Maternal Hypotension SyndromePhase 4NCT03719625
Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
A Phase 4 study testing Ephedrine and Norepinephrine in people with Maternal Hypotension Syndrome and Cesarean, run by Mongi Slim Hospital.
Trial summary
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Hypotension Syndrome, Cesarean
- What is being tested?
- Ephedrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2019to 30 May 2019
- Phase
- Phase 4
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia
- AGE>15 years
- ASA II status
- No history of hypertension, preeclampsia or cardiopathy
- BMI<40
Who cannot join
- cesarean section under genearl anesthesia or epidural analgesia during labor
Trial locations and contacts
No sites are listed yet.
About this study
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration.
The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
Read the detailed description
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia.
The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
- Conditions
- Maternal Hypotension Syndrome, Cesarean
- Being tested
- Ephedrine, Norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Also called Ephedrin
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
NorepinephrineDrug
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
| Study group | Role | What they receive |
|---|---|---|
| norepinephrin group | Experimental | The patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes Receives: Drug: Norepinephrine |
| Ephedrin group | Experimental | The patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes Receives: Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post spinal hypotension
decrease of systolic arterial blood pressure > 20% baseline
Measured: during the first 20 minutes after spinal anesthesia
Secondary outcomes (6)
Lowest systolic blood pressure
Lowest systolic blood pressure recorded after spinal anesthesia
Measured: uring the first 20 minutes after spinal anesthesia
Incidence of bradycardia
heart rate<50 beats/min
Measured: during the first 20 minutes after spinal anesthesia
incidence of nausea and/or vomiting
incidence of nausea and/or vomiting
Measured: during the first 20 minutes after spinal anesthesia
Apgar score
Apgar score at 1 min, 5 min, 10 min
Measured: 20min after spinal anesthesia
fetal ph
fetal ph
Measured: 20min after spinal anesthesia
fetal blood lactates
fetal blood lactates
Measured: 20min after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start2 Jan 2019 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Hypotension SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled, prospective, randomised trial comparing 2 interventions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719625
- Sponsor's protocol ID
- prophylactic vasopressors
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2018
- Last updated
- 3 Dec 2018
- 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 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
- ClinicalTrials.gov ID
- NCT03719625
- Acronym / sponsor ID
- prophylactic vasopressors
- Conditions
- Maternal Hypotension Syndrome, Cesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 25 Oct 2018 (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.
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration.
The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
Detailed description
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia.
The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- controlled, prospective, randomised trial comparing 2 interventions
| Arm | Type | Receives |
|---|---|---|
| norepinephrin group | Experimental | Drug: NorepinephrineThe patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes |
| Ephedrin group | Experimental | Drug: EphedrineThe patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia
- AGE>15 years
- ASA II status
- No history of hypertension, preeclampsia or cardiopathy
- BMI<40
Key exclusion criteria (1 listed)
- cesarean section under genearl anesthesia or epidural analgesia during labor
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 |
|---|---|---|
| EphedrineAlso: EphedrinComparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section | Drug | Ephedrin group |
| NorepinephrineComparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section | Drug | norepinephrin group |
Primary outcome
Incidence of post spinal hypotension
Time frame: during the first 20 minutes after spinal anesthesia
decrease of systolic arterial blood pressure > 20% baseline
6 secondary outcomes
Lowest systolic blood pressure
Time frame: uring the first 20 minutes after spinal anesthesia
Incidence of bradycardia
Time frame: during the first 20 minutes after spinal anesthesia
incidence of nausea and/or vomiting
Time frame: during the first 20 minutes after spinal anesthesia
Apgar score
Time frame: 20min after spinal anesthesia
fetal ph
Time frame: 20min after spinal anesthesia
fetal blood lactates
Time frame: 20min after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Maternal Hypotension Syndrome
RecruitingObservational study
Organ Dysfunction Score for Obstetric Patients
Pregnancy, Postpartum
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ephedrine and Norepinephrine in people with Maternal Hypotension Syndrome and Cesarean, run by Mongi Slim Hospital.
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 5 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 3 Dec 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Asma Ben Souissi, assistant professor (0021698336883, bsouissiasma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post spinal hypotension (time frame: during the first 20 minutes after spinal anesthesia). 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 3 Dec 2018.