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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397630
Recruitment Status : Terminated (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.)
First Posted : July 19, 2011
Last Update Posted : June 25, 2015
The Physicians' Services Incorporated Foundation
The Ottawa Hospital
Canadian Institutes of Health Research (CIHR)
Sainte Justine Hospital Research Institute
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Labour Dystocia Drug: Oxytocin Phase 3

Detailed Description:

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 section. It is postulated that by more rapidly progressing to the required therapeutic dose, cervical dilatation is achieved more rapidly, the likelihood of a spontaneous vaginal birth is increased, and the risk of occurrence of complications resulting from prolonged labour (such as infection and maternal fatigue) is reduced.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Accelerate Versus Gradual Titration of Oxytocin Dose for Labour Dystocia: A Pilot Study
Study Start Date : April 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Accelerated Oxytocin Titration Drug: Oxytocin
Accelerated Oxytocin Titration
Other Name: Pitocin, Syntocinon, Uteracon

Active Comparator: Gradual Oxytocin Titration Drug: Oxytocin
Accelerated Oxytocin Titration
Other Name: Pitocin, Syntocinon, Uteracon

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

Secondary Outcome Measures :
  1. Caesarean section rate [ Time Frame: From admission to a hospital for delivery until delivery (up to 1 week) ]
  2. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Capability of participant to comprehend English and/or French and to comply with study requirements
  2. ≥ 18 years of age at time of consent
  3. Nulliparity
  4. Singleton pregnancy
  5. Cephalic Presentation
  6. No contraindications to trial of labour or vaginal birth
  7. Term pregnancy (37+0 to 42+0 weeks gestation)
  8. Spontaneous onset of labour
  9. In the ACTIVE phase of the FIRST stage of labour. Active labour is defined as:

    1. The presence of regular uterine contractions
    2. Cervical dilatation of ≥ 3 cm
    3. Cervical effacement of at least 80% (cervical length < 1cm)
  10. DYSTOCIA in the ACTIVE phase of FIRST stage of labour established by the Physician.

    1. Cervical change of < 0.5 cm/hour over four hours OR
    2. NO cervical change in 2 hours
  11. Ruptured amniotic membranes of at least 30 minutes
  12. Normal fetal heart rate pattern at the time of randomization

Exclusion Criteria:

  1. Serious medical condition (severe cardiac, pulmonary, or renal disease)
  2. Known fetal anomaly
  3. Known sensitivity to oxytocin
  4. Contraindications to labour or vaginal birth (uterine scar)
  5. Induced labour (using any method)
  6. Oxytocin use prior to randomization
  7. Second stage of labour
  8. Suspected IUGR (<5th percentile)
  9. Suspected macrosomia at term (>4500 grams)
  10. Oligohydramnios (no 2x2 pocket of fluid on ultrasound prior to rupture of amniotic membranes)
  11. Abnormal FHR pattern at the time of randomization
  12. Suspected chorioamnionitis
  13. Severe pre-eclampsia
  14. Suspected placental abruption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397630

Canada, Ontario
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Canada, Quebec
Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Physicians' Services Incorporated Foundation
The Ottawa Hospital
Canadian Institutes of Health Research (CIHR)
Sainte Justine Hospital Research Institute
Principal Investigator: Jessica Dy, MD Ottawa Hospital Research Institute
Principal Investigator: Shu Qin Wei, MD, PhD Sainte-Justine Hospital

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01397630     History of Changes
Other Study ID Numbers: 2010-521
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications
Reproductive Control Agents
Physiological Effects of Drugs