Trial · NCT03360539
Registered outcomes60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 60
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Composite Birth Outcome | 0-7 days after index birth; vital records, mortality records, and fetal death records | Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life). |
| Primary | Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | within 24 months after index birth; Medicaid claims or hospital discharge data | Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren). |
| Primary | Number of Participants With an Inter-birth Interval of < 21 Months | within 21 months after index birth; vital records | Having a subsequent birth within the first 21 months of the index birth |
| Secondary | Number of Participants With an Infant Born Small for Gestational Age (SGA) | At index birth; vital records | Infant birth weight below the 10th percentile for infants of the same gestational age |
| Secondary | Number of Participants With an Infant Born Large for Gestational Age (LGA) | At index birth birth; vital records | Infant birth weight above the 90th percentile for infants of the same gestational age |
| Secondary | Number of Participants With an Infant Born With Low Birth Weight (LBW) | At index birth; vital records | Number of participants with an infant born with a birth weight of less than 2500 grams. |
| Secondary | Number of Participants With an Infant With Very Low Birth Weight | At index birth; vital records | Number of participants with an infant born with a birth weight of less than 1500 grams. |
| Secondary | Birth Weight (Continuous) | At index birth; vital records | A continuous measure of infant birth weight (grams) |
| Secondary | Number of Participants With a Preterm Birth | At index birth; vital records | Infant born before 37 weeks' gestation (obstetric estimate) |
| Secondary | Number of Participants With an Extremely Preterm Birth | At index birth; vital records | Number of participants with an infant born before 28 weeks' gestation. |
| Secondary | Gestational Age at Birth | At index birth; vital records | Gestational age at birth in weeks (continuous) |
| Secondary | Number of Participants Experiencing Perinatal Mortality | Within 1 week after index birth; mortality records and fetal death records | Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life |
| Secondary | Number of Participants With a NICU Admission of at Least Overnight | At index birth; hospital discharge | Infant admitted to the neonatal intensive care unit (NICU) for at least one night |
| Secondary | Number of Participants Experiencing Neonatal Morbidity | At index birth; hospital discharge | 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. |
| Secondary | Number of Participants Experiencing Cesarean Delivery | At index birth; vital records | Number of participants experiencing a cesarean delivery for their index birth. |
| Secondary | Number of Participants Experiencing Severe Acute Maternal Morbidity | At index birth; hospital discharge | Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC). |
| Secondary | Number of Participants Experiencing Maternal Mortality | Within one year after index birth; mortality records | Number of participants experiencing all-cause mortality within one year postpartum. |
| Secondary | Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse | Within two years after index birth; Medicaid claims, hospital discharge | Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum. |
| Secondary | Number of Participants Experiencing Violence or Homicide | Within 2 years after index birth; Medicaid claims, mortality records | Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code |
| Secondary | Number of Participants With a Postpartum Visit | Within 12 weeks after index birth; Medicaid claims | Number of participants with a postpartum visit in first 12 weeks after an index birth. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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