The Preeclampsia Registry
The Preeclampsia Registry
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 is a life-threatening complication of pregnancy, diagnosed by the development of
 high blood pressure and protein in the urine in the latter half of pregnancy. Preeclampsia
 affects approximately 5 percent of pregnancies, up to 300,000 pregnant women in the U.S.
 annually. Approximately 75,000 of these women suffer severe maternal outcomes: organ failure,
 massive blood loss, permanent disability or death; and severe fetal outcomes: prematurity,
 abnormal fetal growth, and long-term disability or death of their babies.

 Despite years of research along multiple investigational lines, the cause and mechanisms
 underlying preeclampsia remain unclear. At this point in time, the only "cure" for
 preeclampsia remains delivery of the placenta. Given the onset of preeclampsia at sometimes
 very preterm gestational ages, delivery can be associated with substantial risks of
 prematurity. In addition, delays in diagnosis and treatment of preeclampsia can put
 pregnancies at significant risk. An improved understanding of this condition is essential for
 the development of novel screening, diagnostic, and therapeutic approaches for mothers and
 their babies.

 To further our scientific understanding of preeclampsia, large, longitudinal studies of women
 and their families are needed. The Preeclampsia Registry will provide a large-scale data
 registry and sample repository resource with unique attributes to address these important
 questions, including long-term longitudinal follow up of participants and engagement of
 families.

 Specific Procedures

 Participants will log on to The Preeclampsia Registry website to enter their name, address,
 phone number, and email. An email will be sent to participants containing a unique login ID,
 which is the participant's email address, and a password. Participants will return to the
 registry website to login and will be asked to change their password. Participants will
 review the informed consent documents, and provide informed consent. Participants will have
 the opportunity to contact the Research Coordinator with questions regarding the consent
 and/or registry.

 Once informed consent is obtained, participants will complete the registry questionnaire on
 The Preeclampsia Registry website (www.preeclampsiaregistry.org). The participants will have
 the ability to return to the website to complete or update information as often as necessary.
 Participants will have the option of scanning and uploading their own medical records to The
 Preeclampsia Registry website using their unique login and password. The registry will also
 ask participants to complete and sign a medical records release form to provide permission
 for a member of the registry staff to request the participant's medical records from the
 doctor and/or hospital where they were treated. The registry will send out notifications by
 email periodically to remind participants to return to the registry website to update their
 information and their children's information, make changes to their medical history, and add
 new pregnancies if applicable.

 Saliva samples for DNA extraction are being collected on some participants. All participants
 will be asked to provide their permission to be contacted in the future about donating a
 sample of blood, tissue, or other biospecimen for future research. Participants will not be
 required to submit biological specimens in order to participate in the Registry and will need
 to sign a separate consent to donate a sample.

 Self reported data collected from participants includes Personal History, Maternal Outcomes,
 Brief Reproductive History, Medical History, Family Medical History, Biological Father
 Information, Demographic Information, Prenatal Care, Medications/Drug use During Pregnancy,
 Metabolic Questions, Pregnancy Symptoms, Hypertension, Delivery and Baby Information, and
 Postpartum data.

 Medical records will be used primarily to confirm a diagnosis of PE or other hypertensive
 disorder of pregnancy; however, they will also be used to validate any self-reported data as
 available.

 Participant medical information will be stored electronically within the Registry. The names
 of the Registry participants will be deleted from their stored medical information and
 replaced with a linkage code, making the record de-identified. Access to participant medical
 information contained within the Registry will be restricted to the Principal Investigator
 and her designees.

 Participants will be asked to provide their permission to share their de-identified (coded)
 information with other registries and databases. This information may be used for
 retrospective research or to plan for clinical trials. Participants will be asked to allow
 the Foundation investigators to review this information to determine if the participants may
 be eligible for participation in future research studies being conducted by secondary
 investigators (not affiliated with the Foundation). Interested Registry participants
 contacted for possible participation in future research studies being conducted by secondary
 investigators will undergo a separate informed consent process for each such research study.

 The Registry's Steering Committee will conduct a formal review of proposals of
 investigator-driven research projects and will provide recommendations to the PI. The PI,
 under the Registry's current protocol, must grant final approval for all studies conducted
 using medical information contained within the Registry. Such approvals shall be obtained
 prior to providing investigator information from the Registry; shall be based upon
 considerations of scientific quality and validity; shall be granted only for research studies
 related to PE or related hypertensive disorders of pregnancy; and shall be documented. Prior
 to provision of data to any investigator, the information shall be de-identified. The
 Registry shall require investigators to obtain IRB approval prior to its provision of
 de-identified information to the investigator.

 Approved scientists, researchers, and clinicians, will be given only the de-identified
 information and may search the de-identified data for patients for their studies. If an
 affected individual looks like a good match for a specific study, the researcher will contact
 the Registry. A Registry staff member will then contact the participant or the participant's
 family. Researchers will not directly contact participants or their families as they will
 only see de-identified data. It will be the choice of the Registry participant or their
 family to decide to initiate direct contact with the interested researcher.

 Data Management and Statistical Analysis

 The information collected through this registry is maintained by MedSciNet, a company based
 in Sweden that specializes in the development of online database systems for registries,
 clinical trials, and medical bio banks. The data and safety monitoring plan for the registry
 will involve routine monitoring by the Principal Investigator or her designees of 1) removal
 of direct identifiers from information contained within the registry; 2) the documentation of
 provision of de-identified registry information to investigators; 3) the security of the
 database linking the registry linkage codes with participant identifiers and the
 documentation of access to this database for the purpose of gathering data for investigators;
 and 4) any conditions that may negatively impact the confidentiality of information contained
 within the registry.

 High data quality is achieved using standard data entry fields (numeric, date, time,
 dropdown, radio, checkbox fields, open text, etc.) as well as applying standard validation
 rules (mandatory, ranges for dates/numeric fields, data type, etc.) Predefined code lists are
 used to ensure that only standardized values are chosen. Clinical data is entered via forms
 comprised mainly of checkboxes, drop down menus and specified value fields. A few open text
 box fields capture natural history and individual participant experiences. Built-in data
 checks prevent most errors during data entry, further contributing to the ease of use for a
 non-technical user.

 All history of changes of individual data values is kept in the database. The information
 that is kept about each change of the data value includes user performing the change, date
 and time of change, old and new value. Reviewing of audit trail is available at individual
 data point level or at the form level.

 For the collection of outcomes data, standard, well-validated outcomes instruments have been
 used such as the data harmonization criteria established by Co-Lab, the reVITALize data
 definitions validated by the American Congress of Obstetricians and Gynecologists, and the
 common data points suggested by the Women's Health Registries Alliance. Using these
 instruments helps ensure that all basic data captured by the Registry will be compatible and
 interoperable across all registries and biobanks that may share research data. Beyond those
 instruments, the remaining questions have been formulated based on the input of the
 Registry's volunteer Scientific Advisory Council with input from patients and a review of the
 Foundation's Community Forum and social media networks where patients' research questions are
 typically expressed. These validation efforts, already voluntarily undertaken, demonstrate
 the Foundation's intention to maximize the use of its Registry and its willingness and
 commitment to participate in networks that will amplify the Registry's research potential.

 Recruitment Procedures

 Recruitment will involve an IRB approved email that will be sent to Preeclampsia Foundation
 volunteers and mailing list subscribers. Advertisements will be placed online (social media
 sites and webpages) and newspapers or other media sources after IRB approval. Other IRB
 approved forms of advertisement will include printed materials such as brochures, posters,
 pass along cards, and flyers placed in physician offices, public health clinics, and
 community health education events.

 Safety Considerations

 There are no risks of physical harm associated with participation in The Preeclampsia
 Registry. As the registry includes questions that can be sensitive and uncomfortable for an
 individual to answer, participants will be encouraged to skip questions they do not wish to
 answer.

 Benefits

 There are no direct benefits associated with participation in The Preeclampsia Registry. The
 use of information contained within The Preeclampsia Registry for retrospective research
 analysis may be of benefit to future patients with preeclampsia or related hypertensive
 disorders of pregnancy. Participants in the registry will be informed of future research
 studies involving preeclampsia and related hypertensive disorders of pregnancy, for which a
 separate informed consent will be obtained, and may offer direct benefit to The Preeclampsia
 Registry participants.

 Cost and Payments

 All costs associated with the implementation and maintenance of the registry shall be
 supported by the Preeclampsia Foundation. Participants will not be compensated for their time
 and participation in this registry.

 Withdrawal From Study

 Participation in all aspects of this study is voluntary. The consent form states this
 clearly. Should a participant change his/her mind and wish to withdraw participant
 information from the registry, the individual may do so by writing a letter or email to The
 Preeclampsia Foundation to notify them he/she no longer wants to participate. No explanation
 will be required. If withdrawal is requested, the participant's information will be removed
 from the registry. However, information accessed prior to the request for removal cannot be
 retrieved from researchers that have already accessed it.
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