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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
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Pregnancy; Death of Fetus, Early Pregnancy Uremia in Pregnancy Without Hypertension

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Study Design

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection and Identification of Preeclampsia Via Volatile Biomarkers
Study Start Date : September 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

30 preeclamptic pregnant women with gestational age >24 weeks and no chronic medical disorders who are not in labor and their fetus is alive.
Normal pregnancy
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.
Healthy non-pregnant
30 healthy non-pregnant control women not on medications and has not delivered a baby or conceived during the year before the breath collection

Outcome Measures

Primary Outcome Measures :
  1. Volatile Biomarkers [ Time Frame: Volatile Biomarkers will be collected from pregnant women and analysed afterward ]

Biospecimen Retention:   Samples Without DNA
Breath Serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women treated in the Nazareth Hospital and Emek Medical Center

Inclusion Criteria:

  • All participants are nonsmokers, non obese, young women between 18 and 40 years old who'll be able to provide breath samples.

Exclusion Criteria:

  • Women taking medicines or antioxidants are excluded except the pregnant women who are on traditional prenatal vitamins and those in the preeclampsia group on antihypertensive medication.
  • Obese women or those with chronic diseases and those with a history of chronic hypertension, insulin-dependent diabetes or renal disease are excluded.
  • minors and insane
Contacts and Locations

Information from the National Library of Medicine

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 Hospital
Nazareth, Israel, 16100
Sponsors and Collaborators
The Nazareth Hospital, Israel
Technion, Israel Institute of Technology
HaEmek Medical Center, Israel
Principal Investigator: Marwan M Hakim, M.D, D.Sc he Nazareth Hospital E.M.M.S
More Information

Responsible Party: Marwan Hakim, DoCTOR, The Nazareth Hospital, Israel
ClinicalTrials.gov Identifier: NCT01291342     History of Changes
Other Study ID Numbers: 1702
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: August 2012

Keywords provided by Marwan Hakim, The Nazareth Hospital, Israel:
Volatile biomarkers
Chemical sensors

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications