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A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor
Plain-language guide to NCT01634854: not phased randomized trial of Oxytocin, 130 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01634854
- Phase
- not phased
- Status
- completed
- Start
- 2012-07
- Completion (planned or actual)
- 2014-05
- Participants
- 130 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Induction of Labor in Multiparous Women
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
It had two arms (groups): Vaginal Misoprostol (active comparator) and Intravenous Oxytocin (active comparator).
The registry classes the interventions as drug.
More on the Plan
Safety of either drug is not in question.
Who Took Part
Enrollment: 130 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.
Examples of who could join: Clinical candidate for labor induction utilizing either misoprostol or oxytocin. Greater than or equal to 18 years of age. Greater than 37 weeks gestation;.
The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: any clinical contraindication to misoprostol as induction drug; age less than 18 years; contraindication to vaginal birth.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Oxytocin study did not mask who received what.
It started in 2012-07 with completion listed for 2014-05.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Time From Induction to Vaginal Delivery (time frame: Time to delivery in minutes from initiation of medication, up to 24 hours).
It also tracked 6 secondary outcomes, for example Neonatal APGAR Scores, Neonatal Weight at Delivery, Maternal Delivery Outcomes, Maternal Satisfaction With Labor, Number of Participants With Excessive Uterine Activity Necessitating Treatment and NICU Admission and APGAR Less Than 7 at 5 Minutes.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 130 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.