The Effects of Combined Spinal-epidural Anesthetics During Labor
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 40
- Primary Endpoint
- Middle cerebral artery flow
Study Overview
Brief Summary
Women who fulfil the inclusion criteria and who intended to regional anesthesia will be randomized into the epidural anesthesia arm or to the spinal-epidural anesthesia arm. Sonographic evaluation of the flow in the uterine artery, umbilical artery, and middle cerebral artery will be documented to each patient prior and following the regional anesthesia.
Detailed Description
Patients will receive information regarding the available anesthesia during labor that are available in the delivery room including regional and systemic.
After receiving the patient informed consent for regional anesthesia (epidural or spinal-epidural), patients will be offered to participate in our study.
After receiving the patients' informed consent for participating in the study, patients will be randomized to either the epidural anesthesia group or to the spinal-epidural anesthesia group.
A doppler ultrasound will be performed on each patient prior to and following the regional anesthesia, the flow in the uterine artery, umbilical artery, and the middle cerebral artery of the fetus will be recorded.
Demographic and obstetrical information will be collected from the patients' electronic files.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Middle cerebral artery flow
Time Frame: Up to 48 hours from onset of anesthesia
Changes in middle cerebral artery flow before and after regional anesthesia
Uterine artery flow
Time Frame: Up to 48 hours from onset of anesthesia
Changes in uterine artery flow before and after regional anesthesia
Umbilical artery flow
Time Frame: Up to 48 hours from onset of anesthesia
Changes in umbilical artery flow before and after regional anesthesia
Secondary Outcomes
- Fetal bradycardia within 1 hour(Up to one hour from onset of anesthesia)
- Fetal heart rate abnormalities(Up to 48 hours from onset of anesthesia)
- Mode of delivery(Up to delivery)
- Umbilical artery blood acidity level (PH)(Immediate after delivery)
- Meconial amniotic fluid(Up to delivery)
- Apgar at 1 and 5 minutes(Up to 5 minutes from delivery)
- Admission to Neonatal Intensive Care Unit (NICU)(Up to 72 hours from delivery)
Investigators
SAAR AHARONI MD
Principal Investigator
Rambam Health Care Campus