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Trial · NCT03360539

Outcomes60

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With a Composite Birth Outcome0-7 days after index birth; vital records, mortality records, and fetal death recordsDiffers from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglectwithin 24 months after index birth; Medicaid claims or hospital discharge dataDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With an Inter-birth Interval of < 21 Monthswithin 21 months after index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Infant Born Small for Gestational Age (SGA)At index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Infant Born Large for Gestational Age (LGA)At index birth birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Infant Born With Low Birth Weight (LBW)At index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Infant With Very Low Birth WeightAt index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBirth Weight (Continuous)At index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.gramsMEAN
SECONDARYNumber of Participants With a Preterm BirthAt index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With an Extremely Preterm BirthAt index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYGestational Age at BirthAt index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.weeksMEAN
SECONDARYNumber of Participants Experiencing Perinatal MortalityWithin 1 week after index birth; mortality records and fetal death recordsDiffers from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With a NICU Admission of at Least OvernightAt index birth; hospital discharge
Differs from randomized sample as it excludes participants with missing outcome data, those who experienced an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Neonatal MorbidityAt index birth; hospital dischargeDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Cesarean DeliveryAt index birth; vital recordsDiffers from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Severe Acute Maternal MorbidityAt index birth; hospital dischargeThe analysis population for this outcome includes participants who matched to an index birth in claims data.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Maternal MortalityWithin one year after index birth; mortality records
Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance AbuseWithin two years after index birth; Medicaid claims, hospital discharge
Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Violence or HomicideWithin 2 years after index birth; Medicaid claims, mortality records
Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With a Postpartum VisitWithin 12 weeks after index birth; Medicaid claims
Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy.
ParticipantsCOUNT_OF_PARTICIPANTS

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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