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Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Plain-language guide to NCT03138252: phase 3 randomized trial of Oxytocin, 180 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03138252
- Phase
- phase 3
- Status
- completed
- Start
- 2014-11
- Completion (planned or actual)
- 2017-07
- Participants
- 180 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Cervical Ripening; Induction of Labor; Multiparity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Oxytocin.
Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.
It had two arms (groups): Cervical Ripening Balloon Alone (active comparator) and Cervical Ripening Balloon + Oxytocin (active comparator).
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
The registry classes the interventions as drug.
Who Took Part
180 actual participants took part.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: any contraindication to cervical ripening balloon, pitocin, or vaginal delivery; placenta within 2 cm of cervical os; placental abruption, chorioamninoitis, or systemic infection prior to induction.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.
It started in 2014-11 with completion listed for 2017-07.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Time From Cervical Ripening to Delivery (time frame: Time to delivery).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Oxytocin in 180 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.