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Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial
Plain-language guide to NCT00468520: not phased randomized trial of Oxytocin, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00468520
- Phase
- not phased
- Status
- completed
- Start
- 2003-11
- Completion (planned or actual)
- 2005-10
- Participants
- 200 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Pregnancy; Induced Labor; Cervical Ripening
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
Scientific validation of this practice is lacking.
The registry classes the interventions as drug.
More on the Plan
This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening.
Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols.
Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.
Who Took Part
The registry lists 200 actual participants took part.
It was open to women only aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Presenting for induction as determined by their primary obstetrical provider. With fetuses in cephalic presentation. Gestational age greater than 23 weeks.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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 2003-11 with completion listed for 2005-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Delivery rate (proportion) (time frame: Within 24 hours).
It also tracked 4 secondary outcomes, for example vaginal delivery rate, use of anesthesia/analgesia, overall complication rate (composite) and duration of induction and labor.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 200 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.