Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02697123 |
| Other study ID # |
H-36192 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
January 2024 |
Study information
| Verified date |
December 2021 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The purpose of the study is to prospectively assess the prevalence of venous thrombosis in
women hospitalized for Cesarean Section, vaginal delivery or extended antepartum
hospitalization by using Compression ultrasound of the entire proximal venous system of the
lower limb veins.
Description:
After initial admission of the patients for Cesarean Section, Vaginal Delivery or any other
antepartum hospitalization, patients undergo extensive counseling regarding various aspects
of the Duplex Ultrasonography procedure and the purpose of the study for screening of the
venous thrombosis in asymptomatic patients. Patients electing to proceed will have written
informed consent obtained and their baseline demographic and medical characteristics
recorded. 48-72 hours after Cesarean Section, 24-48 hours after vaginal delivery and 48 to 72
hours after antepartum hospitalization, participants also undergo a bilateral lower extremity
Venous Ultrasonographic examination which is the standard diagnostic procedure for detecting
the VTE of the lower limbs. The latter group will be re-scanned 14-21 days and, when
feasible, 45 days after admission.
The compression ultrasound study will be performed by post-doctoral research fellows, who
will be formally trained for lower extremity ultrasound, under direct supervision. Diagnostic
Criteria and Interpretation · The gray scale compression sonographic findings of acute DVT
are based on direct visualization of the thrombus and lack of venous compressibility. Altered
luminal echogenicity and alterations in flow characteristics are secondary signs. ·
Visualization of thrombus is variable, depending on the extent, age, and echogenicity
(ranging from anechoic to complex) of the clot. · in case of thrombosis, Each Doppler image
should demonstrate spontaneous and phasic flow. · Loss of phasic variation suggests proximal
obstruction (intrinsic or extrinsic). · Prominent pulsations can be due to right sided heart
failure and may be a manifestation of tricuspid valve regurgitation. Normal - Vein is totally
compressible. Duplex Doppler reveals spontaneous phasic waveform Acute DVT - Vein is non
compressible, but deformable and smooth. Vein is generally distended, with or without luminal
echoes. The thrombus can be free floating. Spectral Doppler may be normal, continuous, or not
present
If no DVT is seen on ultrasonography, then participants will be followed up clinically
throughout the remainder of their hospitalization without further intervention. Participants
with a DVT in the deep venous circulation will be referred to radiology for confirmation and
if positive for DVT the patient will be offered treatment per current clinical guidelines for
symptomatic DVT. This was the approach taken in most similar studies involving detection of
DVT in asymptomatic non-pregnant women.
If a VTE is seen in the superficial veins of the lower extremity, another lower extremity
venous Ultrasonographic evaluation will be scheduled 48 hours later. If a persistent
superficial VTE is seen, the patient will be referred for evaluation and therapy per current
clinical guidelines.
Ultrasound procedure data and all the information related to the findings of this study like
the reports, ultrasound pictures or demographic informations will be stored in the subject's
medical records which will be created specifically for this study.
All the imaging will be reviewed blindly by one sonographer and one radiologist for image
quality. If the image is not qualified and patient is still at hospital will redo the Doppler
ultrasound. if the patient is discharged will exclude that patient from the study.
We will also collect demographic data and other clinical information of the patient such as
maternal age, prenatal records, ultrasounds reports at different gestational age,
consultations, maternal past medical history, maternal past obstetrical history, medications
receive during pregnancy, gestational age at the time of procedure, first manifestation of
the DVT, treatments, process of these conditions, outcome, gestational age at birth, fetal
anomalies, early neonatal outcome.
