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The Preeclampsia Registry (TPR)

This study is currently recruiting participants.
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Verified September 2016 by Preeclampsia Foundation
Information provided by (Responsible Party):
Preeclampsia Foundation Identifier:
First received: December 10, 2013
Last updated: September 28, 2016
Last verified: September 2016
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.

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 ]

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


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
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
  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 identifier: 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
  More Information

Additional Information:
Responsible Party: Preeclampsia Foundation Identifier: NCT02020174     History of Changes
Other Study ID Numbers: 001
Study First Received: December 10, 2013
Last Updated: September 28, 2016
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 processed this record on September 21, 2017