Haemodynamic Effects of Oxytocin and Carbetocin

Haemodynamic Assessment at Primary Caesarean Section After Administration of Carbetocin Versus Oxytocin: a Doubleblind Randomized Trail

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01277978

Enrollment

Registered

2011-01-17

Start date

2008-01-31

Completion date

2008-07-31

Last updated

2011-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Reaction to Oxytocic Agents, Cesarean Section; Complications, Pregnancy Related

Keywords

Caesarean section, Cardiovascular effects, Postpartum hemorrhage, Carbetocin, Oxytocin

Brief summary

The purpose of this study is to evaluate the immediate effects of carbetocin and oxytocin on maternal hemodynamic parameters (heart rate and blood pressure) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section.

Detailed description

As there is a trend toward childbearing in later life, pre-existing maternal cardiovascular problems may become more frequent during pregnancy and at delivery. In addition the increasing number of women with congenital or acquired cardiac diseases may not tolerate the induced haemodynamic changes as well as healthy patients. Therefore uterotonic drugs must be safe for the cardiovascular system. Currently oxytocin is used as a common uterotonic agent in obstetrics. The use of this drug in uterotonic reasons can cause serious haemodynamic side effects which has been shown by several investigators. Preliminary clinical observations of maternal heart rate and blood pressure suggest that that the use of carbetocin causes less hemodynamic changes than oxytocin. Primary objective(s): To evaluate the effect of carbetocin on maternal hemodynamic parameters (heart rate, blood pressure, systemic vascular resistance, cardiac output, stroke volume, heart rate variability, and blood pressure variability) in a non-invasive setup (TaskeForce®-Monitor) during primary Caesarean section. To compare the haemodynamic changes of carbetocin versus oxytocin. Secondary objective(s) To evaluate the need of additional drugs and methods to control uterine tone.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Healthy pregnant women undergoing elective caesarean section with regional anesthesia

Exclusion criteria

---Women with * placenta praevia * placental abruption * multiple gestation * pregnancy related complications and disorders (i.e. preeclampsia, gestational diabetes) * pre-existing diseases (e.g. insulin-dependent diabetes, cardiovascular or renal diseases, thyroid disease * taking medication with known impact on the cardiovascular system * undergoing caesarean section with general anesthesia * secondary caesarean section

Design outcomes

Primary

Measure	Time frame	Description
Immediate hemodynamic effects of carbetocin and oxytocin	1 day	Maternal heart rate, blood pressure, stroke volume, cardiac output, and systemic vascular resistance will be measured non-invasively. Measurements will be performed starting immediately following administration of the study medication.

Secondary

Measure	Time frame	Description
Adverse effects	2 day	Number of participants with adverse events as a measure of safety and tolerability
Uterotonic effect	1 day	Impact of both drugs on uterine tone
Estimation of blood loss	2 day	Measurement of pre- and postoperative hemoglobin levels (routine clinical blood sample).

Countries

Austria

Outcome results