Detection and Identification of Preeclampsia Via Volatile Biomarkers (DIP)
Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of preeclampsia is unknown.
Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most likely to be involved.
More than 100 clinical, biophysical, and biochemical tests have been recommended to predict or identify the patient at risk for the future development of the disease.
The results of the pooled data for the various tests and the lack of agreement between serial tests suggest that none of these clinical tests is sufficiently reliable for use as a screening test in clinical practice. As a result there is obviously a great need to develop a novel technology for the early detection of this pregnancy complication before its clinical manifestations appear. An early detection can help in early treatment to prevent or at least minimize the sequel of this disease.
The aim of this project is the early detection of "Preeclampsia" and other pregnancy complications using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple and inexpensive toll termed NA-NOSE.
Phase-I: The primary phase of this project is the comparison between volatile biomarkers' patterns of pregnant women suffering from "Preeclampsia", pregnant women that are considered to have "Normal Pregnancy", and healthy "Non-Pregnant" women.
Phase-II: The secondary phase of this project is the ability to predict "Preeclampsia", as compared, head-to-head, with other potential predictors used in the current clinical practice.
Pregnancy; Death of Fetus, Early Pregnancy
Uremia in Pregnancy Without Hypertension
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Detection and Identification of Preeclampsia Via Volatile Biomarkers|
- Volatile Biomarkers [ Time Frame: Volatile Biomarkers will be collected from pregnant women and analysed afterward ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||September 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
30 preeclamptic pregnant women with gestational age >24 weeks and no chronic medical disorders who are not in labor and their fetus is alive.
30 normotensive pregnant women with gestational age >24 weeks and no chronic medical disorders who has no obstetrical problems, not in labor and their fetus is alive.
30 healthy non-pregnant control women not on medications and has not delivered a baby or conceived during the year before the breath collection
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01291342
|Nazareth, Israel, 16100|
|Principal Investigator:||Marwan M Hakim, M.D, D.Sc||he Nazareth Hospital E.M.M.S|