Actively Recruiting

Age: 20Years - 40Years
FEMALE
Healthy Volunteers
ID06813989

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

Led by Haseki Training and Research Hospital · Updated on 2025-03-18

60

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand the relationship between changes in carotid artery blood flow and low blood pressure following spinal anesthesia in pregnant women aged 20 to 40 undergoing cesarean delivery. The study focuses on how carotid blood flow and corrected flow time measurements change before and after spinal anesthesia and their connection to post-spinal hypotension. Participants are women classified as ASA 1-2 with uncomplicated pregnancies at term. Participants will receive spinal anesthesia with a standardized dose of 10 mg heavy bupivacaine and 10 mcg fentanyl as part of their cesarean delivery. Doppler ultrasound will be used to measure the diameter and flow velocity of the left carotid artery at three different points before anesthesia and repeated three minutes after returning to the supine position post-anesthesia. Blood pressure and fluid administration will be monitored from the start of anesthesia until delivery to assess hypotension occurrence. During the study, each participant will undergo two carotid ultrasound exams performed by the same investigator. Hemodynamic data, including blood pressure changes and fluid resuscitation, will be recorded throughout the procedure. The main outcome measured is post-spinal hypotension between anesthesia and delivery, with secondary outcomes including the amount of fluid given. The study participation involves minimal additional procedures beyond standard care and ultrasound measurements.

CONDITIONS

Brief Title

Carotid Flow Measurements in Pregnant Women

Who Can Participate

Age: 20Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Uncomplicated term pregnant women aged 20-40 years classified as ASA 1-2
Not Eligible

You will not qualify if you...

  • Diagnosed with preeclampsia or eclampsia or systolic blood pressure above 160
  • History of arrhythmia
  • Contraindications for spinal anesthesia
  • Body mass index over 40
  • Gestational age under 36 weeks or over 41 weeks
  • Chronic kidney insufficiency (glomerular filtration rate under 60)
  • Carotid stenosis or previous cerebrovascular events
  • Placental anomalies
  • Initially planned for vaginal delivery but switched to cesarean after trauma
  • Emergency cesarean decision upon operating room arrival
  • Failed spinal anesthesia requiring switch to general anesthesia before delivery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - On the day of surgery

Participants undergo carotid ultrasound measurements using Doppler and pulse wave analysis before spinal anesthesia to evaluate carotid artery flow.

1 visit (in-person, at operating room arrival)

Monitoring

Duration - From spinal anesthesia until surgical delivery (hours)

Participants are monitored for blood pressure and hemodynamic changes from spinal anesthesia until surgical delivery, including repeated carotid flow measurements after spinal anesthesia.

Continuous monitoring during surgery

Trial Site Locations

Total: 1 location

1

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Berna Caliskan, MD

B

Berna Caliskan

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Ultrasonographic Carotid Artery Flow Measurements as Predictors of Spinal Anesthesia-Induced Hypotension in Elderly Patients: A Prospective Observational Study.

Hyae Jin Kim, Ah-Reum Cho, Hanbit Lee...

https://pubmed.ncbi.nlm.nih.gov/36437555

Predictability of preoperative carotid artery-corrected flow time for hypotension after spinal anaesthesia in patients undergoing caesarean section: A prospective observational study.

Hye Jin Kim, Yong Seon Choi, Seung Hyun Kim...

https://pubmed.ncbi.nlm.nih.gov/33122575