NCT07534891

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

December 18, 2025

Last Update Submit

April 11, 2026

Conditions

Keywords

Spinal anesthesia, elective cesarean section, maternal hypotension, graduated compression stockings, leg elevation, randomized controlled trial

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

EXPERIMENTAL

Moderate-pressure graduated compression stockings were applied

Device: compression stockings

Leg elevation

EXPERIMENTAL

After spinal anesthesia, a 30° leg elevation was applied to the patient throughout the surgery.

Other: Leg elevation

Control

NO INTERVENTION

Routine surgical preparation is performed.

Interventions

a medical device that applies graduated pressure to the lower extremities to enhance venous return

Compression stockings

a positional intervention involving elevation of the lower extremities above the level of the heart to enhance venous return"

Leg elevation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailskadın
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Kahramanmaraş Afşin Devlet Hastanesi

Kahramanmaraş, Kahramanmaraş, 46500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Stockings, Compression

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Officials

  • Tülay Bülbül, doçent

    Erciyes Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was designed as a single-blind, parallel-group randomized controlled trial.
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

Locations