The Effects of Combined Spinal-epidural Anesthetics During Labor
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJuly 9, 2019
July 1, 2019
2.1 years
July 5, 2019
July 5, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Uterine artery flow
Changes in uterine artery flow before and after regional anesthesia
Up to 48 hours from onset of anesthesia
Umbilical artery flow
Changes in umbilical artery flow before and after regional anesthesia
Up to 48 hours from onset of anesthesia
Middle cerebral artery flow
Changes in middle cerebral artery flow before and after regional anesthesia
Up to 48 hours from onset of anesthesia
Secondary Outcomes (7)
Fetal heart rate abnormalities
Up to 48 hours from onset of anesthesia
Fetal bradycardia within 1 hour
Up to one hour from onset of anesthesia
Mode of delivery
Up to delivery
Meconial amniotic fluid
Up to delivery
Umbilical artery blood acidity level (PH)
Immediate after delivery
- +2 more secondary outcomes
Study Arms (2)
Epidural Anesthesia
ACTIVE COMPARATORWomen in labor receiving epidural anesthesia
Spinal-epidural
ACTIVE COMPARATORWomen in labor receiving spinal-epidural anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saar Aharoni, MD
Rambam Heath-Care Campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 9, 2019
Study Start
August 1, 2019
Primary Completion
August 31, 2021
Study Completion
April 1, 2022
Last Updated
July 9, 2019
Record last verified: 2019-07