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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.
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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
| The Ottawa Hospital | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerated Oxytocin Titration | Experimental |
| |
| Gradual Oxytocin Titration | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Accelerated Oxytocin Titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consent Rate |
| From screening for eligibility until randomization (up to 5 weeks) |
| Protocol Violation Rate | a) The proportion among those randomized of deviation from study protocol with regards to duration of oxytocin augmentation prior to operative intervention | From admission to a hospital for delivery until delivery (up to 1 week) |
| Maternal satisfaction |
| from hospital admission to 4 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Caesarean section rate | From admission to a hospital for delivery until delivery (up to 1 week) | |
| Rate of Maternal and Fetal/Neonatal Adverse Events |
|
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Inclusion Criteria:
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
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:
DYSTOCIA in the ACTIVE phase of FIRST stage of labour established by the Physician.
Ruptured amniotic membranes of at least 30 minutes
Normal fetal heart rate pattern at the time of randomization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Dy, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Shu Qin Wei, MD, PhD | Sainte-Justine Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada | ||
| Sainte-Justine Hospital |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Sainte Justine Hospital Research Institute |
| UNKNOWN |
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| From admission to the hospital for delivery until discharge of the baby from the neonatal intensive care unit (up to 4 weeks after birth) |
| Montreal |
| Quebec |
| H3T 1C5 |
| Canada |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |