The Effects of Combined Spinal-epidural Anesthetics During Labor

Not Applicable

• Conditions: Anesthesia
• Interventions: Procedure: spina-epidural anesthesia; Procedure: Epidural anesthesia

• Registration Number: NCT04012450
• Lead Sponsor: Rambam Health Care Campus

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 Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-05
• Last Update Submitted: 2019-07-05
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09
• Study Start: 2019-08-01
• Primary Completion: 2021-08-31
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal-epidural	spina-epidural anesthesia	Women in labor receiving spinal-epidural anesthesia
Epidural Anesthesia	Epidural anesthesia	Women in labor receiving epidural anesthesia

Primary Outcome Measures

Name	Time	Method
Middle cerebral artery flow	Up to 48 hours from onset of anesthesia	Changes in middle cerebral artery flow before and after regional anesthesia
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

Secondary Outcome Measures

Name	Time	Method
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
Fetal heart rate abnormalities	Up to 48 hours from onset of anesthesia	Fetal heart rate deceleration
Umbilical artery blood acidity level (PH)	Immediate after delivery	Umbilical artery blood PH
Meconial amniotic fluid	Up to delivery	Meconial amniotic fluid
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