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Effect of Intermittent Pneumatic Compression Device of Lower Limbs in Oligohydramnios

Amniotic Fluid Index and Fetal Doppler Indices Measurment After Application of Intermittent Pneumatic Compression Device on Lower Limbs in Pregnant Women With Oligohydramnios

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05474326
Enrollment
30
Registered
2022-07-26
Start date
2022-08-15
Completion date
2023-12-31
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amniotic Fluid; Disorder, Oligohydramnios

Brief 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

Detailed 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.

Interventions

DEVICEintermittent pneumatic pressure device (Kendall SCD™ 700 Smart Compression™ System)

application of intermittent pneumatic pressure device (Kendall SCD™ 700 Smart Compression™ System) on lower limbs and its effect on fetal and maternal doppler and amniotic fluid index in women with oligohydramnios. the compression system will be applicated on lower limbs for one hour in which it will produce intermittent compression on lower limbs. amniotic fluid amnout assessment will be done after this including doppler studies in order to detect any change in amniotic fluid amount or dopper.

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

The Kendall SCD™ 700 Smart Compression™ Controller is an intermittent pneumatic compression (IPC) device application of this intermittent pneumatic pressure device on lower limbs in women with oligohydramnios and its effect on maternal uterine artery doppler, fetal umbilical artery doppler, middle cerebral artery doppler

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

pregnant women with a diagnosis of oligohydramnios

Exclusion criteria

* fetal malformation * rupture of membranes * documented viral infection with rubella, cytomegalovirus, herpes simplex, toxoplsma in pregnancy

Design outcomes

Primary

MeasureTime frameDescription
pulsatility index in maternal uterine arteryone hourPulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the maternal uterine artery will be calculated before the application of IPC on lower maternal limbs PI of the maternal uterine artery will be re-calculated after the application of IPC on lower maternal limbs for one hour
pulsatility index in fetal umbilical arteryone hourPulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the fetal umbilical artery will be calculated before the application of IPC on lower maternal limbs PI of the fetal umbilical artery will be re-calculated after the application of IPC on lower maternal limbs for one hour
pulsatility index in fetal middle cerebral arteryone hourPulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the fetal middle cerebral artery will be calculated before the application of IPC on lower maternal limbs PI of the fetal middle cerebral artery will be re-calculated after the application of IPC on lower maternal limbs for one hour
pulsatility index in fetal renal arteryone hourPulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the fetal renal artery will be calculated before the application of IPC on lower maternal limbs PI of the fetal renal artery will be re-calculated after the application of IPC on lower maternal limbs for one hour
amniotic fluid indexone hourbasline amniotic fluid index (AFI in centemeters) will be calculated before the application of IPC on lower maternal limbs amniotic fluid index (AFI in centemeters) will be re-calculated after the application of IPC on lower maternal limbs for one hour

Contacts

Primary ContactInshirah Sgayer, MD
inshirah.sg.sh@gmail.com0508890662

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026