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Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin
Plain-language guide to NCT01373359: phase 3 randomized trial of Oxytocin, 652 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01373359
- Phase
- phase 3
- Status
- completed
- Start
- 2007-03
- Completion (planned or actual)
- 2008-01
- Participants
- 652 (actual)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Postpartum Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Oxytocin.
It had two arms (groups): Sublingual misoprostol (experimental) and Oxytocin (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 652 actual participants took part.
It was open to women only aged from 18 years up to 35 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women with a gestational age \>28weeks. Singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy).
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: women with pregnancy induced hypertension; antepartum haemorrhage; previous caesarean section or presence of uterine scar.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
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 and care provider.
It started in 2007-03 with completion listed for 2008-01.
It ran at 1 site in India.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): mean blood loss (time frame: 2 hours after delivery). postpartum hemorrhage (Blood loss >500 mls) (time frame: 2 hours after delivery).
It also tracked 2 secondary outcomes, for example Medication side effects.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Oxytocin in 652 people.
With 652 participants it is a large trial for this field.
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.