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Trial · NCT03463993

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Postpartum Haemorrhage (PPH)Up to 48 hours post-caesarean sectionPPH based on Haematocrit calculation and PPH based on Haemoglobin calculation
SecondaryEstimated Blood LossAt caesarean sectionBlood loss during caesarean section based on visual estimation and calculation.
SecondaryAmount of Blood TransfusedAt caesarean section up to 48 hours post-caesarean sectionRequirement by participant of blood transfusion
SecondaryNumber of Participants With Use of Additional UterotonicsAt caesarean section up to 48 hours post-caesarean sectionNumber of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol).
SecondaryNumber of Participants With Tranexamic Acid Side EffectsFrom intravenous infusion of the drug up to 48 hours post-caesarean sectionNumber of participants with adverse effects related to tranexamic acid use
SecondaryNumber of Participants Requiring Emergency Surgery for PPHAt caesarean section up to 48 hours post-caesarean sectionNumber of participants requiring emergency surgical procedures to manage any PPH that occurs
SecondaryNumber of Days of Participants' Hospital StayFrom date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlierThe number of days the participant stayed in hospital from the date of admission to date of discharge from hospital.
SecondaryNeonatal Outcome - WeightFrom date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlierNeonatal birth weight in grams
SecondaryNeonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After DeliveryScores at 1 minute from time of delivery and at 5 minutes after delivery
APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores out of 10 at 1 minute and 5 minutes. A measure of the physical condition of a newborn infant. It is obtained by adding points (maximum score of 2, 1, or 0 as minimum score) for Appearance (0 - blue/pale, 1 - pink body, blue extremities, 2 - pink); Pulse (0 - absent heart rate, 1 - below 100 beats per minute, 2 - over 100 beats per minute), Grimace (Reflex irritability - 0 - floppy, 1 - minimal response to stimulation, 2- prompt response to stimulation), Activity (muscle tone: 0 - absent, 1 - Flexed arms and legs, 2 - active), Respiration ( 0 - absent, 1 - slow or irregular, 2 - vigorous cry). APGAR score at 1minute or 5 minute can be a minimum of of 0 (0+0+0+0+0) or maximum of 10 (2 for each parameter above).
SecondaryNeonatal Outcome - Number of Neonates Admitted to the Neonatal UnitFrom date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlierNumber of neonates requiring admission to the neonatal unit from time of delivery at caesarean section
SecondaryNeonatal Outcome - Number of Neonates Diagnosed With JaundiceFrom date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlierNumber of neonates with clinical jaundice (yellowing of the skin or whites of the eyes)
SecondaryNeonatal Outcome - Thromboembolic EventFrom date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlierNumber of neonatal thromboembolic events
SecondaryNeonatal Outcome - DeathFrom date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlierNeonatal death that occurs

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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