Pregnancy Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Althaia Xarxa Assitensial i Universitaria Manresa | Manresa | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Althaia Xarxa Assistencial Universitària de Manresa |
Spain,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 10 minutes before epidural | |
Primary | 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. | 5 minutes after epidural | |
Primary | 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. | 10 minutes after epidural | |
Primary | 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. | 15 minutes after epidural | |
Primary | 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. | 30 minutes after epidural | |
Primary | 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. | 45 minutes after epidural | |
Primary | 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. | 60 minutes after epidural | |
Secondary | 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. | 10 minutes before epidural | |
Secondary | 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. | 5 minutes after epidural | |
Secondary | 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. | 10 minutes after epidural | |
Secondary | 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. | 15 minutes after epidural | |
Secondary | 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. | 30 minutes after epidural | |
Secondary | 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. | 45 minutes after epidural | |
Secondary | 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. | 60 minutes after epidural | |
Secondary | 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. | 10 minutes before epidural | |
Secondary | 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. | 5 minutes after epidural | |
Secondary | 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. | 10 minutes after epidural | |
Secondary | 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. | 15 minutes after epidural | |
Secondary | 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. | 30 minutes after epidural | |
Secondary | 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. | 45 minutes after epidural | |
Secondary | 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. | 60 minutes after epidural | |
Secondary | 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 |
10 minutes before epidural | |
Secondary | 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 |
5 minutes after epidural | |
Secondary | 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 |
10 minutes after epidural | |
Secondary | 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 |
15 minutes after epidural | |
Secondary | 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 |
30 minutes after epidural | |
Secondary | 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 |
45 minutes after epidural | |
Secondary | 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 |
60 minutes after epidural | |
Secondary | 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. | 10 minutes before epidural | |
Secondary | 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. | 5 minutes after epidural | |
Secondary | 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. | 10 minutes after epidural | |
Secondary | 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. | 15 minutes after epidural | |
Secondary | 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. | 30 minutes after epidural | |
Secondary | 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. | 45 minutes after epidural | |
Secondary | 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. | 60 minutes after epidural | |
Secondary | 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 |
10 minutes before epidural | |
Secondary | 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 |
5 minutes after epidural | |
Secondary | 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 |
10 minutes after epidural | |
Secondary | 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 |
15 minutes after epidural | |
Secondary | 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 |
30 minutes after epidural | |
Secondary | 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 |
45 minutes after epidural | |
Secondary | 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 |
60 minutes after epidural | |
Secondary | 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 |
10 minutes before epidural | |
Secondary | 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 |
5 minutes after epidural | |
Secondary | 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 |
10 minutes after epidural | |
Secondary | 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 |
15 minutes after epidural | |
Secondary | 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 |
30 minutes after epidural | |
Secondary | 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 |
45 minutes after epidural | |
Secondary | 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 |
60 minutes after epidural | |
Secondary | 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 |
10 minutes before epidural | |
Secondary | 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 |
5 minutes after epidural | |
Secondary | 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 |
10 minutes after epidural | |
Secondary | 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 |
15 minutes after epidural | |
Secondary | 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 |
30 minutes after epidural | |
Secondary | 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 |
45 minutes after epidural | |
Secondary | 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 |
60 minutes after epidural | |
Secondary | (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. |
10 minutes before epidural | |
Secondary | (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. |
5 minutes after epidural | |
Secondary | (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. |
10 minutes after epidural | |
Secondary | (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. |
15 minutes after epidural | |
Secondary | (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. |
30 minutes after epidural | |
Secondary | (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. |
45 minutes after epidural | |
Secondary | (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. |
60 minutes after epidural | |
Secondary | 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). | 10 minutes before epidural | |
Secondary | 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). | 5 minutes after epidural | |
Secondary | 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). | 10 minutes after epidural | |
Secondary | 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). | 15 minutes after epidural | |
Secondary | 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). | 30 minutes after epidural | |
Secondary | 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). | 45 minutes after epidural | |
Secondary | 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). | 60 minutes after epidural | |
Secondary | 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 | 10 minutes before epidural | |
Secondary | 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 | 5 minutes after epidural | |
Secondary | 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 | 10 minutes after epidural | |
Secondary | 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 | 15 minutes after epidural | |
Secondary | 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 | 30 minutes after epidural | |
Secondary | 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 | 45 minutes after epidural | |
Secondary | 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 | 60 minutes after epidural | |
Secondary | 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. | 10 minutes before epidural | |
Secondary | 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. | 5 minutes after epidural | |
Secondary | 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. | 10 minutes after epidural | |
Secondary | 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. | 15 minutes after epidural | |
Secondary | 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. | 30 minutes after epidural | |
Secondary | 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. | 45 minutes after epidural | |
Secondary | 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. | 60 minutes after epidural | |
Secondary | 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. | 10 minutes before epidural | |
Secondary | 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. | 5 minutes after epidural | |
Secondary | 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. | 10 minutes after epidural | |
Secondary | 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. | 15 minutes after epidural | |
Secondary | 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. | 30 minutes after epidural | |
Secondary | 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. | 45 minutes after epidural | |
Secondary | 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. | 60 minutes after epidural | |
Secondary | 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 | 10 minutes before epidural | |
Secondary | 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 | 5 minutes after epidural | |
Secondary | 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 | 10 minutes after epidural | |
Secondary | 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 | 15 minutes after epidural | |
Secondary | 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 | 30 minutes after epidural | |
Secondary | 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 | 45 minutes after epidural | |
Secondary | 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 | 60 minutes after epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 10 minutes before epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 5 minutes after epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 10 minutes after epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 15 minutes after epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 30 minutes after epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 45 minutes after epidural | |
Secondary | Accelerations (units of measure: beats per minute) | These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds. | 60 minutes after epidural | |
Secondary | 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. | 10 minutes before epidural | |
Secondary | 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. | 5 minutes after epidural | |
Secondary | 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. | 10 minutes after epidural | |
Secondary | 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. | 15 minutes after epidural | |
Secondary | 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. | 30 minutes after epidural | |
Secondary | 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. | 45 minutes after epidural | |
Secondary | 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. | 60 minutes after epidural |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Terminated |
NCT02537145 -
PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
|