Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity

NCT07832019 | Not Yet Recruiting

• 2 other identifiers: NEU-2026-6714Ethics approval
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta accreta spectrum (PAS) is associated with substantial maternal and neonatal morbidity, and accurate antenatal prediction of its severity remains challenging. Although several sonographic markers exist, most are subjective and operator-dependent, and few predict surgical complexity or adverse perinatal outcomes. This prospective observational cohort study evaluates the Placenta-Cervical Interface Angle (PCIA), a novel geometric transvaginal ultrasound marker, defined as the angle between the longitudinal axis of the cervical canal and the tangent line drawn to the lower placental edge. The study assesses the predictive performance of the PCIA for severe PAS and its association with intraoperative morbidity and adverse perinatal outcomes.

Conditions

Placenta Accreta Spectrum; Placenta Previa; Placenta Accreta

Keywords

placenta-cervical interface angle; PAS severity; perinatal outcome

Outcome Measures

Primary Outcomes (1)

• Predictive performance of the Placenta-Cervical Interface Angle (PCIA) for severe placenta accreta spectrum

  Diagnostic accuracy of the sonographically measured PCIA for predicting surgically or histologically confirmed severe PAS, expressed as area under the ROC curve (AUC), sensitivity, specificity, and positive and negative predictive values. The optimal cut-off is determined by the Youden index.

  From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery

Secondary Outcomes (7)

• Estimated intraoperative blood loss

  At delivery / cesarean surgery

• Adverse neonatal outcome

  At delivery and the immediate neonatal period

• Inter-observer reproducibility of PCIA measurement

  At the time of antenatal ultrasound assessment

• Red blood cell transfusion

  At delivery and during the perioperative period

• Operative time

  At delivery / cesarean surgery

Study Arms (1)

Pregnant women at risk of PAS

Pregnant women at or beyond 20 weeks of gestation with placenta previa or an anterior low-lying placenta and suspected placenta accreta spectrum, undergoing transvaginal measurement of the Placenta-Cervical Interface Angle and followed to delivery.

Procedure: Pregnant women at risk of PAS

Interventions

Pregnant women at risk of PAS PROCEDURE

Transvaginal ultrasonography performed in the sagittal plane to measure the Placenta-Cervical Interface Angle (PCIA), defined as the angle between the longitudinal axis of the cervical canal and the tangent to the lower placental edge, together with assessment of classic sonographic PAS markers.

Pregnant women at risk of PAS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at or beyond 20 weeks of gestation with placenta previa or an anterior low-lying placenta and suspected placenta accreta spectrum, followed at a single tertiary perinatology clinic.

You may qualify if:

• Gestational age greater than 20 weeks
• Placenta previa or low-lying placenta
• Suspected placenta accreta spectrum
• History of cesarean delivery

You may not qualify if:

• Major fetal anomaly
• Multiple pregnancy
• Uterine malformation
• Inadequate image quality
• Active vaginal bleeding

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University, Faculty of Medicine, Perinatology Clinic

Konya, Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

• Skupski DW, Duzyj CM, Scholl J, Perez-Delboy A, Ruhstaller K, Plante LA, Hart LA, Palomares KTS, Ajemian B, Rosen T, Kinzler WL, Ananth C; Perinatal Research Consortium. Evaluation of classic and novel ultrasound signs of placenta accreta spectrum. Ultrasound Obstet Gynecol. 2022 Apr;59(4):465-473. doi: 10.1002/uog.24804.

  PMID: 34725869 BACKGROUND

• Agarwal N, Hernandez-Andrade E, Sibai BM, Amro FH, Coselli JO, Bartal MF, Lai D, Torres EES, Backley S, Johnson A, Espinoza J, Bergh EP, Zhu S, Salazar A, Blackwell SC, Papanna R. Quantifying placenta accreta spectrum severity and its associated blood loss: a novel transvaginal ultrasound scoring system. Am J Obstet Gynecol MFM. 2024 Oct;6(10):101451. doi: 10.1016/j.ajogmf.2024.101451. Epub 2024 Aug 5.

  PMID: 39096965 BACKGROUND

• Varthaliti A, Psarris A, Koutroumanis P, Gkiaourakis G, Daskalaki MA, Antsaklis P, Daskalakis G, Theodora M. Prognostic Significance of Serial Ultrasonography in Placenta Accreta Spectrum and Its Impact on Perinatal Outcomes. Medicina (Kaunas). 2025 Sep 5;61(9):1612. doi: 10.3390/medicina61091612.

  PMID: 41011001 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa

Condition Hierarchy (Ancestors)

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

Study Officials

• Ali ACAR, Prof.Dr

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatice Sule Mazloomyar, MD

CONTACT

05061194179; haticesulemazloomyar@erbakan.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Obstetrics and Gynecology / Perinatology

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 21, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)