Abdominal Circumference Measure in Caesarian Section (ACirCuS)

April 6, 2024 updated by: Meryem Essafti, CHU Mohammed VI Marrakech

Preoperative Measurement of Abdominal Circumference as a Predictor of Difficult Spinal Anesthesia and Maternal Hypotension During Caesarian Section

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

Study Contact Backup

Study Locations

  • Morocco
      • Marrakech, Morocco, 40000
        • Recruiting
        • CHU Mohammed VI
        • Contact:
        • Contact:
        • Principal Investigator:
          • MERYEM ESSAFTI, MD
        • Sub-Investigator:
          • MARINA NDE BOKOBA, MD

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
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with difficult spinal anesthesia
Time Frame: During surgery
More than two needle reorientations in the first puncture or more than one skin puncture
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Maternal hypotension
Time Frame: The first hour after spinal anesthesia is performed
Systolic blood pressure below 90 mmHg or a drop of more than 20% of base value
The first hour after spinal anesthesia is performed

Collaborators and Investigators

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

Sponsor

CHU Mohammed VI Marrakech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

April 6, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data collected throughout the trial will be shared

IPD Sharing Time Frame

Beginning 3 months and ending 1 year after the publication of results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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