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出境医 / 临床实验 / The Effects of Combined Spinal-epidural Anesthetics During Labor

The Effects of Combined Spinal-epidural Anesthetics During Labor

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Epidural anesthesia Procedure: spina-epidural anesthesia Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Combined Spinal-epidural Anesthetics During Labor
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : April 1, 2022
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. Uterine artery flow [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Changes in uterine artery flow before and after regional anesthesia

  2. Umbilical artery flow [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Changes in umbilical artery flow before and after regional anesthesia

  3. Middle cerebral artery flow [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Changes in middle cerebral artery flow before and after regional anesthesia


Secondary Outcome Measures :
  1. Fetal heart rate abnormalities [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Fetal heart rate deceleration

  2. Fetal bradycardia within 1 hour [ Time Frame: Up to one hour from onset of anesthesia ]
    Fetal bradycardia

  3. Mode of delivery [ Time Frame: Up to delivery ]
    Mode of delivery - vaginal/instrumental/cesarean section

  4. Meconial amniotic fluid [ Time Frame: Up to delivery ]
    Meconial amniotic fluid

  5. Umbilical artery blood acidity level (PH) [ Time Frame: Immediate after delivery ]
    Umbilical artery blood PH

  6. Apgar at 1 and 5 minutes [ Time Frame: Up to 5 minutes from delivery ]
    Apgar at 1 and 5 minutes

  7. Admission to Neonatal Intensive Care Unit (NICU) [ Time Frame: Up to 72 hours from delivery ]
    Admission to NICU


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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)

Contacts and Locations

Contacts
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Contact: Saar Aharoni, MD + 972 523395351 saaraharoni@gmail.com

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Layout table for investigator information
Principal Investigator: Saar Aharoni, MD Rambam Heath-Care Campus
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Uterine artery flow [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Changes in uterine artery flow before and after regional anesthesia
  • Umbilical artery flow [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Changes in umbilical artery flow before and after regional anesthesia
  • Middle cerebral artery flow [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Changes in middle cerebral artery flow before and after regional anesthesia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Fetal heart rate abnormalities [ Time Frame: Up to 48 hours from onset of anesthesia ]
    Fetal heart rate deceleration
  • Fetal bradycardia within 1 hour [ Time Frame: Up to one hour from onset of anesthesia ]
    Fetal bradycardia
  • Mode of delivery [ Time Frame: Up to delivery ]
    Mode of delivery - vaginal/instrumental/cesarean section
  • Meconial amniotic fluid [ Time Frame: Up to delivery ]
    Meconial amniotic fluid
  • Umbilical artery blood acidity level (PH) [ Time Frame: Immediate after delivery ]
    Umbilical artery blood PH
  • Apgar at 1 and 5 minutes [ Time Frame: Up to 5 minutes from delivery ]
    Apgar at 1 and 5 minutes
  • Admission to Neonatal Intensive Care Unit (NICU) [ Time Frame: Up to 72 hours from delivery ]
    Admission to NICU
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Combined Spinal-epidural Anesthetics During Labor
Official Title  ICMJE The Effects of Combined Spinal-epidural Anesthetics During Labor
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Procedure: Epidural anesthesia
    Performing an epidural anesthesia
  • Procedure: spina-epidural anesthesia
    Performing a spina-epidural anesthesia
Study Arms  ICMJE
  • Active Comparator: Epidural Anesthesia
    Women in labor receiving epidural anesthesia
    Intervention: Procedure: Epidural anesthesia
  • Active Comparator: Spinal-epidural
    Women in labor receiving spinal-epidural anesthesia
    Intervention: Procedure: spina-epidural anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Saar Aharoni, MD + 972 523395351 saaraharoni@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012450
Other Study ID Numbers  ICMJE 0500-15-RMB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party SAAR AHARONI MD, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Saar Aharoni, MD Rambam Heath-Care Campus
PRS Account Rambam Health Care Campus
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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