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

NCT01397630 | Terminated Phase 3 DMC

• 1 other identifier: 2010-521
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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' protocol. The aims of this pilot feasibility are:

1. 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. 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. 3.To obtain preliminary data on the acceptability of the accelerated oxytocin titration protocol among obstetrical providers and participants.

Conditions

Labour Dystocia

Outcome Measures

Primary Outcomes (3)

• Consent Rate

  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

  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

  1. Pain score on visual analog scale during labour and delivery 2. North Bristol modified Mackey childbirth satisfaction rating scale

  from hospital admission to 4 weeks postpartum

Secondary Outcomes (2)

• Caesarean section rate

  From admission to a hospital for delivery until delivery (up to 1 week)

• Rate of Maternal and Fetal/Neonatal Adverse Events

  From admission to the hospital for delivery until discharge of the baby from the neonatal intensive care unit (up to 4 weeks after birth)

Study Arms (2)

Accelerated Oxytocin Titration

EXPERIMENTAL

Drug: Oxytocin

Gradual Oxytocin Titration

ACTIVE COMPARATOR

Drug: Oxytocin

Interventions

Oxytocin DRUG

Accelerated Oxytocin Titration

Also known as: Pitocin, Syntocinon, Uteracon

Accelerated Oxytocin Titration; Gradual Oxytocin Titration

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Physicians' Services Incorporated Foundation: collaborator
• The Ottawa Hospital: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Sainte Justine Hospital Research Institute: collaborator

Study Sites (2)

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sainte-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jessica Dy, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Shu Qin Wei, MD, PhD

  Sainte-Justine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 19, 2011
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

CA (2)