The Effects of Combined Spinal-epidural Anesthetics During Labor

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Epidural anesthesia; Procedure: spina-epidural 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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Saar Aharoni, MD, Rambam Heath-Care Campus

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 0500-15-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No