Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum

Completed

• Conditions: Placenta Accreta Spectrum
• Interventions: Device: Ultrasound evaluation, with grayscale and color Doppler imaging

• Registration Number: NCT04314791
• Lead Sponsor: Hatem AbuHashim

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.

The placenta accreta index (PAI) score (a nine-point score) was proposed in 2015 to predict PAS based on US parameters in a high-risk population by retrospective data analysis. The probability of histological invasion was found to increase with increasing the PAI score. This study aimed to prospectively evaluate the diagnostic performance of the PAI in the prediction of PAS in relation to histopathological findings.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Study First Posted: 2020-03-19
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
US scan with calculation of the PAI	Ultrasound evaluation, with grayscale and color Doppler imaging	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the PAI	through study completion, an average of 1 year	The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.

Trial Locations

Locations (1)

Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, Egypt