Clinical trial NCT04012450: The Effects of Combined Spinal-epidural Anesthetics During Labor
Official title: The Effects of Combined Spinal-epidural Anesthetics During Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Uterine artery flow
timeFrame: Up to 48 hours from onset of anesthesia
measure: Umbilical artery flow
timeFrame: Up to 48 hours from onset of anesthesia
measure: Middle cerebral artery flow
timeFrame: Up to 48 hours from onset of anesthesia
Secondary outcomes:
measure: Fetal heart rate abnormalities
timeFrame: Up to 48 hours from onset of anesthesia
measure: Fetal bradycardia within 1 hour
timeFrame: Up to one hour from onset of anesthesia
measure: Mode of delivery
timeFrame: Up to delivery
measure: Meconial amniotic fluid
timeFrame: Up to delivery
measure: Umbilical artery blood acidity level (PH)
timeFrame: Immediate after delivery
measure: Apgar at 1 and 5 minutes
timeFrame: Up to 5 minutes from delivery
measure: Admission to Neonatal Intensive Care Unit (NICU)
timeFrame: Up to 72 hours from delivery
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Heath-Care Campus
name: Saar Aharoni, MD
role: PRINCIPAL_INVESTIGATOR
References: