The Effects of Combined Spinal-epidural Anesthetics During Labor

Rambam Health Care Campus

Status: Unknown

Conditions: Anesthesia

Treatments: Procedure: spina-epidural anesthesia; Procedure: Epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04012450

0500-15-RMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Epidural Anesthesia

Active Comparator group

Description:

Women in labor receiving epidural anesthesia

Treatment:

Procedure: Epidural anesthesia

Spinal-epidural

Active Comparator group

Description:

Women in labor receiving spinal-epidural anesthesia

Treatment:

Procedure: spina-epidural anesthesia