drugset / Trial / NCT01397630

Accelerated Titration of Oxytocin for Nulliparous Patients With Labour Dystocia: ACTION Pilot Study

NCT01397630 ↗

RandomizedParallel-groupTriple-blindTreatment

Summary

The ultimate objective is to test the hypothesis that an 'accelerated titration' protocol for labour augmentation with oxytocin reduces the risk of caesarean births relative to a 'gradual titration' protocol. The aims of this pilot feasibility are: 1. To assess the feasibility of a large multi-centre randomized control trial comparing the two above oxytocin protocols (accelerated titration versus gradual titration for correction of dystocia). 2. More specifically, to identify potential challenges in the study implementation, particularly with respect to patient recruitment, randomization, blinding, and compliance/adherence to the labour management guidelines and study protocols. 3. To obtain preliminary data on the acceptability of the accelerated oxytocin titration protocol among obstetrical providers and participants.

Timeline

Start
2012-04
Primary completion
2013-10
Completion
2013-11

Outcome

Outcome not reported

Stopped (Enrollment): “Due to budgetary concerns, the TSC decided it best to adjust sample size as there was sufficient data to assess feasibility. Recruitment was terminated early.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Oxytocin Peptide — —

Indications