Effect of Vitamin D Deficiency on the Frequency and Severity of Spinal Anesthesia-Induced Hypotension in Pregnant Women Undergoing Cesarean Section

NCT07057362 | Recruiting

• 1 other identifier: 2025/63
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia-induced hypotension remains a common and significant complication during cesarean sections, posing risks for both mother and fetus. Vitamin D deficiency, frequently observed in pregnant women, is associated with altered vascular function and potential hemodynamic instability. This prospective observational study aims to investigate whether vitamin D deficiency is associated with an increased incidence and severity of spinal anesthesia-induced hypotension in pregnant women undergoing elective cesarean delivery. Vitamin D levels will be measured preoperatively, and intraoperative hemodynamic parameters will be closely monitored. The findings could contribute to improved management strategies for pregnant patients at risk of severe hypotension.

Conditions

Spinal Anesthesia-induced Hypotension; Vitamin D Deficiency; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypotension After Spinal Anesthesia

  Hypotension is defined as a ≥20% decrease in systolic blood pressure from baseline or an absolute systolic value \<90 mmHg. The presence or absence of hypotension will be recorded.

  ntraoperative (0-30 minutes after spinal anesthesia)

Secondary Outcomes (2)

• Total Vasopressor Dose Administered

  Intraoperative (0-30 minutes after spinal anesthesia)

• Total Crystalloid Volume Administered

  Intraoperative (0-30 minutes after spinal anesthesia)

Study Arms (2)

Vitamin D Deficient Group

Pregnant women with serum 25-hydroxyvitamin D levels below the defined deficiency threshold

Other: Intraoperative Hemodynamic Monitoring

Vitamin D Sufficient Grup

Pregnant women with normal or sufficient vitamin D levels

Other: Intraoperative Hemodynamic Monitoring

Interventions

Intraoperative Hemodynamic Monitoring OTHER

Continuous intraoperative monitoring of systolic blood pressure and heart rate following spinal anesthesia. Vasopressor usage and total fluid administration will be recorded.

Vitamin D Deficient Group; Vitamin D Sufficient Grup

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 18 years and older who are scheduled for elective cesarean section under spinal anesthesia at a tertiary care university hospital. All participants will be clinically stable and provide informed consent prior to enrollment. The study population will be stratified based on serum vitamin D levels into deficient and sufficient groups for analysis of hypotension outcomes.

You may qualify if:

• Pregnant women aged 18 years or older
• Scheduled for elective cesarean delivery under spinal anesthesia
• Able and willing to provide written informed consent

You may not qualify if:

• Emergency cesarean sections
• History of significant cardiovascular disease (e.g., arrhythmia, heart failure)
• Known neurological disorders affecting autonomic function
• Current vitamin D supplementation within the past 30 days
• Inability to undergo blood sampling or provide valid hemodynamic data
• Contraindication to spinal anesthesia

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Duzce University Faculty of Medicine, Department of Anesthesiology and Reanimation

Düzce, Merkez, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Gizem DEMIR SENOGLU

CONTACT

+905059313588; gizem123demir@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: March 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)