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NCT Number: NCT07832019

Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity

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.

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Key information

Conditions

Placenta Accreta Spectrum Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Placenta Previa Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Necmettin Erbakan University, Faculty of Medicine, Perinatology Clinic

Konya, 42090, Turkey (Türkiye)

Location contact

Hatice Şule Mazloomyar

CONTACT

[email protected]

05061194179

About this study

Pregnant women with placenta previa or an anteriorly located low-lying placenta followed at the Perinatology Clinic, Necmettin Erbakan University Faculty of Medicine, will be enrolled prospectively. Using transvaginal ultrasonography in the sagittal plane, the Placenta-Cervical Interface Angle (PCIA) will be measured as the angle formed between the longitudinal axis along the cervical canal and the tangent line to the lower placental edge. All measurements will be performed with an empty bladder in the lithotomy position using a Voluson 8 ultrasound system within the same gestational-age window. Classic sonographic PAS markers will also be assessed, including placental lacunae, bridging vessels, loss of the clear zone, myometrial thickness, bladder-wall invasion, and cervical length. Demographic and clinical variables (age, BMI, gravidity, parity, smoking, IVF versus spontaneous conception, prior cesarean and other uterine surgery) will be recorded. Surgical and perinatal outcomes, including operative time, estimated blood loss, red-blood-cell transfusion, intensive-care requirement, hysterectomy, and neonatal outcomes, will be recorded. To assess reproducibility, a second operator will repeat the measurement in approximately 20% of participants and the intraclass correlation coefficient (ICC) will be calculated. Data will be analyzed with SPSS. The predictive performance of the PCIA for severe PAS and adverse perinatal outcomes will be evaluated by ROC analysis, with the optimal cut-off determined by the Youden index; sensitivity, specificity, and positive and negative predictive values will be calculated. Multivariable logistic regression will be used to identify independent predictors. A p-value below 0.05 will be considered statistically significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Estimated intraoperative blood loss

    Time frame: At delivery / cesarean surgery

    Estimated intraoperative blood loss, measured in milliliters (mL).

  2. Adverse neonatal outcome

    Time frame: At delivery and the immediate neonatal period

    Proportion of neonates with an adverse outcome, defined as neonatal intensive care unit (NICU) admission, measured as percentage of neonates.

  3. Inter-observer reproducibility of PCIA measurement

    Time frame: At the time of antenatal ultrasound assessment

    Intraclass correlation coefficient (ICC) of the PCIA measured independently by two operators in approximately 20% of participants.

  4. Red blood cell transfusion

    Time frame: At delivery and during the perioperative period

    Number of units of red blood cells transfused, measured in units

  5. Operative time

    Time frame: At delivery / cesarean surgery

    Total duration of the surgical procedure, measured in minutes

  6. Hysterectomy

    Time frame: At delivery / cesarean surgery

    Proportion of participants requiring hysterectomy, measured as percentage of participants.

  7. Intensive care unit admission

    Time frame: During the postoperative hospital stay

    Proportion of participants requiring intensive care unit admission, measured as percentage of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Sule Mazloomyar, MD

CONTACT

[email protected]

05061194179

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Placenta-Cervical Interface Angle: A Novel Sonographic Marker for Predicting Placenta Accreta Spectrum Severity and Perinatal Outcomes

Acronym: PCIA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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