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Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term
Plain-language guide to NCT02416583: not phased randomized trial of Oxytocin, 140 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02416583
- Phase
- not phased
- Status
- completed
- Start
- 2015-04
- Completion (planned or actual)
- 2018-07
- Participants
- 140 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Failed Induction of Labor
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix.
It had two arms (groups): Oxytocin & Membrane sweeping (active comparator) and Oxytocin & Dinoprostone (active comparator).
Women assigned to "Concurrent oxytocin with membrane sweeping" had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day.
The registry classes the interventions as drug and procedure.
Who Took Part
The registry lists 140 actual participants took part.
It was open to women only.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Gestational age \>=37.0 weeks. Bishop score \<=6. Intact amniotic membrane. Absence of labor. Live fetus with vertex presentation.
The full record lists 8 inclusion and 2 exclusion criteria; among the exclusions: multiple pregnancy; placenta previa.
How the Study Was Run
It was run as a randomized, parallel-group and open-label 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.
Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2015-04 with completion listed for 2018-07.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Vaginal delivery within 24 hours.
It also tracked 3 secondary outcomes, for example Successful labor induction, Incidence of cesarean delivery and The interval from start of oxytocin to delivery.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 140 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.