Anesthesia
Conditions
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.
Interventions
PROCEDUREEpidural anesthesia
Performing an epidural anesthesia
PROCEDUREspina-epidural anesthesia
Performing a spina-epidural anesthesia
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Gestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia
Exclusion criteria
Contraindication to regional anesthesia Placental abnormalities (placenta previa, placenta accreta, placental separation) Pregnancy following fetal reduction or intrauterine fetal death (IUFD) Fetal malformations Intrauterine growth retardation (IUGR) Suspected chorioamnionitis (including body temperature above 38.5 degrees Celsius)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine artery flow | Up to 48 hours from onset of anesthesia | Changes in uterine artery flow before and after regional anesthesia |
| Umbilical artery flow | Up to 48 hours from onset of anesthesia | Changes in umbilical artery flow before and after regional anesthesia |
| Middle cerebral artery flow | Up to 48 hours from onset of anesthesia | Changes in middle cerebral artery flow before and after regional anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal heart rate abnormalities | Up to 48 hours from onset of anesthesia | Fetal heart rate deceleration |
| Fetal bradycardia within 1 hour | Up to one hour from onset of anesthesia | Fetal bradycardia |
| Mode of delivery | Up to delivery | Mode of delivery - vaginal/instrumental/cesarean section |
| Meconial amniotic fluid | Up to delivery | Meconial amniotic fluid |
| Umbilical artery blood acidity level (PH) | Immediate after delivery | Umbilical artery blood PH |
| Apgar at 1 and 5 minutes | Up to 5 minutes from delivery | Apgar at 1 and 5 minutes |
| Admission to Neonatal Intensive Care Unit (NICU) | Up to 72 hours from delivery | Admission to NICU |
Contacts
Primary ContactSaar Aharoni, MD
Outcome results
None listed