Cesarean Section ComplicationsPhase 4EHCOPRESPANCT07108881
Ultrasound Guided Fluid Loading Before Spinal Anesthesia
A Phase 4 study testing C and T in people with Cesarean Section Complications and Spinal Anesthesia, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Perioperative hypotension is a common complication of spinal anesthesia during cesarean sections. The aim of this study was to evaluate the effectiveness of echoguided correction of hypovolemia through crystalloid preloading on the incidence of arterial hypotension during scheduled cesarean sections under spinal… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Spinal Anesthesia, Hypotension
- What is being tested?
- C and T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteTunisia
- Study dates
- 1 May 2024to 25 Mar 2025
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA II score, singleton pregnancy cesarean section
Who cannot join
- Spinal anesthesia failure general anesthesia postpartum hemorhage saline solution volume > 1000 ml for preloading echocardiography: difficulties Poor echogenicity
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Tunis maternity and neonatology center, minisetry of public health
Tunis, 1007
About this study
Official title: Ultrasound Guided Fluid Loading Before Spinal Anesthesia for Cesarean Section in Hypovolemic Parturient: Double-Blind Randomized Controlled Trial
Perioperative hypotension is a common complication of spinal anesthesia during cesarean sections.
The aim of this study was to evaluate the effectiveness of echoguided correction of hypovolemia through crystalloid preloading on the incidence of arterial hypotension during scheduled cesarean sections under spinal anesthesia.
Read more
It was a double-blind, randomized controlled trial study conducted on hypovolemic parturients, scheduled for cesarean section. investigators compared ultrasound guided correction of hypovolemia to a standard care protocol without preloading.
Hypovolemia was defined as a ≥12% increase in the variation of the velocity-time integral of subaortic blood flow during a passive leg raising test.
Preloading was guided by the variation of the velocity-time integral of subaortic blood flow during volume expansion tests.
Read the detailed description
In the literature, numerous studies have compared the different pre-filling and co-filling protocols with different solutes. The majority of them conclude that co-filling is superior to pre-filling when the same type of solute is used. Pre-filling with crystalloids was then abandoned in favor of co-filling with crystalloids It is essential to remember that several invasive or non-invasive means of hemodynamic monitoring have previously been validated in pregnant women The use of invasive tools for assessing blood volume, particularly arterial and central venous catheters, is limited given the brevity of obstetric procedures, the risk of morbidity in awake patients and their high costs. Although non-invasive methods are preferable, some remain imperfect, notably carotid Doppler and bioimpedance devices Transthoracic echocardiography stands out as a particularly reliable and relevant non-invasive tool for assessing cardiac output and blood volume in parturients It allows analysis of the variation of the subaortic velocity time integral (∆ ITV s-a) during the passive leg raise test (LET). It is the only dynamic preload parameter validated in patients during spontaneous ventilation, thus allowing assessment of blood volume.
After reviewing the literature, the investigators found no studies about, exclusively hypovolemic patients, the effect of combining pre-filling with co-filling with crystalloids, monitored by echocardiographic preload-dependence indices, on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.
In this study, monitoring was performed by transthoracic echocardiography, based on the variation in subaortic TVI following the passive leg raise test and vascular fluid tests.
The objective of this prospective randomized study was to evaluate the efficacy of ultrasound-guided correction of hypovolemia by pre-filling with crystalloids on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.
- Conditions
- Cesarean Section Complications, Spinal Anesthesia, Hypotension, Hypovolemia, Sympathetic Blockade, Fluid Loading
- Being tested
- C, T
- Medical subject headings
- Hypotension, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDrug
Also called isotonic saline solution preloading
isotonic saline solution infusion (fluid preloading) to achieve correction of hypovolemia before spinal anesthesia using cardiac ultrasoud guidance by measurment of VTI variation after a 250ml saline solution loading, with a maximum of 4 challenges, until hypovolemia complete correction
TDrug
Also called isotonic saline solution coloading with ephedrine boluses
isotonic saline solution coloading after spinal anesthesia associated with recsue boluses of Ephedrine would be the "standard of care" in this arm. No correction of hypovolemia is done before spinal anesthesia. parturients receive a cristalloid coloading with saline isotonic solution with rescue boluses of ephedrine if hypotesion happens after spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group C | Active comparator | hypovolemic parturient receiving cardiac -ultrasound -VTI guided cristalloid preloading with 1 to 4 fluid challenges of 250 ml each until they reach a normal volemic state before receiving spinal anesthesia Receives: Drug: C |
| groupT | Placebo comparator | hypovolemic parturient reiving the standard care ie; they dont receive any preloading but coloading with critalloids with rescue boluses of ephedrine if hypotension happens Receives: Drug: T |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-spinal anesthesia arterial hypotension during surgery
The incidence of intraoperative post-spinal hypotension Defined by a drop in blood pressure (BP) of more than 20% of its reference value, or a blood pressure (BP) < 100 mmHg
Measured: 60 minutes
Secondary outcomes (10)
Time to onset of the first episode of arterial hypotension (min)
hypotension is Defined by a drop in SBP of more than 20% of its reference value, or a SBP < 100mmHg
Measured: 60 minutes
Duration of hypotensive episode (min)
the duration of hypotension from the onset of the first episode until reaching normal ranges again
Measured: 60 minutes
Depth of hypotension (% fall from baseline value)
hypotension is Defined by a drop in SBP of more than 20% of its baseline value, or a SBP < 100mmHg
Measured: 60 minutes
Variation in intraoperative cardiac output (% drop from baseline)
cardiac output is expected to rise of fall from its baseline and is caculated in percenttages of variation from its baseline
Measured: 60 minutes
Consumption of per-op vasopressors (mg of ephedrine)
total dose of ephedrine given in case of hypotension
Measured: 60 minutes
Volume of cristalloids and colloids infused (ml)
total volume of critalloids given either when preloading bfeore spinal anesthesia or while coloading after spinal anesthesia
Measured: 60 minutes
Incidence of maternal bradycardia (%) -
(Heart Rate < 50 bpm)
Measured: 60 minutes
Incidence of intraoperative nausea and vomiting (%)
nausea and vomiting usually at the moments of severe hypotension
Measured: 60 minutess
Fetal pH at the umbilical cord at birth.
right after delivery
Measured: 30 minutes
Newborn APGAR score at the first and fifth minute
at birth
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 May 2024
- Primary completion1 Dec 2024
- Study completion25 Mar 2025
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 Cesarean Section ComplicationsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hypovolemic participant were chosen among all pauturient scheduled for cesarean section. hypovolemia was detected using VTI variation mesurment in spine position with passive legs raising then they were randomized into two groups group C: had an ultrasound guided preloading with 1 to 4 fluid challenges of 250 ml of cristalloids each group T: received the standard care, ie: critalloids co-loading with recsue ephedrine doses if needed
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108881
- Sponsor's protocol ID
- 0123
- Acronym
- EHCOPRESPA
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben Marzouk S, Fouzai B, Dhraief N, Ben Amor F, Hkiri T, Hamdi H, Trablesi S, Kalai A, Maghrebi H. Cardiac ultrasound-guided crystalloid preloading before spinal anesthesia vs. standard coloading for scheduled cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2026 May;66:104840. doi: 10.1016/j.ijoa.2025.104840. Epub 2025 Dec 29.
PubMed 41529542
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Fluid Loading Before Spinal Anesthesia for Cesarean Section in Hypovolemic Parturient: Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07108881
- Acronym / sponsor ID
- EHCOPRESPA / 0123
- Conditions
- Cesarean Section Complications, Spinal Anesthesia, Hypotension, Hypovolemia, Sympathetic Blockade, Fluid Loading
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 7 Aug 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.
Perioperative hypotension is a common complication of spinal anesthesia during cesarean sections.
The aim of this study was to evaluate the effectiveness of echoguided correction of hypovolemia through crystalloid preloading on the incidence of arterial hypotension during scheduled cesarean sections under spinal anesthesia.
It was a double-blind, randomized controlled trial study conducted on hypovolemic parturients, scheduled for cesarean section. investigators compared ultrasound guided correction of hypovolemia to a standard care protocol without preloading.
Hypovolemia was defined as a ≥12% increase in the variation of the velocity-time integral of subaortic blood flow during a passive leg raising test.
Preloading was guided by the variation of the velocity-time integral of subaortic blood flow during volume expansion tests.
Detailed description
In the literature, numerous studies have compared the different pre-filling and co-filling protocols with different solutes. The majority of them conclude that co-filling is superior to pre-filling when the same type of solute is used. Pre-filling with crystalloids was then abandoned in favor of co-filling with crystalloids It is essential to remember that several invasive or non-invasive means of hemodynamic monitoring have previously been validated in pregnant women The use of invasive tools for assessing blood volume, particularly arterial and central venous catheters, is limited given the brevity of obstetric procedures, the risk of morbidity in awake patients and their high costs. Although non-invasive methods are preferable, some remain imperfect, notably carotid Doppler and bioimpedance devices Transthoracic echocardiography stands out as a particularly reliable and relevant non-invasive tool for assessing cardiac output and blood volume in parturients It allows analysis of the variation of the subaortic velocity time integral (∆ ITV s-a) during the passive leg raise test (LET). It is the only dynamic preload parameter validated in patients during spontaneous ventilation, thus allowing assessment of blood volume.
After reviewing the literature, the investigators found no studies about, exclusively hypovolemic patients, the effect of combining pre-filling with co-filling with crystalloids, monitored by echocardiographic preload-dependence indices, on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.
In this study, monitoring was performed by transthoracic echocardiography, based on the variation in subaortic TVI following the passive leg raise test and vascular fluid tests.
The objective of this prospective randomized study was to evaluate the efficacy of ultrasound-guided correction of hypovolemia by pre-filling with crystalloids on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- hypovolemic participant were chosen among all pauturient scheduled for cesarean section. hypovolemia was detected using VTI variation mesurment in spine position with passive legs raising then they were randomized into two groups group C: had an ultrasound guided preloading with 1 to 4 fluid challenges of 250 ml of cristalloids each group T: received the standard care, ie: critalloids co-loading with recsue ephedrine doses if needed
| Arm | Type | Receives |
|---|---|---|
| group C | Active comparator | Drug: Chypovolemic parturient receiving cardiac -ultrasound -VTI guided cristalloid preloading with 1 to 4 fluid challenges of 250 ml each until they reach a normal volemic state before receiving spinal anesthesia |
| groupT | Placebo comparator | Drug: Thypovolemic parturient reiving the standard care ie; they dont receive any preloading but coloading with critalloids with rescue boluses of ephedrine if hypotension happens |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA II score, singleton pregnancy cesarean section
Key exclusion criteria (1 listed)
- Spinal anesthesia failure general anesthesia postpartum hemorhage saline solution volume > 1000 ml for preloading echocardiography: difficulties Poor echogenicity
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 |
|---|---|---|
| CAlso: isotonic saline solution preloadingisotonic saline solution infusion (fluid preloading) to achieve correction of hypovolemia before spinal anesthesia using cardiac ultrasoud guidance by measurment of VTI variation after a 250ml saline solution loading, with a maximum of 4 challenges, until hypovolemia complete correction | Drug | group C |
| TAlso: isotonic saline solution coloading with ephedrine bolusesisotonic saline solution coloading after spinal anesthesia associated with recsue boluses of Ephedrine would be the "standard of care" in this arm. No correction of hypovolemia is done before spinal anesthesia. parturients receive a cristalloid coloading with saline isotonic solution with rescue boluses of ephedrine if hypotesion happens after spinal anesthesia | Drug | groupT |
Primary outcome
incidence of post-spinal anesthesia arterial hypotension during surgery
Time frame: 60 minutes
The incidence of intraoperative post-spinal hypotension Defined by a drop in blood pressure (BP) of more than 20% of its reference value, or a blood pressure (BP) < 100 mmHg
10 secondary outcomes
Time to onset of the first episode of arterial hypotension (min)
Time frame: 60 minutes
Duration of hypotensive episode (min)
Time frame: 60 minutes
Depth of hypotension (% fall from baseline value)
Time frame: 60 minutes
Variation in intraoperative cardiac output (% drop from baseline)
Time frame: 60 minutes
Consumption of per-op vasopressors (mg of ephedrine)
Time frame: 60 minutes
Volume of cristalloids and colloids infused (ml)
Time frame: 60 minutes
Incidence of maternal bradycardia (%) -
Time frame: 60 minutes
Incidence of intraoperative nausea and vomiting (%)
Time frame: 60 minutess
Fetal pH at the umbilical cord at birth.
Time frame: 30 minutes
Newborn APGAR score at the first and fifth minute
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 41529542Ben Marzouk S, Fouzai B, Dhraief N, Ben Amor F, Hkiri T, Hamdi H, Trablesi S, Kalai A, Maghrebi H. Cardiac ultrasound-guided crystalloid preloading before spinal anesthesia vs. standard coloading for scheduled cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2026 May;66:104840. doi: 10.1016/j.ijoa.2025.104840. Epub 2025 Dec 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing C and T in people with Cesarean Section Complications and Spinal Anesthesia, run by University Tunis El Manar at 1 site in Tunisia.
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: finished, as of the sponsor's last update on 7 Aug 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 Tunisia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of post-spinal anesthesia arterial hypotension during surgery (time frame: 60 minutes). 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 NCT07108881, 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 7 Aug 2025.