Preeclampsia Clinical Trial
Official title:
Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies and Volatile Organic Compounds in Maternal Saliva Characteristic of Preeclampsia
NCT number | NCT02554604 |
Other study ID # | 0122-15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | September 2018 |
Verified date | August 2018 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Dr. Yael Einbinder | Kfar Saba | |
Israel | Laboratory of Renal Physiology, Meir Medical Center , | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Saliva measurement | Saliva samples will be collected from the volunteers during their pregnancy follow up during the first trimester 12-14 weeks, second trimester 28-32 weeks and on delivery day. | 9 months | |
Primary | 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 | Blood samples for lipid profile and HDL | blood samples will be collected from the volunteers during their pregnancy follow up during the first trimester 12-14 weeks, second trimester 28-32 weeks and on delivery day. | 9 months |
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