Haemodynamic Effects of Oxytocin and Carbetocin

Study Overview
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Brief Summary
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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
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carbetocin<br>Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 100 ug Carbetocin (the clinical standard dose) following delivery of the baby. | |
| Oxytocin<br>Women undergoing elective caesarean sectio in regional anesthesia randomised to receive 5 IU oxytocin (the clinical standard dose) following delivery of the baby. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate hemodynamic effects of carbetocin and oxytocin | 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. | 1 day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caesarean section, Cardiovascular effects, Postpartum hemorrhage, Carbetocin, Oxytocin