Labour DystociaPhase 3ACTIONNCT01397630
Accelerated Titration of Oxytocin for Nulliparous Patients With Labour Dystocia: ACTION Pilot Study
A Phase 3 study testing Oxytocin in people with Labour Dystocia, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labour Dystocia
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2012to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capability of participant to comprehend English and/or French and to comply with study requirements
- ≥ 18 years of age at time of consent
- Nulliparity
- Singleton pregnancy
- Cephalic Presentation
- No contraindications to trial of labour or vaginal birth
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- Term pregnancy (37+0 to 42+0 weeks gestation)
- Spontaneous onset of labour
- In the ACTIVE phase of the FIRST stage of labour. Active labour is defined as:
- The presence of regular uterine contractions
- Cervical dilatation of ≥ 3 cm
- Cervical effacement of at least 80% (cervical length < 1cm)
- DYSTOCIA in the ACTIVE phase of FIRST stage of labour established by the Physician.
- Cervical change of < 0.5 cm/hour over four hours OR
- NO cervical change in 2 hours
- Ruptured amniotic membranes of at least 30 minutes
- Normal fetal heart rate pattern at the time of randomization
Who cannot join
- Serious medical condition (severe cardiac, pulmonary, or renal disease)
- Known fetal anomaly
- Known sensitivity to oxytocin
- Contraindications to labour or vaginal birth (uterine scar)
- Induced labour (using any method)
- Oxytocin use prior to randomization
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- Second stage of labour
- Suspected IUGR (<5th percentile)
- Suspected macrosomia at term (>4500 grams)
- Oligohydramnios (no 2x2 pocket of fluid on ultrasound prior to rupture of amniotic membranes)
- Abnormal FHR pattern at the time of randomization
- Suspected chorioamnionitis
- Severe pre-eclampsia
- Suspected placental abruption
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sainte-Justine Hospital
Montreal, Quebec, H3T 1C5
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
About this study
Official title: Accelerate Versus Gradual Titration of Oxytocin Dose for Labour Dystocia: A Pilot Study
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:
- 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).
- 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.
- To obtain preliminary data on the acceptability of the accelerated oxytocin titration protocol among obstetrical providers and participants.
Read the 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.
- Conditions
- Labour Dystocia
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin, Syntocinon, Uteracon
Accelerated Oxytocin Titration
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Oxytocin Titration | Experimental | Not described Receives: Drug: Oxytocin |
| Gradual Oxytocin Titration | Active comparator | Not described Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate
- The proportion of patients who are eligible and thus meet inclusion/exclusion criteria at time of labour onset
- The proportion of eligible participants who consent to participate and are randomized
Measured: From screening for eligibility until randomization (up to 5 weeks)
Protocol Violation Rate
- The proportion among those randomized of deviation from study protocol with regards to duration of oxytocin augmentation prior to operative intervention
Measured: From admission to a hospital for delivery until delivery (up to 1 week)
Maternal satisfaction
- Pain score on visual analog scale during labour and delivery
- North Bristol modified Mackey childbirth satisfaction rating scale
Measured: from hospital admission to 4 weeks postpartum
Secondary outcomes (2)
Caesarean section rate
Measured: From admission to a hospital for delivery until delivery (up to 1 week)
Rate of Maternal and Fetal/Neonatal Adverse Events
- Rate of tachysystole and hyperstimulation
- Rate of abnormal FHR pattern
- Composite index of adverse fetal outcome (cord arterial pH < 7.1, base deficit ≥ 12 mmol/L, 5 minute Apgar score ≤ 7)
- Admission of a term infant to the neonatal intensive care unit
- Proportion requiring unblinding of protocol
Measured: From admission to the hospital for delivery until discharge of the baby from the neonatal intensive care unit (up to 4 weeks after birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionNov 2013
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour DystociaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, The Ottawa Hospital, Canadian Institutes of Health Research (CIHR), Sainte Justine Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Jessica Dy, MD, Principal investigator, Ottawa Hospital Research InstituteShu Qin Wei, MD, PhD, Principal investigator, Sainte-Justine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397630
- Sponsor's protocol ID
- 2010-521
- Acronym
- ACTION
- Status last verified
- Jun 2015
- First submitted
- 7 Jul 2011
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerate Versus Gradual Titration of Oxytocin Dose for Labour Dystocia: A Pilot Study
- ClinicalTrials.gov ID
- NCT01397630
- Acronym / sponsor ID
- ACTION / 2010-521
- Conditions
- Labour Dystocia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, The Ottawa Hospital, Canadian Institutes of Health Research (CIHR), Sainte Justine Hospital Research Institute
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- To obtain preliminary data on the acceptability of the accelerated oxytocin titration protocol among obstetrical providers and participants.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated Oxytocin Titration | Experimental | Drug: Oxytocin |
| Gradual Oxytocin Titration | Active comparator | Drug: Oxytocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Capability of participant to comprehend English and/or French and to comply with study requirements
- ≥ 18 years of age at time of consent
- Nulliparity
- Singleton pregnancy
- Cephalic Presentation
Key exclusion criteria (14 listed)
- Serious medical condition (severe cardiac, pulmonary, or renal disease)
- Known fetal anomaly
- Known sensitivity to oxytocin
- Contraindications to labour or vaginal birth (uterine scar)
- Induced labour (using any method)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Pitocin, Syntocinon, UteraconAccelerated Oxytocin Titration | Drug | Accelerated Oxytocin Titration, Gradual Oxytocin Titration |
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
2 secondary outcomes
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)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
Related trials for Labour Dystocia
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
Not yet recruiting
Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour
Prolonged Labor, Labor Dystocia
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Dy, MD principal investigator
Ottawa Hospital Research Institute
Shu Qin Wei, MD, PhD principal investigator
Sainte-Justine Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxytocin in people with Labour Dystocia, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent Rate (time frame: From screening for eligibility until randomization (up to 5 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.