Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum

NCT04314791 | Completed

• 1 other identifier: MS.17.04.143
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the PAI

  The diagnostic accuracy of the PAI in comparison with the histopathological confirmation in hysterectomy specimens.

  through study completion, an average of 1 year

Study Arms (1)

US scan with calculation of the PAI

Device: Ultrasound evaluation, with grayscale and color Doppler imaging

Interventions

Ultrasound evaluation, with grayscale and color Doppler imaging 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.

US scan with calculation of the PAI

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

Sponsors & Collaborators

• Hatem AbuHashim: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

• 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.

  PMID: 25446658 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Hatem Abu Hashim

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

• Eman Shalaby

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

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: March 14, 2020
• First Posted: March 19, 2020
• Study Start: July 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

EG (1)