|
Field
Secondary Outcomes (End Points)
|
Before
Pregnancy, birth, and maternal health outcomes
• Infant outcomes observed at birth
o Small for gestational age (VR)
o Large for gestational age (VR)
o Low birthweight [<2500 grams] (VR)
o Very low birthweight [<1500 grams] (VR)
o Birthweight [continuous] (VR)
o Preterm birth [<37 weeks’ gestation by obstetric estimate] (VR)
o Extremely preterm birth [<28 weeks’ gestation] (VR)
o Gestational age at birth [continuous] (VR)
o Perinatal mortality [fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life] (MR, FDR)
o Neonatal intensive care unit admission of at least overnight (HD)
o Neonatal morbidity [assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis] (HD)
• Maternal outcomes
o Cesarean delivery (VR)
o Severe acute maternal morbidity [as defined by the CDC] (HD)
o Maternal mortality [up to one year after birth] (MR)
o Neonatal abstinence disorder or maternal drug/substance abuse [2 years post-delivery] (MC, HD)
o Maternal experience of violence or homicide (MC, MR)
o Postpartum visit within the first 12 weeks (MC)
• Utilization and quality of prenatal care
o Adequate prenatal care [Adequacy of Prenatal Care Utilization (APNCU) Index] (VR)
o Number of emergency department visits during pregnancy (HD)
o Dental visit (preventive or treatment) during pregnancy (MC)
o Ultrasound at 18-22 weeks (anatomy scan) (MC)
o Share of recommended prenatal screenings completed (MC)
• Mental health outcomes
o Any mental health diagnosis or outpatient treatment [diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit during pregnancy or 60 days postpartum] (MC)
o Diagnosis of depression/anxiety/stress reaction during pregnancy or 60 days postpartum (MC)
o Antidepressant prescription during pregnancy or 60 days postpartum (MC)
o Outpatient mental health visit during pregnancy or 60 days postpartum (MC)
o Mental health treatment follow up [second antidepressant prescription or outpatient mental health visit with 120 days of treatment initiation] (MC)
o Mental health related emergency/inpatient visit during pregnancy or 12 months postpartum (HD)
o Number of mental health related emergency/inpatient visits during pregnancy or 12 months postpartum (HD)
Child Health & Development
• Accidents, suspected abuse and neglect and emergency care utilization
o Health care encounter or mortality associated with ICD codes indicating major injury in first 24 months of life (MC, HD, MR)
o Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect in first 24 months of life (MC, HD, MR)
o Number of injuries in first 24 months of life (HD)
o Any ED visit during first 24 months of life (HD)
o Number of ED visits first 24 months of life (HD)
o All-cause child mortality in first 24 months of life or fetal death (MR, FDR)
• Outcomes related to preventative care
o Proportion of recommended well-child visits by 15 months (MC)
o At least one lead screening by 15 months (MC)
o At least one developmental screening by 12 months (MC)
o At least one dental visit in the first 24 months (MC)
o Share of recommended fluoride treatments in first 24 months of life (MC)
Maternal Life-Course
• Birth spacing outcomes
o Inter-birth interval of < 24 months (VR)
o Inter-birth interval of < 15 months (VR)
o Inter-birth interval measured at 60 months postpartum [continuous] (VR)
• Postpartum family planning while enrolled in postpartum Medicaid coverage (6 weeks)
o Any family planning related counseling or service (MC, HD)
o Received a highly or moderately effective method of contraception (MC, HD)
o Immediate postpartum long-acting reversible contraception (MC, HD)
• Postpartum family planning within one year
o Any family planning related counseling or service (MC, HD)
o Received a highly or moderately effective method of contraception (MC, HD)
o Postpartum intrauterine device insertion (MC, HD)
• Timing of postpartum family planning take-up
o Time to first take-up of family planning [months from pregnancy] (MC, HD)
o Time to first take-up of highly effective contraception methods [months from discharge] (MC, HD)
Connection to social services
• Enrollment in SNAP, WIC, TANF during pregnancy and first 24 months of child’s life
• Medicaid coverage: continuous enrollment for the child in the first 24 months of child’s life
• Participation in early head start in the first 24 months of child’s life
• Receipt of ABC childcare voucher in the first 24 months of child’s life
We will also examine longer-term indicators of the impact of NFP. We will release additional information about these outcomes in the years after trial enrollment. Examples of anticipated analyses include:
• Longer-term health related outcomes: Inter-birth interval [continuous] (VR), child and adult mortality, intimate partner violence, child health outcomes (ex: asthma, mental health), child and adult health utilization
• Maternal educational attainment: completion of high school (from data provided by the South Carolina Department of Education)
• Child school readiness and achievement: participation in a state-run pre-kindergarten program, test scores in third grade (from data provided by the South Carolina Department of Education)
• Criminal justice involvement: maternal arrests, child arrests (from data provided by South Carolina Law Enforcement Division and the Department of Juvenile Justice)
• Service coordination: enrollment in SNAP, WIC, TANF, early childhood intervention, education and childcare opportunities
• Medicaid coverage: continuous enrollment for the child
• Economic wellbeing: credit scores
|
After
Pregnancy, birth, and maternal health outcomes
• Infant outcomes observed at birth
o Small for gestational age (VR)
o Large for gestational age (VR)
o Low birthweight [<2500 grams] (VR)
o Very low birthweight [<1500 grams] (VR)
o Birthweight [continuous] (VR)
o Preterm birth [<37 weeks’ gestation by obstetric estimate] (VR)
o Extremely preterm birth [<28 weeks’ gestation] (VR)
o Gestational age at birth [continuous] (VR)
o Perinatal mortality [fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life] (MR, FDR)
o Neonatal intensive care unit admission of at least overnight (HD)
o Neonatal morbidity [assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis] (HD)
• Maternal outcomes
o Cesarean delivery (VR)
o Severe acute maternal morbidity [as defined by the CDC] (HD)
o Maternal mortality [up to one year after birth] (MR)
o Neonatal abstinence disorder or maternal drug/substance abuse [2 years post-delivery] (MC, HD)
o Maternal experience of violence or homicide (MC, MR)
o Postpartum visit within the first 12 weeks (MC)
• Utilization and quality of prenatal care
o Adequate prenatal care [Adequacy of Prenatal Care Utilization (APNCU) Index] (VR)
o Number of emergency department visits during pregnancy (HD)
o Dental visit (preventive or treatment) during pregnancy (MC)
o Ultrasound at 18-22 weeks (anatomy scan) (MC)
o Share of recommended prenatal screenings completed (MC)
• Mental health outcomes
o Any mental health diagnosis or outpatient treatment [diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit during pregnancy or 60 days postpartum] (MC)
o Diagnosis of depression/anxiety/stress reaction during pregnancy or 60 days postpartum (MC)
o Antidepressant prescription during pregnancy or 60 days postpartum (MC)
o Outpatient mental health visit during pregnancy or 60 days postpartum (MC)
o Mental health treatment follow up [second antidepressant prescription or outpatient mental health visit with 120 days of treatment initiation] (MC)
o Mental health related emergency/inpatient visit during pregnancy or 12 months postpartum (HD)
o Number of mental health related emergency/inpatient visits during pregnancy or 12 months postpartum (HD)
Child Health & Development
• Accidents, suspected abuse and neglect and emergency care utilization
o Health care encounter or mortality associated with ICD codes indicating major injury in first 24 months of life (MC, HD, MR)
o Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect in first 24 months of life (MC, HD, MR)
o Number of injuries in first 24 months of life (HD)
o Any ED visit during first 24 months of life (HD)
o Number of ED visits first 24 months of life (HD)
o All-cause child mortality in first 24 months of life (MR)
• Outcomes related to preventative care
o Proportion of recommended well-child visits by 15 months (MC)
o At least one lead screening by 15 months (MC)
o At least one developmental screening by 12 months (MC)
o At least one dental visit in the first 24 months (MC)
o Share of recommended fluoride treatments in first 24 months of life (MC)
Maternal Life-Course
• Birth spacing outcomes
o Inter-birth interval of < 24 months (VR)
o Inter-birth interval of < 15 months (VR)
o Inter-birth interval measured at 60 months postpartum [continuous] (VR)
• Postpartum family planning while enrolled in postpartum Medicaid coverage (6 weeks)
o Any family planning related counseling or service (MC, HD)
o Received a highly or moderately effective method of contraception (MC, HD)
o Immediate postpartum long-acting reversible contraception (MC, HD)
• Postpartum family planning within one year
o Any family planning related counseling or service (MC, HD)
o Received a highly or moderately effective method of contraception (MC, HD)
o Postpartum intrauterine device insertion (MC, HD)
• Timing of postpartum family planning take-up
o Time to first take-up of family planning [months from pregnancy] (MC, HD)
o Time to first take-up of highly effective contraception methods [months from discharge] (MC, HD)
Connection to social services
• Enrollment in SNAP, WIC, TANF during pregnancy and first 24 months of child’s life
• Medicaid coverage: continuous enrollment for the child in the first 24 months of child’s life
• Participation in early head start in the first 24 months of child’s life
• Receipt of ABC childcare voucher in the first 24 months of child’s life
We will also examine longer-term indicators of the impact of NFP. We will release additional information about these outcomes in the years after trial enrollment. Examples of anticipated analyses include:
• Longer-term health related outcomes: Inter-birth interval [continuous] (VR), child and adult mortality, intimate partner violence, child health outcomes (ex: asthma, mental health), child and adult health utilization
• Maternal educational attainment: completion of high school (from data provided by the South Carolina Department of Education)
• Child school readiness and achievement: participation in a state-run pre-kindergarten program, test scores in third grade (from data provided by the South Carolina Department of Education)
• Criminal justice involvement: maternal arrests, child arrests (from data provided by South Carolina Law Enforcement Division and the Department of Juvenile Justice)
• Service coordination: enrollment in SNAP, WIC, TANF, early childhood intervention, education and childcare opportunities
• Medicaid coverage: continuous enrollment for the child
• Economic wellbeing: credit scores
|