Postspinal HypotensionNCT06813989
Carotid Flow Measurements in Pregnant Women
An observational study of Postspinal Hypotension and Pregnant Women Undergoing Cesarean Delivery, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postspinal Hypotension, Pregnant Women Undergoing Cesarean Delivery
- What is being tested?
- carotid ultrasound
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 1 Jun 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women scheduled for cesarean section
Who may be able to join
- "Uncomplicated term pregnant women aged 20-40 years classified as ASA 1-2.
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Berna Caliskan contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haseki Training and Research Hospital
Istanbul
Berna Caliskan, MD, +905067108770, caliskan.b@gmail.com
Berna, caliskan.b@gmail.com
About this study
Official title: Evaluation of the Effectiveness of Carotid Flow Measurements in Predicting Post-Spinal Hypotension in Pregnant Women
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.
Read the 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.
- Being tested
- carotid ultrasound
- Keywords
- carotid blood flow, corrected carotid flow time, postspinal hypotension, cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: carotid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from spinal anaesthesia till surgical delivery
Secondary outcomes (1)
fluid resuscitation
amount of fluid given for co loading during anaesthesia application
Measured: from spinal anaesthesia till surgical delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Feb 2025
- Primary completion15 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postspinal HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, MD, Principal investigator, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813989
- Sponsor's protocol ID
- 14-2025
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36437555Kim 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.
PubMed 33122575