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Trial · NCT00135707

Registered outcomes36

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

ListOutcomeTime frameDescription
PrimaryComposite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate20 weeks through discharge following delivery
Severe hypertension (blood pressure \[BP\]\>= 160/110) or mild hypertension (BP\>= 140/90) \>= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death
PrimarySevere Hypertension20 weeks through discharge following delivery
Included here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death.
PrimarySevere or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels20 weeks through discharge following delivery
Elevated liver enzyme levels are specified as an aspartate aminotransferase level of \>= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
PrimarySevere or Mild Pregnancy-associated Hypertension With Thrombocytopenia20 weeks through discharge following delivery
Thrombocytopenia defined as a platelet count of \<100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
PrimarySevere or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level20 weeks through discharge following delivery
Elevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
PrimarySevere or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure20 weeks through discharge following delivery
Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
PrimarySevere or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders20 weeks through discharge following delivery
Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
PrimarySevere or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group20 weeks through discharge following delivery
Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
PrimarySevere or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death20 weeks through discharge or prior to discharge following delivery admission
Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
SecondaryPreeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)20 weeks through discharge following deliveryHELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
SecondaryPregnancy Associated Hypertension20 weeks through discharge following delivery
SecondaryMedically Indicated Delivery Because of Hypertension20 weeks through discharge following delivery
SecondaryAspartate Aminotransferase ≥100 U/Liter20 weeks through discharge
SecondaryCreatinine ≥1.5 mg/dl (133 μmol/Liter)20 weeks through discharge
SecondaryAntepartum BleedingDuring pregnancy
SecondaryPremature Rupture of MembranesDuring pregnancy
SecondaryPlacental AbruptionDuring pregnancy
SecondaryCesarean DeliveryDelivery
SecondaryMaternal DeathDelivery through hospital discharge
SecondaryPostpartum Pulmonary EdemaAfter delivery through discharge

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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