Venous ThrombosisNCT02697123
Prospective Assessment of the Deep Vein Thrombosis (DVT) in Hospitalized Obstetrics Patients
An observational study of Venous Thrombosis and Pregnancy, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Venous Thrombosis, Pregnancy
- What is being tested?
- antepartum and postpartum
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Aug 2019
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients presenting to TCH/Women's Pavilion and Ben Taub Hospital for Cesarean Section, vaginal delivery or any antepartum hospitalization will considered for the study.
Who may be able to join
- All patients hospitalized for Cesarean Section,
- All patients hospitalized for vaginal delivery
- any other antepartum indication of hospitalization.
Who cannot join
- Psychiatric illness
- social situations that could limit compliance with study activities
- all patients who lack capacity to consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Venous Thrombosis, Pregnancy
- Being tested
- antepartum and postpartum
- Keywords
- Venous Thrombosis, Pregnancy, postpartum, antepartum
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antepartum and postpartumOther
This is a prospective observational cohort study.
| Study group | Role | What they receive |
|---|---|---|
| antepartum and postpartum | This prospective, observational cohort study was designed to assess the incidence of VTE in patients hospitalized for Cesarean Section, Vaginal delivery or any antepartum indication. Receives: Other: antepartum and postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Venous Thrombosis in patients hospitalized for Cesarean Section, Vaginal delivery or any antepartum indication
Measured: 48 hours (plus or minus 24 hours) after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2019
- Study completionAug 2019
Why it stopped: PI is no longer at the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael A Belfort, Baylor College of Medicine
- Investigators
- Steven L Clark, M.D., Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697123
- Sponsor's protocol ID
- H-36192
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2016
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of the Deep Vein Thrombosis (DVT) in Hospitalized Obstetrics Patients
- ClinicalTrials.gov ID
- NCT02697123
- Acronym / sponsor ID
- H-36192
- Conditions
- Venous Thrombosis, Pregnancy
- Keywords
- Venous Thrombosis, Pregnancy, postpartum, antepartum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI is no longer at the institution
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antepartum and postpartum | – | Other: antepartum and postpartumThis prospective, observational cohort study was designed to assess the incidence of VTE in patients hospitalized for Cesarean Section, Vaginal delivery or any antepartum indication. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients presenting to TCH/Women's Pavilion and Ben Taub Hospital for Cesarean Section, vaginal delivery or any antepartum hospitalization will considered for the study.
Key inclusion criteria (3 listed)
- All patients hospitalized for Cesarean Section,
- All patients hospitalized for vaginal delivery
- any other antepartum indication of hospitalization.
Key exclusion criteria (3 listed)
- Psychiatric illness
- social situations that could limit compliance with study activities
- all patients who lack capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antepartum and postpartumThis is a prospective observational cohort study. | Other | antepartum and postpartum |
Primary outcome
incidence of Venous Thrombosis in patients hospitalized for Cesarean Section, Vaginal delivery or any antepartum indication
Time frame: 48 hours (plus or minus 24 hours) after delivery.
Results and safety
The study was stopped early (reason given: PI is no longer at the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven L Clark, M.D. study chair
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and Pregnancy, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI is no longer at the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of Venous Thrombosis in patients hospitalized for Cesarean Section, Vaginal delivery or any antepartum indication (time frame: 48 hours (plus or minus 24 hours) after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.