Maternal Hypotension Associated With Spinal Anesthesia During Cesarean SectionNCT07534891
The Effect of Compression Stockings and Leg Elevation on Hemodynamic Stability in Elective Cesarean Sections Under Spinal Anesthesia: A Single-Blind Randomized Controlled Trial
A study testing compression stockings and Leg elevation in people with Maternal Hypotension Associated With Spinal Anesthesia During Cesarean Section, run by Seçil Yavaş at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Maternal Hypotension Associated With Spinal Anesthesia During Cesarean Section
- What is being tested?
- compression stockings and Leg elevation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- -
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Afşin Devlet Hastanesi
Kahramanmaraş, Kahramanmaraş, 46500
About this study
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.
Read more
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.
- Being tested
- compression stockings, Leg elevation
- Keywords
- Spinal anesthesia, elective cesarean section, maternal hypotension, graduated compression stockings, leg elevation, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression stockingsDevice
a medical device that applies graduated pressure to the lower extremities to enhance venous return
Leg elevationOther
a positional intervention involving elevation of the lower extremities above the level of the heart to enhance venous return"
| Study group | Role | What they receive |
|---|---|---|
| Compression stockings | Experimental | Moderate-pressure graduated compression stockings were applied Receives: Device: compression stockings |
| Leg elevation | Experimental | After spinal anesthesia, a 30° leg elevation was applied to the patient throughout the surgery. Receives: Other: Leg elevation |
| Control | No intervention | Routine surgical preparation is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal intraoperative hypotension
Maternal hypotension during spinal anesthesia
Measured: throughout the cesarean section
Maternal intraoperatif hipotansiyon
Maternal intraoperatif hipotansiyon
Measured: throughout the cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Nov 2023
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Hypotension Associated With Spinal Anesthesia During Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a single-blind, parallel-group randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seçil Yavaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seçil Yavaş, TC Erciyes University
- Investigators
- Tülay Bülbül, doçent, Principal investigator, Erciyes Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534891
- Sponsor's protocol ID
- ErciyesU-SBE-SY-02
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Compression Stockings and Leg Elevation on Hemodynamic Stability in Elective Cesarean Sections Under Spinal Anesthesia: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07534891
- Acronym / sponsor ID
- ErciyesU-SBE-SY-02
- Keywords
- Spinal anesthesia, elective cesarean section, maternal hypotension, graduated compression stockings, leg elevation, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seçil YavaşUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study was designed as a single-blind, parallel-group randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Compression stockings | Experimental | Device: compression stockingsModerate-pressure graduated compression stockings were applied |
| Leg elevation | Experimental | Other: Leg elevationAfter spinal anesthesia, a 30° leg elevation was applied to the patient throughout the surgery. |
| Control | No intervention | –Routine surgical preparation is performed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- -
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compression stockingsa medical device that applies graduated pressure to the lower extremities to enhance venous return | Device | Compression stockings |
| Leg elevationa positional intervention involving elevation of the lower extremities above the level of the heart to enhance venous return" | Other | Leg elevation |
Primary outcome
Maternal intraoperative hypotension
Time frame: throughout the cesarean section
Maternal hypotension during spinal anesthesia
Maternal intraoperatif hipotansiyon
Time frame: throughout the cesarean section
Maternal intraoperatif hipotansiyon
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tülay Bülbül, doçent principal investigator
Erciyes Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression stockings and Leg elevation in people with Maternal Hypotension Associated With Spinal Anesthesia During Cesarean Section, run by Seçil Yavaş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal intraoperative hypotension (time frame: throughout the cesarean section). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.