Comparison of Maternal Hemodynamics During Spinal Anesthesia with Different Cesarean Delivery Positioning

March 15, 2025 updated by: Ahmed Yousef Mohamed, Aswan University
Cesarean delivery is a common surgical procedure, and maintaining maternal hemodynamic stability during the procedure is crucial for both maternal and fetal outcomes . Hemodynamic instability, such as hypotension following spinal anesthesia, is a frequent complication and can lead to adverse maternal and neonatal outcomes. Traditionally, after spinal anesthesia, women are positioned supine, sometimes with a slight left lateral tilt to mitigate the risk of aortocaval compression . However, recent studies and clinical observations suggest that delayed supine positioning-keeping the patient in a sitting or semi-sitting position for a period following spinal anesthesiamay improve hemodynamic stability. These alternative positions may help to mitigate the abrupt drop in blood pressure commonly seen after spinal anesthesia by allowing for a more gradual redistribution of blood volume . Understanding the optimal positioning strategy could lead to improved clinical protocols that enhance maternal and fetal safety. By comparing immediate supine positioning with delayed supine positioning (in sitting and semi-sitting positions), this study aims to provide evidence on which positioning strategy offers the best hemodynamic outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ahmed Yousef Mohamed, Resident of Anesthesia
  • Phone Number: +201112842063
  • Email: Maxedo.67@gmail.com

Study Locations

  • Egypt
      • Aswan, Egypt
        • Aswan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women scheduled for elective cesarean delivery.
  • Age between 18 and 40 years.
  • ASA (American Society of Anesthesiologists) physical status II.

Exclusion Criteria:

  • Emergency cesarean delivery.
  • Pre-existing cardiovascular disease.
  • Severe preeclampsia or eclampsia.
  • Multiple pregnancies.
  • Known fetal anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (N=72): Immediate Supine Position
Behavioral: Positioninng during Cs

  1. Group A (N=72): Immediate Supine Position (Control):

    Immediately after administering spinal anesthesia, participants will be placed in a supine position. To reduce the risk of aortocaval compression, a slight left lateral tilt (approximately 15 degrees) will be applied. This is the traditional positioning method and serves as the control group for comparison.

  2. Group В (N=72): Sitting Position:

    After spinal anesthesia, participants will be positioned in a sitting position with the ack supported at a 90-degree angle for the first 2 minutes. Knees will be bent, and feet will be supported.

  3. Group С (N=72): Semi-Sitting Position:

After spinal anesthesia, participants will be positioned in a semi-sitting position with the back supported at the back supported at for the first 2 minutes.

Similar to the sitting position, knees and feet will be flat.
Experimental: Group В (N=72): Sitting Position
Behavioral: Positioninng during Cs

  1. Group A (N=72): Immediate Supine Position (Control):

    Immediately after administering spinal anesthesia, participants will be placed in a supine position. To reduce the risk of aortocaval compression, a slight left lateral tilt (approximately 15 degrees) will be applied. This is the traditional positioning method and serves as the control group for comparison.

  2. Group В (N=72): Sitting Position:

    After spinal anesthesia, participants will be positioned in a sitting position with the ack supported at a 90-degree angle for the first 2 minutes. Knees will be bent, and feet will be supported.

  3. Group С (N=72): Semi-Sitting Position:

After spinal anesthesia, participants will be positioned in a semi-sitting position with the back supported at the back supported at for the first 2 minutes.

Similar to the sitting position, knees and feet will be flat.
Experimental: Group С (N=72): Semi-Sitting Position
Behavioral: Positioninng during Cs

  1. Group A (N=72): Immediate Supine Position (Control):

    Immediately after administering spinal anesthesia, participants will be placed in a supine position. To reduce the risk of aortocaval compression, a slight left lateral tilt (approximately 15 degrees) will be applied. This is the traditional positioning method and serves as the control group for comparison.

  2. Group В (N=72): Sitting Position:

    After spinal anesthesia, participants will be positioned in a sitting position with the ack supported at a 90-degree angle for the first 2 minutes. Knees will be bent, and feet will be supported.

  3. Group С (N=72): Semi-Sitting Position:

After spinal anesthesia, participants will be positioned in a semi-sitting position with the back supported at the back supported at for the first 2 minutes.

Similar to the sitting position, knees and feet will be flat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.
Time Frame: 9 Months
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University

Collaborators

Aswan University Hospital

Investigators

  • Study Chair: Ayman Mohamadi Eldemrdash, MD Of Anesthesia, Aswan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 25, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 15, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 966/9/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Positioninng during Cs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe