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Trial · NCT07894705

Registered outcomes38

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

ListOutcomeTime frameDescription
PrimaryMean latency from diagnosis of hypertensive disorders of pregnancy (HDP) to delivery (continuous, mean with standard deviation)from randomization to deliveryThe number of days from randomization to delivery will be analyzed as a continuous variable
SecondaryBlood pressure control (continuous, mean with standard deviation)from randomization to deliveryBP control will be analyzed as mean systolic and diastolic blood pressures; frequency of acute treatment (oral or IV) of severe range elevated BPs
SecondarySerum Soluble fms-like tyrosine kinase 1 / placental growth factor (sFlt-1/PlGF) (log ratio)from randomization to delivery
Weekly serum sFlt-1/PlGF will be obtained from randomization until delivery. The clinical care team will be blinded to the results of this test as this is not part of our institutional protocol for inpatient management of HDP. The results will be analyzed at the conclusion of the study.
SecondaryThe frequency of hemolysis, elevated liver enzymes, low platelets (HELLP)from randomization through 6 weeks postpartum
SecondaryFrequency of placental abruptionfrom randomization to delivery
SecondaryFrequency of eclampsiafrom randomization through 6 weeks postpartum
SecondaryFrequency of strokefrom randomization through 6 weeks postpartum
SecondaryFrequency of MI or anginafrom randomization through 6 weeks postpartum
SecondaryFrequency of heart failurefrom randomization through 6 weeks postpartum
SecondaryFrequency of intensive care unit (ICU) admission or intubationfrom randomization through 6 weeks postpartum
SecondaryFrequency of readmission within 42 days postpartumfrom randomization through 6 weeks postpartum
SecondaryFrequency of maternal deathfrom randomization through 6 weeks postpartum
SecondaryFrequency of encephalopathyfrom randomization through 6 weeks postpartum
SecondaryFrequency of pulmonary edemafrom randomization through 6 weeks postpartum
SecondaryFrequency of Renal Failurefrom randomization through 6 weeks postpartum
SecondaryIndication for deliveryat deliveryThe indication for delivery will be categorized as the following non-reassuring fetal status, uncontrolled HTN, worsening symptoms/labs).
SecondaryMode of deliveryat deliveryThe mode of delivery will be categorized as normal spontaneous vaginal delivery (NSVD), forceps assisted vaginal delivery (FAVD), vacuum assisted vaginal delivery (VAVD), C-section.
SecondaryGlobal health status (PRO) per the PRO Measurement Information System (PROMIS Global-10) (continuous, mean with standard deviation)from 4 to 6 weeks postpartum
The PRO Measurement Information System (PROMIS Global-10) is a validated survey of patient-reported outcome measure to assess overall wellbeing. This survey will be administered from 4 to 6 weeks postpartum.
SecondaryBirth experience satisfaction per Birth Satisfaction Scale- Revised (BSS-R (continuous, mean with standard deviation)from delivery to 6 weeks postpartum
The Birth Satisfaction Survey- Revised (BSS-R) is a validated patient satisfaction survey describing L\&D birthing experiences. This survey will be administered at any time from delivery through 6 weeks postpartum.
SecondaryMaternal infant bonding per maternal infant bonding scale (MIBS) (continuous, mean with standard deviation)from 4 to 6 weeks postpartum
The maternal infant bonding scale (MIBS) is a validated is a validated survey of patient-reported outcome measure describing a mother's early emotional feelings and potential bonding challenges with her newborn. This survey will be administered from 4 to 6 weeks postpartum.

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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