NCT07372313

Prediction of Hypotension and Postdural Puncture Headache by Carotid Artery Corrected Flow Time

Not yet recruiting Last updated 28 January 2026

What this trial tests

trial in Hypotension in Pregnant Women in 90 participants. Not yet recruiting.

Timeline

15 February 2026

Primary endpoint
15 December 2026

15 April 2027

Quick facts

Lead sponsor	TC Erciyes University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	90
Start date	15 February 2026
Primary completion	15 December 2026
Estimated completion	15 April 2027

Conditions studied

• Hypotension in Pregnant Women — all drugs for Hypotension in Pregnant Women →
• Headache in Pregnant Women — all drugs for Headache in Pregnant Women →

Sponsor

TC Erciyes University

Who can join

Adults 18 to 49, female only, with Hypotension in Pregnant Women or Headache in Pregnant Women. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Anesthesia for cesarean delivery can be provided through general or neuraxial anesthesia (spinal or epidural). Hypotension is a common complication of both methods. Hypotension associated with spinal anesthesia can cause dizziness, nausea, vomiting, restlessness, and confusion in the mother, while also decreasing blood flow to the baby, leading to hypoxia and fetal acidosis. Untreated persistent hypotension poses a life-threatening risk to both mother and baby.

In recent years, ultrasonography has become widely used to assess volume status. Carotid artery corrected flow time (FTc) is primarily affected by left ventricular preload and is related to myocardial contractility and afterload. Therefore, it can predict intraoperative hypotension.

Postdural puncture headache (PDPH) is a relatively common complication after neuraxial blocks. PDPH is generally defined as an orthostatic headache caused by low cerebrospinal fluid pressure accompanied by neck pain, tinnitus, hearing changes, photophobia, and/or nausea. Risk factors include female gender, young age, pregnancy, a previous history of PDPH, low CSF pressure, and low BMI.

This study will be conducted on pregnant women undergoing elective cesarean sections under spinal anesthesia in the cesarean operating room at Erciyes University Faculty of Medicine Hospital. The correlation between preoperative carotid artery FTc levels in pregnant women and the incidence of intraoperative hypotension and postoperative PDPH will be investigated, as will whether FTc levels are a significant predictor of the likelihood of developing intraoperative hypotension and postoperative PDPH. Carotid artery FTc will be measured 1 hour before surgery, and baseline systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peripheral oxygen saturation (SPO2), and heart rate will be recorded in the operating room. Values will be recorded at 1, 2, 3, 5, 10, 12, 15, and 30 minutes after spinal anesthesia. Patients will be assessed postoperatively for postdural puncture headache using a numerical rating scale (NRS) on days 2, 3, and 7.

This study is expected to demonstrate the ability of preoperative FTc to predict hypotension and PDPH, to determine the threshold value for predicting hypotension and PDPH, and to improve or modify the anesthesia method in patients with predicted hypotension and PDPH.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.