The Effects of Combined Spinal-epidural Anesthetics During Labor

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Combined Spinal-epidural Anesthetics During Labor

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Epidural anesthesia
* Procedure: spina-epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Anesthesia<br>Women in labor receiving epidural anesthesia | Procedure: Epidural anesthesia<br>* Performing an epidural anesthesia<br>|
| Active Comparator: Spinal-epidural<br>Women in labor receiving spinal-epidural anesthesia | Procedure: spina-epidural anesthesia<br>* Performing a spina-epidural anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine artery flow | Changes in uterine artery flow before and after regional anesthesia | Up to 48 hours from onset of anesthesia | 
| Umbilical artery flow | Changes in umbilical artery flow before and after regional anesthesia | Up to 48 hours from onset of anesthesia | 
| Middle cerebral artery flow | Changes in middle cerebral artery flow before and after regional anesthesia | Up to 48 hours from onset of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal heart rate abnormalities | Fetal heart rate deceleration | Up to 48 hours from onset of anesthesia | 
| Fetal bradycardia within 1 hour | Fetal bradycardia | Up to one hour from onset of anesthesia | 
| Mode of delivery | Mode of delivery - vaginal/instrumental/cesarean section | Up to delivery | 
| Meconial amniotic fluid | Meconial amniotic fluid | Up to delivery | 
| Umbilical artery blood acidity level (PH) | Umbilical artery blood PH | Immediate after delivery | 
| Apgar at 1 and 5 minutes | Apgar at 1 and 5 minutes | Up to 5 minutes from delivery | 
| Admission to Neonatal Intensive Care Unit (NICU) | Admission to NICU | Up to 72 hours from delivery |