Abdominal Circumference Measure in Caesarian Section

NCT06357637 | Completed

• 1 other identifier: 59/2023
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Spinal; Cesarean Section

Keywords

Preoperative evaluation; Abdominal circumference; Difficult spinal anesthesia; Maternal hypotension; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Maternal hypotension

  The first hour after spinal anesthesia is performed

Interventions

Measure of abdominal circumference DIAGNOSTIC_TEST

Measure of abdominal circumference preoperatively in both sitting and lying position

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parturients scheduled for elective cesarean section or admitted for emergency cesarean section in the maternal operating theater of Mohammed VI University Hospital during the period of the study

You may qualify if:

• Parturients admitted for elective or emergency cesarean section

You may not qualify if:

• Acute fetal distress
• Umbilical cord prolapse
• Scoliosis
• Contraindication to spinal anesthesia
• Medical history of spinal surgery American Society of Anesthesia Status 4 or 5

Sponsors & Collaborators

• CHU Mohammed VI Marrakech: lead

Study Sites (1)

CHU Mohammed VI

Marrakesh, 40000, Morocco

Location

Related Publications (2)

• 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: 34034957 BACKGROUND

• 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.

  PMID: 9923436 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: April 10, 2024
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 31, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 1 year after the publication of results

Locations

MO (1)