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Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section
Plain-language guide to NCT01571323: phase 1, phase 2 randomized trial of Oxytocin, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01571323
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2012-02
- Completion (planned or actual)
- 2012-08
- Participants
- 150 (actual)
- Design
- randomized, quadruple-blind, prevention
- Conditions studied
- Post Partum Haemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Oxytocin.
The patients were randomly allocated to one of three groups of 50 each.
It had three arms (groups): Misoprostol (active comparator), Oxytocin (active comparator) and Oxytocin and Misoprostol (active comparator).
The registry classes the interventions as drug.
Who Took Part
150 actual participants took part.
It was open to women only aged from 18 years up to 42 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: women with any risk factor.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
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.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2012-02 with completion listed for 2012-08.
It ran at 1 site in Iran.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: changes in hemoglobin levels after delivery (time frame: Hemoglobin values will be determined both before surgery and 24 h following surgery).
It also tracked 1 secondary outcome, for example Hemodynamic variables.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 150 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.