NCT06707428

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 19, 2024

Last Update Submit

November 23, 2024

Conditions

Intraoperative Hypotension

Keywords

hypotensionvasopressorvaricose veins

Outcome Measures

Primary Outcomes (2)

  • decrease in blood pressure

    systolic blood pressure

    one year

  • decrease in blood pressure

    diastolic blood pressure

    one year

Study Arms (2)

Compression stocking using group

EXPERIMENTAL

Wearing varicose vein stockhing is a routine operation preparation

Other: compression stockings

Control Group

NO INTERVENTION

Routine opreration preparation

Interventions

compression stockingsOTHER

compression stockings used during cesarean section

Compression stocking using group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • weeks pregnant women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afşin Devlet Hastanesi

Afşin, Kahramanmaraş, 46600, Turkey (Türkiye)

Location

Related Publications (14)

  • 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

    BACKGROUND

  • 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.

    PMID: 29090733BACKGROUND

  • 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.

    PMID: 32581577BACKGROUND

  • 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.

    PMID: 37685357BACKGROUND

  • 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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 34034957RESULT

  • 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.

    PMID: 31508443RESULT

  • 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.

    PMID: 37667479RESULT

  • 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

    RESULT

  • 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

    RESULT

  • 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.

    PMID: 35256251RESULT

  • 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.

    PMID: 38925990RESULT

  • 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.

    PMID: 28438121RESULT

MeSH Terms

Conditions

HypotensionVaricose Veins

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. student in women's health and diseases nursing

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 27, 2024

Study Start

January 5, 2024

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)