Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum

NCT ID: NCT04314791

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-12-31

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.

Conditions

Placenta Accreta Spectrum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

US scan with calculation of the PAI

Ultrasound evaluation, with grayscale and color Doppler imaging

Intervention Type: DEVICE

In pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015.

Interventions

Ultrasound evaluation, with grayscale and color Doppler imaging

In pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015.

Intervention Type: DEVICE

Eligibility Criteria

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: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hatem AbuHashim

OTHER

Sponsor Role: lead

Responsible Party

Hatem AbuHashim

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hatem Abu Hashim

Role: STUDY_CHAIR

Faculty of Medicine, Mansoura University

Eman Shalaby

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Faculty of Medicine, Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

References

Rac MW, Dashe JS, Wells CE, Moschos E, McIntire DD, Twickler DM. Ultrasound predictors of placental invasion: the Placenta Accreta Index. Am J Obstet Gynecol. 2015 Mar;212(3):343.e1-7. doi: 10.1016/j.ajog.2014.10.022. Epub 2014 Oct 18.

Reference Type: BACKGROUND

PMID: 25446658 (View on PubMed)

Other Identifiers

MS.17.04.143

Identifier Type: -

Identifier Source: org_study_id