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ST- Depression on Electrocardiogram During Caesarean Section in Regional Anaesthesia in Women With Preeclampsia
Plain-language guide to NCT01530230: not phased randomized trial of Oxytocin, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01530230
- Phase
- not phased
- Status
- completed
- Start
- 2005-11
- Completion (planned or actual)
- 2008-04
- Participants
- 25 (actual)
- Design
- randomized, triple-blind
- Conditions studied
- Preeclampsia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
The investigators examined whether there was a difference in the occurrence of ST depressions after injection of five or ten units of oxytocin, in preeclamptic patients delivered by caesarean section (CS) under regional anesthesia.
It had two arms (groups): one (other) and one (other).
The registry classes the interventions as drug.
More on the Plan
ST depression on electrocardiograms has been reported in healthy women undergoing cesarean section in regional anesthesia.
A Holter monitor was used to record electrocardiograms.
Non-invasive blood pressure and heart rate were monitored.
Who Took Part
The registry lists 25 actual participants took part.
It was open to women only aged from 18 years up to 50 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: multiple birth,; obesity (body mass index \> 35),; age \< 18 years,.
How the Study Was Run
Design: randomized, single-group and triple-blind.
The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2005-11 with completion listed for 2008-04.
It ran at 1 site in Sweden.
What Was Measured
Researchers chose this as the main measure: Depression of the ST segment on electrocardiograms (time frame: From start of caesarean section until 20 minutes after delivery).
It also tracked 1 secondary outcome, for example Mean arterial pressure and heart rate.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 25 people.
Its size is small, so on its own it can only give an early look.
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.