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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05512065
Other study ID # 22-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date March 30, 2024

Study information

Verified date October 2023
Source Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound
Ultrasound scan of the right and left uterine arteries and umbilical artery.

Locations

Country Name City State
Canada Mount Sinai Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Pain score at baseline - questionnaire Pain score - verbal numeric rating scale (0-10) prior to combined spinal epidural 1 minute
Secondary Pain score at 10 min - questionnaire Pain score - verbal numeric rating scale (0-10) at 10 min after combined spinal epidural 1 minute
Secondary Pain score at 30 min - questionnaire Pain score - verbal numeric rating scale (0-10) at 30 min after combined spinal epidural 1 minute
Secondary 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
Secondary 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
Secondary 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
Secondary Desaturation: oxygen level <95% Oxygen level <95%, monitored q5 for 30 minutes following combined spinal epidural 30 minutes
Secondary Sensory block level at 10 minutes Sensory block level at 10 minutes following combined spinal epidural 10 minutes
Secondary Sensory block level at 30 minutes Sensory block level at 30 minutes following combined spinal epidural 30 minutes
Secondary Duration of labour Onset of labour until delivery of the placenta up to 24 hours
Secondary Type of delivery Type of delivery will be recorded: vaginal, cesarean section, instrumental delivery up to 24 hours
Secondary Presence of hypertonic uterine contractions Presence of hypertonic uterine contractions as noted by the nursing or obstetric team. up to 24 hours
Secondary fetal heart rate at baseline fetal heart rate at baseline, prior to combined spinal epidural 5 minutes
Secondary fetal heart rate q5 min up to 30 minutes fetal heart rate q5 min up to 30 minutes following combined spinal epidural 30 minutes
Secondary presence of fetal bradycardia - questionnaire presence of fetal bradycardia (fetal heart rate <110) up to 24 hours
Secondary presence of fetal tachycardia - questionnaire presence of fetal tachycardia (fetal heart rate >160) up to 24 hours
Secondary Neonatal weight Neonatal weight measured after delivery in grams 2 minutes
Secondary Apgar score at 1 minute Apgar score at 1 minute 1 minute
Secondary Apgar score at 5 minutes Apgar score at 5 minutes 5 minute2
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