C C113492 Dysfunctional Labor Uterine contractions (less than 3 in 10 minutes or inadequate strength) that do not result in progressive cervical dilation. Dysfunctional Labor Prolongation in the duration of labor, typically during the first stage of labor. Diagnosis of a delay in labor is dependent upon careful monitoring of uterine contraction intensity, duration, and frequency, cervical dilation, and the descent of the fetus through the pelvis. C128707 GAIA Dysfunctional Labor Level of Diagnostic Certainty Terminology C C128717 GAIA Level 1 Dysfunctional First Stage of Labor GAIA Level 1 Dysfunctional First Stage of Labor is defined by progress of less than 0.5 cm of cervical dilation per hour, for at least 4 hours, in women with established labor (i.e. have regular contractions and cervical dilation of at least 4 cm) and with confirmed ruptured membranes. Level 1 Dysfunctional First Stage of Labor Level 1 Dysfunctional First Stage of Labor is defined by progress of less than 0.5 cm of cervical dilation per hour, for at least 4 hours, in women with established labor (i.e. have regular contractions and cervical dilation of at least 4 cm) and with confirmed ruptured membranes. C128707 GAIA Dysfunctional Labor Level of Diagnostic Certainty Terminology C C128718 GAIA Level 2 Dysfunctional First Stage of Labor GAIA Level 2 Dysfunctional First Stage of Labor is defined by progress of less than 0.5 cm of cervical dilation per hour, for at least 4 hours, in women with established labor (i.e. have regular contractions and cervical dilation of at least 4 cm) without certainty of ruptured membranes. Level 2 Dysfunctional First Stage of Labor Level 2 Dysfunctional First Stage of Labor is defined by progress of less than 0.5 cm of cervical dilation per hour, for at least 4 hours, in women with established labor (i.e. have regular contractions and cervical dilation of at least 4 cm) without certainty of ruptured membranes. C128707 GAIA Dysfunctional Labor 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 Labor 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 Labor Level of Diagnostic Certainty Terminology C C128005 GAIA Insufficient Evidence for Diagnosis of Preeclampsia GAIA Insufficient Evidence for Diagnosis of Preeclampsia is defined as a pregnancy with gestational age greater than or equal to 20 weeks and either a) The inability to measure blood pressure OR b) The inability to evaluate for proteinuria. Insufficient Evidence for Preeclampsia Insufficient Evidence for Preeclampsia is defined as a pregnancy with gestational age greater than or equal to 20 weeks and either a) The inability to measure blood pressure OR b) The inability to evaluate for proteinuria. C126860 GAIA Preeclampsia Level of Diagnostic Certainty Terminology C C128008 GAIA Insufficient Evidence for Diagnosis of Preeclampsia with Severe Features GAIA Insufficient Evidence for Diagnosis of Preeclampsia with Severe Features is a pregnancy with a gestational age greater than or equal to 20 weeks and the inability to measure blood pressure. Insufficient Evidence for Preeclampsia with Severe Features Insufficient Evidence for Preeclampsia with Severe Features is a pregnancy with a gestational age greater than or equal to 20 weeks and the inability to measure blood pressure. C126860 GAIA Preeclampsia Level of Diagnostic Certainty Terminology C C128011 GAIA Insufficient Evidence for Diagnosis of Gestational Hypertension GAIA Insufficient Evidence for Diagnosis of Gestational Hypertension is defined by two criteria: first, a pregnancy with gestational age greater than or equal to 20 weeks; second, one or more of the following requirements: a) The inability to measure blood pressure; b) The inability to evaluate for proteinuria. Insufficient Evidence for Gestational Hypertension Insufficient Evidence for Gestational Hypertension is defined by two criteria: first, a pregnancy with gestational age greater than or equal to 20 weeks; second, one or more of the following requirements: a) The inability to measure blood pressure; b) The inability to evaluate for proteinuria. C126860 GAIA Preeclampsia 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 Gestational Diabetes Mellitus Insufficient Evidence for 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 C128725 GAIA Level 1 Low Birth Weight GAIA Level 1 Low Birth Weight is defined by one of the two following criteria: first, a newborn infant is weighed within 24 hours of birth; an electronic scale that is graduated to 10 grams is used; the scale is calibrated at least once a year; the scale is placed on level, hard surface; the scale is tared to zero grams; AND the birth weight recorded is less than 2500 grams; OR second, a birth weight is recorded as less than 2500 grams as assessed per the health care facility's standard operating procedure, which fulfills criteria 1 to 5 of diagnostic level of certainty one. Level 1 Low Birth Weight Level 1 Low Birth Weight is defined by one of the two following criteria: first, a newborn infant is weighed within 24 hours of birth; an electronic scale that is graduated to 10 grams is used; the scale is calibrated at least once a year; the scale is placed on level, hard surface; the scale is tared to zero grams; AND the birth weight recorded is less than 2500 grams; OR second, a birth weight is recorded as less than 2500 grams as assessed per the health care facility's standard operating procedure, which fulfills criteria 1 to 5 of diagnostic level of certainty one. C128701 GAIA Low Birth Weight Level of Diagnostic Certainty Terminology C C128726 GAIA Level 2 Low Birth Weight GAIA Level 2 Low Birth Weight is defined by either one of the following two criteria: first, a newborn infant is weighed within 24 hours of birth; either an electronic or a spring scale that is graduated to 50 grams is used; the scale is calibrated at least once a year, or more often if moved; the scale is tared to zero grams or 0.00 kg; AND the birth weight recorded is less than 2500 grams; OR second, a birth weight is recorded as less than 2500 grams as assessed per the health care facility's standard operating procedure, which fulfills criteria 1 to 4 of diagnostic level of certainty two. Level 2 Low Birth Weight Level 2 Low Birth Weight is defined by either one of the following two criteria: first, a newborn infant is weighed within 24 hours of birth; either an electronic or a spring scale that is graduated to 50 grams is used; the scale is calibrated at least once a year, or more often if moved; the scale is tared to zero grams or 0.00 kg; AND the birth weight recorded is less than 2500 grams; OR second, a birth weight is recorded as less than 2500 grams as assessed per the health care facility's standard operating procedure, which fulfills criteria 1 to 4 of diagnostic level of certainty two. C128701 GAIA Low Birth Weight Level of Diagnostic Certainty Terminology C C128728 GAIA Level 4 Low Birth Weight GAIA Level 4 Low Birth Weight is defined by either one of the following two criteria: first, the newborn's weight is assessed between 1 and 2 days of age (first 48 hrs of life); AND second, a proxy measure of birth weight is used, AND the weight category is assessed as less than 2500 grams. Level 4 Low Birth Weight Level 4 Low Birth Weight is defined by either one of the following two criteria: first, the newborn's weight is assessed between 1 and 2 days of age (first 48 hrs of life); AND second, a proxy measure of birth weight is used, AND the weight category is assessed as less than 2500 grams. C128701 GAIA Low Birth Weight Level of Diagnostic Certainty Terminology C C128729 GAIA Level 1 Neonatal Encephalopathy GAIA Level 1 Neonatal Encephalopathy is defined by three criteria: first, a newborn infant (1-28 days of life) born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or seizures; third, difficulty with initiating and maintaining respiration; fourth, depression of muscle tone. Level 1 Neonatal Encephalopathy Level 1 Neonatal Encephalopathy is defined by three criteria: first, a newborn infant (1-28 days of life) born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or 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 infant (1 to 28 days of life) born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or 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 infant (1 to 28 days of life) born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or 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 three criteria: first, a newborn infant (1-28 days of life) born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or seizures; third, none of the following: a) difficulty with initiating or maintaining respiration; b) depression of muscle tone. Level 3 Neonatal Encephalopathy Level 3 Neonatal Encephalopathy is defined by three criteria: first, a newborn infant (1-28 days of life) born at or beyond 35 weeks of gestation; second, an abnormal level of alertness or seizures; third, none of the following: a) difficulty with initiating or maintaining respiration; b) depression of muscle tone. C128699 GAIA Neonatal Encephalopathy Level of Diagnostic Certainty Terminology C C128733 GAIA Level 1 Small for Gestational Age GAIA Level 1 Small for Gestational Age is defined by three criteria: first, weight below the 10th percentile for gestational age; second, assessment of weight by both of the following: a) Newborn weighed within 24 hours of birth; AND b) Weight assessed using a calibrated electronic scale with 10 g resolution; third, the gestational age is assessed by confirmatory ultrasound during the first trimester, with or without certain LMP, or IUI or embryo transfer date OR by first trimester ultrasound. Level 1 Small for Gestational Age Level 1 Small for Gestational Age is defined by three criteria: first, weight below the 10th percentile for gestational age; second, assessment of weight by both of the following: a) Newborn weighed within 24 hours of birth; AND b) Weight assessed using a calibrated electronic scale with 10 g resolution; third, the gestational age is assessed by confirmatory ultrasound during the first trimester, with or without certain LMP, or IUI or embryo transfer date OR by first trimester ultrasound. C128703 GAIA Small for Gestational Age Level of Diagnostic Certainty Terminology C C128743 GAIA Level 2 Placenta Previa GAIA Level 2 Placenta Previa is defined by three criteria: first, painless vaginal bleeding during the second or third trimester; second, a high presenting part or abnormal fetal lie; third, pelvic exam with fullness palpable in the fornices (avoiding digital cervical exam) OR a speculum exam with placental tissue visible through an open cervical os. Level 2 Placenta Previa Level 2 Placenta Previa is defined by three criteria: first, painless vaginal bleeding during the second or third trimester; second, a high presenting part or abnormal fetal lie; third, pelvic exam with fullness palpable in the fornices (avoiding digital cervical exam) OR a speculum exam with placental tissue visible through an open cervical os. C128706 GAIA Antenatal Bleeding Level of Diagnostic Certainty Terminology C C128753 GAIA Level 1 Gestational Diabetes Mellitus GAIA Level 1 Gestational Diabetes Mellitus is defined by three criteria: first, at least one of the following requirements must be met: a) absence of pre-gestational diabetes [pre-gestational diabetes is defined as a) previous diagnosis of diabetes while not pregnant OR b) first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol) OR c) first trimester fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L)]; second, gestational age with level 1 or level 2 certainty, using the GAIA definition for gestational age; third, a diagnosis of gestational diabetes as determined by a positive result from an international standard oral glucose tolerance test using venous blood samples. Level 1 Gestational Diabetes Mellitus Level 1 Gestational Diabetes Mellitus is defined by three criteria: first, at least one of the following requirements must be met: a) absence of pre-gestational diabetes [pre-gestational diabetes is defined as a) previous diagnosis of diabetes while not pregnant OR b) first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol) OR c) first trimester fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L)]; second, gestational age with level 1 or level 2 certainty, using the GAIA definition for gestational age; third, a diagnosis of gestational diabetes as determined by a positive result from an international standard oral glucose tolerance test using venous blood samples. C128709 GAIA Gestational Diabetes Mellitus Level of Diagnostic Certainty Terminology C C128754 GAIA Level 2 Gestational Diabetes Mellitus GAIA Level 2 Gestational Diabetes Mellitus is defined by three criteria: first, absence of pre-gestational diabetes [pre-gestational diabetes is defined as a) previous diagnosis of diabetes while not pregnant OR b) first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol) OR c) first trimester fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L)]; second, gestational age with at least level 1-2 certainty, using the GAIA definition for gestational age; third 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 three criteria: first, absence of pre-gestational diabetes [pre-gestational diabetes is defined as a) previous diagnosis of diabetes while not pregnant OR b) first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol) OR c) first trimester fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L)]; second, gestational age with at least level 1-2 certainty, using the GAIA definition for gestational age; third 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 three criteria: first, absence of pre-gestational diabetes [pre-gestational diabetes is defined as a) previous diagnosis of diabetes while not pregnant OR b) first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol) OR c) first trimester fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L)]; second, gestational age with at least level 3 certainty, using the GAIA definition for gestational age; third, 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 three criteria: first, absence of pre-gestational diabetes [pre-gestational diabetes is defined as a) previous diagnosis of diabetes while not pregnant OR b) first trimester hemoglobin A1c level of greater than or equal to 6.5% (47.5 mmol/mol) OR c) first trimester fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L)]; second, gestational age with at least level 3 certainty, using the GAIA definition for gestational age; third, 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 C128757 GAIA Level 1 Postnatally Diagnosed Congenital Microcephaly GAIA Level 1 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), with GA assessed by either a certain last menstrual period (LMP) date with confirmatory 1st trimester (less than 14 weeks) 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 to 36 weeks); third, the measurement is taken either between 24 and 36 hours after birth or at the end of the pregnancy. Level 1 Postnatally Diagnosed Congenital Microcephaly Level 1 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), with GA assessed by either a certain last menstrual period (LMP) date with confirmatory 1st trimester (less than 14 weeks) 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 to 36 weeks); third, the measurement is taken either between 24 and 36 hours after birth or at the end of the pregnancy. C128700 GAIA Congenital Microcephaly 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), with GA assessed by either a certain last menstrual period (LMP) date with confirmatory 1st trimester (less than 14 weeks) 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 to 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 taking into consideration the molding of the head; 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), with GA assessed by either a certain last menstrual period (LMP) date with confirmatory 1st trimester (less than 14 weeks) 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 to 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 taking into consideration the molding of the head; 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 gestational age (GA), with GA assessed based on uncertain LMP 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 to 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 taking into consideration the molding of the head; 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 gestational age (GA), with GA assessed based on uncertain LMP 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 to 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 taking into consideration the molding of the head; 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, and second, the case meets criteria for microcephaly using a validated algorithm: 1 inpatient diagnosis OR 2 outpatient diagnoses OR 1 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, and second, the case meets criteria for microcephaly using a validated algorithm: 1 inpatient diagnosis OR 2 outpatient diagnoses OR 1 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 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 last menstrual period (LMP) date with fundal height and no confirmatory first or second 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 to 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 last menstrual period (LMP) date with fundal height and no confirmatory first or second 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 to 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 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), with GA based on certain or uncertain last menstrual period (LMP) date, with fundal height and no confirmatory first or second trimester ultrasound (US) scan, OR uncertain LMP with second trimester ultrasound, 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 to 36 weeks); third, no confirmation of microcephaly with any additional 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), with GA based on certain or uncertain last menstrual period (LMP) date, with fundal height and no confirmatory first or second trimester ultrasound (US) scan, OR uncertain LMP with second trimester ultrasound, 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 to 36 weeks); third, no confirmation of microcephaly with any additional US or by HC measurement 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), with GA based on certain last menstrual period (LMP) date with confirmatory first or second trimester ultrasound (US) scan, OR uncertain LMP with second trimester ultrasound, intrauterine insemination (IUI), OR embryo transfer, OR certain or uncertain LMP with fundal height and no confirmatory first or second trimester scan; second, HC 2 SD below mean or <3 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 >=37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, HC at 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), with GA based on certain last menstrual period (LMP) date with confirmatory first or second trimester ultrasound (US) scan, OR uncertain LMP with second trimester ultrasound, intrauterine insemination (IUI), OR embryo transfer, OR certain or uncertain LMP with fundal height and no confirmatory first or second trimester scan; second, HC 2 SD below mean or <3 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 >=37 weeks and Intergrowth-21st reference charts for GA 24-36 weeks); third, HC at 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 C128768 GAIA Level 1 Neonatal Respiratory Distress GAIA Level 1 Neonatal Respiratory Distress is defined by four criteria: first, the newborn must be between 0 and 28 days of life; second, the presence of any one of the following three symptoms that indicate an abnormal respiratory rate: a) Tachypnea (respiratory rate of 60 or more breaths per minute); b) Bradypnea (respiratory rate of less than 30 breaths per minute); c) Apnea [cessation of respiratory effort (no breaths) for at least 20 seconds]; third, 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); d) Central cyanosis (whole body, including lips and tongue) on room air; e) Low Apgar score (less than 7 points) at 10 minutes, with respiration score less than 2; fourth, examination and documentation by qualified, trained health care providers who are appropriate for the clinical setting. Level 1 Neonatal Respiratory Distress Level 1 Neonatal Respiratory Distress is defined by four criteria: first, the newborn must be between 0 and 28 days of life; second, the presence of any one of the following three symptoms that indicate an abnormal respiratory rate: a) Tachypnea (respiratory rate of 60 or more breaths per minute); b) Bradypnea (respiratory rate of less than 30 breaths per minute); c) Apnea [cessation of respiratory effort (no breaths) for at least 20 seconds]; third, 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); d) Central cyanosis (whole body, including lips and tongue) on room air; e) Low Apgar score (less than 7 points) at 10 minutes, with respiration score less than 2; fourth, examination and documentation by qualified, trained health care providers who are appropriate for the clinical setting. C128702 GAIA Neonatal Respiratory Distress Level of Diagnostic Certainty Terminology C C128770 GAIA Level 1 Failure to Thrive GAIA Level 1 Failure to Thrive is defined by four criteria: first, the infant's age is determined by a documented birth date; second, weights are obtained using an electronic scale; third, a minimum of two documented weights measured at least four weeks apart; fourth, the weight for age deceleration must pass through at least two centile spaces on a growth chart. Additionally, the following information applies to this term: a. Age: This case definition is limited to infants up to 12 months of age. b. Weight and Length: Weight should be documented on the appropriate growth chart at the time of assessment. A fall through 2 centile spaces may be demonstrated at any point in the first 12 months of life, using any two weights as long as they are taken at least 4 weeks apart. Details of use of the weight balances allowable under this case definition and use of the Infantometer for length assessment are in Appendix A. c. Growth charts: For infants born at 37 weeks gestation or above, the WHO growth charts should be applied. When using weight for age use the growth chart most accurate for the infants age. The birth to 6 months age range should be used where data is available for this range only, the birth to 2 years chart should be used where data is available beyond 6 months of life. When using weight for length, use the chart for birth to 2 years. For infants born less than 37 completed weeks gestation, the Intergrowth charts for postnatal growth standards in preterm infant should be used. All infants should be plotted on their respective growth chart using their corrected age. Links to relevant growth charts can be found in Appendix A (www.gaia-consortium.net). Level 1 Failure to Thrive Level 1 Failure to Thrive is defined by four criteria: first, the infant's age is determined by a documented birth date; second, weights are obtained using an electronic scale; third, a minimum of two documented weights measured at least four weeks apart; fourth, the weight for age deceleration must pass through at least two centile spaces on a growth chart. Additionally, the following information applies to this term: a. Age: This case definition is limited to infants up to 12 months of age. b. Weight and Length: Weight should be documented on the appropriate growth chart at the time of assessment. A fall through 2 centile spaces may be demonstrated at any point in the first 12 months of life, using any two weights as long as they are taken at least 4 weeks apart. Details of use of the weight balances allowable under this case definition and use of the Infantometer for length assessment are in Appendix A. c. Growth charts: For infants born at 37 weeks gestation or above, the WHO growth charts should be applied. When using weight for age use the growth chart most accurate for the infants age. The birth to 6 months age range should be used where data is available for this range only, the birth to 2 years chart should be used where data is available beyond 6 months of life. When using weight for length, use the chart for birth to 2 years. For infants born less than 37 completed weeks gestation, the Intergrowth charts for postnatal growth standards in preterm infant should be used. All infants should be plotted on their respective growth chart using their corrected age. Links to relevant growth charts can be found in Appendix A (www.gaia-consortium.net). C128704 GAIA Failure to Thrive Level of Diagnostic Certainty Terminology C C128771 GAIA Level 2a Failure to Thrive GAIA Level 2a Failure to Thrive is defined by either of two criteria: first, the following four requirements must be present: a) Infant age determined by a documented birth date; b) Weights are obtained using a beam balance scale; c) A minimum of two documented weights measured at least four weeks apart; d) Weight for age deceleration must pass through at least two centile spaces on a growth chart; OR second, the following four requirements must be present: a) Infants have an undocumented birth date, where age is determined based on mother's recall to the nearest month; b) Weights are obtained using an electronic scale; c) A minimum of two weights measured at least four weeks apart; d) Weight for age deceleration must pass through at least two centile spaces on a growth chart. Level 2a Failure to Thrive Level 2a Failure to Thrive is defined by either of two criteria: first, the following four requirements must be present: a) Infant age determined by a documented birth date; b) Weights are obtained using a beam balance scale; c) A minimum of two documented weights measured at least four weeks apart; d) Weight for age deceleration must pass through at least two centile spaces on a growth chart; OR second, the following four requirements must be present: a) Infants have an undocumented birth date, where age is determined based on mother's recall to the nearest month; b) Weights are obtained using an electronic scale; c) A minimum of two weights measured at least four weeks apart; d) Weight for age deceleration must pass through at least two centile spaces on a growth chart. C128704 GAIA Failure to Thrive Level of Diagnostic Certainty Terminology C C128772 GAIA Level 2b Failure to Thrive GAIA Level 2b Failure to Thrive is defined by either of two criteria: first, the following four requirements must be present: a) Infant age determined by a documented birth date; b) Weights are obtained using a spring balance scale; c) A minimum of two weights measured at least four weeks apart; d) Weight for age deceleration must pass through at least two centile spaces on a growth chart; OR second, the following three requirements must be present: a) Weight is measured using an electronic scale or beam balance scale; b) Length is documented using infantometer; c) Weight for length ratio less than or equal to the third centile on an appropriate growth chart. Level 2b Failure to Thrive Level 2b Failure to Thrive is defined by the following criteria: first, the following four requirements must be present: a) Infant age determined by a documented birth date; b) Weights are obtained using a spring balance scale; c) A minimum of two weights measured at least four weeks apart; d) Weight for age deceleration must pass through at least two centile spaces on a growth chart; OR second, the following three requirements must be present: a) Weight is measured using an electronic scale or beam balance scale; b) Length is documented using infantometer; c) Weight for length ratio less than or equal to the third centile on an appropriate growth chart. C128704 GAIA Failure to Thrive Level of Diagnostic Certainty Terminology C 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 GA based on LMP without confirmatory 1st or 2nd trimester ultrasound; 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 to 36 weeks); third, the measurement is taken 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 GA based on LMP without confirmatory 1st or 2nd trimester ultrasound; 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 to 36 weeks); third, the measurement is taken 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 C 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), with GA based on certain last menstrual period (LMP) date, with confirmatory first or second trimester ultrasound (US) scan, OR uncertain LMP with second trimester ultrasound, 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 to 36 weeks); third, no confirmation of microcephaly with any additional US or 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), with GA based on certain last menstrual period (LMP) date, with confirmatory first or second trimester ultrasound (US) scan, OR uncertain LMP with second trimester ultrasound, 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 to 36 weeks); third, no confirmation of microcephaly with any additional US or by HC measurement at either birth or autopsy. C128700 GAIA Congenital Microcephaly 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, 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 C128915 GAIA Insufficient Evidence for Diagnosis of Fetal Growth Restriction GAIA Insufficient Evidence for Diagnosis of Fetal Growth Restriction is defined as the absence of an ultrasound for use in the assessment of estimated fetal weight. Insufficient Evidence for Fetal Growth Restriction Insufficient Evidence for Fetal Growth Restriction is defined as the absence of an ultrasound for use in the assessment of estimated fetal weight. C128708 GAIA Fetal Growth Restriction Level of Diagnostic Certainty Terminology