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Effect of Intermittent Pneumatic Compression Device of Lower Limbs in Oligohydramnios

Primary Purpose

Oligohydramnios, Amniotic Fluid; Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intermittent pneumatic pressure device (Kendall SCD™ 700 Smart Compression™ System)
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oligohydramnios

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pregnant women with idiopathic oligohydramnios

    Arm Description

    women with singleton pregnancy between 32-41 weeks oligohydramnios diagnosed by ultrasound by the amniotic fluid index (AFI) method oligohydramnios is diagnosed if AFI index is less than 5 cm

    Outcomes

    Primary Outcome Measures

    pulsatility index in maternal uterine artery
    Pulsed 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 artery
    Pulsed 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 artery
    Pulsed 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 artery
    Pulsed 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 index
    basline 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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 7, 2021
    Last Updated
    July 25, 2022
    Sponsor
    Western Galilee Hospital-Nahariya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05474326
    Brief Title
    Effect of Intermittent Pneumatic Compression Device of Lower Limbs in Oligohydramnios
    Official Title
    Amniotic Fluid Index and Fetal Doppler Indices Measurment After Application of Intermittent Pneumatic Compression Device on Lower Limbs in Pregnant Women With Oligohydramnios
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Galilee Hospital-Nahariya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oligohydramnios, Amniotic Fluid; Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pregnant women with idiopathic oligohydramnios
    Arm Type
    Experimental
    Arm Description
    women with singleton pregnancy between 32-41 weeks oligohydramnios diagnosed by ultrasound by the amniotic fluid index (AFI) method oligohydramnios is diagnosed if AFI index is less than 5 cm
    Intervention Type
    Device
    Intervention Name(s)
    intermittent pneumatic pressure device (Kendall SCD™ 700 Smart Compression™ System)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    pulsatility index in maternal uterine artery
    Description
    Pulsed 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
    Time Frame
    one hour
    Title
    pulsatility index in fetal umbilical artery
    Description
    Pulsed 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
    Time Frame
    one hour
    Title
    pulsatility index in fetal middle cerebral artery
    Description
    Pulsed 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
    Time Frame
    one hour
    Title
    pulsatility index in fetal renal artery
    Description
    Pulsed 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
    Time Frame
    one hour
    Title
    amniotic fluid index
    Description
    basline 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
    Time Frame
    one hour

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    pregnant women
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inshirah Sgayer, MD
    Phone
    0508890662
    Email
    inshirah.sg.sh@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    inshirah sgayer, MD
    Organizational Affiliation
    GALILEE MEDICAL CENTER ISRAEL
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Intermittent Pneumatic Compression Device of Lower Limbs in Oligohydramnios

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