Cardiovascular Effects of Carbetocin Given During Electiv... | NCT02636816

Studies
Cardiovascular Effects of Carbetocin Given During Elective Cesarean

NCT02636816

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Nov 17, 2016Estimated

Enrollment

57Actual

Phase

Phase 4

Conditions

Effect of Carbetocin on Cardiovascular System
Pregnancy

Interventions

carbetocin

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Nov 30, 2015

First Submission Date that Met QC Criteria

Dec 21, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

Name	Class
Edwards Lifesciences	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients undergoing elective cesarean under spinal are included in the study. These patients are treated with carbetocin to reduce blood loss from the lining of the womb after delivery of the baby. The study is a randomised double blind controlled trial with 2 groups. One group will receive carbetocin quickly, the second group will receive carbetocin slowly. The investigators will compare the difference between groups with respect to side effects and the effect of carbetocin on the cardiovascular system.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infusion	Experimental	carbetocin is given slowly	Drug: carbetocin
Bolus	Active Comparator	carbetocin is given quickly	Drug: carbetocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carbetocin	Drug	drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.	Bolus Infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
incidence of side effects occurring within timeframe below	headache, nausea, vomiting, facial flushing	30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vit Gunka, MD FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Women's Hospital		Vancouver	British Columbia	V6H 3N1	Canada

Type	Date	Date Unknown
Release	Apr 27, 2017
Reset	Aug 4, 2017
Release	Aug 22, 2017
Unrelease		Yes
Release	Sep 5, 2017
Reset	Apr 11, 2018

Submission Tracking

Estimated Results First Submitted Date

Apr 27, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 27, 2017			Aug 4, 2017
Aug 22, 2017

Intervention Browse Module

MeSH Terms

ID	Term
C020731	carbetocin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided