Prediction of Hypotension During Cesarean Delivery Using Positional Change of Hemodynamic Parameters

NCT05685212 | Completed

• 1 other identifier: hypotension Cesarean section
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

This was a prospective observational study between January 2022 and June 2022. The investigators included parturients aged 18 to 45 years, consenting, classified ASA II and III, scheduled for elective or emergency cesarean section (Lucas III-IV). Baseline hemodynamic parameters were measured in 3 different positions: sitting, supine, and left lateral tilt 15°. The investigators defined Δ1 as the change from the sitting position to the supine position ad Δ2 as the change from the left lateral tilt 15° position to the supine position. Our primary endpoint was the incidence of hypotension defined as a decrease of more than 20% from baseline values. The investigators performed univariate and then multivariate analysis.

Conditions

Cesarean Section; Hypotension; Anesthesia, Spinal; Heart Rate; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  a decrease in systolic arterial pressure more than 20% of the baseline (sitting position)

  30 minutes after spinal anesthesia

Secondary Outcomes (1)

• Dose of ephedrine.

  30 minutes after spinal anesthesia

Study Arms (2)

Group Hypotension.

patients who developed hypotension defined as a decrease in systolic arterial pressure more than 20% of the baseline

Group Normotension

patients who did not experience a hypotensive event.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

During the study recruitment period, there were three hundred and thirty-one parturients eligible for recruitment. One hundred and eighty-eight cases were not included and twenty-one were excluded, leaving one hundred and twenty-one women who were recruited. Patients were divided into 2 groups according to the primary endpoint of the study: * Group Normotension: 41 parturients. * Group Hypotension: 80 parturients.

You may qualify if:

• American society of anesthesiologists' (ASA) physical status of II-III.
• Full-term pregnancy.
• Elective cesarean section.
• Emergency cesarean section (Lucas III-IV).

You may not qualify if:

• Emergency cesarean section (Lucas I-II).
• Cesarean section under epidural anesthesia.
• Patients with abnormal placentation.
• Patients with contraindication for spinal anesthesia.
• Patients with personal medical history of cardiac arrythmias or valvular heart disease.
• Patients on beta-blockers.
• Failed spinal anesthesia.
• Conversion to general anesthesia.
• Postpartum hemorrhage.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Faten Haddad

  Mongi Slim local research ethical committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 17, 2023
• Study Start: April 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

TU (1)