Anesthesia, SpinalNCT05269537
Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia
An observational study of Anesthesia, Spinal and Cesarean Section, run by Mansoura University at 1 site in Egypt.
Trial summary
Cardiac output will be measured in healthy parturients undergoing cesarean delivery under spinal anesthesia Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Anesthesia, Spinal, Cesarean Section, Echocardiography
- What is being tested?
- Transthoracic Echocardiography, Spinal Anesthesia and Intrathecal Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2022to 2 Jul 2022
- Phase
- Observational
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Healthy women with full term, singleton pregnancy presenting for elective cesarean delivery under spinal anesthesia in a tertiary obstetric hospital
Who may be able to join
- American Society of Anesthesiologists physical status II parturients.
- Full term, singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
Who cannot join
- Height <150 cm
- Weight <60 kg
- Body mass index (BMI) <18.5 or ≥ 35 kg/m²
- Women presenting in labor
- Contraindications to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection
- Hemoglobin <10 g/dL
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- Current administration of vasoactive drugs (e.g., salbutamol, thyroxin)
- Diabetes mellitus, cardiovascular, or renal disease
- Chronic or pregnancy-induced hypertension
- Polyhydramnios
- Women with high risk for postpartum hemorrhage or uterine atony (e.g., placenta accreta spectrum, ≥3 previous cesarean deliveries)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia. A Prospective Observational Study Using Transthoracic Echocardiography
Cardiac output will be measured in healthy parturients undergoing cesarean delivery under spinal anesthesia
Read the detailed description
ASA-II women undergoing cesarean delivery under spinal anesthesia will be included. Cardiac output will be measured using transthoracic echocardiography at 4 time points: Baseline, after 10 minutes of intrathecal injection, after delivery, and after 1 hour of intrathecal injection. Spinal anesthesia will be administered with 2.5 ml bupivacaine 0.5% and fentanyl 15 μg.
- Conditions
- Anesthesia, Spinal, Cesarean Section, Echocardiography, Cardiac Output
- Being tested
- Transthoracic Echocardiography, Spinal Anesthesia, Intrathecal Bupivacaine, Intrathecal Fentanyl, Crystalloid Coload 1000 mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyRadiation
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Spinal AnesthesiaProcedure or surgery
Performed at the L3-L4 or L4-L5 interspace using 25-gauge spinal needle
Intrathecal BupivacaineDrug
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal FentanylDrug
Fentanyl 15 μg will be administered in the subarachnoid space
Crystalloid Coload 1000 mLDrug
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
Cesarean DeliveryProcedure or surgery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
Intravenous EphedrineDrug
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
OxytocinDrug
Intravenous oxytocin 10 U in 500 mL Ringer acetate will be administered over 30 minutes starting immediately after delivery of the fetus
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Cardiac output will be measured at baseline using transthoracic echocardiography. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Crystalloid coload 1000 mL will be administered: Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection. Cardiac output will be measured at 10 minutes after intrathecal injection, immediately after delivery, at 1 hour after intrathecal injection. Cesarean delivery will be performed. Intravenous ephedrine will be administered to correct hypotension. After delivery, 10 units of oxytocin in 500 ml Ringer acetate will be administered over 30 minutes. Receives: Radiation: Transthoracic Echocardiography; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Drug: Crystalloid Coload 1000 mL; Procedure: Cesarean Delivery; Drug: Intravenous Ephedrine; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac output
Cardiac output measured using transthoracic echocardiography
Measured: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Secondary outcomes (8)
Changes in stroke volume
Measured: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Changes in heart rate
Measured: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Number of subjects requiring ephedrine
Measured: From intrathecal injection to the end of cesarean delivery
Incidence of hypotension
Systolic blood pressure <80% of baseline
Measured: From intrathecal injection to the end of cesarean delivery
Incidence of severe hypotension
Systolic blood pressure <70% of baseline
Measured: From intrathecal injection to the end of cesarean delivery
Incidence of bradycardia
Heart rate <50 beats/min
Measured: From intrathecal injection to the end of cesarean delivery
Incidence of nausea and/or vomiting
Measured: From intrathecal injection to the end of cesarean delivery
Neonatal Apgar scores
Measured: At 1 and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start12 Mar 2022
- Primary completion2 Jul 2022
- Study completion2 Jul 2022
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 Anesthesia, SpinalStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Tawfik, Mansoura University
- Investigators
- Mohamed M Tawfik, MD, Principal investigator, Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals, Mansoura, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269537
- Sponsor's protocol ID
- MS.20.08.1232
- Status last verified
- Nov 2022
- First submitted
- 25 Feb 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tawfik MM, Hafez SM, Abdelmohaymen HA, Ismail OM. Serial echocardiographic measurements of cardiac output after spinal anesthesia for scheduled cesarean delivery in healthy patients: a prospective observational study. Int J Obstet Anesth. 2025 Nov;64:104752. doi: 10.1016/j.ijoa.2025.104752. Epub 2025 Aug 8.
PubMed 40795509
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia. A Prospective Observational Study Using Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT05269537
- Acronym / sponsor ID
- MS.20.08.1232
- Conditions
- Anesthesia, Spinal, Cesarean Section, Echocardiography, Cardiac Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 2 Jul 2022 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 8 Mar 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.
Cardiac output will be measured in healthy parturients undergoing cesarean delivery under spinal anesthesia
Detailed description
ASA-II women undergoing cesarean delivery under spinal anesthesia will be included. Cardiac output will be measured using transthoracic echocardiography at 4 time points: Baseline, after 10 minutes of intrathecal injection, after delivery, and after 1 hour of intrathecal injection. Spinal anesthesia will be administered with 2.5 ml bupivacaine 0.5% and fentanyl 15 μg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Radiation: Transthoracic Echocardiography, Procedure: Spinal Anesthesia, Drug: Intrathecal Bupivacaine, Drug: Intrathecal Fentanyl, Drug: Crystalloid Coload 1000 mL, Procedure: Cesarean Delivery, Drug: Intravenous Ephedrine, Drug: OxytocinCardiac output will be measured at baseline using transthoracic echocardiography. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Crystalloid coload 1000 mL will be administered: Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection. Cardiac output will be measured at 10 minutes after intrathecal injection, immediately after delivery, at 1 hour after intrathecal injection. Cesarean delivery will be performed. Intravenous ephedrine will be administered to correct hypotension. After delivery, 10 units of oxytocin in 500 ml Ringer acetate will be administered over 30 minutes. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy women with full term, singleton pregnancy presenting for elective cesarean delivery under spinal anesthesia in a tertiary obstetric hospital
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status II parturients.
- Full term, singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
Key exclusion criteria (11 listed)
- Height <150 cm
- Weight <60 kg
- Body mass index (BMI) <18.5 or ≥ 35 kg/m²
- Women presenting in labor
- Contraindications to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection
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 |
|---|---|---|
| Transthoracic EchocardiographyMeasurement of cardiac output in supine position with left lateral tilt at baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection | Radiation | Study Group |
| Spinal AnesthesiaPerformed at the L3-L4 or L4-L5 interspace using 25-gauge spinal needle | Procedure or surgery | Study Group |
| Intrathecal BupivacaineBupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space | Drug | Study Group |
| Intrathecal FentanylFentanyl 15 μg will be administered in the subarachnoid space | Drug | Study Group |
| Crystalloid Coload 1000 mLRinger acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection | Drug | Study Group |
| Cesarean DeliveryLower segment cesarean section using the Pfannenstiel incision and uterine exteriorization | Procedure or surgery | Study Group |
| Intravenous EphedrineIntravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively. | Drug | Study Group |
| OxytocinIntravenous oxytocin 10 U in 500 mL Ringer acetate will be administered over 30 minutes starting immediately after delivery of the fetus | Drug | Study Group |
Primary outcome
Changes in cardiac output
Time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Cardiac output measured using transthoracic echocardiography
8 secondary outcomes
Changes in stroke volume
Time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Changes in heart rate
Time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Number of subjects requiring ephedrine
Time frame: From intrathecal injection to the end of cesarean delivery
Incidence of hypotension
Time frame: From intrathecal injection to the end of cesarean delivery
Incidence of severe hypotension
Time frame: From intrathecal injection to the end of cesarean delivery
Incidence of bradycardia
Time frame: From intrathecal injection to the end of cesarean delivery
Incidence of nausea and/or vomiting
Time frame: From intrathecal injection to the end of cesarean delivery
Neonatal Apgar scores
Time frame: At 1 and 5 minutes after delivery
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 29 Nov 2022.
- Derived from this study: PubMed 40795509Tawfik MM, Hafez SM, Abdelmohaymen HA, Ismail OM. Serial echocardiographic measurements of cardiac output after spinal anesthesia for scheduled cesarean delivery in healthy patients: a prospective observational study. Int J Obstet Anesth. 2025 Nov;64:104752. doi: 10.1016/j.ijoa.2025.104752. Epub 2025 Aug 8.
- 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.
Mohamed M Tawfik, MD principal investigator
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals, Mansoura, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Spinal and Cesarean Section, run by Mansoura 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 11 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 29 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?
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?
Changes in cardiac output (time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection). 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 NCT05269537, 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 29 Nov 2022.