Suspended

The Effects of Combined Spinal-epidural Anesthetics During Labor

What is being tested

Epidural anesthesia

+ spina-epidural anesthesia

Procedure

Who is being recruted

From 18 to 40 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: August 2019

See protocol details

Summary

Principal SponsorRambam Health Care Campus

Study ContactSaar Aharoni, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2019

Actual date on which the first participant was enrolled.

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 TitleThe Effects of Combined Spinal-epidural Anesthetics During Labor

NCT04012450

Principal SponsorRambam Health Care Campus

Study ContactSaar Aharoni, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Women in labor receiving epidural anesthesia

Group II

Active Comparator

Women in labor receiving spinal-epidural anesthesia

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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SuspendedNo study centers