Predicting Spinal Hypotension in Cesarean Section

NCT07499947 | Recruiting

• 1 other identifier: 2026/82
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Anesthesia; Cesarean Section; Hypotension

Keywords

Bupivacaine; Cesarean; Spinal anesthesia; Hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

  From the time of spinal bupivacaine administration up to 30 minutes post-administration.

Study Arms (1)

Spinal Anestezi CS

Spinal Anes Cs

Eligibility Criteria

• Age: 18 Months - 45 Months
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Parturients undergoing cesarean section

You may qualify if:

• American Society of Anesthesiologists (ASA) Class II
• Having regular antenatal visits
• Singleton pregnancy at ≥37 weeks of gestation
• Pregnant women aged 18-45 -

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

University hospital

Kayseri, 38050, Turkey (Türkiye)

RECRUITING

Related Links

• International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia
• Postspinal Anesthesia Hypotension in Caesarean Delivery: A Narrative Review

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kudret Doğru, 1

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kudret Dogru, 1

CONTACT

+905334735112; kdogru@erciyes.edu.tr

Aynur Karayo Akin, 2

CONTACT

+905326460336; draynurak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. MD

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 30, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)