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The Preeclampsia Registry (TPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020174
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Preeclampsia Foundation

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.

Condition or disease
Preeclampsia Eclampsia HELLP Syndrome Toxemia Hypertensive Disorder of Pregnancy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20000 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 20 Years
Official Title: The Preeclampsia Registry
Actual Study Start Date : September 1, 2013
Estimated Primary Completion Date : May 2030
Estimated Study Completion Date : May 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records [ Time Frame: Will be assessed yearly, up to 20 years ]

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.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Exclusion Criteria:

  • Those unable to provide consent
  • Prisoners
  • Individuals unable to speak English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020174


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

Locations
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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
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Principal Investigator: Eleni Z Tsigas, BA Preeclampsia Foundation
Additional Information:
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Responsible Party: Preeclampsia Foundation
ClinicalTrials.gov Identifier: NCT02020174    
Other Study ID Numbers: 001
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be shared with proper internal and ethical approval. De-identified data may also be shared with approved study investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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:
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Toxemia
Sepsis
Pre-Eclampsia
Eclampsia
HELLP Syndrome
Hypertension
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation