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Carotid Flow Measurements in Pregnant Women

Evaluation of the Effectiveness of Carotid Flow Measurements in Predicting Post-Spinal Hypotension in Pregnant Women

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06813989
Enrollment
60
Registered
2025-02-07
Start date
2025-02-15
Completion date
2025-06-01
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postspinal Hypotension, Pregnant Women Undergoing Cesarean Delivery

Keywords

carotid blood flow, corrected carotid flow time, postspinal hypotension, cesarean delivery

Brief summary

The goal of this observational study is to reveal the relation between carotid flow changes and post-spinal hypotension in pregnant women between the ages of 20-40. The main question it aims to answer is: Do the carotid flow blood flow measurements and corrected flow time change before and after spinal anaesthesia related to postspinal hypotension? Participants are already receiving spinal anaesthesia to receive a caesarean section. As part of their regular anaesthesia management protocol, they will answer questions about anaesthesia management. The participants will only examined by ultrasound twice.

Detailed description

In this study, Doppler ultrasound measurements will be taken to evaluate the diameter and flow velocity of the left carotid artery in pregnant women aged 20-40 years, classified as ASA 1-2 term and uncomplicated, upon their arrival at the operating room in the supine position. Measurements will be performed three times at the cricoid level, before the carotid bifurcation, and directly from the arch to mitigate any errors due to the measurer. These measurements will be conducted by the same individual (B.C) and repeated three minutes after returning to the supine position post-spinal anaesthesia, with changes between the two measurements recorded. The spinal anaesthesia dose will be standardized with 10 mg of heavy bupivacaine and 10 mcg of fentanyl. Hemodynamic data from the time patients enter the operating room until baby delivery will be recorded. Hypotension during this period will be defined as (1) a decrease in systolic blood pressure \>30% or a decrease in mean arterial pressure (MAP) \>20% from baseline, or (2) systolic blood pressure \<90 mmHg or MAP \<65 mmHg. Carotid flow measurements and the amount of crystalloid administered during spinal anaesthesia will be noted in hypotensive and non-hypotensive patients.

Interventions

The investigator will perform a carotid ultrasound just 2 cm before the carotid bulb and measure the corrected flow time and flow using Doppler and pulse wave analysis. The corrected carotid flow time will be calculated according to Bazett's equation.

Sponsors

Haseki Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Uncomplicated term pregnant women aged 20-40 years classified as ASA 1-2.

Exclusion criteria

* Those diagnosed with preeclampsia or eclampsia or with systolic blood pressure above 160 Individuals with arrhythmia Individuals with contraindications for spinal anesthesia Individuals with Ba MI over 40 Those with a gestational age under 36 weeks or over 41 weeks Individuals with chronic kidney insufficiency (GRF under 60) Those with carotid stenosis or a history of previous cerebrovascular events Patients with placental anomalies Those initially planned for expected delivery but later switched to cesarean after being taken to trauma. Patients were taken to the operating room with an emergency cesarean decision In case of failed spinal anaesthesia, those who switched to general anaesthesia before delivery

Design outcomes

Primary

MeasureTime frameDescription
postspinal hypotensionfrom spinal anaesthesia till surgical deliveryHypotension is defined as (1) a decrease in systolic blood pressure \>30% or a decrease in mean arterial pressure (MAP) \>20% from baseline, or (2) systolic blood pressure \<90 mmHg or MAP \<65 mmHg.

Secondary

MeasureTime frameDescription
fluid resuscitationfrom spinal anaesthesia till surgical deliveryamount of fluid given for co loading during anaesthesia application

Countries

Turkey (Türkiye)

Contacts

Primary ContactBerna Caliskan, MD
caliskan.b@gmail.com05067108770
Backup ContactBerna Caliskan
caliskan.b@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026