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Elective Induction vs Spontaneous Labour in Patients With Heart Disease
Plain-language guide to NCT01677364: not phased randomized trial of Oxytocin, 50 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01677364
- Phase
- not phased
- Status
- completed
- Start
- 2009-07
- Completion (planned or actual)
- 2010-12
- Participants
- 50 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Heart; Disease,Complicating Pregnancy, Pre-existing
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Oxytocin.
It had two arms (groups): induction of labour (active comparator) and Spontaneous Labour (no intervention).
Patients were allowed to go into spontaneous labour.
The registry classes the interventions as drug.
More on the Plan
Induction of labour was done with oxytocin.
Who Took Part
The registry lists 50 actual participants took part.
It was open to women only aged from 19 years up to 37 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: NYHA class I-II.
The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: previous cesarean section,; primary pulmonary hypertension,; eisenmenger syndrome,.
How the Study Was Run
Design: randomized, single-group and open-label.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
Being open-label, the Oxytocin study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-07 with completion listed for 2010-12.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Duration of labour (time frame: at the time of delivery). Rate of caesarean section (time frame: at the time of delivery). Number of patients with delivery during workday hours (time frame: at the time of delivery).
It also tracked 2 secondary outcomes, for example number of patients with maternal complications and number of patients with adverse neonatal outcome.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 50 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.