The Preeclampsia Registry

NCT06377878 | Recruiting DMC

• 1 other identifier: Pro00008369
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Preeclampsia; Eclampsia; HELLP Syndrome; Toxemia; Hypertensive Disorder of Pregnancy

Keywords

Preeclampsia; Eclampsia; HELLP; HELLP Syndrome; Toxemia; Hypertensive Disorder of Pregnancy; Registry; Pregnancy Complication; Pregnancy; Maternal Death; Premature; High Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (1)

• Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records

  Will be assessed yearly, up to 20 years

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Preeclampsia Foundation: lead

Study Sites (1)

Preeclampsia Foundation

Melbourne, Florida, 32940, United States

RECRUITING

Related Publications (2)

• Bijl RC, Bangert SE, Shree R, Brewer AN, Abrenica-Keffer N, Tsigas EZ, Koster MPH, Seely EW. Patient journey during and after a pre-eclampsia-complicated pregnancy: a cross-sectional patient registry study. BMJ Open. 2022 Mar 3;12(3):e057795. doi: 10.1136/bmjopen-2021-057795.

  PMID: 35241475 DERIVED

• Shree R, Hatfield-Timajchy K, Brewer A, Tsigas E, Vidler M. Information needs and experiences from pregnancies complicated by hypertensive disorders: a qualitative analysis of narrative responses. BMC Pregnancy Childbirth. 2021 Nov 2;21(1):743. doi: 10.1186/s12884-021-04219-0.

  PMID: 34724906 DERIVED

Related Links

• The Preeclampsia Foundation

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.

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; HELLP Syndrome; Toxemia; Pregnancy Complications; Maternal Death; Premature Birth; Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eleni Z Tsigas, BA

  Preeclampsia Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VeeAnn Argyle

CONTACT

321-421-6957; Registry@preeclampsia.org

Eleni Z Tsigas, BA

CONTACT

321-421-6957

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: September 1, 2013
• Primary Completion (Estimated): May 1, 2040
• Study Completion (Estimated): May 1, 2040
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)