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Trial · NCT04733157

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Postpartum Hemorrhage (PPH)Up to day 2 postpartum
Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.
SecondaryBlood Loss Using Hemoglobin ValuesUp to day 2 postpartumCalculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values
SecondaryMean Blood Loss as Estimated by Obstetrician2 hoursVisually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.
SecondaryOccurrence of Postpartum ShockUp to day 2 postpartumNumber of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.
SecondaryUse of Supplementary Uterotonic(s)Up to day 2 postpartumNumber of women requiring supplementary uterotonics
SecondaryPostpartum TransfusionUp to day 2 postpartumNumber of women given postpartum transfusion
SecondaryEmergency Surgery for PPHUp to day 2 postpartumNumber of participants who had emergency surgery for PPH including caesarean hysterectomies
SecondaryChange in Peripartum HaemoglobinUp to day 2 postpartumMean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.
SecondaryNumber of Participants With a Decrease in Peripartum HemoglobinUp to day 2 postpartumNumber of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL
SecondaryChange in Peripartum HaematocritUp to day 2 postpartumMean change in haematocrit percentage between the study groups from baseline to day 2 postpartum
SecondaryAdmission Into Intensive Care UnitUp to day 2 postpartumNumber of participants transferred to intensive care unit
SecondaryDeath From Any CauseUp to date of death or day 4 from admissionNumber of participants who died from any cause
SecondaryBlood Pressure MeasurementsUp to 2 hours after the caesarean sectionBlood pressure at 15, 30, 45, 60, and 120 min after delivery
SecondaryNumber of Mild Adverse EventsUp to 24 hours after administrationNumber of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
SecondaryNumber of Severe Adverse EventsUp to day 3 postpartum
* Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound) * Pulmonary embolism (if the diagnosis is confirmed by radiological examination) * Myocardial infarction * Seizure * Renal failure requiring dialysis
SecondaryAny Other Unexpected Adverse EventUp to day 3 postpartumNumber of unexpected events during and after the adminstration of study drug and duration of observation
SecondaryLength of Hospital StayUp to day 3 postpartumDuration of hospital admission in days

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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