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Cardiovascular Effects of Carbetocin Given During Elective Cesarean

NCT ID: NCT02636816

Last Updated: 2016-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Effect of Carbetocin on Cardiovascular System Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Infusion

carbetocin is given slowly

Group Type EXPERIMENTAL

carbetocin

Intervention Type DRUG

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

Bolus

carbetocin is given quickly

Group Type ACTIVE_COMPARATOR

carbetocin

Intervention Type DRUG

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

Interventions

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carbetocin

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

Intervention Type DRUG

Other Intervention Names

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Duratocin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vit Gunka, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H15-03007

Identifier Type: -

Identifier Source: org_study_id