Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum
1 other identifier
observational
113
0 countries
N/A
Brief Summary
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome. Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler. Magnetic resonance imaging (MRI) has been used to predict the depth of placental invasion, but it is expensive and often not immediately available. Recently, a new imaging technique utilizing three-dimensional (3D)/four-dimensional (4D) volume rendering ultrasound (VRU) was proposed as a promising tool for the preoperative diagnosis of placenta previa accerta spectrum. By using "crystal vue" and "realistic vue" volume rendering mode, it could detect 11 out of 12 cases (91.6%) of PAS which was subsequently confirmed during surgery. Accordingly, The aim of this study is to examine the diagnostic performance of 3D/four-dimensional (4D) volume rendering ultrasound (VRU) for placenta previa accerta spectrum in correlation with the clinical (operative) and pathological findings.
Trial Health
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participants targeted
Target at P50-P75 for all trials
Started Feb 2020
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJanuary 18, 2020
January 1, 2020
1 year
January 12, 2020
January 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy of 3D/4D VRU software
The diagnostic accuracy of 3D/4D VRU software in comparison with the intra operative findings and histopathological confirmation if hysterectomy will be done.
Intra-operative (i.e. during surgery).
Study Arms (1)
US scan with 3D/4D VRU software
Interventions
Every patient will be evaluated by grayscale 2D-ultrasound and color Doppler. Then, a Samsung WS 80A Elite US scanner with 3D/4D VRU software will be used to assess the placental invasion by applying the two modes ("crystal vue" and "realistic vue"). The image analysis will be performed after obtaining the volume dataset. Data will be compared with the intraoperative findings and histopathological confirmation if hysterectomy will be done.
Eligibility Criteria
Pregnant females during the third trimester of pregnancy, with a single fetus in the current pregnancy, a previous delivery by at least 1 cesarean section and having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.
You may qualify if:
- Pregnant women in their third trimester
- with a single fetus in the current pregnancy
- a previous delivery by at least 1 cesarean section
- having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment
You may not qualify if:
- cases with twin or multiple pregnancies,
- cases with a non-previa placenta or posterior low lying or previa placenta,
- cases without previous deliveries by cesarean section
- cases before the third trimester of pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hatem AbuHashimlead
Related Publications (1)
Aryananda RA, Akbar A, Wardhana MP, Gumilar KE, Wicaksono B, Ernawati E, Sulistyono A, Aditiawarman A, Joewono HT, Dachlan EG, Parange A, Dekker GA. New three-dimensional/four-dimensional volume rendering imaging software for detecting the abnormally invasive placenta. J Clin Ultrasound. 2019 Jan;47(1):9-13. doi: 10.1002/jcu.22641. Epub 2018 Sep 23.
PMID: 30246313RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hatem Abu Hashim
Faculty of Medicine, Mansoura University
- PRINCIPAL INVESTIGATOR
Asmaa Mahran
Mahala General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 12, 2020
First Posted
January 18, 2020
Study Start
February 1, 2020
Primary Completion
February 1, 2021
Study Completion
March 1, 2021
Last Updated
January 18, 2020
Record last verified: 2020-01