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

NCT ID: NCT04229953

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Placenta Accreta Spectrum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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US scan with 3D/4D VRU software

US scan with 3D/4D VRU software

Intervention Type DEVICE

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.

Interventions

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US 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hatem AbuHashim

OTHER

Sponsor Role lead

Responsible Party

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Hatem AbuHashim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hatem Abu Hashim

Role: STUDY_CHAIR

Faculty of Medicine, Mansoura University

Asmaa Mahran

Role: PRINCIPAL_INVESTIGATOR

Mahala General Hospital

Central Contacts

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Hatem Abu Hashim, MD.FRCOG.PhD

Role: CONTACT

+20502300002

References

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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.

Reference Type RESULT
PMID: 30246313 (View on PubMed)

Other Identifiers

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MS.19.05.656

Identifier Type: -

Identifier Source: org_study_id

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