Placenta Accreta, Third Trimester Clinical Trial
Official title:
Detection of Placenta Accreta by Means of Volatile Organic Compounds in Exhaled Women Breath. A Prospective Case Control Study.
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.
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, TechnionāIsrael, 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).
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