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Detection and Identification of Preeclampsia Via Volatile Biomarkers

NCT01291342 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2013-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy; Death of Fetus, Early Pregnancy
  • Uremia in Pregnancy Without Hypertension

Sponsors & Collaborators

  • Technion, Israel Institute of Technology

    collaborator OTHER

  • HaEmek Medical Center, Israel

    collaborator OTHER

  • The Nazareth Hospital, Israel

    lead OTHER

Principal Investigators

  • Marwan M Hakim, M.D, D.Sc · he Nazareth Hospital E.M.M.S

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291342 on ClinicalTrials.gov