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
About this trial
This is an interventional other trial for Oligohydramnios
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
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
NCT ID
NCT05474326
First Posted
December 7, 2021
Last Updated
July 25, 2022
Sponsor
Western Galilee Hospital-Nahariya
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
We'll reach out to this number within 24 hrs