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Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum

Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum: A Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04229953
Enrollment
113
Registered
2020-01-18
Start date
2020-02-01
Completion date
2021-03-01
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta Spectrum

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.

Interventions

DEVICEUS scan with 3D/4D VRU software

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.

Sponsors

Hatem AbuHashim
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of 3D/4D VRU softwareIntra-operative (i.e. during surgery).The diagnostic accuracy of 3D/4D VRU software in comparison with the intra operative findings and histopathological confirmation if hysterectomy will be done.

Contacts

Primary ContactHatem Abu Hashim, MD.FRCOG.PhD
hatem_ah@hotmail.com+20502300002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026