The Effect of Compression Stockings and Leg Elevation on Hemodynamic Stability in Elective Cesarean Sections Under Spinal Anesthesia: A Single-Blind Randomized Controlled Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2025
CompletedFirst Submitted
Initial submission to the registry
December 18, 2025
CompletedFirst Posted
Study publicly available on registry
April 16, 2026
CompletedApril 16, 2026
December 1, 2025
1.3 years
December 18, 2025
April 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maternal intraoperative hypotension
Maternal hypotension during spinal anesthesia
throughout the cesarean section
Maternal intraoperatif hipotansiyon
Maternal intraoperatif hipotansiyon
throughout the cesarean section
Study Arms (3)
Compression stockings
EXPERIMENTALModerate-pressure graduated compression stockings were applied
Leg elevation
EXPERIMENTALAfter spinal anesthesia, a 30° leg elevation was applied to the patient throughout the surgery.
Control
NO INTERVENTIONRoutine surgical preparation is performed.
Interventions
a medical device that applies graduated pressure to the lower extremities to enhance venous return
a positional intervention involving elevation of the lower extremities above the level of the heart to enhance venous return"
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seçil Yavaşlead
Study Sites (1)
Kahramanmaraş Afşin Devlet Hastanesi
Kahramanmaraş, Kahramanmaraş, 46500, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tülay Bülbül, doçent
Erciyes Üniversitesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- UZMAN HEMŞİRE
Study Record Dates
First Submitted
December 18, 2025
First Posted
April 16, 2026
Study Start
November 1, 2023
Primary Completion
February 20, 2025
Study Completion
February 20, 2025
Last Updated
April 16, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share