Clinical Trial: Vasculitis Pregnancy Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: The Vasculitis Pregnancy Registry (V-PREG)

Brief Summary:

The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess

  1. each woman's vasculitis severity and pregnancy-related experiences, and
  2. pregnancy outcomes.

Detailed Summary:

The study will consist of several on-line surveys to assess each woman's vasculitis severity, pregnancy-related experiences, and pregnancy outcomes. Participants will be asked to complete questionnaires at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate that it will take approximately 20 minutes to complete each survey.

All women enrolled in the Vasculitis Patient-Powered Research Network (V-PPRN) (with specified disease, sex, and age inclusion criteria described below) will be invited via email to participate in this on-line study. The survey data will be stored by the Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to the Study Chairs.


Sponsor: University of Pennsylvania

Current Primary Outcome: Unique pregnancy characteristics among women with vasculitis. [ Time Frame: Four years ]

To understand pregnancy characteristics and outcomes among women with vasculitis using patient-reported questionnaires in each trimester.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: October 26, 2015
Date Started: November 2015
Date Completion: December 2019
Last Updated: April 27, 2017
Last Verified: April 2017