Prospective Assessment of the Deep Vein Thrombosis (DVT) in Hospitalized Obstetrics Patients

NCT02697123 | Terminated DMC

• 1 other identifier: H-36192
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thrombosis; Pregnancy

Keywords

Venous Thrombosis; Pregnancy; postpartum; antepartum

Outcome Measures

Primary Outcomes (1)

• incidence of Venous Thrombosis in patients hospitalized for Cesarean Section, Vaginal delivery or any antepartum indication

  48 hours (plus or minus 24 hours) after delivery.

Study Arms (1)

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.

Other: antepartum and postpartum

Interventions

antepartum and postpartum OTHER

This is a prospective observational cohort study.

antepartum and postpartum

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All patients hospitalized for Cesarean Section,
• All patients hospitalized for vaginal delivery
• any other antepartum indication of hospitalization.

You may not qualify if:

• Psychiatric illness
• social situations that could limit compliance with study activities
• all patients who lack capacity to consent.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Postpartum Period

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Steven L Clark, M.D.

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 3, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 15, 2025

Record last verified: 2024-12

Locations

US (1)