The Preeclampsia Registry (TPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Preeclampsia Foundation
Sponsor:
Information provided by (Responsible Party):
Preeclampsia Foundation
ClinicalTrials.gov Identifier:
NCT02020174
First received: December 10, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition
Preeclampsia
Eclampsia
HELLP Syndrome
Toxemia
Hypertensive Disorder of Pregnancy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Target Follow-Up Duration: 20 Years
Official Title: The Preeclampsia Registry

Resource links provided by NLM:


Further study details as provided by Preeclampsia Foundation:

Primary Outcome Measures:
  • Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records [ Time Frame: Will be assessed yearly, up to 20 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimens are not currently being collected, however, participants are asked for their permission to be contacted about providing a biospecimen in the future. It is not certain yet what type of biospecimen may be collected.


Estimated Enrollment: 20000
Study Start Date: July 2013
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants who self-report a medical diagnosis of preeclampsia or related hypertensive disorders of pregnancy (HDP), their family members, and women who have never had a diagnosis of preeclampsia (controls) will be invited to participate in this registry. Data will be collected on family members (including children) as reported by the participating individual. Minors who have been affected by preeclampsia, such as teens, will be allowed to participate with consent provided by a parent or guardian as well as assent given by the minor. The registry and informed consent may be completed by an authorized representative on behalf of a woman with a history of preeclampsia if she is physically or mentally disabled or is deceased.

Criteria

Inclusion Criteria:

  • Women who were medically diagnosed with preeclampsia or a related hypertensive disorder of pregnancy (HDP) such as eclampsia or HELLP syndrome.
  • Female 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.

Exclusion Criteria:

  • Those unable to provide consent
  • Prisoners
  • Individuals unable to speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020174

Contacts
Contact: Alina N Brewer, BA 801-994-4103 Registry@preeclampsia.org
Contact: Eleni Z Tsigas, BA 321-421-6957

Locations
United States, Florida
Preeclampsia Foundation Recruiting
Melbourne, Florida, United States, 32940
Contact: Alina N Brewer, BA    801-994-4103    Registry@preeclampsia.org   
Principal Investigator: Eleni Z Tsigas, BA         
Sub-Investigator: Hilary Gammill, MD         
Sub-Investigator: James Roberts, MD         
Sponsors and Collaborators
Preeclampsia Foundation
Investigators
Principal Investigator: Eleni Z Tsigas, BA Preeclampsia Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Preeclampsia Foundation
ClinicalTrials.gov Identifier: NCT02020174     History of Changes
Other Study ID Numbers: 001
Study First Received: December 10, 2013
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Preeclampsia Foundation:
Preeclampsia
Eclampsia
HELLP
HELLP Syndrome
Toxemia
Hypertensive Disorder of Pregnancy
Registry
Pregnancy Complication
Pregnancy
Maternal Death
Premature
High Blood Pressure
Hypertension

Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
HELLP Syndrome
Hypertension
Pregnancy Complications
Syndrome
Toxemia
Cardiovascular Diseases
Disease
Hypertension, Pregnancy-Induced
Infection
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014