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NCT Number: NCT07057362

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Duzce University Faculty of Medicine, Department of Anesthesiology and Reanimation

Düzce, Merkez, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gizem DEMIR SENOGLU

CONTACT

[email protected]

+905059313588

About this study

Detailed Description Spinal anesthesia is the most commonly used technique for cesarean section and is associated with a high incidence of maternal hypotension, which can adversely affect both maternal well-being and neonatal outcomes. Despite standard preventive strategies such as fluid preloading and vasopressor use, significant hypotension still occurs in a considerable proportion of patients.

Vitamin D deficiency is a prevalent condition among pregnant women and has been implicated in the modulation of cardiovascular and autonomic functions. Low serum levels of 25-hydroxyvitamin D may impair vascular smooth muscle contractility, endothelial function, and baroreflex sensitivity, potentially contributing to exaggerated hypotensive responses under spinal anesthesia.

This prospective observational study aims to evaluate the relationship between maternal vitamin D status and the incidence and severity of spinal anesthesia-induced hypotension during elective cesarean delivery. Eligible pregnant women scheduled for elective cesarean section under spinal anesthesia will have their serum 25-hydroxyvitamin D levels measured preoperatively. Intraoperative hemodynamic parameters will be continuously monitored, and episodes of hypotension will be recorded and analyzed in relation to vitamin D status.

The primary outcome of the study is the incidence of spinal hypotension, defined as a ≥20% decrease in systolic blood pressure from baseline or an absolute value below 90 mmHg. Secondary outcomes include total vasopressor dose, fluid requirement.

Findings from this study may identify vitamin D deficiency as a novel risk factor for spinal anesthesia-induced hypotension and inform new preventive strategies for hemodynamic management in cesarean deliveries

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Hypotension After Spinal Anesthesia

    Time frame: ntraoperative (0-30 minutes 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.

Secondary outcomes

  1. Total Vasopressor Dose Administered

    Time frame: Intraoperative (0-30 minutes after spinal anesthesia)

    Cumulative amount (in mg) of vasopressor (e.g., ephedrine or phenylephrine) used to manage hypotension.

  2. Total Crystalloid Volume Administered

    Time frame: Intraoperative (0-30 minutes after spinal anesthesia)

    Total amount (in mL) of intravenous crystalloids given from the time of spinal anesthesia until delivery.

Study contacts

Contact information is provided by the study sponsor or research team.

Gizem DEMIR SENOGLU

CONTACT

[email protected]

+905059313588

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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