Status:
TERMINATED
Accelerated Titration of Oxytocin for Nulliparous Patients With Labour Dystocia: ACTION Pilot Study
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
The Ottawa Hospital
Conditions:
Labour Dystocia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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' p...
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 sl...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01397630
Start Date
April 1 2012
End Date
November 1 2013
Last Update
June 25 2015
Active Locations (2)
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1
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
2
Sainte-Justine Hospital
Montreal, Quebec, Canada, H3T 1C5