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Detection of Placenta Accreta Via Exhaled Women Breath

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ClinicalTrials.gov Identifier: NCT03947047
Recruitment Status : Unknown
Verified August 2019 by Sivan Easton, HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : May 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Sivan Easton, HaEmek Medical Center, Israel

Study Description
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Brief Summary:
Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The incidence of placenta accreta increased during the last years due to the increase in cesarean delivery rate, which is the main risk factor. Pre-cesarean diagnosis of placenta accreta may improve surgical outcome. Early diagnosis allows appropriate preparation of multidisciplinary team (including, among others; OB-GYN, urologists, anesthesiologists, neonatologists) and massive blood products. Pre-cesarean diagnosis is based on imaging, mainly ultra-sound. This modality has significant false positive rate which may result in extreme sources investment and even indicated pre-term labor, in vain. Volatolome is a complex of volatile markers emitted in several processes in the human body and collected from breath, skin, urine, blood, feces and more. This profile may be used to identify volatile markers for specific medical conditions. NA-NOSE is an electronic device knowing to identify differences in the Volatolome between "healthy" and "sick" subjects. The objective of this study is to identify specific volatile profile for placenta accreta which will help to distinguish between women with placenta accreta and those without.

Condition or disease Intervention/treatment
Placenta Accreta, Third Trimester Diagnostic Test: NA-NOSE

Detailed Description:

Pregnant women with clinical risk factors for placenta accreta will perform targeted sonographic evaluation for detection of placenta accreta features, according to a standard protocol. Of those with clinical and sonographic risk factors who will agree to participate in the study, will be asked to breathe through a collection device (NA-NOSE) for "lung wash". The participant will be instructed to inhale through the device and exhale to the ambient air for about 3 minutes. After the lung wash step, the collector will inform the participant that she is about to start filling the collective bags. At the end of a regular breath, after exhaling, the collector will ask the participant to take a deep breath so the full volume of the lungs is filled, and then exhale until both the dead space bag and collection bag are full. After filling the first bag, a second bag will be placed and the participant will be asked to repeat the act. In addition, a venous blood sample of 8-10 ml will be taken from each participant.

The samples will be transferred to the Department of Chemical Engineering and Russell Berrie Nanotechnology Institute, Technion-Israel, Institute of Technology. The samples will be analyzed to determine the nature and composition of the volatile biomarkers in the related breath and blood samples.

In this way, the investigators will identify among women who have clinical and sonographic risk factors for placenta accreta, those biomarkers distinguishing women with placenta accreta (group 1) from those who will not have placenta accreta at birth (group 2).

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of Placenta Accreta by Means of Volatile Organic Compounds in Exhaled Women Breath. A Prospective Case Control Study.
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Placenta Accreta
Women found to have abnormal placentation (any degree of placenta accreta) during the cesarean section.
 Diagnostic Test: NA-NOSE
Breath and blood samples for distinguishing biomarkers.
No Placenta Accreta
Women found to have normal placenta separation during the cesarean section.
 Diagnostic Test: NA-NOSE
Breath and blood samples for distinguishing biomarkers.


Outcome Measures
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Primary Outcome Measures :
  1. Detection of placenta accreta [ Time Frame: 2 years ]
    The aim of the study is to improve pre-cesarean detection of placenta accreta using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple inexpensive tool termed NA-NOSE.


Biospecimen Retention:   Samples Without DNA
Organic Compounds in Exhaled Women Breath and blood samples.

Eligibility Criteria
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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:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women, 28 weeks of gestation or more, with known risk factors for placenta accreta referred to our institute to perform an ultrasound scan for detecting abnormal placentation.
Criteria

Inclusion Criteria:

  1. Pregnancy > 28 weeks of gestation.
  2. Agreement to participate and sign an informed consent.
  3. Ability to give breath and blood samples.

  4. Risk factors for placenta accreta:

    1. Placenta previa.
    2. Previous 1 or more cesarean sections with placenta in the scar area.

    3. Previous uterine procedures (myomectomy, curretage) and sonographic suspicion of abnormal placentation.

      - Exclusion Criteria: None

      -

Contacts and Locations
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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): NCT03947047


Contacts
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Contact: Raed Salim, MD +972-4-6494030 salim_ra@clalit.org.il
Contact: Sivan Easton, MD +972-4-6494355 sivan_ea@clalit.org.il

Locations
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Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Raed Salim, MD    97246494031    salim_ra@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Technion, Israel Institute of Technology
Investigators
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Principal Investigator: Sivan Easton, MD Emek Medical Center
More Information
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Responsible Party: Sivan Easton, Principal Investigator, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03947047    
Other Study ID Numbers: 0021-19-EMC
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Decision regarding IPD sharing, will be taken later.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sivan Easton, HaEmek Medical Center, Israel:
Exhaled Women Breath
Placenta Accreta
Ultrasound
Additional relevant MeSH terms:
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Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases