Detection of Placenta Accreta Via Exhaled Women Breath

NCT03947047 | Unknown DMC

• 1 other identifier: 0021-19-EMC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta, Third Trimester

Keywords

Exhaled Women Breath; Placenta Accreta; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Detection of placenta accreta

  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.

  2 years

Study Arms (2)

Placenta Accreta

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

Diagnostic Test: NA-NOSE

No Placenta Accreta

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

Diagnostic Test: NA-NOSE

Interventions

NA-NOSE DIAGNOSTIC_TEST

Breath and blood samples for distinguishing biomarkers.

No Placenta Accreta; Placenta Accreta

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnancy \> 28 weeks of gestation.
• Agreement to participate and sign an informed consent.
• Ability to give breath and blood samples.
• Risk factors for placenta accreta:
• Placenta previa.
• Previous 1 or more cesarean sections with placenta in the scar area.
• Previous uterine procedures (myomectomy, curretage) and sonographic suspicion of abnormal placentation.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Organic Compounds in Exhaled Women Breath and blood samples.

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Sivan Easton, MD

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raed Salim, MD

CONTACT

+972-4-6494030; salim_ra@clalit.org.il

Sivan Easton, MD

CONTACT

+972-4-6494355; sivan_ea@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: August 6, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

IL (1)