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Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
Plain-language guide to NCT02150954: phase 4 randomized trial of Oxytocin, 121 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02150954
- Phase
- phase 4
- Status
- completed
- Start
- 2007-12
- Completion (planned or actual)
- 2009-03
- Participants
- 121 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Induction of Labor
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Oxytocin.
It had two arms (groups): one (active comparator) and foley bulb with standard incremental pitocin infusion protocol (active comparator).
The registry classes the interventions as drug.
Who Took Part
121 actual participants took part.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with a singleton pregnancy. Term pregnancy (\> 37 weeks gestation). Age ≥ 18 years. Bishop score \< 5. Contractions \< 6/hr.
The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: rupture of membranes; antepartum bleeding; placenta previa or low lying placenta.
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.
The Oxytocin group and the comparison group ran side by side rather than switching.
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 2007-12 with completion listed for 2009-03.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Time to the Second Stage of Labor (time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)). Time to Delivery (time frame: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)).
It also tracked 7 secondary outcomes, for example Rate of Cesarean Delivery, Time to Active Labor, Time to Foley Expulsion or Removal, Incidence of Uterine Hyperstimulation, Neonatal Outcome: Birthweight and Neonatal Outcome: Placental Abruption.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 121 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.