Detection and Identification of Preeclampsia Via Volatile Biomarkers (DIP)
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|ClinicalTrials.gov Identifier: NCT01291342|
Recruitment Status : Completed
First Posted : February 8, 2011
Last Update Posted : February 6, 2013
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.
|Condition or disease|
|Pregnancy; Death of Fetus, Early Pregnancy Uremia in Pregnancy Without Hypertension|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Observational Model:||Case Control|
|Official Title:||Detection and Identification of Preeclampsia Via Volatile Biomarkers|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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
- Volatile Biomarkers [ Time Frame: Volatile Biomarkers will be collected from pregnant women and analysed afterward ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291342
|Nazareth, Israel, 16100|
|Principal Investigator:||Marwan M Hakim, M.D, D.Sc||he Nazareth Hospital E.M.M.S|