Spinal HypotensionNCT06825806
Doppler Indices to Predict Spinal Hypotension During Cesarean Section
An observational study of Spinal Hypotension and Doppler, run by Cairo University at 1 site in Egypt.
Trial summary
Spinal anesthesia is safe and advisable anesthetic during cesarean section, despite that spinal induced hypotension is a common associated problem. Therefore early recognition of these critical events should take high priority to avoid serious consequences. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Spinal Hypotension, Doppler
- What is being tested?
- Femoral artery Doppler
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2025to 3 Apr 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women undergoing cesarean section
Who may be able to join
- ASA II
- singleton pregnancy
- full term
Who cannot join
- vascular disease
- contraindication to spinal anesthesia
- inability to obtain adequate Doppler
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Artery Doppler Indices as an Emerging Predictor of Spinal Anesthesia-induced Hypotension in Elective Cesarean Section: A Prospective Observational Study
Spinal anesthesia is safe and advisable anesthetic during cesarean section, despite that spinal induced hypotension is a common associated problem. Therefore early recognition of these critical events should take high priority to avoid serious consequences. in this regards several parameters were available to detect spinal hypotension but non is satisfactory till now. Researchers of this study aimed to evaluated the diagnostic accuracy of femoral artery Doppler to predict hypotension
- Conditions
- Spinal Hypotension, Doppler
- Being tested
- Femoral artery Doppler
- Keywords
- Spinal hypotension; Cesarean section; femoral Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral artery DopplerDevice
Right common femoral artery will be examined before and after spinal anesthesia to evaluate pulsatility index, resisitive index, and waveform morphology
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the change in pulsatility index to predict spinal hypotension
Measured: baseline and immediately after spinal anesthesia
Secondary outcomes (4)
accuracy of change in waveform morphology to predict spinal hypotension
Measured: baseline and immediately after spinal anesthesia
baseline shock index to predict hypotension
Measured: baseline
baseline PI to predict spinal hypotension
Measured: baseline
baseline RI to predict hypotension
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start14 Feb 2025
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
- Investigators
- Helmy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825806
- Sponsor's protocol ID
- Doppler and spinal hypotension
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data regarding this research will be available from the corresponding author upon reasonable request
Publications
Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
PubMed 34034957Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.
PubMed 39848332Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
PubMed 29090733Kim ES, Sharma AM, Scissons R, Dawson D, Eberhardt RT, Gerhard-Herman M, Hughes JP, Knight S, Marie Kupinski A, Mahe G, Neumyer M, Poe P, Shugart R, Wennberg P, Williams DM, Zierler RE. Interpretation of peripheral arterial and venous Doppler waveforms: A consensus statement from the Society for Vascular Medicine and Society for Vascular Ultrasound. Vasc Med. 2020 Oct;25(5):484-506. doi: 10.1177/1358863X20937665. Epub 2020 Jul 15.
PubMed 32667274Helmy MA, Helmy KA, Kaddah RA, Shamma MA, Ali MA, Milad LM. Femoral artery Doppler as a novel predictor of spinal hypotension in elective cesarean delivery cases: a prospective observational study. Int J Obstet Anesth. 2025 Aug;63:104706. doi: 10.1016/j.ijoa.2025.104706. Epub 2025 Jun 18.
PubMed 40550198
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Artery Doppler Indices as an Emerging Predictor of Spinal Anesthesia-induced Hypotension in Elective Cesarean Section: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06825806
- Acronym / sponsor ID
- Doppler and spinal hypotension
- Conditions
- Spinal Hypotension, Doppler
- Keywords
- Spinal hypotension; Cesarean section; femoral Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 3 Apr 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 13 Feb 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.
Spinal anesthesia is safe and advisable anesthetic during cesarean section, despite that spinal induced hypotension is a common associated problem. Therefore early recognition of these critical events should take high priority to avoid serious consequences. in this regards several parameters were available to detect spinal hypotension but non is satisfactory till now. Researchers of this study aimed to evaluated the diagnostic accuracy of femoral artery Doppler to predict hypotension
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing cesarean section
Key inclusion criteria (3 listed)
- ASA II
- singleton pregnancy
- full term
Key exclusion criteria (3 listed)
- vascular disease
- contraindication to spinal anesthesia
- inability to obtain adequate Doppler
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 |
|---|---|---|
| Femoral artery DopplerRight common femoral artery will be examined before and after spinal anesthesia to evaluate pulsatility index, resisitive index, and waveform morphology | Device | – |
Primary outcome
Accuracy of the change in pulsatility index to predict spinal hypotension
Time frame: baseline and immediately after spinal anesthesia
4 secondary outcomes
accuracy of change in waveform morphology to predict spinal hypotension
Time frame: baseline and immediately after spinal anesthesia
baseline shock index to predict hypotension
Time frame: baseline
baseline PI to predict spinal hypotension
Time frame: baseline
baseline RI to predict hypotension
Time frame: baseline
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 6 Apr 2025.
- Results publication: PubMed 34034957Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
- Results publication: PubMed 39848332Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.
- Results publication: PubMed 29090733Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
- Results publication: PubMed 32667274Kim ES, Sharma AM, Scissons R, Dawson D, Eberhardt RT, Gerhard-Herman M, Hughes JP, Knight S, Marie Kupinski A, Mahe G, Neumyer M, Poe P, Shugart R, Wennberg P, Williams DM, Zierler RE. Interpretation of peripheral arterial and venous Doppler waveforms: A consensus statement from the Society for Vascular Medicine and Society for Vascular Ultrasound. Vasc Med. 2020 Oct;25(5):484-506. doi: 10.1177/1358863X20937665. Epub 2020 Jul 15.
- Derived from this study: PubMed 40550198Helmy MA, Helmy KA, Kaddah RA, Shamma MA, Ali MA, Milad LM. Femoral artery Doppler as a novel predictor of spinal hypotension in elective cesarean delivery cases: a prospective observational study. Int J Obstet Anesth. 2025 Aug;63:104706. doi: 10.1016/j.ijoa.2025.104706. Epub 2025 Jun 18.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data regarding this research will be available from the corresponding author upon reasonable request
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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.
Helmy principal investigator
Cairo University
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 Spinal Hypotension and Doppler, run by Cairo 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 3 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 6 Apr 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?
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?
Accuracy of the change in pulsatility index to predict spinal hypotension (time frame: baseline and immediately after spinal anesthesia). 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 NCT06825806, which also lists 5 linked publications.
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 6 Apr 2025.