Cesarean SectionNCT05685212
Prediction of Hypotension During Cesarean Delivery Using Positional Change of Hemodynamic Parameters
An observational study of Cesarean Section and Hypotension, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Hypotension, Anesthesia, Spinal
- How many people
- 121 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2023to 30 Aug 2023
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- American society of anesthesiologists' (ASA) physical status of II-III.
- Full-term pregnancy.
- Elective cesarean section.
- Emergency cesarean section (Lucas III-IV).
Who cannot join
- 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.
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- Failed spinal anesthesia.
- Conversion to general anesthesia.
- Postpartum hemorrhage.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2046
About this study
Official title: Prediction of Hypotension After Spianl Anesthesia During Cesarean Delivery: Utility of Positional Change of Hymodynamic Parameters
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.
Read the detailed description
The investigators conducted a monocentric prospective observational study between January 2022 and June 2022, in the maternity unit of Mongi Slim University Hospital in Tunisia. The investigators aimed to have a population that is representative of all parturients scheduled for cesarean section, thereby they included American Society of Anesthesiologists physical status I and II parturients aged 18 to 45 at term and scheduled for either elective cesarean section or emergency cesarean section (Lucas III-IV).
The investigators chose hypotension as the primary endpoint, defined as a decrease in SAP of more than 20% of the baseline values. Secondary endpoints included total dose of ephedrine, incidence of symptomatic hypotension defined as hypotension plus nausea and/or vomiting and/or dizziness, time to onset of hypotension, duration of hypotension, and the use of rescue bolus of norepinephrine.
The investigators tried to standardize the anesthetic management. Parturients were monitored with a three-lead electrocardiogram, non-invasive arterial pressure, pulse oximetry, and capnography through a facial mask. Baseline maternal hemodynamic parameters were measured 3 times at 1-minute interval in three different positions: consecutively sitting position, supine position, and left lateral tilt 15° position. Spinal anesthesia was performed in the sitting position in the L3-L4 or L4-L5 vertebral interspace. Patients received doses of local anesthetic weighted to their height. Patients were co-loaded with an infusion of normal saline using a pressurized bad. Hypotension was treated with IV bolus of ephedrine in increments of 6 mg. If hypotension persisted or reoccurred after the patient had already received 60 mg of ephedrine, The investigators resorted to rescue bolus of norepinephrine in increments of 5 µg. After child delivery, patients received a standard dose of 10 IU of oxytocin, additional doses were added if the obstetrician requested it.
The investigators collected data regarding demographic characteristics, obstetric characteristic, anesthetic management, and details about the hypotensive event.
- Conditions
- Cesarean Section, Hypotension, Anesthesia, Spinal, Heart Rate, Blood Pressure
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
a decrease in systolic arterial pressure more than 20% of the baseline (sitting position)
Measured: 30 minutes after spinal anesthesia
Secondary outcomes (1)
Dose of ephedrine.
cumulative needed dose in mg of ephedrine
Measured: 30 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Apr 2023
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Faten Haddad, Principal investigator, Mongi Slim local research ethical committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685212
- Sponsor's protocol ID
- hypotension Cesarean section
- Status last verified
- Sep 2023
- First submitted
- 4 Jan 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hypotension After Spianl Anesthesia During Cesarean Delivery: Utility of Positional Change of Hymodynamic Parameters
- ClinicalTrials.gov ID
- NCT05685212
- Acronym / sponsor ID
- hypotension Cesarean section
- Conditions
- Cesarean Section, Hypotension, Anesthesia, Spinal, Heart Rate, Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 17 Jan 2023 (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.
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.
Detailed description
The investigators conducted a monocentric prospective observational study between January 2022 and June 2022, in the maternity unit of Mongi Slim University Hospital in Tunisia. The investigators aimed to have a population that is representative of all parturients scheduled for cesarean section, thereby they included American Society of Anesthesiologists physical status I and II parturients aged 18 to 45 at term and scheduled for either elective cesarean section or emergency cesarean section (Lucas III-IV).
The investigators chose hypotension as the primary endpoint, defined as a decrease in SAP of more than 20% of the baseline values. Secondary endpoints included total dose of ephedrine, incidence of symptomatic hypotension defined as hypotension plus nausea and/or vomiting and/or dizziness, time to onset of hypotension, duration of hypotension, and the use of rescue bolus of norepinephrine.
The investigators tried to standardize the anesthetic management. Parturients were monitored with a three-lead electrocardiogram, non-invasive arterial pressure, pulse oximetry, and capnography through a facial mask. Baseline maternal hemodynamic parameters were measured 3 times at 1-minute interval in three different positions: consecutively sitting position, supine position, and left lateral tilt 15° position. Spinal anesthesia was performed in the sitting position in the L3-L4 or L4-L5 vertebral interspace. Patients received doses of local anesthetic weighted to their height. Patients were co-loaded with an infusion of normal saline using a pressurized bad. Hypotension was treated with IV bolus of ephedrine in increments of 6 mg. If hypotension persisted or reoccurred after the patient had already received 60 mg of ephedrine, The investigators resorted to rescue bolus of norepinephrine in increments of 5 µg. After child delivery, patients received a standard dose of 10 IU of oxytocin, additional doses were added if the obstetrician requested it.
The investigators collected data regarding demographic characteristics, obstetric characteristic, anesthetic management, and details about the hypotensive event.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- American society of anesthesiologists' (ASA) physical status of II-III.
- Full-term pregnancy.
- Elective cesarean section.
- Emergency cesarean section (Lucas III-IV).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hypotension
Time frame: 30 minutes after spinal anesthesia
a decrease in systolic arterial pressure more than 20% of the baseline (sitting position)
1 secondary outcome
Dose of ephedrine.
Time frame: 30 minutes after spinal anesthesia
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 2 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Faten Haddad principal investigator
Mongi Slim local research ethical committee
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 Cesarean Section and Hypotension, run by Mongi Slim Hospital at 1 site in Tunisia.
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 4 inclusion and 9 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 2 Oct 2023. 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 Tunisia. 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?
Incidence of hypotension (time frame: 30 minutes after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2023.