This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic OutcomesNCT06857162
Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning
A study testing Positioninng during Cs in people with This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes and Maternal Hemodynamic, run by Aswan University at 1 site in Egypt.
Trial summary
Cesarean delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes, Maternal Hemodynamic, Maternal Positioning During CS
- What is being tested?
- Positioninng during Cs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2025to 1 Sep 2025
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women scheduled for elective cesarean delivery.
- Age between 18 and 40 years.
- ASA (American Society of Anesthesiologists) physical status II.
Who cannot join
- Emergency cesarean delivery.
- Pre-existing cardiovascular disease.
- Severe preeclampsia or eclampsia.
- Multiple pregnancies.
- Known fetal anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Cesarean delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal outcomes. Traditionally, after spinal anesthesia, women are positioned supine, sometimes with a slight left lateral tilt to mitigate the risk of aortocaval compression . However, recent studies and clinical observations suggest that delayed supine positioning-keeping the patient in a sitting or semi-sitting position for a period following spinal anesthesiamay improve hemodynamic stability. These alternative positions may help to mitigate the abrupt drop in blood pressure commonly seen after spinal anesthesia by allowing for a more gradual redistribution of blood volume . Understanding the optimal positioning strategy could lead to improved clinical protocols that enhance maternal and fetal safety. By comparing immediate supine positioning with delayed supine positioning (in sitting and semi-sitting positions), this study aims to provide evidence on which positioning strategy offers the best hemodynamic outcomes.
- Conditions
- This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes, Maternal Hemodynamic, Maternal Positioning During CS
- Being tested
- Positioninng during Cs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioninng during CsBehavioural
- Group A (N=72): Immediate Supine Position (Control): Immediately after administering spinal anesthesia, participants will be placed in a supine position. To reduce the risk of aortocaval compression, a slight left lateral tilt (approximately 15 degrees) will be applied. This is the traditional positioning method and serves as the control group for comparison.
- Group В (N=72): Sitting Position: After spinal anesthesia, participants will be positioned in a sitting position with the ack supported at a 90-degree angle for the first 2 minutes. Knees will be bent, and feet will be supported.
- Group С (N=72): Semi-Sitting Position:
After spinal anesthesia, participants will be positioned in a semi-sitting position with the back supported at the back supported at for the first 2 minutes.
Similar to the sitting position, knees and feet will be flat.
| Study group | Role | What they receive |
|---|---|---|
| Group A (N=72): Immediate Supine Position | Active comparator | Not described Receives: Behavioral: Positioninng during Cs |
| Group В (N=72): Sitting Position | Experimental | Not described Receives: Behavioral: Positioninng during Cs |
| Group С (N=72): Semi-Sitting Position | Experimental | Not described Receives: Behavioral: Positioninng during Cs |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start25 Apr 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic OutcomesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Principal investigator, Ahmed Yousef Mohamed, Aswan University
- Investigators
- Ayman Mohamadi Eldemrdash, MD Of Anesthesia, Study chair, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857162
- Sponsor's protocol ID
- 966/9/24
- Status last verified
- Aug 2024
- First submitted
- 26 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mohamady Eldemrdash A, Elabd Hassan I, Youssef Mohamed A, Ahmed Raslan HM. Post-spinal position and its impact on hemodynamic, block height, and comfort in caesarean delivery: A randomized assessor-blinded trial. Rev Esp Anestesiol Reanim (Engl Ed). 2026 Apr;73(4):502089. doi: 10.1016/j.redare.2026.502089. Epub 2026 Mar 21.
PubMed 41871806
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning
- ClinicalTrials.gov ID
- NCT06857162
- Acronym / sponsor ID
- 966/9/24
- Conditions
- This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes, Maternal Hemodynamic, Maternal Positioning During CS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 4 Mar 2025 (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 delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal outcomes. Traditionally, after spinal anesthesia, women are positioned supine, sometimes with a slight left lateral tilt to mitigate the risk of aortocaval compression . However, recent studies and clinical observations suggest that delayed supine positioning-keeping the patient in a sitting or semi-sitting position for a period following spinal anesthesiamay improve hemodynamic stability. These alternative positions may help to mitigate the abrupt drop in blood pressure commonly seen after spinal anesthesia by allowing for a more gradual redistribution of blood volume . Understanding the optimal positioning strategy could lead to improved clinical protocols that enhance maternal and fetal safety. By comparing immediate supine positioning with delayed supine positioning (in sitting and semi-sitting positions), this study aims to provide evidence on which positioning strategy offers the best hemodynamic outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (N=72): Immediate Supine Position | Active comparator | Behavioral: Positioninng during Cs |
| Group В (N=72): Sitting Position | Experimental | Behavioral: Positioninng during Cs |
| Group С (N=72): Semi-Sitting Position | Experimental | Behavioral: Positioninng during Cs |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women scheduled for elective cesarean delivery.
- Age between 18 and 40 years.
- ASA (American Society of Anesthesiologists) physical status II.
Key exclusion criteria (5 listed)
- Emergency cesarean delivery.
- Pre-existing cardiovascular disease.
- Severe preeclampsia or eclampsia.
- Multiple pregnancies.
- Known fetal anomalies.
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 |
|---|---|---|
| Positioninng during Cs1. Group A (N=72): Immediate Supine Position (Control): Immediately after administering spinal anesthesia, participants will be placed in a supine position. To reduce the risk of aortocaval compression, a slight left lateral tilt (approximately 15 degrees) will be applied. This is the traditional positioning method and serves as the control group for comparison. 2. Group В (N=72): Sitting Position: After spinal anesthesia, participants will be positioned in a sitting position with the ack supported at a 90-degree angle for the first 2 minutes. Knees will be bent, and feet will be supported. 3. Group С (N=72): Semi-Sitting Position: After spinal anesthesia, participants will be positioned in a semi-sitting position with the back supported at the back supported at for the first 2 minutes. Similar to the sitting position, knees and feet will be flat. | Behavioural | Group A (N=72): Immediate Supine Position, Group В (N=72): Sitting Position, Group С (N=72): Semi-Sitting Position |
Primary outcome
To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.
Time frame: 9 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 41871806Mohamady Eldemrdash A, Elabd Hassan I, Youssef Mohamed A, Ahmed Raslan HM. Post-spinal position and its impact on hemodynamic, block height, and comfort in caesarean delivery: A randomized assessor-blinded trial. Rev Esp Anestesiol Reanim (Engl Ed). 2026 Apr;73(4):502089. doi: 10.1016/j.redare.2026.502089. Epub 2026 Mar 21.
- Individual participant dataSharing planned: Undecided
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.
Ayman Mohamadi Eldemrdash, MD Of Anesthesia study chair
Aswan 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 Positioninng during Cs in people with This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes and Maternal Hemodynamic, run by Aswan 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 3 inclusion and 5 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 19 Mar 2025. 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?
Contact Ahmed Yousef Mohamed, Resident of Anesthesia (+201112842063, Maxedo.67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery. (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857162, which also lists 1 linked publication.
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 19 Mar 2025.