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Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Plain-language guide to NCT04707950: phase 1, phase 2 randomized trial of Oxytocin, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04707950
- Phase
- phase 1, phase 2
- Status
- status unknown
- Start
- 2020-01-01
- Completion (planned or actual)
- 2021-02-25
- Participants
- 60 (estimated)
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Postpartum Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1, phase 2 trial tested Oxytocin.
It had two arms (groups): study group will be given tranexamic acid (active comparator) and Control group (placebo comparator).
The control group will not be given Tranexamic acid but only the standard management ( Oxytocin ).
The registry classes the interventions as drug.
More on the Plan
Participants will be divided into two groups: a study group \& a control group.
Who Took Part
The registry lists 60 planned participants were the target.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 0 inclusion and 14 exclusion criteria; among the exclusions: age less than 18 years; women who are not at high risk for pph; women attending for normal vaginal delivery.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Oxytocin study did not mask who received what.
It started in 2020-01-01 with completion listed for 2021-02-25.
It ran at 2 sites in Egypt (2).
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: Volume of blood loss (time frame: 30 minutes after baby delivery).
It also tracked 7 secondary outcomes, for example transfusion requirements, additional medical intervention, additional surgical or radiological interventions to control bleeding, Change in maternal hematocrit concentration, Tranexamic acid side effects and thromboembolic events.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 60 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.