Carotid Flow Measurements in Pregnant Women

NCT ID: NCT06813989

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Postspinal Hypotension Pregnant Women Undergoing Cesarean Delivery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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postspinal hypotension

Hypotension 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, within the time period starting from spinal anaesthesia and surgical delivery.

carotid ultrasound

Intervention Type OTHER

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.

Interventions

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carotid ultrasound

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berna Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Haseki Training and Research Hospital

Locations

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Haseki Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berna Caliskan, MD

Role: CONTACT

05067108770

Berna Caliskan

Role: CONTACT

Facility Contacts

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Berna Caliskan, MD

Role: primary

+905067108770

Berna

Role: backup

References

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Kim HJ, Cho AR, Lee H, Kim H, Kwon JY, Lee HJ, Kang C, Jeon S, Kim N. Ultrasonographic Carotid Artery Flow Measurements as Predictors of Spinal Anesthesia-Induced Hypotension in Elderly Patients: A Prospective Observational Study. Med Sci Monit. 2022 Nov 28;28:e938714. doi: 10.12659/MSM.938714.

Reference Type RESULT
PMID: 36437555 (View on PubMed)

Kim HJ, Choi YS, Kim SH, Lee W, Kwon JY, Kim DH. Predictability of preoperative carotid artery-corrected flow time for hypotension after spinal anaesthesia in patients undergoing caesarean section: A prospective observational study. Eur J Anaesthesiol. 2021 Apr 1;38(4):394-401. doi: 10.1097/EJA.0000000000001376.

Reference Type RESULT
PMID: 33122575 (View on PubMed)

Other Identifiers

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14-2025

Identifier Type: -

Identifier Source: org_study_id

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