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A Trial of Oral Misoprostol for Labor Augmentation
Plain-language guide to NCT00906347: phase 4 randomized trial of Oxytocin, 350 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00906347
- Phase
- phase 4
- Status
- completed
- Start
- 2008-12
- Completion (planned or actual)
- 2011-01
- Participants
- 350 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Labor Augmentation
- 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): Oxytocin augmentation (active comparator) and Misoprostol augmentation (active comparator).
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
The registry classes the interventions as drug.
Who Took Part
350 actual participants took part.
It was open to women only aged from 16 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Clinical decision to augment labor. Gestational age \> than or equal to 36 weeks. Reassuring fetal heart rate tracing. Cervical dilation between 4 and 8 cm. Ruptured membranes with clear amniotic fluid.
The full record lists 11 inclusion and 9 exclusion criteria; among the exclusions: non-reassuring fetal heart rate tracing at time of enrollment; meconium stained amniotic fluid; previous uterine incision.
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.
Being open-label, the Oxytocin study did not mask who received what.
It started in 2008-12 with completion listed for 2011-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Uterine Tachysystole (time frame: Up to four hours after administration of study drug).
It also tracked 7 secondary outcomes, for example Infant Apgar Score <4, Umbilical Cord Artery pH <7.1, Admission of Neonatal Intensive Care Unit, Maternal Chorioamnionitis, Maternal Hypovolemia Requiring Blood Transfusion and Method of Delivery.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 350 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.