Carbetocin Versus Oxytocin and Hemodynamic Effects

NCT00977769 | Completed Phase 4 Results

• 1 other identifier: 2009carb
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Effects of; Anesthesia, in Pregnancy

Keywords

cesarean delivery; blood pressure; cardiac output

Outcome Measures

Primary Outcomes (2)

• Cardiac Output

  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

  The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.

  2.5 min

Secondary Outcomes (1)

• Bleeding

  120 minutes

Study Arms (3)

carbetocin 100 µg

EXPERIMENTAL

Carbetocin injection, 100µg, single injection

Drug: carbetocin 100 µg

oxytocin 5 u

ACTIVE COMPARATOR

Oxytocin 5U, injection, single injection

Drug: oxytocin 5 u

placebo (NaCl)

PLACEBO COMPARATOR

Saline single injection

Drug: placebo (NaCl)

Interventions

carbetocin 100 µg DRUG

Hemodynamic effect of

Also known as: Pabal, injection

carbetocin 100 µg

oxytocin 5 u DRUG

Hemodynamic effect of

Also known as: Syntocinon, injection

oxytocin 5 u

placebo (NaCl) DRUG

Hemodynamic effect of

Also known as: Saline, injection

placebo (NaCl)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women for planned cesarean section

You may not qualify if:

• Bleeding disorders
• Placenta disorders

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (2)

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

Oslo, 0027, Norway

Location

Division of Anesthesia and Intensive Care Medicine

Oslo, 0027, Norway

Location

Related Publications (2)

• 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.

  PMID: 23598289 RESULT

• 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.

  PMID: 34127491 DERIVED

MeSH Terms

Interventions

carbetocin; Injections; Oxytocin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Professor Leiv Arne Rosseland
• Organization: Oslo University Hospital

lrossela@ous-hf.no

+4723070000

Study Officials

• Leiv Arne Rosseland, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 6, 2014
• Results First Posted: May 6, 2014

Record last verified: 2014-04

Locations

NO (2)