AnesthesiaNCT04012450
The Effects of Combined Spinal-epidural Anesthetics During Labor
A study testing Epidural anesthesia and spina-epidural anesthesia in people with Anesthesia, run by Rambam Health Care Campus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Epidural anesthesia and spina-epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Epidural anesthesia, spina-epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Performing an epidural anesthesia
spina-epidural anesthesiaProcedure or surgery
Performing a spina-epidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Epidural Anesthesia | Active comparator | Women in labor receiving epidural anesthesia Receives: Procedure: Epidural anesthesia |
| Spinal-epidural | Active comparator | Women in labor receiving spinal-epidural anesthesia Receives: Procedure: spina-epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine artery flow
Changes in uterine artery flow before and after regional anesthesia
Measured: Up to 48 hours from onset of anesthesia
Umbilical artery flow
Changes in umbilical artery flow before and after regional anesthesia
Measured: Up to 48 hours from onset of anesthesia
Middle cerebral artery flow
Changes in middle cerebral artery flow before and after regional anesthesia
Measured: Up to 48 hours from onset of anesthesia
Secondary outcomes (7)
Fetal heart rate abnormalities
Fetal heart rate deceleration
Measured: Up to 48 hours from onset of anesthesia
Fetal bradycardia within 1 hour
Fetal bradycardia
Measured: Up to one hour from onset of anesthesia
Mode of delivery
Mode of delivery - vaginal/instrumental/cesarean section
Measured: Up to delivery
Meconial amniotic fluid
Meconial amniotic fluid
Measured: Up to delivery
Umbilical artery blood acidity level (PH)
Umbilical artery blood PH
Measured: Immediate after delivery
Apgar at 1 and 5 minutes
Apgar at 1 and 5 minutes
Measured: Up to 5 minutes from delivery
Admission to Neonatal Intensive Care Unit (NICU)
Admission to NICU
Measured: Up to 72 hours from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAAR AHARONI MD, Rambam Health Care Campus
- Investigators
- Saar Aharoni, MD, Principal investigator, Rambam Heath-Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012450
- Sponsor's protocol ID
- 0500-15-RMB
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Spinal-epidural Anesthetics During Labor
- ClinicalTrials.gov ID
- NCT04012450
- Acronym / sponsor ID
- 0500-15-RMB
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Anesthesia | Active comparator | Procedure: Epidural anesthesiaWomen in labor receiving epidural anesthesia |
| Spinal-epidural | Active comparator | Procedure: spina-epidural anesthesiaWomen in labor receiving spinal-epidural anesthesia |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Gestational age of 37 and above Singleton Vertex presentation Desired regional anesthesia
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaPerforming an epidural anesthesia | Procedure or surgery | Epidural Anesthesia |
| spina-epidural anesthesiaPerforming a spina-epidural anesthesia | Procedure or surgery | Spinal-epidural |
Primary outcome
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
7 secondary outcomes
Fetal heart rate abnormalities
Time frame: Up to 48 hours from onset of anesthesia
Fetal bradycardia within 1 hour
Time frame: Up to one hour from onset of anesthesia
Mode of delivery
Time frame: Up to delivery
Meconial amniotic fluid
Time frame: Up to delivery
Umbilical artery blood acidity level (PH)
Time frame: Immediate after delivery
Apgar at 1 and 5 minutes
Time frame: Up to 5 minutes from delivery
Admission to Neonatal Intensive Care Unit (NICU)
Time frame: Up to 72 hours from delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saar Aharoni, MD principal investigator
Rambam Heath-Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing Epidural anesthesia and spina-epidural anesthesia in people with Anesthesia, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saar Aharoni, MD (+ 972 523395351, saaraharoni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine artery flow (time frame: Up to 48 hours from onset of anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.