Carotid Flow Measurements in Pregnant Women

NCT06813989 | Recruiting

• 1 other identifier: 14-2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postspinal Hypotension; Pregnant Women Undergoing Cesarean Delivery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• postspinal hypotension

  Hypotension 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.

  from spinal anaesthesia till surgical delivery

Secondary Outcomes (1)

• fluid resuscitation

  from spinal anaesthesia till surgical delivery

Study Arms (1)

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.

Other: carotid ultrasound

Interventions

carotid ultrasound 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.

postspinal hypotension

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pregnant women scheduled for cesarean section

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 36437555 RESULT

• 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.

  PMID: 33122575 RESULT

Study Officials

• Berna Caliskan, MD

  Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna Caliskan, MD

CONTACT

05067108770; caliskan.b@gmail.com

Berna Caliskan

CONTACT

caliskan.b@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 15, 2025
• Primary Completion: May 15, 2025
• Study Completion: June 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)