Effect of Intermittent Pneumatic Compression Device of Lower Limbs in Oligohydramnios

NCT05474326 | Unknown DMC FDA Device

• 1 other identifier: 9999
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Oligohydramnios; Amniotic Fluid; Disorder

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  one hour

Study Arms (1)

pregnant women with idiopathic oligohydramnios

EXPERIMENTAL

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

Device: intermittent pneumatic pressure device (Kendall SCD™ 700 Smart Compression™ System)

Interventions

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

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.

pregnant women with idiopathic oligohydramnios

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women with a diagnosis of oligohydramnios

You may not qualify if:

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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

MeSH Terms

Conditions

Oligohydramnios

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• inshirah sgayer, MD

  GALILEE MEDICAL CENTER ISRAEL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inshirah Sgayer, MD

CONTACT

0508890662; inshirah.sg.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Inshirah Sgayer

Model Details: 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

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: July 26, 2022
• Study Start: August 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07