- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534891
The Effect of Compression Stockings and Leg Elevation on Hemodynamic Stability in Elective Cesarean Sections Under Spinal Anesthesia: A Single-Blind Randomized Controlled Trial
Aim:
This study aimed to evaluate the effects of compression stockings and leg elevation on maternal intraoperative hypotension, vasopressor requirement, and neonatal well-being parameters in women undergoing elective cesarean section spinal anesthesia.
Methods:
This single-blind randomized controlled experimental study was conducted in the obstetrics service and operating room of Afşin State Hospital between November 1, 2023, and February 20, 2025. A total of 90 pregnant women who met the inclusion criteria were randomly assigned into three groups: the compression stockings group (n=30), the leg elevation group (n=30), and the control group (n=30). Spinal anesthesia was administered to all participants according to a standardized protocol. Maternal systolic, diastolic, and mean arterial blood pressure, as well as heart rate, were monitored at regular intervals during the intraoperative period. The occurrence of hypotension, vasopressor use, and side effects such as nausea and vomiting were recorded. Neonatal outcomes included the 5-minute APGAR score and umbilical venous blood gas parameters (pH and base excess). Data were analyzed using appropriate statistical methods.
Results:
Intraoperative systolic, diastolic, and mean arterial blood pressure values were significantly higher in both the compression stockings and leg elevation groups compared to the control group (p<0.05). The rate of vasopressor use was significantly lower in both intervention groups compared to the control group (p<0.05). There were no statistically significant differences among the groups in terms of neonatal APGAR scores, umbilical venous pH, and base excess values (p>0.05).
Conclusion:
The use of compression stockings and leg elevation in women undergoing elective cesarean section تحت spinal anesthesia are effective, safe, and feasible non-pharmacological methods for maintaining maternal hemodynamic stability. These interventions reduce vasopressor requirements and hypotension-related side effects without adversely affecting short-term neonatal outcomes. The findings suggest that these methods can be integrated into clinical nursing practice for the prevention of spinal anesthesia-induced hypotension.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kahramanmaraş
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Kahramanmaraş, Kahramanmaraş, Turkey (Türkiye), 46500
- Kahramanmaraş Afşin Devlet Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-
Inclusion Criteria:
Gestational age between 37-40 weeks, Planned elective cesarean section, Maternal age between 19-40 years, Singleton pregnancy, Planned spinal anesthesia, Estimated fetal weight between 2500-4000 g.
Exclusion Criteria:
Known hypertensive disorders, History of severe lower extremity injury, History of deep vein thrombosis, Use of anticoagulant therapy, Placental invasion or placental localization abnormalities with a high risk of bleeding, Requirement for general anesthesia, Known fetal anomalies, Signs of acute or chronic fetal distress, Development of maternal complications during the operation.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Compression stockings
Moderate-pressure graduated compression stockings were applied
|
a medical device that applies graduated pressure to the lower extremities to enhance venous return
|
|
Experimental: Leg elevation
After spinal anesthesia, a 30° leg elevation was applied to the patient throughout the surgery.
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a positional intervention involving elevation of the lower extremities above the level of the heart to enhance venous return"
|
|
No Intervention: Control
Routine surgical preparation is performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal intraoperative hypotension
Time Frame: throughout the cesarean section
|
Maternal hypotension during spinal anesthesia
|
throughout the cesarean section
|
|
Maternal intraoperatif hipotansiyon
Time Frame: throughout the cesarean section
|
Maternal intraoperatif hipotansiyon
|
throughout the cesarean section
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tülay Bülbül, doçent, Erciyes Üniversitesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErciyesU-SBE-SY-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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