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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05646342
Other study ID # SAR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date April 1, 2023

Study information

Verified date December 2022
Source Mohammed VI University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 . 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 .


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,


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date April 1, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All Pregnante Women in good health after 24 week of preganancy Exclusion Criteria: - All young women under 18 years old - unhealthy women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Measure of CO by ECHocardiac Machine
we will realise ETT before and after PLR in all women that eligible of crieria inclusion , in obstetric consultation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mohammed VI University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 in all the 5 mounths
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