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In Vitro Myometrial Contractions in Laboring and Non-laboring Women
Plain-language guide to NCT01689311: not phased interventional trial of Oxytocin, 53 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01689311
- Phase
- not phased
- Status
- completed
- Start
- 2009-03
- Completion (planned or actual)
- 2011-08
- Participants
- 53 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Postpartum Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs.
It had 1 arm (groups): Treatment (experimental).
The registry classes the interventions as drug.
More on the Plan
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity.
Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol.
The researchers will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.
Who Took Part
Enrollment: 53 actual participants took part.
It was open to women only.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Gestational age 37-41 weeks. Patients requiring primary or first repeat Cesarean section. Cesarean section under spinal anesthesia.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patients who require general anesthesia; patient who had previous myometrial surgery or more than one previous cesarean section; patients with placental anomalies.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-03 with completion listed for 2011-08.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Amplitude of contraction (time frame: 4-5 hours).
It also tracked 3 secondary outcomes, for example Integrated area under response curve (AUC), Basal tone and Frequency of contraction.
What This Means in Plain Language
Put simply, this is a not phased trial of Oxytocin in 53 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.