Carotid Flow Measurements in Pregnant Women

Haseki Training and Research Hospital

Status: Enrolling

Conditions: Pregnant Women Undergoing Cesarean Delivery; Postspinal Hypotension

Treatments: Other: carotid ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06813989

14-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 1 patient group

postspinal hypotension

Description:

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.

Treatment:

Other: carotid ultrasound