Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05474326 |
Other study ID # |
9999 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 15, 2022 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
July 2022 |
Source |
Western Galilee Hospital-Nahariya |
Contact |
Inshirah Sgayer, MD |
Phone |
0508890662 |
Email |
inshirah.sg.sh[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
the study will examine the effect of application of intermittent pneumatic pressure device on
lower limbs on the amniotic fluid amount and fetal doppler indices in women with
oligohydramnios
Description:
oligohydramnios is diagnosed based on ultrasonographic finding of amniotic fluid index less
than 5 cm.
Etiologies of oligohydramnios includes infection with viruses such as rubella, cytomegalo
virus or parasites such as toxoplasma. other etiologies includes rupture of membranes or
fetal malformatios especially urinary tract anomalies. in addition, placental insuffiency may
lead to oligohydramnios and can be diagnosed through abnormal doppler measures in the
umbilical and middle cereberal arteries. when these etiologies are excluded oligohydramnios
is considered to be idiopathic.
The Kendall SCD™ 700 Smart Compression™ Controller is an intermittent pneumatic compression
(IPC) device which delivers compression to the legs and feet to aid in the prevention of
Venous Thromboembolism in at-risk patient.
previous studies had shown that intermittent pneumatic compression device may increase
cardiac output through preload increase.
the study hypothesis that after the application of IPC there will be an improvement in the
preload and cardiac which will lead to an increase in placental perfusion and eventually will
lead to increase in amniotic fluid amount and improvement in fetal doppler measurement.
the study will include women with a diagnosis of idiopathic oligohydramnios between 32-41
weeks and who will agree to participate in the study the diagnosis of idiopathic
oligohydramnios is based on ultrasonographic diagnosis of amniotic fluid index of less than 5
cm after exclusion of other etiologies.
The amniotic fluid index (AFI) is measured by dividing the uterus into four imaginary
quadrants. The linea nigra is used to divide the uterus into right and left halves.The
umbilicus serves as the dividing point for the upper and lower halves.
The transducer is kept parallel to the patient's longitudinal axis and perpendicular to the
floor. The deepest, unobstructed, vertical pocket of fluid is measured in each quadrant in
centimeters. The four pocket measurements are then added to calculate the AFI. Normal AFI
values range from 5 to 25 cm. women with AFI<5 cm will be diagnosed with oligohydramnios.
The amniotic fluid fluid index (AFI) will be measured in centemeters before the application
of IPC the IPC device will be applied to the lower limbs for one hour after this a repeated
measurement of AFI in centemeters will be performed.
additionally, doppler studies will be performed. Pulsed wave high-resolution color doppler
uhrasonography will be used to identify and to obtain blood flow velocity waveforms from the
following vessels: (1) umbilical artery, from a free loop of theumbilical cord; (2) middle
cerebral artery, from the main vessel identified branching from the circle of Willis at the
anterior wing of the sphenoid; (3) renal artery, from the vessel identified branching from
the abdominal aorta into the hilum of the kidney, and (4) maternal uterine artery, from the
vessel branching from the internal iliac artery on the placental side.
In all vessels the pulsatility index will be calculated with the mean of at least three
consecutive waveforms used for analysis.