Carbetocin Versus Oxytocin and Hemodynamic Effects

NCT ID: NCT00977769

Last Updated: 2014-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-10-31

Brief Summary

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A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

Detailed Description

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Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.

Conditions

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Effects of; Anesthesia, in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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carbetocin 100 µg

Carbetocin injection, 100µg, single injection

Group Type EXPERIMENTAL

carbetocin 100 µg

Intervention Type DRUG

Hemodynamic effect of

oxytocin 5 u

Oxytocin 5U, injection, single injection

Group Type ACTIVE_COMPARATOR

oxytocin 5 u

Intervention Type DRUG

Hemodynamic effect of

placebo (NaCl)

Saline single injection

Group Type PLACEBO_COMPARATOR

placebo (NaCl)

Intervention Type DRUG

Hemodynamic effect of

Interventions

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carbetocin 100 µg

Hemodynamic effect of

Intervention Type DRUG

oxytocin 5 u

Hemodynamic effect of

Intervention Type DRUG

placebo (NaCl)

Hemodynamic effect of

Intervention Type DRUG

Other Intervention Names

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Pabal, injection Syntocinon, injection Saline, injection

Eligibility Criteria

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Inclusion Criteria

* Healthy pregnant women for planned cesarean section

Exclusion Criteria

* Bleeding disorders
* Placenta disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leiv Arne Rosseland

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leiv Arne Rosseland, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet

Oslo, , Norway

Site Status

Division of Anesthesia and Intensive Care Medicine

Oslo, , Norway

Site Status

Countries

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Norway

References

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Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesaeter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.

Reference Type RESULT
PMID: 23598289 (View on PubMed)

Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.

Reference Type DERIVED
PMID: 34127491 (View on PubMed)

Other Identifiers

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2009carb

Identifier Type: -

Identifier Source: org_study_id

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