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Intraoperative HypotensionNCT06707428

Do Compression Stockings Used During Cesarean Sections Affect Intraoperative Hypotension and Nausea?

A study testing compression stockings in people with Intraoperative Hypotension, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Intraoperative Hypotension
What is being tested?
compression stockings
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Jan 2024to 25 Jun 2024
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 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 37-38 weeks pregnant women

Who cannot join

  • chronic disease
  • women who developed complications during surgery
  • women with multiple pregnancies
  • women with pregnancies with known fetal anomalies

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Afşin Devlet Hastanesi

    Afşin, Kahramanmaraş, 46600

Other trials in Turkey (Türkiye)

About this study

The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Read the detailed description

Cesarean section is among the most common surgeries in young and healthy individuals. Its frequency is increasing in our country and on a global scale. A total of 57% of all births in our country were performed by cesarean section between 2018 and 2023.

Spinal anesthesia is frequently used during cesarean sections with its advantages such as the patient being conscious, not having a risk of aspiration, not causing respiratory depression in the newborn, and the mother being able to breastfeed early. However, Spinal Anesthesia has complications such as hypotension and post-spinal headache, bradycardia and asystole, nausea, hypoventilation, total spinal block, urinary retention, spinal hematoma, back pain, infection, transient neurological symptoms, or cranial nerve paralysis. The present study aimed to determine the effects of compression stockings used during cesarean section on intraoperative hypotension.

Being tested
compression stockings
Keywords
hypotension, vasopressor, varicose veins
Medical subject headings
Hypotension, Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • compression stockingsOther

    compression stockings used during cesarean section

Study groups in NCT06707428
Study groupRoleWhat they receive
Compression stocking using groupExperimentalWearing varicose vein stockhing is a routine operation preparation
Receives: Other: compression stockings
Control GroupNo interventionRoutine opreration preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. decrease in blood pressure

    systolic blood pressure

    Measured: one year

  2. decrease in blood pressure

    diastolic blood pressure

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start5 Jan 2024
  3. Primary completion25 Jun 2024
  4. Study completion25 Jun 2024

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06707428
Sponsor's protocol ID
ErciyesU-SBE-SY-01
Status last verified
Nov 2024
First submitted
19 Nov 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pradhan, A., Das, T., Sraban, S., Pradhan, K., & Raut, K. (2016). Study the Hemodynamic changes after leg wrapping in elective cesarean section under spinal anesthesia. J Med Sci Clin Res, 4(11), 12-20.https://doi.org/10.18535/jmscr/v4i11.66

  • Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

    PubMed 29090733

  • Ferre F, Martin C, Bosch L, Kurrek M, Lairez O, Minville V. Control of Spinal Anesthesia-Induced Hypotension in Adults. Local Reg Anesth. 2020 Jun 3;13:39-46. doi: 10.2147/LRA.S240753. eCollection 2020.

    PubMed 32581577

  • Chang YJ, Liu CC, Huang YT, Wu JY, Hung KC, Liu PH, Lin CH, Lin YT, Chen IW, Lan KM. Assessing the Efficacy of Inferior Vena Cava Collapsibility Index for Predicting Hypotension after Central Neuraxial Block: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Aug 31;13(17):2819. doi: 10.3390/diagnostics13172819.

    PubMed 37685357

  • Ağaçayak, E., Yavuz, M., Tunç, S. Y., Akın, G., Ertuğrul, S., Yıldırım, Z. B., & Gül, T. (2019). Comparison neonatal outcomes of elective cesareans performed with spinal or general anesthesia and normal births without anesthesia. Dicle Medical Journal , 46(2), 299-305.https://doi.org/10.5798/dicletip.574822

  • Adatepe S. (2020). Comparison of neonatal outcomes of elective cesarean sections performed with spinal or general anesthesia and normal deliveries without anesthesia.Specialization Thesis. Tokat Gaziosmanpaşa University.

  • Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.

    PubMed 34034957

  • Ebrahim Elgzar WT, Ebrahim Said H, Ebrahim HA. Effect of lower leg compression during cesarean section on post-spinal hypotension and neonatal hemodynamic parameters: nonrandomized controlled clinical trial. Int J Nurs Sci. 2019 Jun 10;6(3):252-258. doi: 10.1016/j.ijnss.2019.06.003. eCollection 2019 Jul 10.

    PubMed 31508443

  • Ulgu MM, Birinci S, Altun Ensari T, Gozukara MG. Cesarean section rates in Turkey 2018-2023: Overview of national data by using Robson ten group classification system. Turk J Obstet Gynecol. 2023 Sep 4;20(3):191-198. doi: 10.4274/tjod.galenos.2023.68235.

    PubMed 37667479

  • Mohamed AI, Elazhary RA, Abdelhady RM, Abd-ElSadek BR, Said KM. Utilization of lower leg compression technique for reducing spinal induced hypotension, and related risks for mothers and neonates during cesarean delivery. J Nurs Educ Pract 2016;6(7):11e8. https://doi.org/10.5430/jnep.v6n7p11

  • Mohamad A., Rama B., Farshid G., Kourosh F., Reza A. (2020). A randomized double-blind clinical trial evaluating the effect of Elastic Stocking on Hemodynamic Changes and dose use of ephedrine for elective cesarean surgery under spinal anesthesia. International Journal of Surgery Open, 27, 58-63, https://doi.org/10.1016/j.ijso.2020.10.019

  • Wan L, Shen PY, Zhang SX, Wang LZ. Leg Compression Versus Control for Prevention of Spinal Anesthesia Induced Hypotension in Elective Cesarean Delivery: A Meta-Analysis of Randomized Controlled Trials. J Perianesth Nurs. 2022 Aug;37(4):501-508. doi: 10.1016/j.jopan.2021.10.011. Epub 2022 Mar 4.

    PubMed 35256251

  • Yao HQ, Huang JY, Dong YF, Sun XX, Wang LZ. Effect of pneumatic leg compression on phenylephrine dose for hypotension prophylaxis via variable rate infusion at cesarean delivery: an unblinded randomized controlled trial. Int J Obstet Anesth. 2024 Nov;60:104218. doi: 10.1016/j.ijoa.2024.104218. Epub 2024 Jun 11.

    PubMed 38925990

  • Hasanin A, Aiyad A, Elsakka A, Kamel A, Fouad R, Osman M, Mokhtar A, Refaat S, Hassabelnaby Y. Leg elevation decreases the incidence of post-spinal hypotension in cesarean section: a randomized controlled trial. BMC Anesthesiol. 2017 Apr 24;17(1):60. doi: 10.1186/s12871-017-0349-8.

    PubMed 28438121

Questions about this trial

What is this clinical trial studying?

A study testing compression stockings in people with Intraoperative Hypotension, run by TC Erciyes University 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 1 inclusion and 4 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 27 Nov 2024. 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?

decrease in blood pressure (time frame: one year). 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?

On the ClinicalTrials.gov record for NCT06707428, which also lists 14 linked publications.

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 27 Nov 2024.

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