Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
1 other identifier
observational
30
1 country
2
Brief Summary
The study is design to assess if there is a correlation between diagnosis of preeclampsia and its severity to changes in HDL quality, in terms of composition and function and to determine whether preeclampsia-induced changes in VOCs in saliva can be used for the early diagnosis of preeclampsia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 9, 2019
August 1, 2018
3 years
September 17, 2015
September 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
signs and symptoms of preeclampsia
blood pressure, BMI, presence of edema, urinalysis-proteinuria, in addition to all routine second and third trimester checkups that will be documented.
9 months
Secondary Outcomes (1)
Blood samples for lipid profile and HDL
9 months
Other Outcomes (1)
Saliva measurement
9 months
Study Arms (1)
Pregnant woman
Pregnant woman with identified risk factors for the development of preeclampsia
Eligibility Criteria
Pregnant woman followed in Community Obstetric Clinics and in the High Risk Obstetric Clinic at Meir Medical Center who agree to participate in the study. Woman will be recruited based on the presence of one or more risk factors for the development of preeclampsia including: first pregnancy, overweight at the beginning of pregnancy or significant weight gain during pregnancy , previous history of preeclampsia and a first degree family member with a history of preeclampsia
You may qualify if:
- Pregnant woman followed in Community Obstetric Clinics and in the High Risk Obstetric Clinic at Meir Medical Center who agree to participate in the study.
- Woman will be recruited based on the presence of one or more risk factors for the development of preeclampsia including: first pregnancy, overweight at the beginning of pregnancy or significant weight gain during pregnancy , previous history of preeclampsia and a first degree family member with a history of preeclampsia.
You may not qualify if:
- Participants with multiple fetuses (previous medical history of hypertension, chronic kidney disease, diabetes mellitus) or who are unable to provide informed consent due to language barrier or other cause, will be excluded from the study.
- Patients who were not recruited to the study at the beginning of pregnancy will be allowed to join at any stage, including on delivery day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dr. Yael Einbinder
Kfar Saba, Israel
Laboratory of Renal Physiology, Meir Medical Center ,
Kfar Saba, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Nephrologist
Study Record Dates
First Submitted
September 17, 2015
First Posted
September 18, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
September 9, 2019
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share