Clinical Trial: The Preeclampsia Registry
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: The Preeclampsia Registry
Brief Summary: The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments.
Detailed Summary:
Preeclampsia is a life-threatening complication of pregnancy, diagnosed by the development of high blood pressure and protein in the urine in the latter half of pregnancy. Preeclampsia affects approximately 5 percent of pregnancies, up to 300,000 pregnant women in the U.S. annually. Approximately 75,000 of these women suffer severe maternal outcomes: organ failure, massive blood loss, permanent disability or death; and severe fetal outcomes: prematurity, abnormal fetal growth, and long-term disability or death of their babies.
Despite years of research along multiple investigational lines, the cause and mechanisms underlying preeclampsia remain unclear. At this point in time, the only "cure" for preeclampsia remains delivery of the placenta. Given the onset of preeclampsia at sometimes very preterm gestational ages, delivery can be associated with substantial risks of prematurity. In addition, delays in diagnosis and treatment of preeclampsia can put pregnancies at significant risk. An improved understanding of this condition is essential for the development of novel screening, diagnostic, and therapeutic approaches for mothers and their babies.
To further our scientific understanding of preeclampsia, large, longitudinal studies of women and their families are needed. The Preeclampsia Registry will provide a large-scale data registry and sample repository resource with unique attributes to address these important questions, including long-term longitudinal follow up of participants and engagement of families.
Specific Procedures
Participants will log on to The Preeclampsia Registry website to enter their name, address, phone number, and email. An email will be sent to participants containing a unique login ID, whic
Sponsor: Preeclampsia Foundation
Current Primary Outcome: Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records [ Time Frame: Will be assessed yearly, up to 20 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Preeclampsia Foundation
Dates:
Date Received: December 10, 2013
Date Started: July 2013
Date Completion: May 2023
Last Updated: September 28, 2016
Last Verified: September 2016
