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FOLCROM Trial: Foley Catheter in Rupture of Membranes
Plain-language guide to NCT01973036: not phased randomized trial of Oxytocin, 201 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01973036
- Phase
- not phased
- Status
- completed
- Start
- 2014-03
- Completion (planned or actual)
- 2016-07
- Participants
- 201 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Premature Rupture of Membranes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
It had two arms (groups): Oxytocin (active comparator) and Foley Catheter and Oxytocin (experimental).
The registry classes the interventions as device and drug.
Who Took Part
Enrollment: 201 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 ≥ 34 weeks by best obstetric estimate. Willing to participate and able to understand and sign the informed consent document before randomization. Women of reproductive age.
The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: multiple gestations; lethal fetal anomalies, e.g., anencephaly, trisomy 13, trisomy 18; latex allergy.
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.
Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2014-03 with completion listed for 2016-07.
It ran at 5 sites in United States (5).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Time From Induction of Labor Until Delivery (time frame: Time from induction to delivery (average 14.2 hours)).
It also tracked 17 secondary outcomes, for example Number of Participants With Chorioamnionitis, Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin, Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin, Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries, Rate of Failed Induction of Labor as the Indication for Cesarean and Rate of Endomyometritis.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 201 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.