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Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions

Primary Purpose

Hemodynamic Instability, Epidural, Pregnancy

Status
Not yet recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Levobupivacaine
Ropivacaine
Sponsored by
Althaia Xarxa Assistencial Universitària de Manresa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodynamic Instability focused on measuring Hemodynamic instability, Epidural, Pregnancy, Fetal Cardiac disorder

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: - Woman > 18 years Request epidural anesthesia (EA) Expansion period Low obstetric risk ASA I-II (only one associated comorbidity, example: arterial hypertension, etc.) Cervix dilation ≥ 3 single fetus Gestational age > 36 weeks Normal Fetal Heart Rate (110 -160 beats / minute) Normal Cardiotocographic record or absence of fetal heart rate patterns suggestive of risk of loss of fetal well-being or non-reassuring cardiotocographic record. Exclusion Criteria: VAS ≤ 2 Breech presentation Maternal fever > 38 years Pre-eclampsia and severe eclampsia Prenatal bleeding ASA II (more than one comorbidity) Chronic pain Substance abuse Contraindications for epidural analgesia (EA) Allergy to local anesthetics BMI >40 kg/m² Presence of RCTG not reassuring

Sites / Locations

  • Althaia Xarxa Assitensial i Universitaria Manresa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Levobupivacaina

Ropivacaina

Arm Description

Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour

Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour

Outcomes

Primary Outcome Measures

Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure :dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

Secondary Outcome Measures

Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Arealimits) will also be included
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.

Full Information

First Posted
March 20, 2023
Last Updated
May 17, 2023
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
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1. Study Identification

Unique Protocol Identification Number
NCT05877131
Brief Title
Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions
Official Title
Randomized Clinical Trial to Evaluate the Efficacy of Levobupivacaine 0.125% vs Ropivacaine 0.2%, in Hemodynamic Alterations in Pregnant Women in Labor and Their Fetal Repercussions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Althaia Xarxa Assistencial Universitària de Manresa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
INTRODUCTION: Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being. METHODOLOGY/DESIGN: It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects. DISCUSSION: Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.
Detailed Description
Any patient presenting in the delivery room or gynecology-obstetrics office of the hospital with prodromes, midwives or gynecologists will inform the principal investigator (PI). The IP will contact the patient to inform them of what the study consists of and if they wish to participate in it. In case of acceptance, the explanatory documentation and a questionnaire will be delivered to determine if it meets the inclusion criteria. If the pregnant patient at term meets the inclusion criteria, she is recruited to enter the study, it will also be used to resolve any doubts that the patient may have. Once the patient has signed the informed consent, the collaborating researcher (CI) of the recruiting center will be notified to contact the Althaia Innovation and Research Unit to find out the patient's assignment group. The collaborating researcher will be in charge of notifying the patient of the group to which she has been assigned (Intervention Group A or B). Initially, the basal hemodynamic constants will be recorded: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), systemic vascular resistance (SVR), cardiac output (CO), index Pulse Pressure Variation (PPV), Stroke Volume Variation (SVV), Heart Rate (HR), Stroke Volume (SV), Partial Pressure Oxygen Saturation (SpO2) via Clearsight device ®; pain score (VAS); degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The FHR will also be recorded, as well as the different pathological patterns of the RCTG that appear, the Philips Avalon FM 30 monitor will be used for this. The steps to follow for the administration of local anesthetic through the epidural catheter will be the following: The mother's data (before and after AE) will be collected, including hemodynamic data: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), vascular resistance heart rate (SVR), cardiac output (CO), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (VSV), heart rate (HR), stroke volume (SV), blood saturation partial pressure of oxygen (SpO2); pain score (VAS), degree of analgesia achieved, satisfaction obtained, time onset of analgesia, level of sensory block using the pin-prick test and the hot-cold test; degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The fetal data (before and after the AE) of the FHR (values above or below the normal limits) will also be included, as well as the different pathological patterns of the RCTG that appear, due to hypotension or alterations. associated hemodynamics. All pregnant women who will participate in this study will carry an intravenous cannula and will receive a fluid load of 500 cc. The position of the patients will be in a sitting position and the epidural puncture will be performed at the level of the L2-3 or L3-4 intervertebral space using a Tuohy 18 epidural needle. The loss of resistance technique with air or saline will be used according to the standards of our service. A volume of 2 ml of 2% lidocaine will be administered via the epidural via the epidural catheter, after 3 minutes (it will be evaluated if undesirable effects appear: such as motor block due to accidental dural puncture, hypotension, nausea, vomiting), it will be administered to pregnant women the final volume (10 cc) of the local anesthetic randomly assigned via epidural. After the administration of the initial bolus (Group A - Group B), the different constants or parameters to be evaluated will be recorded. The measurement of the different hemodynamic variables will be recorded through a non-invasive device, the Clearsight®. The device will automatically determine the constants, which will be recorded at 5, 10, 15, 30, 45 and 60 minutes. In the event of recording an episode of hypotension after the first 60 minutes, a record of all the hemodynamic variables evaluated will be made every 5 minutes for the following 60 minutes. It will be determined which of the local anesthetics at low concentrations administered via the epidural is related to alteration of the hemodynamic parameters. To measure the different parameters, a non-invasive device (Clearsight) will be used, which will determine the existing hemodynamic alterations before, after, and during the first hour after the administration of the initial dose through the lumbar epidural catheter, as well as in the event of an episode. of hypotension or changes in FHR and/or RCTG after the first hour of catheter placement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Epidural, Pregnancy, Fetal Cardiac Disorder
Keywords
Hemodynamic instability, Epidural, Pregnancy, Fetal Cardiac disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levobupivacaina
Arm Type
Active Comparator
Arm Description
Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour
Arm Title
Ropivacaina
Arm Type
Active Comparator
Arm Description
Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
To evaluate the efficacy of low-dose levobupivacaine (0.125%) (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
To evaluate the efficacy of low-dose ropivacaine (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.
Primary Outcome Measure Information:
Title
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
10 minutes before epidural
Title
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
5 minutes after epidural
Title
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
10 minutes after epidural
Title
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
15 minutes after epidural
Title
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
30 minutes after epidural
Title
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
45 minutes after epidural
Title
Systemic vascular resistance ( units of measure :dyn*s/cm5)
Description
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Time Frame
60 minutes after epidural
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
10 minutes before epidural
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
5 minutes after epidural
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
10 minutes after epidural
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
15 minutes after epidural
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
30 minutes after epidural
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
45 minutes after epidural
Title
Systolic Blood Pressure (units of measure :mmHg)
Description
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Time Frame
60 minutes after epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
10 minutes before epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
5 minutes after epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
10 minutes after epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
15 minutes after epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
30 minutes after epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
45 minutes after epidural
Title
Diastolic Blood Pressure (units of measure :mmHg)
Description
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Time Frame
60 minutes after epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
10 minutes before epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
5 minutes after epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
10 minutes after epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
15 minutes after epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
30 minutes after epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
45 minutes after epidural
Title
Mean Arterial Pressure (units of measure :mmHg)
Description
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is: PAM = (GC x RVP) + PVC
Time Frame
60 minutes after epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
10 minutes before epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
5 minutes after epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
10 minutes after epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
15 minutes after epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
30 minutes after epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
45 minutes after epidural
Title
Pulse Pressure (units of measure :mmHg)
Description
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Time Frame
60 minutes after epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
10 minutes before epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
5 minutes after epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
10 minutes after epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
15 minutes after epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
30 minutes after epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
45 minutes after epidural
Title
Cardiac Output (units of measure :L/min)
Description
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume: Cardiac output = heart rate x stroke volume
Time Frame
60 minutes after epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Time Frame
10 minutes before epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Time Frame
5 minutes after epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Time Frame
10 minutes after epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Arealimits) will also be included
Time Frame
15 minutes after epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Time Frame
30 minutes after epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Time Frame
45 minutes after epidural
Title
Cardiac Index ( units of measure :L/min/m2)
Description
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index. Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Time Frame
60 minutes after epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
10 minutes before epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
5 minutes after epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
10 minutes after epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
15 minutes after epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
30 minutes after epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
45 minutes after epidural
Title
Pulse Pressure Variation ( units of measure :% Percent)
Description
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax + PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Time Frame
60 minutes after epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
10 minutes before epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
5 minutes after epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
10 minutes after epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
15 minutes after epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
30 minutes after epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
45 minutes after epidural
Title
(Maternal) Heart Rate (units of measure: beats per minute)
Description
The number of times the heart beats during a certain period, usually one minute. The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Time Frame
60 minutes after epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
10 minutes before epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
5 minutes after epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
10 minutes after epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
15 minutes after epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
30 minutes after epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
45 minutes after epidural
Title
Stroke Volume (units of measure :ml)
Description
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Time Frame
60 minutes after epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
10 minutes before epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
5 minutes after epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
10 minutes after epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
15 minutes after epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
30 minutes after epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
45 minutes after epidural
Title
Systolic Variation Volume ( units of measure :% Percent)
Description
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Time Frame
60 minutes after epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
10 minutes before epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
5 minutes after epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
10 minutes after epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
15 minutes after epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
30 minutes after epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
45 minutes after epidural
Title
Arterial Oxigen Saturation ( units of measure :% Percent)
Description
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Time Frame
60 minutes after epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
10 minutes before epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
5 minutes after epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
10 minutes after epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
15 minutes after epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
30 minutes after epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
45 minutes after epidural
Title
Fetal heart rate (units of measure: beats per minute)
Description
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Time Frame
60 minutes after epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
10 minutes before epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
5 minutes after epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
10 minutes after epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
15 minutes after epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
30 minutes after epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
45 minutes after epidural
Title
Variability (units of measure: beats per minute)
Description
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Time Frame
60 minutes after epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
10 minutes before epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
5 minutes after epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
10 minutes after epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
15 minutes after epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
30 minutes after epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
45 minutes after epidural
Title
Accelerations (units of measure: beats per minute)
Description
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Time Frame
60 minutes after epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
10 minutes before epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
5 minutes after epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
10 minutes after epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
15 minutes after epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
30 minutes after epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
45 minutes after epidural
Title
Decelerations (units of measure: beats per minute)
Description
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Time Frame
60 minutes after epidural

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Woman > 18 years Request epidural anesthesia (EA) Expansion period Low obstetric risk ASA I-II (only one associated comorbidity, example: arterial hypertension, etc.) Cervix dilation ≥ 3 single fetus Gestational age > 36 weeks Normal Fetal Heart Rate (110 -160 beats / minute) Normal Cardiotocographic record or absence of fetal heart rate patterns suggestive of risk of loss of fetal well-being or non-reassuring cardiotocographic record. Exclusion Criteria: VAS ≤ 2 Breech presentation Maternal fever > 38 years Pre-eclampsia and severe eclampsia Prenatal bleeding ASA II (more than one comorbidity) Chronic pain Substance abuse Contraindications for epidural analgesia (EA) Allergy to local anesthetics BMI >40 kg/m² Presence of RCTG not reassuring
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricio Roberto Argañaraz Quinteros, Physician
Phone
0034600609107
Email
mraq1969@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Gonzalez Suarez
Facility Information:
Facility Name
Althaia Xarxa Assitensial i Universitaria Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Arnau Bartes, Epidemiologist
Phone
0034938759300
Ext
3414
Email
aarnau@althaia.cat

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12850637
Citation
ACOG Committee on Practice Bulletins. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 44, July 2003. (Replaces Committee Opinion Number 252, March 2001). Obstet Gynecol. 2003 Jul;102(1):203-13. No abstract available.
Results Reference
background
PubMed Identifier
8281589
Citation
Preston R, Crosby ET, Kotarba D, Dudas H, Elliott RD. Maternal positioning affects fetal heart rate changes after epidural analgesia for labour. Can J Anaesth. 1993 Dec;40(12):1136-41. doi: 10.1007/BF03009602.
Results Reference
background
PubMed Identifier
30130346
Citation
Lappen JR, Chien EK, Mercer BM. Contraction-Associated Maternal Heart Rate Decelerations: A Pragmatic Marker of Intrapartum Volume Status. Obstet Gynecol. 2018 Oct;132(4):1011-1017. doi: 10.1097/AOG.0000000000002808.
Results Reference
background
PubMed Identifier
26333691
Citation
Valensise H, Lo Presti D, Tiralongo GM, Pisani I, Gagliardi G, Vasapollo B, Frigo MG. Foetal heart rate deceleration with combined spinal-epidural analgesia during labour: a maternal haemodynamic cardiac study. J Matern Fetal Neonatal Med. 2016;29(12):1980-6. doi: 10.3109/14767058.2015.1072156. Epub 2015 Aug 28.
Results Reference
background
PubMed Identifier
719463
Citation
Collins KM, Bevan DR, Beard RW. Fluid loading to reduce abnormalities of fetal heart rate and maternal hypotension during epidural analgesia in labour. Br Med J. 1978 Nov 25;2(6150):1460-1. doi: 10.1136/bmj.2.6150.1460.
Results Reference
background
PubMed Identifier
8304890
Citation
Umstad MP, Ross A, Rushford DD, Permezel M. Epidural analgesia and fetal heart rate abnormalities. Aust N Z J Obstet Gynaecol. 1993 Aug;33(3):269-72. doi: 10.1111/j.1479-828x.1993.tb02083.x.
Results Reference
background
PubMed Identifier
15321453
Citation
Kubli M, Shennan AH, Seed PT, O'Sullivan G. A randomised controlled trial of fluid pre-loading before low dose epidural analgesia for labour. Int J Obstet Anesth. 2003 Oct;12(4):256-60. doi: 10.1016/S0959-289X(03)00071-2.
Results Reference
background
PubMed Identifier
15494990
Citation
Hofmeyr G, Cyna A, Middleton P. Prophylactic intravenous preloading for regional analgesia in labour. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000175. doi: 10.1002/14651858.CD000175.pub2.
Results Reference
background
PubMed Identifier
29073508
Citation
Peyronnet V, Roses A, Girault A, Bonnet MP, Goffinet F, Tsatsaris V, Lecarpentier E. Lower limbs venous compression reduces the incidence of maternal hypotension following epidural analgesia during term labor. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:94-99. doi: 10.1016/j.ejogrb.2017.10.016. Epub 2017 Oct 16.
Results Reference
background

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Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions

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