An observational study in Spinal Anesthesia-induced Hypotension, Vitamin D Deficiency and Cesarean Section, sponsored by Duzce University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Duzce University · Observational
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.
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
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's planned enrollment of 140 is close to the median of 138 across 183 observational studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Duzce University is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
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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.
Exclusion Criteria:
Pregnant women with serum 25-hydroxyvitamin D levels below the defined deficiency threshold
Other: Intraoperative Hemodynamic Monitoring
Pregnant women with normal or sufficient vitamin D levels
Other: Intraoperative Hemodynamic Monitoring
Continuous intraoperative monitoring of systolic blood pressure and heart rate following spinal anesthesia. Vasopressor usage and total fluid administration will be recorded.
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.
Time frame: ntraoperative (0-30 minutes after spinal anesthesia)
Total Vasopressor Dose Administered
Cumulative amount (in mg) of vasopressor (e.g., ephedrine or phenylephrine) used to manage hypotension.
Time frame: Intraoperative (0-30 minutes after spinal anesthesia)
Total Crystalloid Volume Administered
Total amount (in mL) of intravenous crystalloids given from the time of spinal anesthesia until delivery.
Time frame: Intraoperative (0-30 minutes after spinal anesthesia)
Plan to share: No — The study involves sensitive clinical data from pregnant women. Individual participant data will not be shared publicly due to privacy concerns.
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