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

NCT06857162 | Not Yet Recruiting

• 1 other identifier: 966/9/24
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

This Study Aims to Provide Evidence on Which Positioning Strategy Offers the Best Hemodynamic Outcomes; Maternal Hemodynamic; Maternal Positioning During CS

Outcome Measures

Primary Outcomes (1)

• To compare the incidence and severity of hypotension in immediate supine, sitting, and semi-sitting positions during cesarean delivery.

  9 Months

Study Arms (3)

Group A (N=72): Immediate Supine Position

ACTIVE COMPARATOR

Behavioral: Positioninng during Cs

Group В (N=72): Sitting Position

EXPERIMENTAL

Behavioral: Positioninng during Cs

Group С (N=72): Semi-Sitting Position

EXPERIMENTAL

Behavioral: Positioninng during Cs

Interventions

Positioninng during Cs BEHAVIORAL

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.

Group A (N=72): Immediate Supine Position; Group В (N=72): Sitting Position; Group С (N=72): Semi-Sitting Position

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aswan University: lead
• Aswan University Hospital: collaborator

Study Sites (1)

Aswan University Hospital

Aswān, Aswan Governorate, Egypt

Location

Study Officials

• Ayman Mohamadi Eldemrdash, MD Of Anesthesia

  Aswan University

  STUDY CHAIR

Central Study Contacts

Ahmed Yousef Mohamed, Resident of Anesthesia

CONTACT

+201112842063; Maxedo.67@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anethesia and Intensive Care

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: April 25, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-08

Locations

EG (1)