Caesarean DeliveryPhase 3NCT07327866
Comparison of Classic and Sequential Spinal Techniques for Preventing Hypotension During Cesarean Delivery.
A Phase 3 study testing Classic group and Sequential group in people with Caesarean Delivery and Hypotension Postprocedural, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Given the clinical importance of maternal hypotension, the potential advantages of sequential spinal dosing warrant formal evaluation in a prospective, adequately powered randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Caesarean Delivery, Hypotension Postprocedural
- What is being tested?
- Classic group and Sequential group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2026to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women aged 18-45 years.
- ASA physical status II-III.
- Scheduled for elective cesarean section under standardized spinal anesthesia.
Who cannot join
- Allergy to local anesthetics.
- Emergency cesarean section.
- Contraindication to spinal anesthesia (e.g., coagulopathy, infection at the puncture site).
- Preexisting hypertension on medication or pre-eclampsia with severe features.
- Known cardiac disease accompanied by hemodynamic instability.
- Allergy to study drugs.
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- Fetal distress or non-reassuring cardiotocography (CTG).
- BMI >40 kg/m².
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Azhar University
Cairo, Egypt, 11865
Neveen A. Kohaf, PhD, 01060383012, nevenabdo@azhar.edu.eg
Hany Baumy, M.D
About this study
Official title: Incidence of Post-Spinal Anaesthesia Hypotension in Caesarean Delivery: A Randomized Trial of Classic Versus Sequential Spinal Technique
Given the clinical importance of maternal hypotension, the potential advantages of sequential spinal dosing warrant formal evaluation in a prospective, adequately powered randomized controlled trial. We therefore designed this study to compare the incidence of post-spinal hypotension between the classic single-shot spinal and the sequential fractionated spinal techniques in elective cesarean delivery.
- Conditions
- Caesarean Delivery, Hypotension Postprocedural
- Being tested
- Classic group, Sequential group
- Keywords
- Classic, Sequential Spinal Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic groupProcedure or surgery
In the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution.
Sequential groupProcedure or surgery
In the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution.
| Study group | Role | What they receive |
|---|---|---|
| Classic group | Experimental | In the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution. Receives: Procedure: Classic group |
| Sequential group | Active comparator | In the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution. Receives: Procedure: Sequential group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-spinal hypotension
Occurrence of maternal hypotension within 15 minutes after intrathecal injection, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or an absolute SBP below 90 mmHg. This outcome directly measures the hemodynamic stability achieved by each spinal technique.
Measured: Assessed during the first 15 minutes after the intrathecal injection.
Secondary outcomes (7)
Time to first hypotensive episode
The interval between the time of intrathecal injection and the first recorded episode of hypotension. This reflects how long each technique maintains stable blood pressure before any drop occurs.
Measured: Measured continuously for 15 minutes following the intrathecal injection.
Number of hypotensive episodes
The total count of discrete hypotensive events occurring within the observation period after spinal anesthesia. This indicates the frequency and severity of blood pressure fluctuations.
Measured: Assessed within 15 minutes after intrathecal injection.
Total vasopressor dose
The total amount of phenylephrine and/or ephedrine administered to correct hypotension during the observation period, serving as an indirect measure of hemodynamic stability.
Measured: Assessed within 15 minutes after spinal administration.
Maximal sensory block level and time to T4
Determines the highest dermatomal sensory level achieved and the time required to reach the T4 level, indicating block quality and onset characteristics of the anesthetic technique. Maximal sensory block level is assessed by testing loss of sensation to cold or pinprick over the trunk in a cephalad-caudal direction and mapping the highest blocked dermatome (e.g., using an alcohol swab or pin along the midline and comparing to known dermatomal levels such as T4 at the nipple line). Time to T4 is measured as the interval in minutes from completion of intrathecal injection to the first assessment at which loss of sensation reaches the T4 dermatome, documented with the same stimulus and dermatomal map.
Measured: Evaluated from injection until block stabilization within 20 minutes.
Maternal nausea and vomiting
Incidence of intraoperative nausea or vomiting related to hypotension or anesthetic effect.
Measured: Monitored intraoperatively up to delivery.
Maternal satisfaction
Maternal satisfaction will be evaluated using a 5-point Likert scale addressing analgesia adequacy, comfort, and overall anesthesia experience. Each participant will rate her satisfaction as follows: 1 for "very dissatisfied," indicating poor pain control and significant discomfort; 2 for "dissatisfied," reflecting partial relief with ongoing discomfort; 3 for "neutral," denoting acceptable but unremarkable pain relief; 4 for "satisfied," representing good pain control with minimal discomfort; and 5 for "very satisfied," indicating excellent analgesia and a fully positive anesthesia experience.
Measured: Assessed after delivery before discharge from recovery.
Neonatal outcomes (Apgar scores and umbilical artery pH)
Measures neonatal wellbeing through 1-minute and 5-minute Apgar scores and umbilical artery blood pH to assess the effect of maternal hemodynamics on fetal oxygenation.
Measured: Determined immediately after delivery (Apgar at 1 and 5 minutes; pH from cord sample at birth).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean DeliveryStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327866
- Sponsor's protocol ID
- RC. 16.10.2025
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Post-Spinal Anaesthesia Hypotension in Caesarean Delivery: A Randomized Trial of Classic Versus Sequential Spinal Technique
- ClinicalTrials.gov ID
- NCT07327866
- Acronym / sponsor ID
- RC. 16.10.2025
- Conditions
- Caesarean Delivery, Hypotension Postprocedural
- Keywords
- Classic, Sequential Spinal Technique
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
Given the clinical importance of maternal hypotension, the potential advantages of sequential spinal dosing warrant formal evaluation in a prospective, adequately powered randomized controlled trial. We therefore designed this study to compare the incidence of post-spinal hypotension between the classic single-shot spinal and the sequential fractionated spinal techniques in elective cesarean delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic group | Experimental | Procedure: Classic groupIn the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution. |
| Sequential group | Active comparator | Procedure: Sequential groupIn the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women aged 18-45 years.
- ASA physical status II-III.
- Scheduled for elective cesarean section under standardized spinal anesthesia.
Key exclusion criteria (9 listed)
- Allergy to local anesthetics.
- Emergency cesarean section.
- Contraindication to spinal anesthesia (e.g., coagulopathy, infection at the puncture site).
- Preexisting hypertension on medication or pre-eclampsia with severe features.
- Known cardiac disease accompanied by hemodynamic instability.
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 |
|---|---|---|
| Classic groupIn the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution. | Procedure or surgery | Classic group |
| Sequential groupIn the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution. | Procedure or surgery | Sequential group |
Primary outcome
Incidence of post-spinal hypotension
Time frame: Assessed during the first 15 minutes after the intrathecal injection.
Occurrence of maternal hypotension within 15 minutes after intrathecal injection, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or an absolute SBP below 90 mmHg. This outcome directly measures the hemodynamic stability achieved by each spinal technique.
7 secondary outcomes
Time to first hypotensive episode
Time frame: Measured continuously for 15 minutes following the intrathecal injection.
Number of hypotensive episodes
Time frame: Assessed within 15 minutes after intrathecal injection.
Total vasopressor dose
Time frame: Assessed within 15 minutes after spinal administration.
Maximal sensory block level and time to T4
Time frame: Evaluated from injection until block stabilization within 20 minutes.
Maternal nausea and vomiting
Time frame: Monitored intraoperatively up to delivery.
Maternal satisfaction
Time frame: Assessed after delivery before discharge from recovery.
Neonatal outcomes (Apgar scores and umbilical artery pH)
Time frame: Determined immediately after delivery (Apgar at 1 and 5 minutes; pH from cord sample at birth).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Yes. Data can be shared upon a reasonable request from the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Classic group and Sequential group in people with Caesarean Delivery and Hypotension Postprocedural, run by Al-Azhar 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 9 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: opening soon, as of the sponsor's last update on 8 Jan 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neveen A Kohaf, Ph.D (+201060383012, nevenabdo@azhar.edu.eg), 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: Assessed during the first 15 minutes after the intrathecal injection.). 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 8 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.