trimester US scan; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US scan using appropriate standardized reference charts according to GA and gender for the population (e.g., WHO growth reference charts if GA is greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA of 24-36 weeks); third, HC measurement at either birth or autopsy is in the normal range using appropriate standardized reference charts according to GA and gender for the population, which means that this is NOT a case of prenatally diagnosed congenital microcephaly. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology C C128769 GAIA Level 2 Neonatal Respiratory Distress GAIA Level 2 Neonatal Respiratory Distress is defined by four criteria: first, the newborn must be between 0 and 28 days of life; second, an abnormal respiratory rate (not measured, but reported as "rapid breathing", "slow breathing", having periods of "no breathing", or "abnormal breathing"); third, the presence of any one of the following five clinical symptoms that indicate labored breathing: a) Nasal flaring (dilatation of alae nasi); b) Noisy respirations in the form of expiratory grunting, stridor, or wheeze; c) Retractions or increased chest indrawings on inspiration (subcostal, intercostal, sternal, suprasternal notch) or seesaw respirations; d) Central cyanosis (whole body, including lips and tongue) on room air; e) Low Apgar score (less than 7 points) at 10 minutes with a respiration score less than 2; fourth, one of the following two requirements: a) No medical record documentation, but reporting through either a non-medical observer (e.g., mother, father, community worker) or via standard census mechanisms (e.g., Demographic and Health Surveillance System), or b) Collection of information from medical review or billing codes. Level 2 Neonatal Respiratory Distress Level 2 Neonatal Respiratory Distress is defined by four criteria: first, the newborn must be between 0 and 28 days of life; second, an abnormal respiratory rate (not measured, but reported as "rapid breathing", "slow breathing", having periods of "no breathing", or "abnormal breathing"); third, the presence of any one of the following five clinical symptoms that indicate labored breathing: a) Nasal flaring (dilatation of alae nasi); b) Noisy respirations in the form of expiratory grunting, stridor, or wheeze; c) Retractions or increased chest indrawings on inspiration (subcostal, intercostal, sternal, suprasternal notch) or seesaw respirations; d) Central cyanosis (whole body, including lips and tongue) on room air; e) Low Apgar score (less than 7 points) at 10 minutes with a respiration score less than 2; fourth, one of the following two requirements: a) No medical record documentation, but reporting through either a non-medical observer (e.g., mother, father, community worker) or via standard census mechanisms (e.g., Demographic and Health Surveillance System), or b) Collection of information from medical review or billing codes. C128702 GAIA Neonatal Respiratory Distress Level of Diagnostic Certainty Terminology C C128774 GAIA Level 3b Failure to Thrive GAIA Level 3b Failure to Thrive is defined by three criteria: first, infants have no weight available; second, physical examination is consistent with failure to thrive, which is defined as having at least two findings, one of which must be a major finding: reduced subcutaneous fat stores, poor muscle mass, loose skin folds, prominent ribs, and thin limbs. Less specific findings include sparse hair, rashes, pallor, irritable temperament, and lethargy/fatigue; third, a mid-upper arm circumference (MUAC) measurement, which is indicative of severe wasting, that is less than or equal to 110 mm in infants up to six months of age, and that is less than or equal to 115 mm in infants six to twelve months of age. Level 3b Failure to Thrive Level 3b Failure to Thrive is defined by three criteria: first, infants have no weight available; second, physical examination is consistent with failure to thrive, which is defined as having at least two findings, one of which must be a major finding: reduced subcutaneous fat stores, poor muscle mass, loose skin folds, prominent ribs, and thin limbs. Less specific findings include sparse hair, rashes, pallor, irritable temperament, and lethargy/fatigue; third, a mid-upper arm circumference (MUAC) measurement, which is indicative of severe wasting, that is less than or equal to 110 mm in infants up to six months of age, and that is less than or equal to 115 mm in infants six to twelve months of age. C128704 GAIA Failure to Thrive Level of Diagnostic Certainty Terminology C C128776 GAIA Level 1 First Trimester Spontaneous Abortion GAIA Level 1 First Trimester Spontaneous Abortion is defined by two criteria: first, at least one of the following three requirements must be met: a) Crown-rump length greater than or equal to 7 mm and no visible heartbeat on transvaginal ultrasound; OR b) Crown-rump length greater than or equal to 15 mm and no visible heartbeat on abdominal ultrasound; OR c) Ultrasound examination demonstrating mean gestational sac diameter greater than or equal to 25 mm and no visible embryo or yolk sac; second, at least one of the following three requirements must be met: a) A second transvaginal ultrasound performed greater than or equal to 7 days later (or 14 days later if transabdominal) confirming the diagnosis of a non-viable pregnancy; OR b) The absence of an embryo with heartbeat 2 weeks or more after a transabdominal scan that initially showed a gestational sac without a yolk sac; OR c) The absence of an embryo with a heartbeat 11 days or more after a transvaginal scan that initially showed a gestational sac with a yolk sac. Alternatively, GAIA Level 1 First Trimester Spontaneous Abortion can be defined by the following two criteria: first, the gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters ( Level 1-2) (using the Brighton Preterm Birth Gestational Age algorithm); second, at least one of the following four requirements must be met: a) Positive urine or blood pregnancy test that becomes negative after 7 days; OR b) Products of conception found on histopathological evaluation of pregnancy tissue; OR c) Ultrasound examination demonstrating an empty uterine cavity in a woman who had clear evidence of intrauterine pregnancy on previous ultrasound examination; OR d) Vaginal bleeding, external cervical os open or closed, with visible expulsion of pregnancy tissues/products of conception. Level 1 First Trimester Spontaneous Abortion Level 1 First Trimester Spontaneous Abortion is defined by two criteria: first, at least one of the following three requirements must be met: a) Crown-rump length greater than or equal to 7 mm and no visible heartbeat on transvaginal ultrasound; OR b) Crown-rump length greater than or equal to 15 mm and no visible heartbeat on abdominal ultrasound; OR c) Ultrasound examination demonstrating mean gestational sac diameter greater than or equal to 25 mm and no visible embryo or yolk sac; second, at least one of the following three requirements must be met: a) A second transvaginal ultrasound performed greater than or equal to 7 days later (or 14 days later if transabdominal) confirming the diagnosis of a non-viable pregnancy; OR b) The absence of an embryo with heartbeat 2 weeks or more after a transabdominal scan that initially showed a gestational sac without a yolk sac; OR c) The absence of an embryo with a heartbeat 11 days or more after a transvaginal scan that initially showed a gestational sac with a yolk sac. Alternatively, GAIA Level 1 First Trimester Spontaneous Abortion can be defined by the following two criteria: first, the gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters ( Level 1-2) (using the Brighton Preterm Birth Gestational Age algorithm); second, at least one of the following four requirements must be met: a) Positive urine or blood pregnancy test that becomes negative after 7 days; OR b) Products of conception found on histopathological evaluation of pregnancy tissue; OR c) Ultrasound examination demonstrating an empty uterine cavity in a woman who had clear evidence of intrauterine pregnancy on previous ultrasound examination; OR d) Vaginal bleeding, external cervical os open or closed, with visible expulsion of pregnancy tissues/products of conception. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128777 GAIA Level 2 First Trimester Spontaneous Abortion GAIA Level 2 First Trimester Spontaneous Abortion is defined by three criteria: first, it does not qualify as a Level 1 First Trimester Spontaneous Abortion; second, at least one of the following three requirements must be met: a) Crown-rump length greater than 7 mm and no visible heartbeat, confirmed by transvaginal ultrasound; OR b) Crown-rump length greater than 15 mm and no visible heartbeat, confirmed by abdominal ultrasound; OR c) Mean gestational sac diameter is 25 mm or more and no visible embryo; third, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 1-2) (using Brighton Preterm Birth Gestational Age algorithm). Level 2 First Trimester Spontaneous Abortion Level 2 First Trimester Spontaneous Abortion is defined by three criteria: first, it does not qualify as a Level 1 First Trimester Spontaneous Abortion; second, at least one of the following three requirements must be met: a) Crown-rump length greater than 7 mm and no visible heartbeat, confirmed by transvaginal ultrasound; OR b) Crown-rump length greater than 15 mm and no visible heartbeat, confirmed by abdominal ultrasound; OR c) Mean gestational sac diameter is 25 mm or more and no visible embryo; third, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 1-2) (using Brighton Preterm Birth Gestational Age algorithm). C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128778 GAIA Level 3 First Trimester Spontaneous Abortion GAIA Level 3 First Trimester Spontaneous Abortion is defined by three criteria: first, it does not qualify as either a Level 1 or Level 2 First Trimester Spontaneous Abortion; second, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 3) (using Brighton Preterm Birth Gestational Age algorithm); third, a positive urine or blood pregnancy test that becomes negative after 7 days. Level 3 First Trimester Spontaneous Abortion Level 3 First Trimester Spontaneous Abortion is defined by three criteria: first, it does not qualify as either a Level 1 or Level 2 First Trimester Spontaneous Abortion; second, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 3) (using Brighton Preterm Birth Gestational Age algorithm); third, a positive urine or blood pregnancy test that becomes negative after 7 days. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128781 GAIA Level 1 Second Trimester Spontaneous Abortion GAIA Level 1 Second Trimester Spontaneous Abortion is defined by two criteria: first, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm); second, at least one of the following requirements must be met: a) No visible heartbeat on ultrasound; OR b) Visible expulsion of pregnancy tissues/products of conception on examination of the cervix; OR c) Products of conception found on histopathological evaluation of uterine contents. Level 1 Second Trimester Spontaneous Abortion Level 1 Second Trimester Spontaneous Abortion is defined by two criteria: first, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 1-2) (Brighton Preterm Birth Gestational Age algorithm); second, at least one of the following requirements must be met: a) No visible heartbeat on ultrasound; OR b) Visible expulsion of pregnancy tissues/products of conception on examination of the cervix; OR c) Products of conception found on histopathological evaluation of uterine contents. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C128782 GAIA Level 2 Second Trimester Spontaneous Abortion GAIA Level 2 Second Trimester Spontaneous Abortion is defined by three criteria: first, it does not qualify as a Level 1 Second Trimester Spontaneous Abortion; second, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 3) (Brighton Preterm Birth Gestational Age algorithm); third, one of the following three requirements must be met: a) No visible heartbeat on ultrasound; b) Visible expulsion of pregnancy tissues/products of conception on examination of the cervix; c) Products of conception found on histopathological evaluation of uterine contents. Level 2 Second Trimester Spontaneous Abortion Level 2 Second Trimester Spontaneous Abortion is defined by three criteria: first, it does not qualify as a Level 1 Second Trimester Spontaneous Abortion; second, gestational age is within the pre-defined range for the selected abortion definition as assessed by maternal and/or fetal parameters (Level 3) (Brighton Preterm Birth Gestational Age algorithm); third, one of the following three requirements must be met: a) No visible heartbeat on ultrasound; b) Visible expulsion of pregnancy tissues/products of conception on examination of the cervix; c) Products of conception found on histopathological evaluation of uterine contents. C128705 GAIA Spontaneous Abortion and Ectopic Pregnancy Level of Diagnostic Certainty Terminology C C112843 Severe Preeclampsia Preeclampsia with a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 110 mmHg or higher on two occasions at least 4 hours apart while on bedrest. It is associated with thrombocytopenia (platelets less than 100,000 per microliter), impaired liver function (twice normal elevation of hepatic transaminases; severe, persistent right upper quadrant or epigastric pain), progressive renal insufficiency (serum creatinine greater than 1.1 mg/dL or doubling of baseline in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances. Preeclampsia with Severe Features Preeclampsia with Severe Features is defined by three criteria: First, the gestational age of he pregnancy must be equal to or greater than 20 weeks; Second, a diagnosis of new onset maternal hypertension (systolic blood pressure equal or greater than 140mmHg and /or diastolic blood pressure equal to or greater than 90mmHg) that is sustained on two measurements over a minimum of one hour; Third, at least one of the criteria for severe disease. C126860 GAIA Preeclampsia Level of Diagnostic Certainty Terminology C C127944 GAIA Level 1 Assessment of Premature Preterm Rupture of Membranes GAIA Level 1 Assessment of Premature Preterm Rupture of Membranes is defined by five criteria: first, presentation between 24 0/7 and 36 6/7 weeks gestation with a clinical history of rupture of membranes, the fluid from which may be any color, including clear, blood-tinged, meconium-tinged (fetal stool), or purulent-tinged (yellowish, suggesting infection); second, the patient is determined to not be in preterm labor (having less than or equal to 4 contractions per hour documented clinically or on tocodynometer, with less than 2cm cervical dilation); third, visible leakage of fluid on vaginal speculum exam; fourth, one of the two following requirements must be met: a) Visible arborization (ferning) on microscopy of amniotic fluid; OR b) Ultrasound with oligohydramnios (amniotic fluid index (AFI) less than 5, or maximum vertical pocket (MVP) less than 2); fifth, documentation of the membrane rupture by one of the following diagnostic tests: a) Positive intra-amniotic dye-injection method; b) Positive result on amniotic fluid alpha-fetoprotein test kit; c) Amniotic fluid pH measurement (nitrazine paper test); d) Amniotic fluid placental alpha macroglobulin-1 protein assay (PAMG-1) test (AmniSure test); e) Amniotic fluid insulin-like growth factor binding protein (IGFBP-1) test (Actim PROM test). Level 1 Assessment of Premature Preterm Rupture of Membranes Level 1 Assessment of Premature Preterm Rupture of Membranes is defined by five criteria: first, presentation between 24 0/7 and 36 6/7 weeks gestation with a clinical history of rupture of membranes, the fluid from which may be any colour, including clear, blood-tinged, meconium-tinged (fetal stool), or purulent-tinged (yellowish, suggesting infection); second, the patient is determined to not be in preterm labor (having less than or equal to 4 contractions per hour documented clinically or on tocodynometer, with less than 2cm cervical dilation); third, visible leakage of fluid on vaginal speculum exam; fourth, one of the two following requirements must be met: a) Visible arborization (ferning) on microscopy of amniotic fluid; OR b) Ultrasound with oligohydramnios (amniotic fluid index (AFI) less than 5, or maximum vertical pocket (MVP) less than 2); fifth, documentation of the membrane rupture by one of the following diagnostic tests: a) Positive intra-amniotic dye-injection method; b) Positive result on amniotic fluid alpha-fetoprotein test kit; c) Amniotic fluid pH measurement (nitrazine paper test); d) Amniotic fluid placental alpha macroglobulin-1 protein assay (PAMG-1) test (AmniSure test); e) Amniotic fluid insulin-like growth factor binding protein (IGFBP-1) test (Actim PROM test). C126861 GAIA Pathways to Preterm Birth Level of Diagnostic Certainty Terminology C C127945 GAIA Level 2 Assessment of Premature Preterm Rupture of Membranes GAIA Level 2 Assessment of Premature Preterm Rupture of Membranes is defined by four criteria: first, presentation between 24 0/7 and 36 6/7 weeks gestation with a clinical history of rupture of membranes, the fluid from which may be any color, including clear, blood-tinged, meconium-tinged (fetal stool), or purulent-tinged (yellowish, suggesting infection); second, the patient is determined to not be in preterm labor (having less than or equal to 4 contractions per hour documented clinically or on tocodynometer, with less than 2cm cervical dilation); third, visible leakage of fluid on vaginal speculum exam; fourth, one of the three following requirements must be met: a) Visible arborization (ferning) on microscopy of amniotic fluid; OR b) Ultrasound with oligohydramnios (amniotic fluid index (AFI) less than 5, or maximum vertical pocket (MVP) less than; OR c) documentation of the membrane rupture by one of the following diagnostic tests: 1) Positive intra-amniotic dye-injection method; 2) Positive result on amniotic fluid alpha-fetoprotein test kit; 3) Amniotic fluid pH measurement (nitrazine paper test); 4) Amniotic fluid placental alpha macroglobulin-1 protein assay (PAMG-1) test (AmniSure test); 5) Amniotic fluid insulin-like growth factor binding protein (IGFBP-1) test (Actim PROM test). Level 2 Assessment of Premature Preterm Rupture of Membranes Level 2 Assessment of Premature Preterm Rupture of Membranes is defined by four criteria: first, presentation between 24 0/7 and 36 6/7 weeks gestation with a clinical history of rupture of membranes, the fluid from which may be any colour, including clear, blood-tinged, meconium-tinged (fetal stool), or purulent-tinged (yellowish, suggesting infection); second, the patient is determined to not be in preterm labor (having less than or equal to 4 contractions per hour documented clinically or on tocodynometer, with less than 2cm cervical dilation); third, visible leakage of fluid on vaginal speculum exam; fourth, one of the three following requirements must be met: a) Visible arborization (ferning) on microscopy of amniotic fluid; OR b) Ultrasound with oligohydramnios (amniotic fluid index (AFI) less than 5, or maximum vertical pocket (MVP) less than; OR c) documentation of the membrane rupture by one of the following diagnostic tests: 1) Positive intra-amniotic dye-injection method; 2) Positive result on amniotic fluid alpha-fetoprotein test kit; 3) Amniotic fluid pH measurement (nitrazine paper test); 4) Amniotic fluid placental alpha macroglobulin-1 protein assay (PAMG-1) test (AmniSure test); 5) Amniotic fluid insulin-like growth factor binding protein (IGFBP-1) test (Actim PROM test). C126861 GAIA Pathways to Preterm Birth Level of Diagnostic Certainty Terminology C C127946 GAIA Level 3 Assessment of Premature Preterm Rupture of Membranes GAIA Level 3 Assessment of Premature Preterm Rupture of Membranes is defined by three criteria: first, presentation between 24 0/7 and 36 6/7 weeks gestation with a clinical history of rupture of membranes, the fluid from which may be any color, including clear, blood-tinged, meconium-tinged (fetal stool), or purulent-tinged (yellowish, suggesting infection); second, the patient is determined to not be in preterm labor (having less than or equal to 4 contractions per hour documented clinically or on tocodynometer, with less than 2cm cervical dilation); third, visible leakage of presumed amniotic fluid, which may be on vaginal speculum examination (pooling in the vagina), on inspection of the perineum (wet perineum due to leakage of fluid from the vagina), or fluid soaked cloth/clothes/sanitary pad. Level 3 Assessment of Premature Preterm Rupture of Membranes Level 3 Assessment of Premature Preterm Rupture of Membranes is defined by three criteria: first, presentation between 24 0/7 and 36 6/7 weeks gestation with a clinical history of rupture of membranes, the fluid from which may be any colour, including clear, blood-tinged, meconium-tinged (fetal stool), or purulent-tinged (yellowish, suggesting infection); second, the patient is determined to not be in preterm labor (having less than or equal to 4 contractions per hour documented clinically or on tocodynometer, with less than 2cm cervical dilation); third, visible leakage of presumed amniotic fluid, which may be on vaginal speculum examination (pooling in the vagina), on inspection of the perineum (wet perineum due to leakage of fluid from the vagina), or fluid soaked cloth/clothes/sanitary pad. C126861 GAIA Pathways to Preterm Birth Level of Diagnostic Certainty Terminology C C127968 GAIA Level 4 Major Functional Defect GAIA Level 4 Major Functional Defect is defined by two criteria: first, at least one of the following requirements must be met: a) For live births, there must be alterations in the functioning of one or more organs or body parts that are not due to a structural defect, that are present at the time of live birth (or propensity to develop alteration present at live birth), and that persist beyond the immediate peripartum period, unless treated through gene therapy or stem cell transplantation; OR b) For stillbirths or spontaneous or therapeutic abortions, there must be alterations in the function of one or more organs or body parts that are not due to a structural defect; second, at least one of the following requirements must be met: a) Documented confirmation in the medical record that the anomaly was present at the time of live birth or at the time of fetal demise, and that the anomaly was diagnosed by a trained maternal or child health care provider who is not a qualified geneticist, neonatologist, pathologist, subspecialist, pediatrician, obstetrician, or family medicine practitioner; OR b) Confirmation by claims data (ICD-9/ICD-10 diagnoses). Level 4 Major Functional Defect Level 4 Major Functional Defect is defined by two criteria: first, at least one of the following requirements must be met: a) For live births, there must be alterations in the functioning of one or more organs or body parts that are not due to a structural defect, that are present at the time of live birth (or propensity to develop alteration present at live birth), and that persist beyond the immediate peripartum period, unless treated through gene therapy or stem cell transplantation; OR b) For stillbirths or spontaneous or therapeutic abortions, there must be alterations in the function of one or more organs or body parts that are not due to a structural defect; second, at least one of the following requirements must be met: a) Documented confirmation in the medical record that the anomaly was present at the time of live birth or at the time of fetal demise, and that the anomaly was diagnosed by a trained maternal or child health care provider who is not a qualified geneticist, neonatologist, pathologist, subspecialist, paediatrician, obstetrician, or family medicine practitioner; OR b) Confirmation by claims data (ICD-9/ICD-10 diagnoses). C126852 GAIA Major Congenital Anomalies Level of Diagnostic Certainty Terminology C C127984 GAIA Level 1 Neonatal Invasive Bloodstream Infection GAIA Level 1 Neonatal Invasive Bloodstream Infection is defined by two criteria: first, identification of a recognized pathogen from a normally sterile site using a validated method; second, if a normally non-pathogenic organism is isolated from blood cultures the following two requirements must be met: a) The cultures must be obtained from two different sites OR taken at two different times; b) One or more of the level 2 criteria must be present. Level 1 Neonatal Blood Stream Infection Level 1 Neonatal Invasive Blood Stream Infection is defined by two criteria: first, identification of a recognized pathogen from a normally sterile site using a validated method; second, if a normally non-pathogenic organism is isolated from blood cultures the following two requirements must be met: a) The cultures must be obtained from two different sites OR taken at two different times; b) One or more of the level 2 criteria must be present. C126854 GAIA Neonatal Infections Level of Diagnostic Certainty Terminology C C127985 GAIA Level 2 Neonatal Invasive Bloodstream Infection GAIA Level 2 Neonatal Invasive Bloodstream Infection is defined by two criteria: first, the criteria does not meet the requirements for level 1 diagnostic certainty; second, three or more of the following requirements must be met: a) Temperature greater than or equal to 37.5 degrees C or less than 35.5 degrees C; b) Tachycardia or new or more frequent episodes of bradycardia; c) New or more frequent episodes of apnea or increased oxygen requirement or increased requirement for ventilatory support; d) Lethargy or moving only when stimulated or hypotonia or irritability; e) Difficulty in feeding or abdominal distention; f) Pallor or poor perfusion or hypotension; g) Abnormal white cell count or I/T (immature/total neutrophil) ratio greater than 0.2; h) Abnormal platelet count; i) Increased number of inflammatory markers (CRP, procalcitonin); j) Metabolic acidosis as defined by a base excess. Level 2 Neonatal Blood Stream Infection Level 2 Neonatal Invasive Blood Stream Infection is defined by two criteria: first, the criteria does not meet the requirements for level 1 diagnostic certainty; second, three or more of the following requirements must be met: a) Temperature greater than or equal to 37.5 degrees C or less than 35.5 degrees C; b) Tachycardia or new or more frequent episodes of bradycardia; c) New or more frequent episodes of apnea or increased oxygen requirement or increased requirement for ventilatory support; d) Lethargy or moving only when stimulated or hypotonia or irritability; e) Difficulty in feeding or abdominal distention; f) Pallor or poor perfusion or hypotension; g) Abnormal white cell count or I/T (immature/total neutrophil) ratio greater than 0.2; h) Abnormal platelet count; i) Increased number of inflammatory markers (CRP, procalcitonin); j) Metabolic acidosis as defined by a base excess. C126854 GAIA Neonatal Infections Level of Diagnostic Certainty Terminology C C127986 GAIA Level 3 Neonatal Invasive Bloodstream Infection GAIA Level 3 Neonatal Invasive Bloodstream Infection is defined by two criteria: first, the criteria does not meet the requirements for level 1 or 2 diagnostic certainty; second, two or more of the following requirements must be met: a) Temperature greater than or equal to 37.5 degrees C or less than 35.5 degrees C; b) Tachypnea or severe chest indrawing or grunting or cyanosis; c) Change in level of activity; d) History of feeding difficulty; e) History of convulsions. Level 3 Neonatal Blood Stream Infection Level 3 Neonatal Invasive Blood Stream Infection is defined by two criteria: first, the criteria does not meet the requirements for level 1 or 2 diagnostic certainty; second, two or more of the following requirements must be met: a) Temperature greater than or equal to 37.5 degrees C or less than 35.5 degrees C; b) Tachypnea or severe chest indrawing or grunting or cyanosis; c) Change in level of activity; d) History of feeding difficulty; e) History of convulsions. C126854 GAIA Neonatal Infections Level of Diagnostic Certainty Terminology C C128018 GAIA Level 1 Antepartum Stillbirth GAIA Level 1 Antepartum Stillbirth is defined by four criteria: first, one or more of the following three requirements must be met: a) Prenatal ultrasound examination (e.g. basic ultrasound or special ultrasound with Doppler) documenting an absence of fetal cardiac activity or movement before the onset of labor; b) Radiology findings consistent with intrauterine fetal death; c) Delivery of an infant with no of signs of life at birth, including no spontaneous movements, no umbilical cord pulse, no heartbeat, no respirations, and Apgar scores of 0 at both 1 and 5 minutes. The determination of the absence of signs of life is made by physical examination after delivery, with or without electronic monitoring of heart rate, respiratory rate, and pulse oximetry; second, the following three criteria must be met: a) Maternal report of the absence of fetal movement for 24 hours or more; b) Maternal physical examination confirming the absence of fetal movement; c) Auscultation for fetal heart tones using electronic devices (e.g. handheld Doppler or fetal heart rate monitor) OR non-electronic devices (e.g. stethoscope, fetoscope, or Pinard horn) that documents the absence of a fetal heartbeat; third, one of the following two requirements must be met: a) Attended delivery, followed by a post-delivery physical examination of the fetus by an obstetrician, a neonatologist, a pediatrician, a maternal-fetal medicine specialist, or a pathologist that is consistent with antepartum death. In a setting where access to a specialist is not feasible, diagnosis by a health care provider trained or experienced to make the diagnosis is acceptable (e.g. general practice physician, mid-wife, nurse practitioner, a physician's assistant, or other qualified trained practitioner); OR b) fetal/placental pathology report that is consistent with antepartum death; fourth, gestational age within the pre-defined range for selected stillbirth definition, as assessed by maternal and/or fetal parameters (level 1 in GA assessment algorithm). Level 1 Antepartum Stillbirth Level 1 Antepartum Stillbirth is defined by four criteria: first, one or more of the following three requirements must be met: a) Prenatal ultrasound examination (e.g. basic ultrasound or special ultrasound with Doppler) documenting an absence of fetal cardiac activity or movement before the onset of labor; b) Radiology findings consistent with intrauterine fetal death; c) Delivery of an infant with no of signs of life at birth, including no spontaneous movements, no umbilical cord pulse, no heartbeat, no respirations, and Apgar scores of 0 at both 1 and 5 minutes. The determination of the absence of signs of life is made by physical examination after delivery, with or without electronic monitoring of heart rate, respiratory rate, and pulse oximetry; second, the following three criteria must be met: a) Maternal report of the absence of fetal movement for 24 hours or more; b) Maternal physical examination confirming the absence of fetal movement; c) Auscultation for fetal heart tones using electronic devices (e.g. handheld Doppler or fetal heart rate monitor) OR non-electronic devices (e.g. stethoscope, fetoscope, or Pinard horn) that documents the absence of a fetal heartbeat; third, one of the following two requirements must be met: a) Attended delivery, followed by a post-delivery physical examination of the fetus by an obstetrician, a neonatologist, a paediatrician, a maternal-fetal medicine specialist, or a pathologist that is consistent with antepartum death. In a setting where access to a specialist is not feasible, diagnosis by a health care provider trained or experienced to make the diagnosis is acceptable (e.g. general practice physician, mid-wife, nurse practitioner, a physician's assistant, or other qualified trained practitioner); OR b) fetal/placental pathology report that is consistent with antepartum death; fourth, gestational age within the pre-defined range for selected stillbirth definition, as assessed by maternal and/or fetal parameters (level 1 in GA assessment algorithm). C126856 GAIA Stillbirth Level of Diagnostic Certainty Terminology C C128022 GAIA Level 1 Intrapartum Stillbirth GAIA Level 1 Intrapartum Stillbirth is defined by four criteria: first, delivery of an infant with no of signs of life at birth, including the following: no spontaneous movements, no umbilical cord pulse, no heartbeat, no respirations, and an Apgar score of 0 at both 1 and 5 minutes. Determination of the absence of signs of life is made by physical examination after delivery, with or without electronic monitoring of heart rate, respiratory rate, and pulse oximetry; second, evidence of a live fetus prior to the onset of labor (confirmed by documentation of fetal movement and of fetal heart tones by ultrasound prior to onset of labor). NOTE: In the absence of evidence of a live fetus prior to the onset of labor, the fetal death should be reported as a stillbirth or an antepartum stillbirth; third, attended delivery followed by post-delivery physical examination by an obstetrician, a neonatologist, a pediatrician, a maternal-fetal medicine specialist, or a pathologist that is consistent with intrapartum death. In a setting where access to a specialist is not feasible, diagnosis by a health care provider trained or experienced to make the diagnosis is acceptable (e.g. general practice physician, mid-wife, or other qualified trained practitioner); fourth, gestational age within the pre-defined range for selected stillbirth definition as assessed by maternal and/or fetal-neonatal parameters (level 1 in GA assessment algorithm). Level 1 Intrapartum Stillbirth Level 1 Intrapartum Stillbirth is defined by four criteria: first, delivery of an infant with no of signs of life at birth, including the following: no spontaneous movements, no umbilical cord pulse, no heartbeat, no respirations, and an Apgar score of 0 at both 1 and 5 minutes. Determination of the absence of signs of life is made by physical examination after delivery, with or without electronic monitoring of heart rate, respiratory rate, and pulse oximetry; second, evidence of a live fetus prior to the onset of labor (confirmed by documentation of fetal movement and of fetal heart tones by ultrasound prior to onset of labor). NOTE: In the absence of evidence of a live fetus prior to the onset of labor, the fetal death should be reported as a stillbirth or an antepartum stillbirth; third, attended delivery followed by post-delivery physical examination by an obstetrician, a neonatologist, a paediatrician, a maternal-fetal medicine specialist, or a pathologist that is consistent with intrapartum death. In a setting where access to a specialist is not feasible, diagnosis by a health care provider trained or experienced to make the diagnosis is acceptable (e.g. general practice physician, mid-wife, or other qualified trained practitioner); fourth, gestational age within the pre-defined range for selected stillbirth definition as assessed by maternal and/or fetal-neonatal parameters (level 1 in GA assessment algorithm). C126856 GAIA Stillbirth Level of Diagnostic Certainty Terminology D C128767 GAIA Level 5 Prenatally Diagnosed Congenital Microcephaly GAIA Level 5 Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA), with GA based on last menstrual period (LMP) date, OR first trimester ultrasound (US) scan, OR intrauterine insemination (IUI) OR embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, HC at birth or autopsy is within the normal range, using appropriate, standardized reference charts according to GA and gender for the population, which means that this is NOT a case of prenatally diagnosed congenital microcephaly. Level 5 Prenatally Diagnosed Congenital Microcephaly Level 5 Prenatally Diagnosed Congenital Microcephaly is defined by three criteria: first, the fetus is at least 24 weeks gestational age (GA), with GA based on last menstrual period (LMP) date, OR first trimester ultrasound (US) scan, OR intrauterine insemination (IUI) OR embryo transfer date; second, a head circumference (HC) measurement either 2 standard deviations (SD) below the mean or less than the third percentile according to fetal US examination, using appropriate, standardized reference charts according to GA and gender for the population (e.g. WHO growth reference charts if GA greater than or equal to 37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, HC at birth or autopsy is within the normal range, using appropriate, standardized reference charts according to GA and gender for the population, which means that this is NOT a case of prenatally diagnosed congenital microcephaly. C128700 GAIA Congenital Microcephaly Level of Diagnostic Certainty Terminology