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Trial · NCT02299414

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryComposite Adverse Perinatal OutcomeUp to 2 weeks postpartum for preeclampsia or 90 days for neonatal death
One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB \<35 weeks (not due to spontaneous preterm labor or membrane rupture).
PrimarySmall for Gestational Age (Safety)Until deliveryBirth weight less than 10th percentile for gestational age at birth according to accepted national standard
SecondaryComposite of Maternal Death or Severe Cardiovascular MorbidityUp to 6 weeks (4-12 weeks) after deliveryOne or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure
SecondarySevere Maternal Hypertension + Components of the Primary Composite EndpointUp to 2 weeks postpartum or 90 days for neonatal deathPersistent severe hypertension with or without proteinuria + the primary composite
SecondaryPreterm Birth and Indicated Preterm Birth (<37 Weeks)Until deliveryPreterm birth and Indicated preterm birth (\<37 weeks) includes any preterm birth less than 37 weeks
SecondaryComposite of Severe Neonatal MorbiditiesUp to 90 days post deliveryOne or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV
SecondaryAdherence to Treatment After Delivery6 weeks (4-12 weeks) after deliveryCounts with high adherence to antihypertensive therapy after delivery for those prescribed medications.
OtherSuperimposed PreeclampsiaUp to 2 weeks after deliveryMild or severe, including eclampsia
OtherSuperimposed Gestational HypertensionEnrollment (between 6 and 18 weeks gestation) to deliveryPersistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation
OtherSevere HypertensionUp to 6 weeks (4-12 weeks) after deliveryBlood pressure ≥160/110
OtherCesarean DeliveryUntil deliveryCesarean delivery
OtherBlood TransfusionUp to 6 weeksDuring pregnancy or postpartum
OtherNICU AdmissionUp to 6 weeks (4-12 weeks) after deliveryAny NICU admission
OtherLow Birth WeightAt birthBirth weight \<2500g
OtherPonderal IndexAt birthMean ponderal index, mass/height\^3 at birth
OtherHead CircumferenceAt birthMean head circumference
OtherPlacental WeightAt deliveryMean placental weight
OtherHypoglycemiaFrom delivery to hospital discharge (2 - 3 days after delivery)Prevalence of hypoglycemia
OtherBradycardiaFrom delivery to hospital discharge (2 - 3 days after delivery)Prevalence of bradycardia
OtherHypotensionFrom delivery to hospital discharge (2 - 3 days after delivery)Incidence (%) with hypotension

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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