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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06357637
Other study ID # 59/2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date May 31, 2024

Study information

Verified date April 2024
Source CHU Mohammed VI Marrakech
Contact MERYEM Essafti, MD
Phone +212662393700
Email essafti.m@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to evaluate preoperative measures of abdominal circumference in patients admitted for a cesarean section. The main questions it aims to answer are: - Can preoperative abdominal circumference predict patients with difficult spinal anesthesia - Can preoperative abdominal circumference predict the occurrence of maternal hypotension during cesarean section Participants will be examined preoperatively in terms of visibility and palpation of spinous processes, abdominal circumference will be measured in the supine and sitting positions with other clinical parameters. Spinal anesthesia will be performed by the same experienced anesthesiologist with a standardized procedure. The number of skin punctures, needle reorientations, traumatic Cerebrospinal fluid, need for a paramedian approach or failure will be recorded. Maternal blood pressure and vasopressor requirements will also be monitored.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Parturients admitted for elective or emergency cesarean section Exclusion Criteria: - Acute fetal distress - Umbilical cord prolapse - Scoliosis - Contraindication to spinal anesthesia - Medical history of spinal surgery American Society of Anesthesia Status 4 or 5

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Measure of abdominal circumference
Measure of abdominal circumference preoperatively in both sitting and lying position

Locations

Country Name City State
Morocco CHU Mohammed VI Marrakech

Sponsors (1)

Lead Sponsor Collaborator
CHU Mohammed VI Marrakech

Country where clinical trial is conducted

Morocco, 

References & Publications (2)

Merveille OC, Childers MK, Kreimid MM, George WD. Weaning from mechanical ventilation in a general rehabilitation center: a commentary. Am J Phys Med Rehabil. 1999 Jan-Feb;78(1):85-6. doi: 10.1097/00002060-199901000-00022. No abstract available. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with difficult spinal anesthesia More than two needle reorientations in the first puncture or more than one skin puncture During surgery
Secondary Rate of Maternal hypotension Systolic blood pressure below 90 mmHg or a drop of more than 20% of base value The first hour after spinal anesthesia is performed
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