The Effects of Combined Spinal-epidural Anesthetics During Labor

NCT ID: NCT04012450

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural Anesthesia

Women in labor receiving epidural anesthesia

Group Type ACTIVE_COMPARATOR

Epidural anesthesia

Intervention Type PROCEDURE

Performing an epidural anesthesia

Spinal-epidural

Women in labor receiving spinal-epidural anesthesia

Group Type ACTIVE_COMPARATOR

spina-epidural anesthesia

Intervention Type PROCEDURE

Performing a spina-epidural anesthesia

Interventions

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Epidural anesthesia

Performing an epidural anesthesia

Intervention Type PROCEDURE

spina-epidural anesthesia

Performing a spina-epidural anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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SAAR AHARONI MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saar Aharoni, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Heath-Care Campus

Central Contacts

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Saar Aharoni, MD

Role: CONTACT

+ 972 523395351

Other Identifiers

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0500-15-RMB

Identifier Type: -

Identifier Source: org_study_id

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