Carbetocin Versus Oxytocin and Hemodynamic Effects

April 4, 2014 updated by: Leiv Arne Rosseland, Oslo University Hospital

Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet
      • Oslo, Norway, 0027
        • Division of Anesthesia and Intensive Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy pregnant women for planned cesarean section

Exclusion Criteria:

  • Bleeding disorders
  • Placenta disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: carbetocin 100 µg
Carbetocin injection, 100µg, single injection
Drug: carbetocin 100 µg
Hemodynamic effect of
Other Names:
  • Pabal, injection
Active Comparator: oxytocin 5 u
Oxytocin 5U, injection, single injection
Drug: oxytocin 5 u
Hemodynamic effect of
Other Names:
  • Syntocinon, injection
Placebo Comparator: placebo (NaCl)
Saline single injection
Drug: placebo (NaCl)
Hemodynamic effect of
Other Names:
  • Saline, injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output
Time Frame: 2.5 minutes
The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
2.5 minutes
Arterial Blood Pressure
Time Frame: 2.5 min
The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
2.5 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 120 minutes
The calculated estimated blood loss from delivery until 2 h after intervention
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Leiv Arne Rosseland, MD PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 15, 2009

First Posted (Estimate)

September 16, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009carb

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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