Detection of Placenta Accreta Via Exhaled Women Breath

NCT ID: NCT03947047

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2021-04-30

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.

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).

Conditions

Placenta Accreta, Third Trimester

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Placenta Accreta

Women found to have abnormal placentation (any degree of placenta accreta) during the cesarean section.

NA-NOSE

Intervention Type: DIAGNOSTIC_TEST

Breath and blood samples for distinguishing biomarkers.

No Placenta Accreta

Women found to have normal placenta separation during the cesarean section.

NA-NOSE

Intervention Type: DIAGNOSTIC_TEST

Breath and blood samples for distinguishing biomarkers.

Interventions

NA-NOSE

Breath and blood samples for distinguishing biomarkers.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Technion, Israel Institute of Technology

OTHER

Sponsor Role: collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Sivan Easton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sivan Easton, MD

Role: PRINCIPAL_INVESTIGATOR

Emek Medical Center

Locations

HaEmek Medical Center

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Raed Salim, MD

Role: CONTACT

salim_ra@clalit.org.il

+972-4-6494030

Sivan Easton, MD

Role: CONTACT

sivan_ea@clalit.org.il

+972-4-6494355

Facility Contacts

Raed Salim, MD

Role: primary

salim_ra@clalit.org.il

97246494031

Other Identifiers

0021-19-EMC

Identifier Type: -

Identifier Source: org_study_id