NCT02636816

Brief Summary

The investigators are investigating whether slow administration of carbetocin is tolerated by patients better than if it is administered quickly, with respect to side effects such as headache, nausea, vomiting and facial flushing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 30, 2015

Last Update Submit

November 15, 2016

Conditions

Effect of Carbetocin on Cardiovascular SystemPregnancy

Outcome Measures

Primary Outcomes (1)

  • percent change in cardiac output parameters as measured by non-invasive cardiac output monitor

    the parameters will be presented as percentage change from the baseline, which is determined prior to the start of the study period

    10 minutes

Secondary Outcomes (1)

  • incidence of side effects occurring within timeframe below

    30 minutes

Study Arms (2)

Infusion

EXPERIMENTAL

carbetocin is given slowly

Drug: carbetocin

Bolus

ACTIVE COMPARATOR

carbetocin is given quickly

Drug: carbetocin

Interventions

carbetocinDRUG

drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.

Also known as: Duratocin
BolusInfusion

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective cesarean delivery under spinal,
  • low risk for post partum hemorrhage,
  • able to understand english

You may not qualify if:

  • cesarean under general anesthesia,
  • bleeding condition,
  • placenta previa,
  • unable to understand english

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Interventions

carbetocin

Study Officials

  • Vit Gunka, MD FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 22, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

CA(1)