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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Accelerate Versus Gradual Titration of Oxytocin Dose for Labour Dystocia: A Pilot Study

Brief 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.

Detailed Summary:

There has been a steady increase in the rate of Caesarean births in Canada and worldwide. Almost half of all primary caesarean sections are performed for labour dystocia - when labour is abnormally slow or when there is no further progression in cervical dilatation. When dystocia occurs, oxytocin is used to increase the frequency and intensity of uterine contractions, with the goal of achieving full cervical dilatation and a vaginal birth. The actual dose required to produce a clinical response (progressive cervical dilatation) varies greatly from patient to patient. There is a wide range of oxytocin regimens currently in use. They may be broadly categorized as being of two types: 1) those involving a gradual titration of oxytocin dose (or 'low dose') and 2) those with accelerated oxytocin titration (also called 'high dose').

In fact, the frequently used terms 'low dose' and 'high dose' are to a certain extent misnomers. Both protocols titrate oxytocin dose to achieve the desired 'physiological frequency' of uterine contractions (usually 4 to 5 contractions in a 10 minute interval) that are normally sufficient to result in progressive labour. Thus, the target dose should, theoretically, be identical and independent of the rate of increase of oxytocin. These protocols differ mainly in the rate at which the desired physiologic response is achieved. While most patients achieve a response to stimulation at oxytocin concentrations between 4 and 10 mU per minute, a proportion of nulliparae require higher doses of oxytocin. Accelerated titration protocols are also frequently associated with a higher maximum concentration of oxytocin. While, most Canadian birthing centres currently follow a 'gradual titration' or 'low dose' protocol, there is evidence that 'accelerated titration' or 'high dose' protocols may be more effective in correcting dystocia and in preventing caesarean sec
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome:

  • Consent Rate [ Time Frame: From screening for eligibility until randomization (up to 5 weeks) ]
    1. The proportion of patients who are eligible and thus meet inclusion/exclusion criteria at time of labour onset
    2. The proportion of eligible participants who consent to participate and are randomized
  • Protocol Violation Rate [ Time Frame: From admission to a hospital for delivery until delivery (up to 1 week) ]
    a) The proportion among those randomized of deviation from study protocol with regards to duration of oxytocin augmentation prior to operative intervention
  • Maternal satisfaction [ Time Frame: from hospital admission to 4 weeks postpartum ]
    1. Pain score on visual analog scale during labour and delivery
    2. North Bristol modified Mackey childbirth satisfaction rating scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Caesarean section rate [ Time Frame: From admission to a hospital for delivery until delivery (up to 1 week) ]
  • Rate of Maternal and Fetal/Neonatal Adverse Events [ Time Frame: From admission to the hospital for delivery until discharge of the baby from the neonatal intensive care unit (up to 4 weeks after birth) ]
    1. Rate of tachysystole and hyperstimulation
    2. Rate of abnormal FHR pattern
    3. Composite index of adverse fetal outcome (cord arterial pH < 7.1, base deficit ≥ 12 mmol/L, 5 minute Apgar score ≤ 7)
    4. Admission of a term infant to the neonatal intensive care unit
    5. Proportion requiring unblinding of protocol


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: July 7, 2011
Date Started: April 2012
Date Completion:
Last Updated: June 23, 2015
Last Verified: June 2015