Spinal AnesthesiapredictionNCT07499947
Predicting Spinal Hypotension in Cesarean Section
An observational study of Spinal Anesthesia and Cesarean Section, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study investigates the predictive value of anthropometric and hemodynamic indices for spinal anesthesia-induced hypotension (SAIH) during cesarean section. While spinal anesthesia is preferred for its rapid onset, SAIH remains a frequent complication risking maternal and fetal safety. Read more about this study
- Who is it for?
- Ages 18 to 45 months, women only
- Conditions the study is for
- Spinal Anesthesia, Cesarean Section, Hypotension
- How many people
- 321 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 months
- Women only
- No healthy volunteers
- Child
Study population: Parturients undergoing cesarean section
Who may be able to join
- American Society of Anesthesiologists (ASA) Class II
- Having regular antenatal visits
- Singleton pregnancy at ≥37 weeks of gestation
- Pregnant women aged 18-45 -
Who cannot join
- Those with eclampsia, those with preeclampsia
- Undergoing an emergency cesarean section
- Those with bleeding diathesis and those receiving anticoagulant therapy
- With a history of carotid artery stenosis,
- Cardiovascular disease,
- Hypertension,
Show all 11Show fewer
- Chronic obstructive pulmonary disease,
- Heart rhythm outside of sinus
- Patients with a history of cerebrovascular disease
- Alcoholism or psychiatric illness
- Placenta previa, accreta, and percreta
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University hospital
Kayseri, 38050
Kudret Doğru, 1, 05334735112 ext. 24034, kdogru@erciyes.edu.tr
About this study
Official title: The Value of Waist Circumference, Body Mass Index, and Modified Shock Index in Predicting Spinal Anesthesia-Induced Hypotension During Cesarean Section: A Prospective Observational Study
This prospective observational study investigates the predictive value of anthropometric and hemodynamic indices for spinal anesthesia-induced hypotension (SAIH) during cesarean section. While spinal anesthesia is preferred for its rapid onset, SAIH remains a frequent complication risking maternal and fetal safety. The study enrolled parturients at Erciyes University, excluding those with hypertension or extreme weight/height. Preoperative measurements included BMI, waist circumference (WC), body roundness index (BRI), and modified shock index (MSI). Following standardized spinal anesthesia with hyperbaric bupivacaine (Harten's dosage), hemodynamic parameters and sensory block levels were monitored. This research aims to determine whether BRI and WC offer superior predictive utility compared with conventional markers such as BMI and MSI to enhance individualized risk assessment in obstetric anesthesia.
Read the detailed description
Spinal anesthesia is the preferred anesthetic technique for cesarean section due to its rapid onset, reliability, and minimal neonatal drug exposure. However, spinal anesthesia-induced hypotension (SAIH) remains the most common and clinically significant complication, with an incidence ranging between 10% and 80% of parturients. The resulting maternal hypotension can lead to symptoms such as nausea, vomiting, and dizziness. At the same time, severe or sustained decreases in blood pressure may compromise uteroplacental perfusion, causing fetal acidosis and distress. Therefore, early prediction and prevention of hypotension are paramount to ensure maternal and neonatal safety.
Several hemodynamic and anthropometric factors have been investigated as potential predictors of SAIH, including baseline blood pressure, heart rate, and indices reflecting intravascular volume or autonomic tone. Among these, the modified shock index (MSI), calculated as the ratio of heart rate to mean arterial pressure, has been proposed as a noninvasive marker of hemodynamic stability and cardiovascular reserve. Likewise, body mass index (BMI), waist circumference (WC), and the body roundness index (BRI) have been associated with alterations in central blood volume, vascular compliance, and sympathetic responsiveness, which may influence susceptibility to post-spinal hypotension.
Pregnancy induces profound physiological changes, including decreased systemic vascular resistance and increased circulating blood volume, which alter cardiovascular responses to sympathetic blockade. These adaptations may interact with individual body composition and baseline hemodynamic parameters, modifying the risk of hypotension. Despite these associations, the predictive utility of anthropometric indices, such as BRI and WC, alongside conventional measures like BMI and MSI, has not been clearly established in obstetric anesthesia.
Symphyseal fundal height (SFH) and AC measurements indirectly indicate compression of the inferior vena cava (IVC). AC and VCL have previously been found to be highly predictive of block level in operations of non-pregnant patients performed under SA with isobaric bupivacaine.
Therefore, this prospective observational study was designed to evaluate the predictive value of waist circumference, body roundness index, body mass index, and modified shock index in identifying parturients at risk for spinal anesthesia-induced hypotension during cesarean delivery. By determining reliable preoperative indicators, this study aims to contribute to individualized risk assessment and the development of preventive strategies in obstetric anesthesia practice.
The study followed a parallel study strategy. Erciyes University's ethical committee approved the study on 2025/82. Patients provided informed consent before the procedure. Patients with pre-existing or pregnancy-induced hypertension, cardiovascular or cerebrovascular disease, contraindications to spinal anesthesia, weighing < 50 kg or > 110 kg, and heights higher than 170 cm or shorter than 150 cm were eliminated. Informed written consent was acquired from all patients participating in the trial.
There was no premeditation among the patients. The patient had standard monitoring, including non-invasive blood pressure, ECG, and pulse oximetry, with recorded baseline blood pressure and heart rate measurements. Two 20-gauge intravenous cannulas will be inserted, and an IV-balanced solution will be administered using these routes. The patient's age, height, weight, and ASA class were recorded. Height (cm), body weight (kg), waist circumference (WC; cm), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) were measured by assistants using a hemodynamic monitor and tape measure. Body mass index (BMI) was computed as weight (kg) divided by height squared (m²). The girth of the midpoint between the lowest point of the rib and the upper edge of the iliac crest was calculated as the waist circumference (WC). The Body Roundness Index (BRI) was calculated using the formula BRI=364.2-365.5×(√1-((WC/(2π))²/(0.5×Height)²). The modified shock index (MSI) was calculated as follows: MSI (heart rate/MAP). After skin infiltration with lidocaine 2%, a 25-gauge Whitacre spinal cannula, 25 G x 3 1/2" (0.5 x 90 mm), with an introducer spinal needle, was placed at the L3-4 vertebral interspace with the patient in a sitting position. After cerebrospinal fluid aspiration, the following anesthetic solutions were delivered over 5 seconds. Patients received a 0.5% hyperbaric bupivacaine volume, calculated based on their height and weight, at a dose of 0.5%. A dosage was derived using Harten's dose chart formulated for Caucasian parturients.
All patients received supplemental oxygen. Bradycardia (defined as a heart rate < 60 beats/min) was treated with 0.5 mg of intravenous atropine. Hypotension, defined as a reduction in baseline systolic blood pressure of >20%, a systolic blood pressure <100 mmHg, or a mean arterial pressure <65 mmHg, was treated with 10 mg of intravenous ephedrine. In the event of dizziness, nausea, or vomiting, the patient was administered 5 mg of ephedrine. To prevent postoperative nausea and vomiting, 4 mg of intravenous ondansetron was administered. Additionally, 1.5 g of intravenous cefuroxime was given prior to the incision for surgical site infection prophylaxis. A surgical incision was necessary when pinprick sensation was lost bilaterally in the T6 dermatome. If the sensory blockage was inadequate 5 minutes after spinal anesthesia insertion, the assessor placed the patient in a 10-degree head-down tilt. If patients experienced discomfort during the procedure, a 0.5 mg/kg propofol and 0.25 mg/kg ketamine bolus were administered via the venous route. If these efforts proved ineffective, the option of switching to general anesthesia was provided. Following birth, 100 IU carbetocin was administered as a uterotonic by gradual intravenous infusion. Paracetamol IV 1000 mg was administered after the procedure. Postoperative analgesia was constituted by TAP block with 20 ml of 0.25% bupivacaine bilaterally.
The upper sensory level of anesthesia was evaluated by systematically measuring the loss of pinprick sensation at the midclavicular line at 2-minute intervals; additionally, motor block was assessed using the Bromage scale.
- Conditions
- Spinal Anesthesia, Cesarean Section, Hypotension
- Keywords
- Bupivacaine, Cesarean, Spinal anesthesia, Hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anestezi CS | Spinal Anes Cs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Spinal Anesthesia-Induced Hypotension (SAIH)
The presence or absence of hypotension (binary variable) will be recorded. The predictive power of the independent variables (BMI, BRI, WC, MSI) for this condition will be evaluated using logistic regression. Nagelkerke's $R^2$ was treated as a component of the analysis procedure, not as a measurement unit.
Measured: From the time of spinal bupivacaine administration up to 30 minutes post-administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start16 Mar 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kudret Dogru, TC Erciyes University
- Investigators
- Kudret Doğru, 1, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499947
- Sponsor's protocol ID
- 2026/82
- Acronym
- prediction
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient information is considered personal data and its sharing is prohibited due to privacy regulations.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Waist Circumference, Body Mass Index, and Modified Shock Index in Predicting Spinal Anesthesia-Induced Hypotension During Cesarean Section: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07499947
- Acronym / sponsor ID
- prediction / 2026/82
- Conditions
- Spinal Anesthesia, Cesarean Section, Hypotension
- Keywords
- Bupivacaine, Cesarean, Spinal anesthesia, Hypotension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study investigates the predictive value of anthropometric and hemodynamic indices for spinal anesthesia-induced hypotension (SAIH) during cesarean section. While spinal anesthesia is preferred for its rapid onset, SAIH remains a frequent complication risking maternal and fetal safety. The study enrolled parturients at Erciyes University, excluding those with hypertension or extreme weight/height. Preoperative measurements included BMI, waist circumference (WC), body roundness index (BRI), and modified shock index (MSI). Following standardized spinal anesthesia with hyperbaric bupivacaine (Harten's dosage), hemodynamic parameters and sensory block levels were monitored. This research aims to determine whether BRI and WC offer superior predictive utility compared with conventional markers such as BMI and MSI to enhance individualized risk assessment in obstetric anesthesia.
Detailed description
Spinal anesthesia is the preferred anesthetic technique for cesarean section due to its rapid onset, reliability, and minimal neonatal drug exposure. However, spinal anesthesia-induced hypotension (SAIH) remains the most common and clinically significant complication, with an incidence ranging between 10% and 80% of parturients. The resulting maternal hypotension can lead to symptoms such as nausea, vomiting, and dizziness. At the same time, severe or sustained decreases in blood pressure may compromise uteroplacental perfusion, causing fetal acidosis and distress. Therefore, early prediction and prevention of hypotension are paramount to ensure maternal and neonatal safety.
Several hemodynamic and anthropometric factors have been investigated as potential predictors of SAIH, including baseline blood pressure, heart rate, and indices reflecting intravascular volume or autonomic tone. Among these, the modified shock index (MSI), calculated as the ratio of heart rate to mean arterial pressure, has been proposed as a noninvasive marker of hemodynamic stability and cardiovascular reserve. Likewise, body mass index (BMI), waist circumference (WC), and the body roundness index (BRI) have been associated with alterations in central blood volume, vascular compliance, and sympathetic responsiveness, which may influence susceptibility to post-spinal hypotension.
Pregnancy induces profound physiological changes, including decreased systemic vascular resistance and increased circulating blood volume, which alter cardiovascular responses to sympathetic blockade. These adaptations may interact with individual body composition and baseline hemodynamic parameters, modifying the risk of hypotension. Despite these associations, the predictive utility of anthropometric indices, such as BRI and WC, alongside conventional measures like BMI and MSI, has not been clearly established in obstetric anesthesia.
Symphyseal fundal height (SFH) and AC measurements indirectly indicate compression of the inferior vena cava (IVC). AC and VCL have previously been found to be highly predictive of block level in operations of non-pregnant patients performed under SA with isobaric bupivacaine.
Therefore, this prospective observational study was designed to evaluate the predictive value of waist circumference, body roundness index, body mass index, and modified shock index in identifying parturients at risk for spinal anesthesia-induced hypotension during cesarean delivery. By determining reliable preoperative indicators, this study aims to contribute to individualized risk assessment and the development of preventive strategies in obstetric anesthesia practice.
The study followed a parallel study strategy. Erciyes University's ethical committee approved the study on 2025/82. Patients provided informed consent before the procedure. Patients with pre-existing or pregnancy-induced hypertension, cardiovascular or cerebrovascular disease, contraindications to spinal anesthesia, weighing < 50 kg or > 110 kg, and heights higher than 170 cm or shorter than 150 cm were eliminated. Informed written consent was acquired from all patients participating in the trial.
There was no premeditation among the patients. The patient had standard monitoring, including non-invasive blood pressure, ECG, and pulse oximetry, with recorded baseline blood pressure and heart rate measurements. Two 20-gauge intravenous cannulas will be inserted, and an IV-balanced solution will be administered using these routes. The patient's age, height, weight, and ASA class were recorded. Height (cm), body weight (kg), waist circumference (WC; cm), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) were measured by assistants using a hemodynamic monitor and tape measure. Body mass index (BMI) was computed as weight (kg) divided by height squared (m²). The girth of the midpoint between the lowest point of the rib and the upper edge of the iliac crest was calculated as the waist circumference (WC). The Body Roundness Index (BRI) was calculated using the formula BRI=364.2-365.5×(√1-((WC/(2π))²/(0.5×Height)²). The modified shock index (MSI) was calculated as follows: MSI (heart rate/MAP). After skin infiltration with lidocaine 2%, a 25-gauge Whitacre spinal cannula, 25 G x 3 1/2" (0.5 x 90 mm), with an introducer spinal needle, was placed at the L3-4 vertebral interspace with the patient in a sitting position. After cerebrospinal fluid aspiration, the following anesthetic solutions were delivered over 5 seconds. Patients received a 0.5% hyperbaric bupivacaine volume, calculated based on their height and weight, at a dose of 0.5%. A dosage was derived using Harten's dose chart formulated for Caucasian parturients.
All patients received supplemental oxygen. Bradycardia (defined as a heart rate < 60 beats/min) was treated with 0.5 mg of intravenous atropine. Hypotension, defined as a reduction in baseline systolic blood pressure of >20%, a systolic blood pressure <100 mmHg, or a mean arterial pressure <65 mmHg, was treated with 10 mg of intravenous ephedrine. In the event of dizziness, nausea, or vomiting, the patient was administered 5 mg of ephedrine. To prevent postoperative nausea and vomiting, 4 mg of intravenous ondansetron was administered. Additionally, 1.5 g of intravenous cefuroxime was given prior to the incision for surgical site infection prophylaxis. A surgical incision was necessary when pinprick sensation was lost bilaterally in the T6 dermatome. If the sensory blockage was inadequate 5 minutes after spinal anesthesia insertion, the assessor placed the patient in a 10-degree head-down tilt. If patients experienced discomfort during the procedure, a 0.5 mg/kg propofol and 0.25 mg/kg ketamine bolus were administered via the venous route. If these efforts proved ineffective, the option of switching to general anesthesia was provided. Following birth, 100 IU carbetocin was administered as a uterotonic by gradual intravenous infusion. Paracetamol IV 1000 mg was administered after the procedure. Postoperative analgesia was constituted by TAP block with 20 ml of 0.25% bupivacaine bilaterally.
The upper sensory level of anesthesia was evaluated by systematically measuring the loss of pinprick sensation at the midclavicular line at 2-minute intervals; additionally, motor block was assessed using the Bromage scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Anestezi CS | – | –Spinal Anes Cs |
Who may qualify
- Ages
- 18 to 45 months
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parturients undergoing cesarean section
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Class II
- Having regular antenatal visits
- Singleton pregnancy at ≥37 weeks of gestation
- Pregnant women aged 18-45 -
Key exclusion criteria (11 listed)
- Those with eclampsia, those with preeclampsia
- Undergoing an emergency cesarean section
- Those with bleeding diathesis and those receiving anticoagulant therapy
- With a history of carotid artery stenosis,
- Cardiovascular disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Spinal Anesthesia-Induced Hypotension (SAIH)
Time frame: From the time of spinal bupivacaine administration up to 30 minutes post-administration.
The presence or absence of hypotension (binary variable) will be recorded. The predictive power of the independent variables (BMI, BRI, WC, MSI) for this condition will be evaluated using logistic regression. Nagelkerke's $R^2$ was treated as a component of the analysis procedure, not as a measurement unit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesiaLink provided by the sponsor.
- Postspinal Anesthesia Hypotension in Caesarean Delivery: A Narrative ReviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient information is considered personal data and its sharing is prohibited due to privacy regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kudret Doğru, 1 principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia and Cesarean Section, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kudret Dogru, 1 (+905334735112 ext. 24034, kdogru@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Spinal Anesthesia-Induced Hypotension (SAIH) (time frame: From the time of spinal bupivacaine administration up to 30 minutes post-administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.