Detection and Identification of Preeclampsia Via Volatile Biomarkers (DIP)

This study has been completed.
Sponsor:
Collaborators:
Technion, Israel Institute of Technology
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
Marwan Hakim, The Nazareth Hospital, Israel
ClinicalTrials.gov Identifier:
NCT01291342
First received: February 5, 2011
Last updated: February 5, 2013
Last verified: August 2012
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection and Identification of Preeclampsia Via Volatile Biomarkers

Resource links provided by NLM:


Further study details as provided by The Nazareth Hospital, Israel:

Primary Outcome Measures:
  • 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

Breath Serum


Estimated Enrollment: 90
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preeclampsia
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291342

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

No publications provided

Responsible Party: Marwan Hakim, DoCTOR, The Nazareth Hospital, Israel
ClinicalTrials.gov Identifier: NCT01291342     History of Changes
Other Study ID Numbers: 1702
Study First Received: February 5, 2011
Last Updated: February 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by The Nazareth Hospital, Israel:
Pregnancy
Preeclampsia
Volatile biomarkers
Chemical sensors
Nanomaterials
Nanosensors
NA-NOSE

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Uremia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014