HypotensionNCT05468125
Maternal Care Bundle to Attenuate Hypotension in Cesarean Section
A study testing guidance in people with Hypotension and Cesarean Section Complications, run by Suez Canal University at 1 site in Egypt.
Trial summary
Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Hypotension, Cesarean Section Complications
- What is being tested?
- guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 1 Dec 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age more than 21 years old and less than 40 years.
- Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).
- None laboring, at term with singleton uncomplicated pregnancies.
- Delivery under spinal anesthesia, with height 150 to 180 cm
- Body mass index of at most 40 kg/m2.
Who cannot join
- Parturient with peri-partum disorders as DM, HTN, cardiac diseases, bronchial asthma or bleeding disorders
- Obesity: BMI >40
- Any known allergy to local anesthetic drugs or ondansetron.
- Apparent anatomical abnormalities or infections in the back region.
- Bleeding disorders e.g., thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Maternal Care Bundle to Attenuate Spinal Induced Hypotension in Cesarean Section
Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.
Read the detailed description
A variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. However, a single technique is ineffective and a combination of interventions is suggested.
A care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. A care bundle consists of a group of (usually) between three and five evidence-based interventions. These are related to a particular condition or event for patient care.
Care bundles are well known in the field of intensive care medicine such as Ventilator-Associated Pneumonia (VAP) care bundle, sepsis care bundle, and Central Line-Associated Bloodstream Infection (CLABSI) care bundle.
To our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia.
In this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.
- Conditions
- Hypotension, Cesarean Section Complications
- Being tested
- guidance
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guidanceProcedure or surgery
either follow the care bundle or the best evidence practice
| Study group | Role | What they receive |
|---|---|---|
| care bundle | Active comparator | will be subjected to a bundle of care of four elements Receives: Procedure: guidance |
| best-evidenced practice | Active comparator | will be guided according to the best-evidenced performance consisting of three elements Receives: Procedure: guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of ephedrine
The total consumption of ephedrine used to manage the spinal induced hypotension with CS
Measured: immediately at the end of the surgery
Secondary outcomes (2)
consumption of atropine
The total consumption of atropine used to manage the spinal induced hypotension with CS
Measured: immediately at the end of the surgery
postspinal hypotension
The incidence of postspinal hypotension in CS
Measured: immediately at the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Aug 2022
- Primary completion20 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
- Investigators
- Abdelrhman Alshawadfy, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468125
- Sponsor's protocol ID
- Maternal care bundle
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Maternal Care Bundle to Attenuate Spinal Induced Hypotension in Cesarean Section
- ClinicalTrials.gov ID
- NCT05468125
- Acronym / sponsor ID
- Maternal care bundle
- Conditions
- Hypotension, Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Jul 2022 (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.
Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.
Detailed description
A variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. However, a single technique is ineffective and a combination of interventions is suggested.
A care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. A care bundle consists of a group of (usually) between three and five evidence-based interventions. These are related to a particular condition or event for patient care.
Care bundles are well known in the field of intensive care medicine such as Ventilator-Associated Pneumonia (VAP) care bundle, sepsis care bundle, and Central Line-Associated Bloodstream Infection (CLABSI) care bundle.
To our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia.
In this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| care bundle | Active comparator | Procedure: guidancewill be subjected to a bundle of care of four elements |
| best-evidenced practice | Active comparator | Procedure: guidancewill be guided according to the best-evidenced performance consisting of three elements |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age more than 21 years old and less than 40 years.
- Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).
- None laboring, at term with singleton uncomplicated pregnancies.
- Delivery under spinal anesthesia, with height 150 to 180 cm
- Body mass index of at most 40 kg/m2.
Key exclusion criteria (6 listed)
- Parturient with peri-partum disorders as DM, HTN, cardiac diseases, bronchial asthma or bleeding disorders
- Obesity: BMI >40
- Any known allergy to local anesthetic drugs or ondansetron.
- Apparent anatomical abnormalities or infections in the back region.
- Bleeding disorders e.g., thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
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 |
|---|---|---|
| guidanceeither follow the care bundle or the best evidence practice | Procedure or surgery | best-evidenced practice, care bundle |
Primary outcome
consumption of ephedrine
Time frame: immediately at the end of the surgery
The total consumption of ephedrine used to manage the spinal induced hypotension with CS
2 secondary outcomes
consumption of atropine
Time frame: immediately at the end of the surgery
postspinal hypotension
Time frame: immediately at the end of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
Abdelrhman Alshawadfy principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guidance in people with Hypotension and Cesarean Section Complications, run by Suez Canal University at 1 site in Egypt.
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 6 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of ephedrine (time frame: immediately at the end of the surgery). 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 15 Nov 2022.