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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01397630
First received: July 7, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Labour Dystocia
Drug: Oxytocin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Accelerate Versus Gradual Titration of Oxytocin Dose for Labour Dystocia: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Consent Rate [ Time Frame: From screening for eligibility until randomization (up to 5 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    1. Pain score on visual analog scale during labour and delivery
    2. North Bristol modified Mackey childbirth satisfaction rating scale


Secondary Outcome Measures:
  • Caesarean section rate [ Time Frame: From admission to a hospital for delivery until delivery (up to 1 week) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 > 4 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 2 hours
  12. Normal fetal heart rate pattern at the time of randomization

Exclusion Criteria:

  1. Severe cardiac or pulmonary disease
  2. Known fetal anomaly
  3. Known sensitivity to oxytocin
  4. Previous caesarean section or uterine surgery
  5. Induced labour (using any method)
  6. Oxytocin use prior to randomization
  7. Second stage of labour
  8. IUGR (<5th percentile)
  9. LGA (>4500 grams)
  10. Suspected chorioamnionitis
  11. Severe pre-eclampsia
  12. Suspected placental abruption
  13. Oligohydramnios (No 2x2 cm amniotic fluid pocket)
  14. Abnormal FHR pattern at the time of randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397630

Locations
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
Investigators
Principal Investigator: Jessica Dy, MD Ottawa Hospital Research Institute
Principal Investigator: Shu Qin Wei, MD, PhD Sainte-Justine Hospital
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01397630     History of Changes
Other Study ID Numbers: 2010-521
Study First Received: July 7, 2011
Last Updated: April 17, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Dystocia
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014