Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women
Primary Purpose
Labor Pain
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Labor Pain focused on measuring combined spinal epidural (CSE), fetal bradycardia, ultrasound, velocimetric index
Eligibility Criteria
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
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound
Arm Description
Ultrasound will be used to measure velocimetric indices of both right and left uterine arteries and umbilical artery.
Outcomes
Primary Outcome Measures
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).
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
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
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).
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
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
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).
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
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
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).
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
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
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).
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
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
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).
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
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
Secondary Outcome Measures
Pain score at baseline - questionnaire
Pain score - verbal numeric rating scale (0-10) prior to combined spinal epidural
Pain score at 10 min - questionnaire
Pain score - verbal numeric rating scale (0-10) at 10 min after combined spinal epidural
Pain score at 30 min - questionnaire
Pain score - verbal numeric rating scale (0-10) at 30 min after combined spinal epidural
Hypotension: systolic blood pressure less than 80% of baseline
Systolic blood pressure < 80% of baseline, monitored q5 for 30 minutes following combined spinal epidural
Hypertension: systolic blood pressure greater than 120% of baseline
Systolic blood pressure > 120% of baseline, monitored q5 for 30 minutes following combined spinal epidural
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
Desaturation: oxygen level <95%
Oxygen level <95%, monitored q5 for 30 minutes following combined spinal epidural
Sensory block level at 10 minutes
Sensory block level at 10 minutes following combined spinal epidural
Sensory block level at 30 minutes
Sensory block level at 30 minutes following combined spinal epidural
Duration of labour
Onset of labour until delivery of the placenta
Type of delivery
Type of delivery will be recorded: vaginal, cesarean section, instrumental delivery
Presence of hypertonic uterine contractions
Presence of hypertonic uterine contractions as noted by the nursing or obstetric team.
fetal heart rate at baseline
fetal heart rate at baseline, prior to combined spinal epidural
fetal heart rate q5 min up to 30 minutes
fetal heart rate q5 min up to 30 minutes following combined spinal epidural
presence of fetal bradycardia - questionnaire
presence of fetal bradycardia (fetal heart rate <110)
presence of fetal tachycardia - questionnaire
presence of fetal tachycardia (fetal heart rate >160)
Neonatal weight
Neonatal weight measured after delivery in grams
Apgar score at 1 minute
Apgar score at 1 minute
Apgar score at 5 minutes
Apgar score at 5 minutes
Full Information
NCT ID
NCT05512065
First Posted
August 19, 2022
Last Updated
October 4, 2023
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05512065
Brief Title
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women
Official Title
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
combined spinal epidural (CSE), fetal bradycardia, ultrasound, velocimetric index
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Ultrasound will be used to measure velocimetric indices of both right and left uterine arteries and umbilical artery.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound scan of the right and left uterine arteries and umbilical artery.
Primary Outcome Measure Information:
Title
Uterine artery velocimetric index - systolic/diastolic ratio (S/D) at baseline
Description
Uterine artery velocimetric index - systolic/diastolic ratio (S/D) will be measured at baseline (prior to combined spinal epidural).
Time Frame
5 minutes
Title
Uterine artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes
Description
Uterine artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 10 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Uterine artery velocimetric index - systolic/diastolic ratio (S/D) at 30 minutes
Description
Uterine artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 30 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Uterine artery velocimetric index - pulsatility index (PI) at baseline
Description
Uterine artery velocimetric index - pulsatility index (PI) will be measured at baseline (prior to combined spinal epidural).
Time Frame
5 minutes
Title
Uterine artery velocimetric index - pulsatility index (PI) at 10 minutes
Description
Uterine artery velocimetric index - pulsatility index (PI) will be measured 10 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Uterine artery velocimetric index - pulsatility index (PI) at 30 minutes
Description
Uterine artery velocimetric index - pulsatility index (PI) will be measured 30 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Uterine artery velocimetric index - resistance index (RI) at baseline
Description
Uterine artery velocimetric index - resistance index (PI) will be measured at baseline (prior to combined spinal epidural).
Time Frame
5 minutes
Title
Uterine artery velocimetric index - resistance index (RI) at 10 minutes
Description
Uterine artery velocimetric index - resistance index (PI) will be measured 10 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Uterine artery velocimetric index - resistance index (RI) at 30 minutes
Description
Uterine artery velocimetric index - resistance index (PI) will be measured 30 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at baseline
Description
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured at baseline (prior to combined spinal epidural).
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes
Description
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 10 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 30 minutes
Description
Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 30 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - pulsatility index (PI) at baseline
Description
Umbilical artery velocimetric index - pulsatility index (PI) will be measured at baseline (prior to combined spinal epidural).
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes
Description
Umbilical artery velocimetric index - pulsatility index (PI) will be measured 10 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - pulsatility index (PI) at 30 minutes
Description
Umbilical artery velocimetric index - pulsatility index (PI) will be measured 30 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - resistance index (PI) at baseline
Description
Umbilical artery velocimetric index - resistance index (PI) will be measured at baseline (prior to combined spinal epidural).
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - resistance index (PI) at 10 minutes
Description
Umbilical artery velocimetric index - resistance index (PI) will be measured 10 minutes after combined spinal epidural
Time Frame
5 minutes
Title
Umbilical artery velocimetric index - resistance index (PI) at 30 minutes
Description
Umbilical artery velocimetric index - resistance index (PI) will be measured 30 minutes after combined spinal epidural
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Pain score at baseline - questionnaire
Description
Pain score - verbal numeric rating scale (0-10) prior to combined spinal epidural
Time Frame
1 minute
Title
Pain score at 10 min - questionnaire
Description
Pain score - verbal numeric rating scale (0-10) at 10 min after combined spinal epidural
Time Frame
1 minute
Title
Pain score at 30 min - questionnaire
Description
Pain score - verbal numeric rating scale (0-10) at 30 min after combined spinal epidural
Time Frame
1 minute
Title
Hypotension: systolic blood pressure less than 80% of baseline
Description
Systolic blood pressure < 80% of baseline, monitored q5 for 30 minutes following combined spinal epidural
Time Frame
30 minutes
Title
Hypertension: systolic blood pressure greater than 120% of baseline
Description
Systolic blood pressure > 120% of baseline, monitored q5 for 30 minutes following combined spinal epidural
Time Frame
30 minutes
Title
Bradycardia: heart rate less than 70% of baseline
Description
Heart rate < 70% of baseline or a heart rate < 50bpm, monitored q5 for 30 minutes following combined spinal epidural
Time Frame
30 minutes
Title
Desaturation: oxygen level <95%
Description
Oxygen level <95%, monitored q5 for 30 minutes following combined spinal epidural
Time Frame
30 minutes
Title
Sensory block level at 10 minutes
Description
Sensory block level at 10 minutes following combined spinal epidural
Time Frame
10 minutes
Title
Sensory block level at 30 minutes
Description
Sensory block level at 30 minutes following combined spinal epidural
Time Frame
30 minutes
Title
Duration of labour
Description
Onset of labour until delivery of the placenta
Time Frame
up to 24 hours
Title
Type of delivery
Description
Type of delivery will be recorded: vaginal, cesarean section, instrumental delivery
Time Frame
up to 24 hours
Title
Presence of hypertonic uterine contractions
Description
Presence of hypertonic uterine contractions as noted by the nursing or obstetric team.
Time Frame
up to 24 hours
Title
fetal heart rate at baseline
Description
fetal heart rate at baseline, prior to combined spinal epidural
Time Frame
5 minutes
Title
fetal heart rate q5 min up to 30 minutes
Description
fetal heart rate q5 min up to 30 minutes following combined spinal epidural
Time Frame
30 minutes
Title
presence of fetal bradycardia - questionnaire
Description
presence of fetal bradycardia (fetal heart rate <110)
Time Frame
up to 24 hours
Title
presence of fetal tachycardia - questionnaire
Description
presence of fetal tachycardia (fetal heart rate >160)
Time Frame
up to 24 hours
Title
Neonatal weight
Description
Neonatal weight measured after delivery in grams
Time Frame
2 minutes
Title
Apgar score at 1 minute
Description
Apgar score at 1 minute
Time Frame
1 minute
Title
Apgar score at 5 minutes
Description
Apgar score at 5 minutes
Time Frame
5 minute2
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mrinalini Balki, MD
Phone
416-586-4800
Ext
5270
Email
mrinalini.balki@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mrinalini Balki, MD
Phone
416-586-4800
Ext
5270
Email
mrinalini.balki@uhn.ca
First Name & Middle Initial & Last Name & Degree
Atsuko Hirano, MD
First Name & Middle Initial & Last Name & Degree
Cristian Arzola, MD
First Name & Middle Initial & Last Name & Degree
Sebastian Hobson, MD
First Name & Middle Initial & Last Name & Degree
Genevieve Lachance, MD
First Name & Middle Initial & Last Name & Degree
Kristi Downey, MSc
First Name & Middle Initial & Last Name & Degree
Yada Kunpalin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women
We'll reach out to this number within 24 hrs