The Preeclampsia Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records
研究概览
简要总结
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. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves.
详细描述
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, which is the participant's email address, and a password. Participants will return to the registry website to login and will be asked to change their password. Participants will review the informed consent documents, and provide informed consent. Participants will have the opportunity to contact the Research Coordinator with questions regarding the consent and/or registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women who were medically diagnosed with preeclampsia or a related hypertensive disorder of pregnancy (HDP) such as eclampsia or HELLP syndrome.
- •Female or Male relatives of affected women
- •Women who have never had preeclampsia or hypertensive disorders of pregnancy, but who would like to serve as "controls" in research studies of preeclampsia.
- •An authorized representative may complete the questionnaire and provide consent for a woman who had preeclampsia, but has died or is disabled as a result.
排除标准
- •Those unable to provide consent
- •Prisoners
- •Individuals unable to speak English
结局指标
主要结局
Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records
时间窗: Will be assessed yearly, up to 20 years
次要结局
未报告次要终点