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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorDuzce University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women aged 18 years or older

Scheduled for elective cesarean delivery under spinal anesthesia

Able and willing to provide written informed consent

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intraoperative Hemodynamic Monitoring

    Other intervention

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Vitamin D Deficient Group1 intervention
Group B: Vitamin D Sufficient Grup1 intervention

Trial outcomes

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.

Time frame
ntraoperative (0-30 minutes after spinal anesthesia)

Secondary outcomes

1

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)
2

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)

Other outcomes

Sponsors and contacts

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