ITV Sosu AortiqueNCT05646342
PLR in a Good Helath After 24 Week of Preganancy
An observational study of ITV Sosu Aortique and Cardiac Output, High, run by Mohammed VI University Hospital.
Trial summary
fluid resuscitation is one of the bases of strategies in ICU to take in charge patients , one of the technique to evaluate preload charge , is Passive leg raising, that allows reliable prediction of fluid responsiveness even in patients with spontaneous breathing activity or arrhythmias . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITV Sosu Aortique, Cardiac Output, High, PLR
- What is being tested?
- Measure of CO by ECHocardiac Machine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Apr 2023
- How long will I take part?
- 2 Months
- 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
- All sexes
- Adult, Older adult
Study population: Moroccan population
Who may be able to join
- All Pregnante Women in good health after 24 week of preganancy
Who cannot join
- All young women under 18 years old
- unhealthy women
About this study
Official title: PLR in a Good Helath Women After 24 Week of Preganancy
fluid resuscitation is one of the bases of strategies in ICU to take in charge patients , one of the technique to evaluate preload charge , is Passive leg raising, that allows reliable prediction of fluid responsiveness even in patients with spontaneous breathing activity or arrhythmias .
In recent years, hemodynamic response to passive leg raising (PLR) has been popularized as a dynamic test of preload responsiveness [1]. This manoeuvre provides an "auto-fluid challenge" which is rapid, transient and reversible. PLR transfers blood contained in the venous reservoir of the lower extremities to the central venous compartment leading to a transient increase in preload and an increase in cardiac output by Frank-Starling mechanism in preload responsive individuals.
untille now the usseuful of PLR in Pregnancy, and also The validity of dynamic measurements of preload to predict fluid response during pregnancy are note clear in littérature .
Read the detailed description
A total of 108 low-risk pregnant women and 54 healthy non-pregnant controls, aged >18 years, participated in the study. Pregnant women attending for the second trimester routine ultrasound screening at 17-19 weeks of gestation were informed about the study and invited to participate if they had a low-risk pregnancy and ultrasound scan did not show any fetal or placental abnormality. Those who agreed were consecutively enrolled and an appointment was made for functional hemodynamic evaluation at 22-24 weeks of gestation. Exclusion criteria were any pre-existing medical condition that may have an effect on the course of pregnancy, and a previous history of preeclampsia, gestational diabetes, intrauterine fetal growth restriction or preterm delivery. Non-pregnant controls were recruited among the nursing, administrative and laboratory staff of the hospital and university. Healthy women of reproductive age were asked to attend for hemodynamic assessment during the follicular phase between day 5 and 10 of the menstrual cycle. Women with a previous history of pregnancy complication and those with a known disease or on regular medication were excluded. Examination was performed,
- Conditions
- ITV Sosu Aortique, Cardiac Output, High, PLR
- Being tested
- Measure of CO by ECHocardiac Machine
- Keywords
- CO, PLR, ETT, Pregnanacy
- Medical subject headings
- Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of CO by ECHocardiac MachineOther
we will realise ETT before and after PLR in all women that eligible of crieria inclusion , in obstetric consultation
What is being measured
The primary outcome is the main question the study is designed to answer.
PLR in a good helath after 24 week of preganancy
we will realise ETT before and after PLR in all women that eligible of crieria inclusion , in obstetric consultation
Measured: in all the 5 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITV Sosu AortiqueStudies 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
- 60 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Mohammed VI University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Oujidi, Mohammed VI University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646342
- Sponsor's protocol ID
- SAR
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLR in a Good Helath Women After 24 Week of Preganancy
- ClinicalTrials.gov ID
- NCT05646342
- Acronym / sponsor ID
- SAR
- Conditions
- ITV Sosu Aortique, Cardiac Output, High, PLR
- Keywords
- CO, PLR, ETT, Pregnanacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohammed VI University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 12 Dec 2022 (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.
fluid resuscitation is one of the bases of strategies in ICU to take in charge patients , one of the technique to evaluate preload charge , is Passive leg raising, that allows reliable prediction of fluid responsiveness even in patients with spontaneous breathing activity or arrhythmias .
In recent years, hemodynamic response to passive leg raising (PLR) has been popularized as a dynamic test of preload responsiveness [1]. This manoeuvre provides an "auto-fluid challenge" which is rapid, transient and reversible. PLR transfers blood contained in the venous reservoir of the lower extremities to the central venous compartment leading to a transient increase in preload and an increase in cardiac output by Frank-Starling mechanism in preload responsive individuals.
untille now the usseuful of PLR in Pregnancy, and also The validity of dynamic measurements of preload to predict fluid response during pregnancy are note clear in littérature .
Detailed description
A total of 108 low-risk pregnant women and 54 healthy non-pregnant controls, aged >18 years, participated in the study. Pregnant women attending for the second trimester routine ultrasound screening at 17-19 weeks of gestation were informed about the study and invited to participate if they had a low-risk pregnancy and ultrasound scan did not show any fetal or placental abnormality. Those who agreed were consecutively enrolled and an appointment was made for functional hemodynamic evaluation at 22-24 weeks of gestation. Exclusion criteria were any pre-existing medical condition that may have an effect on the course of pregnancy, and a previous history of preeclampsia, gestational diabetes, intrauterine fetal growth restriction or preterm delivery. Non-pregnant controls were recruited among the nursing, administrative and laboratory staff of the hospital and university. Healthy women of reproductive age were asked to attend for hemodynamic assessment during the follicular phase between day 5 and 10 of the menstrual cycle. Women with a previous history of pregnancy complication and those with a known disease or on regular medication were excluded. Examination was performed,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Moroccan population
Key inclusion criteria (1 listed)
- All Pregnante Women in good health after 24 week of preganancy
Key exclusion criteria (2 listed)
- All young women under 18 years old
- unhealthy women
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 CO by ECHocardiac Machinewe will realise ETT before and after PLR in all women that eligible of crieria inclusion , in obstetric consultation | Other | – |
Primary outcome
PLR in a good helath after 24 week of preganancy
Time frame: in all the 5 mounths
we will realise ETT before and after PLR in all women that eligible of crieria inclusion , in obstetric consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of ITV Sosu Aortique and Cardiac Output, High, run by Mohammed VI University Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
PLR in a good helath after 24 week of preganancy (time frame: in all the 5 mounths). 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 12 Dec 2022.