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

• Status: Terminated
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Sainte Justine Hospital Research Institute; The Ottawa Hospital; The Physicians' Services Incorporated Foundation
• Treatments: Oxytocin

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 ≥ 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