Anesthesia, SpinalACirCuSNCT06357637
Abdominal Circumference Measure in Caesarian Section
An observational study of Anesthesia, Spinal and Cesarean Section, run by CHU Mohammed VI Marrakech at 1 site in Morocco.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia, Spinal, Cesarean Section
- What is being tested?
- Measure of abdominal circumference
- How many people
- 124 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Dec 2023to 31 May 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Parturients admitted for elective or emergency cesarean section
Who cannot join
- Acute fetal distress
- Umbilical cord prolapse
- Scoliosis
- Contraindication to spinal anesthesia
- Medical history of spinal surgery American Society of Anesthesia Status 4 or 5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia, Spinal, Cesarean Section
- Being tested
- Measure of abdominal circumference
- Keywords
- Preoperative evaluation, Abdominal circumference, Difficult spinal anesthesia, Maternal hypotension, Cesarean Section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of abdominal circumferenceDiagnostic test
Measure of abdominal circumference preoperatively in both sitting and lying position
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with difficult spinal anesthesia
More than two needle reorientations in the first puncture or more than one skin puncture
Measured: During surgery
Secondary outcomes (1)
Rate of Maternal hypotension
Systolic blood pressure below 90 mmHg or a drop of more than 20% of base value
Measured: The first hour after spinal anesthesia is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- CHU Mohammed VI Marrakech
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Essafti, CHU Mohammed VI Marrakech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357637
- Sponsor's protocol ID
- 59/2023
- Acronym
- ACirCuS
- Status last verified
- Jul 2024
- First submitted
- 23 Jan 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected throughout the trial will be shared
Publications
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.
PubMed 34034957Merveille 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.
PubMed 9923436
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Measurement of Abdominal Circumference as a Predictor of Difficult Spinal Anesthesia and Maternal Hypotension During Caesarian Section
- ClinicalTrials.gov ID
- NCT06357637
- Acronym / sponsor ID
- ACirCuS / 59/2023
- Conditions
- Anesthesia, Spinal, Cesarean Section
- Keywords
- Preoperative evaluation, Abdominal circumference, Difficult spinal anesthesia, Maternal hypotension, Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- CHU Mohammed VI MarrakechUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Parturients admitted for elective or emergency cesarean section
Key exclusion criteria (5 listed)
- Acute fetal distress
- Umbilical cord prolapse
- Scoliosis
- Contraindication to spinal anesthesia
- Medical history of spinal surgery American Society of Anesthesia Status 4 or 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of abdominal circumferenceMeasure of abdominal circumference preoperatively in both sitting and lying position | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Rate of Maternal hypotension
Time frame: The first hour after spinal anesthesia is performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 34034957Yu 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.
- Background: PubMed 9923436Merveille 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.
- Individual participant dataSharing planned: Yes. All data collected throughout the trial will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Spinal and Cesarean Section, run by CHU Mohammed VI Marrakech at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with difficult spinal anesthesia (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357637, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.