Predicting low blood pressure from spinal anesthesia during cesarean section
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 study will test whether body-shape measures (body roundness index and waist circumference) and simple heart/blood pressure indexes can help predict which full-term women having a cesarean with spinal anesthesia will develop low blood pressure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 321 (estimated) |
| Ages | 18 Months to 45 Months |
| Sex | Female |
| Sponsor | TC Erciyes University Academic / other |
| Locations | 1 site (Kayseri) |
| Trial ID | NCT07499947 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study of term parturients undergoing elective cesarean with standardized spinal anesthesia using hyperbaric bupivacaine. Before anesthesia, investigators recorded anthropometric measures (BMI, waist circumference, body roundness index) and hemodynamic indices including the modified shock index; intraoperative blood pressure, heart rate, and sensory block levels were then monitored. Women with hypertension, major cardiovascular or cerebrovascular disease, emergency cesarean, placenta accreta spectrum, or on anticoagulants were excluded. The main aim was to compare whether BRI and waist circumference predict spinal anesthesia–induced hypotension better than conventional markers such as BMI or MSI.
Who should consider this trial
Good fit: Term (≥37 weeks) pregnant women aged 18–45 with singleton pregnancies, ASA II, attending regular antenatal care and scheduled for elective cesarean under spinal anesthesia were the target participants.
Not a fit: Patients with preexisting hypertension, significant cardiac or cerebrovascular disease, emergency cesarean, placenta previa/accreta/percreta, bleeding disorders, or on anticoagulants were excluded and are unlikely to benefit from this specific predictive approach.
Why it matters
Potential benefit: If successful, the findings could enable clinicians to identify women at higher risk of spinal anesthesia–induced hypotension and tailor preventive measures and monitoring to improve maternal and fetal safety.
How similar studies have performed: Prior observational work has linked MSI and BMI to post-spinal hypotension, but applying body roundness index and waist circumference as predictors is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) Class II 2. Having regular antenatal visits 3. Singleton pregnancy at ≥37 weeks of gestation 4. Pregnant women aged 18-45 - Exclusion Criteria: 1. Those with eclampsia, those with preeclampsia 2. Undergoing an emergency cesarean section 3. Those with bleeding diathesis and those receiving anticoagulant therapy 4. With a history of carotid artery stenosis, 5. Cardiovascular disease, 6. Hypertension, 7. Chronic obstructive pulmonary disease, 8. Heart rhythm outside of sinus 9. Patients with a history of cerebrovascular disease 10. Alcoholism or psychiatric illness 11. Placenta previa, accreta, and percreta
Where this trial is running
Kayseri
- University hospital — Kayseri, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Kudret Doğru, 1 — TC Erciyes University
- Study coordinator: Kudret Dogru, 1
- Email: kdogru@erciyes.edu.tr
- Phone: +905334735112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.