NCT06825806

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
Last Updated

April 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 8, 2025

Last Update Submit

April 3, 2025

Conditions

Spinal HypotensionDoppler

Keywords

Spinal hypotension; Cesarean section; femoral Doppler

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the change in pulsatility index to predict spinal hypotension

    baseline and immediately after spinal anesthesia

Secondary Outcomes (4)

  • accuracy of change in waveform morphology to predict spinal hypotension

    baseline and immediately after spinal anesthesia

  • baseline shock index to predict hypotension

    baseline

  • baseline PI to predict spinal hypotension

    baseline

  • baseline RI to predict hypotension

    baseline

Interventions

Femoral artery DopplerDEVICE

Right common femoral artery will be examined before and after spinal anesthesia to evaluate pulsatility index, resisitive index, and waveform morphology

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women undergoing cesarean section

You may qualify if:

  • ASA II
  • singleton pregnancy
  • full term

You may not qualify if:

  • vascular disease
  • contraindication to spinal anesthesia
  • inability to obtain adequate Doppler

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 6890, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 34034957BACKGROUND

  • Adolf 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.

    PMID: 39848332BACKGROUND

  • Kinsella 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.

    PMID: 29090733BACKGROUND

  • Kim 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.

    PMID: 32667274BACKGROUND

Related Links

Study Officials

  • Helmy

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and critical care

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 13, 2025

Study Start

February 14, 2025

Primary Completion

April 3, 2025

Study Completion

April 3, 2025

Last Updated

April 6, 2025

Record last verified: 2025-02

Locations

EG(1)