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Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
Plain-language guide to NCT00200252: phase 4 randomized trial of Oxytocin, 300 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00200252
- Phase
- phase 4
- Status
- completed
- Start
- 2005-09
- Completion (planned or actual)
- 2007-07
- Participants
- 300 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Third Stage of Labour
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Oxytocin.
In Canada, oxytocin is given either into the muscle of the thigh or into a vein.
It had three arms (groups): group B (active comparator), group C (active comparator) and group A (active comparator).
Women in group B will receive 10 uts oxytocin IM.
Women in group C will receive oxytocin 5 uts IV.
Women in group A will receive oxytocin 5 uts IM.
The registry classes the interventions as drug.
Who Took Part
The registry lists 300 actual participants took part.
It was open to women only aged from 19 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Women 19 years and older. 32 weeks gestation. Spontaneous vaginal delivery.
The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: previous postpartum hemorrhage; placenta previa; grand multiparity (\>4).
How the Study Was Run
The set-up was randomized, single-group and open-label.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
Being open-label, the Oxytocin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-09 with completion listed for 2007-07.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: change in hematocrit.
It also tracked 13 secondary outcomes, for example estimated blood loss, postpartum hemorrhage (estimated blood loss > 500cc), severe postpartum hemorrhage (estimated blood loss > 1000cc), incidence of hypotension, length of third stage of labour and need for blood transfusion.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 300 people.
The trial is marked completed; 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.