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Detection of Placenta Accreta Via Exhaled Women Breath

NCT03947047 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-08-13

No results posted yet for this study

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.

Conditions

  • Placenta Accreta, Third Trimester

Interventions

DIAGNOSTIC_TEST

NA-NOSE

Breath and blood samples for distinguishing biomarkers.

Sponsors & Collaborators

  • Technion, Israel Institute of Technology

    collaborator OTHER

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • Sivan Easton, MD · Emek Medical Center

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-06
Primary Completion
2021-04-30
Completion
2021-04-30

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 NCT03947047 on ClinicalTrials.gov