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. Identifier: NCT02020174
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : April 12, 2018
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

  Show Detailed Description

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
Study Start Date : July 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

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

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

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 identifier (NCT number): NCT02020174

Contact: Alina N Brewer, BA 801-994-4103
Contact: Eleni Z Tsigas, BA 321-421-6957

United States, Florida
Preeclampsia Foundation Recruiting
Melbourne, Florida, United States, 32940
Contact: Alina N Brewer, BA    801-994-4103   
Principal Investigator: Eleni Z Tsigas, BA         
Sub-Investigator: Hilary Gammill, MD         
Sub-Investigator: James Roberts, MD         
Sponsors and Collaborators
Preeclampsia Foundation
Principal Investigator: Eleni Z Tsigas, BA Preeclampsia Foundation

Additional Information:
Responsible Party: Preeclampsia Foundation Identifier: NCT02020174     History of Changes
Other Study ID Numbers: 001
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be shared with proper internal and ethical approval

Keywords provided by Preeclampsia Foundation:
Hypertensive Disorder of Pregnancy
HELLP Syndrome
Pregnancy Complication
Maternal Death
High Blood Pressure

Additional relevant MeSH terms:
HELLP Syndrome
Pregnancy Complications
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes