The Effects of Combined Spinal-epidural Anesthetics During Labor

Anesthesia Clinical Trial

Official title:

The Effects of Combined Spinal-epidural Anesthetics During Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04012450
• Other study ID #: 0500-15-RMB
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2019
• Source: Rambam Health Care Campus
• Contact: Saar Aharoni, MD
• Phone: + 972 523395351
• Email: saaraharoni[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Epidural anesthesia
Performing an epidural anesthesia
• spina-epidural anesthesia
Performing a spina-epidural anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine artery flow	Changes in uterine artery flow before and after regional anesthesia	Up to 48 hours from onset of anesthesia
Primary	Umbilical artery flow	Changes in umbilical artery flow before and after regional anesthesia	Up to 48 hours from onset of anesthesia
Primary	Middle cerebral artery flow	Changes in middle cerebral artery flow before and after regional anesthesia	Up to 48 hours from onset of anesthesia
Secondary	Fetal heart rate abnormalities	Fetal heart rate deceleration	Up to 48 hours from onset of anesthesia
Secondary	Fetal bradycardia within 1 hour	Fetal bradycardia	Up to one hour from onset of anesthesia
Secondary	Mode of delivery	Mode of delivery - vaginal/instrumental/cesarean section	Up to delivery
Secondary	Meconial amniotic fluid	Meconial amniotic fluid	Up to delivery
Secondary	Umbilical artery blood acidity level (PH)	Umbilical artery blood PH	Immediate after delivery
Secondary	Apgar at 1 and 5 minutes	Apgar at 1 and 5 minutes	Up to 5 minutes from delivery
Secondary	Admission to Neonatal Intensive Care Unit (NICU)	Admission to NICU	Up to 72 hours from delivery