Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women

Study Overview
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Brief Summary
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Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block. Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships. The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.

Official Title
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Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Term pregnant patients requesting labor analgesia Singleton pregnancy Term pregnant patients in active labor ASA<4 No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE Exclusion Criteria: Refusal to consent for the study Known spinal deformities Previous back instrumentation Patients with BMI>50 kg/㎡ due to anticipated technical challenges in Doppler studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>Ultrasound will be used to measure velocimetric indices of both right and left uterine arteries and umbilical artery. | Device: Ultrasound<br>* Ultrasound scan of the right and left uterine arteries and umbilical artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine artery velocimetric index - systolic/diastolic ratio (S/D) at baseline | Uterine artery velocimetric index - systolic/diastolic ratio (S/D) will be measured at baseline (prior to combined spinal epidural). | 5 minutes | 
| Uterine artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes | Uterine artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 10 minutes after combined spinal epidural | 5 minutes | 
| Uterine artery velocimetric index - systolic/diastolic ratio (S/D) at 30 minutes | Uterine artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 30 minutes after combined spinal epidural | 5 minutes | 
| Uterine artery velocimetric index - pulsatility index (PI) at baseline | Uterine artery velocimetric index - pulsatility index (PI) will be measured at baseline (prior to combined spinal epidural). | 5 minutes | 
| Uterine artery velocimetric index - pulsatility index (PI) at 10 minutes | Uterine artery velocimetric index - pulsatility index (PI) will be measured 10 minutes after combined spinal epidural | 5 minutes | 
| Uterine artery velocimetric index - pulsatility index (PI) at 30 minutes | Uterine artery velocimetric index - pulsatility index (PI) will be measured 30 minutes after combined spinal epidural | 5 minutes | 
| Uterine artery velocimetric index - resistance index (RI) at baseline | Uterine artery velocimetric index - resistance index (PI) will be measured at baseline (prior to combined spinal epidural). | 5 minutes | 
| Uterine artery velocimetric index - resistance index (RI) at 10 minutes | Uterine artery velocimetric index - resistance index (PI) will be measured 10 minutes after combined spinal epidural | 5 minutes | 
| Uterine artery velocimetric index - resistance index (RI) at 30 minutes | Uterine artery velocimetric index - resistance index (PI) will be measured 30 minutes after combined spinal epidural | 5 minutes | 
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at baseline | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured at baseline (prior to combined spinal epidural). | 5 minutes | 
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 10 minutes after combined spinal epidural | 5 minutes | 
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 30 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 30 minutes after combined spinal epidural | 5 minutes | 
| Umbilical artery velocimetric index - pulsatility index (PI) at baseline | Umbilical artery velocimetric index - pulsatility index (PI) will be measured at baseline (prior to combined spinal epidural). | 5 minutes | 
| Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes | Umbilical artery velocimetric index - pulsatility index (PI) will be measured 10 minutes after combined spinal epidural | 5 minutes | 
| Umbilical artery velocimetric index - pulsatility index (PI) at 30 minutes | Umbilical artery velocimetric index - pulsatility index (PI) will be measured 30 minutes after combined spinal epidural | 5 minutes | 
| Umbilical artery velocimetric index - resistance index (PI) at baseline | Umbilical artery velocimetric index - resistance index (PI) will be measured at baseline (prior to combined spinal epidural). | 5 minutes | 
| Umbilical artery velocimetric index - resistance index (PI) at 10 minutes | Umbilical artery velocimetric index - resistance index (PI) will be measured 10 minutes after combined spinal epidural | 5 minutes | 
| Umbilical artery velocimetric index - resistance index (PI) at 30 minutes | Umbilical artery velocimetric index - resistance index (PI) will be measured 30 minutes after combined spinal epidural | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score at baseline - questionnaire | Pain score - verbal numeric rating scale (0-10) prior to combined spinal epidural | 1 minute | 
| Pain score at 10 min - questionnaire | Pain score - verbal numeric rating scale (0-10) at 10 min after combined spinal epidural | 1 minute | 
| Pain score at 30 min - questionnaire | Pain score - verbal numeric rating scale (0-10) at 30 min after combined spinal epidural | 1 minute | 
| Hypotension: systolic blood pressure less than 80% of baseline | Systolic blood pressure < 80% of baseline, monitored q5 for 30 minutes following combined spinal epidural | 30 minutes | 
| Hypertension: systolic blood pressure greater than 120% of baseline | Systolic blood pressure > 120% of baseline, monitored q5 for 30 minutes following combined spinal epidural | 30 minutes | 
| Bradycardia: heart rate less than 70% of baseline | Heart rate < 70% of baseline or a heart rate < 50bpm, monitored q5 for 30 minutes following combined spinal epidural | 30 minutes | 
| Desaturation: oxygen level <95% | Oxygen level <95%, monitored q5 for 30 minutes following combined spinal epidural | 30 minutes | 
| Sensory block level at 10 minutes | Sensory block level at 10 minutes following combined spinal epidural | 10 minutes | 
| Sensory block level at 30 minutes | Sensory block level at 30 minutes following combined spinal epidural | 30 minutes | 
| Duration of labour | Onset of labour until delivery of the placenta | up to 24 hours | 
| Type of delivery | Type of delivery will be recorded: vaginal, cesarean section, instrumental delivery | up to 24 hours | 
| Presence of hypertonic uterine contractions | Presence of hypertonic uterine contractions as noted by the nursing or obstetric team. | up to 24 hours | 
| fetal heart rate at baseline | fetal heart rate at baseline, prior to combined spinal epidural | 5 minutes | 
| fetal heart rate q5 min up to 30 minutes | fetal heart rate q5 min up to 30 minutes following combined spinal epidural | 30 minutes | 
| presence of fetal bradycardia - questionnaire | presence of fetal bradycardia (fetal heart rate <110) | up to 24 hours | 
| presence of fetal tachycardia - questionnaire | presence of fetal tachycardia (fetal heart rate >160) | up to 24 hours | 
| Neonatal weight | Neonatal weight measured after delivery in grams | 2 minutes | 
| Apgar score at 1 minute | Apgar score at 1 minute | 1 minute | 
| Apgar score at 5 minutes | Apgar score at 5 minutes | 5 minute2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combined spinal epidural (CSE), fetal bradycardia, ultrasound, velocimetric index