Trial · Interventional

CompletedPhase 4Results postedRegistry data

Carbetocin Versus Oxytocin and Hemodynamic Effects

NCTNCT00977769Other id2009carb

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 76 participants (actual)
Sponsor: Oslo University Hospital · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Norway
Start: Nov 2009
Primary completion: Aug 2011
Completion: Oct 2011
First posted: 16 Sept 2009 (estimated)
Last update posted: 6 May 2014 (estimated)
Conditions: Effects of; Anesthesia, in Pregnancy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2009201020112012

Ph 4
Carbetocin Versus Oxytocin and Hemodynamic Effects
NCT00977769
Nov 2009 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

carbetocin 100 µgDrug
oxytocin 5 uDrug
placebo (NaCl)Drug

Arms3

Experimental
carbetocin 100 µg
Carbetocin injection, 100µg, single injection
Active comparator
oxytocin 5 u
Oxytocin 5U, injection, single injection
Placebo comparator
placebo (NaCl)
Saline single injection

Primary outcomes2

Outcomes the sponsor listed as primary.

Cardiac Output
Time frame · 2.5 minutes
Registry description
The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
Arterial Blood Pressure
Time frame · 2.5 min
Registry description
The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.

Secondary outcomes(1)

Bleeding
Time frame · 120 minutes
Registry description
The calculated estimated blood loss from delivery until 2 h after intervention

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2.5 minutes

Cardiac Output

Group	Value (percentage change in cardiac output)
Carbetocin 100 µg	96
Oxytocin 5 u	82
Placebo (NaCl)	43

Primary outcomeMean· 2.5 min

Arterial Blood Pressure

Group	Value (percentage change in arterial blood pres)
Carbetocin 100 µg	26
Oxytocin 5 u	28
Placebo (NaCl)	16

Secondary and other outcome results(1)

Secondary outcomeMean· 120 minutes

Bleeding

Group	Value (ml blood loss)	Spread
Carbetocin 100 µg	579	623
Oxytocin 5 u	841	556
Placebo (NaCl)	853	518

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Carbetocin 100 µgcarbetocin 100 µg : Hemodynamic effect of	–	0 / 25	9 / 25
Oxytocin 5 uoxytocin 5 u : Hemodynamic effect of	–	0 / 26	9 / 26
Placebo (NaCl)placebo (NaCl) : Hemodynamic effect of	–	0 / 25	2 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2013

Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo.

Rosseland et al. 2013Anesthesiologycited by 92

PMID 23598289DOI 10.1097/aln.0b013e31829416ddPUB-23598289

Full text at the publisher

Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMichelsen 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

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Healthy pregnant women for planned cesarean section Exclusion Criteria: * Bleeding disorders * Placenta disorders

PepBank is a research reference. Talk to a doctor before you use any peptide.