Health TrialsbyHealthPanel

Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity

ConditionsPlacenta Accreta SpectrumPlacenta PreviaPlacenta Accreta
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNecmettin Erbakan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age greater than 20 weeks

Placenta previa or low-lying placenta

Suspected placenta accreta spectrum

History of cesarean delivery

Disqualifiers

Major fetal anomaly

Multiple pregnancy

Uterine malformation

Inadequate image quality

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pregnant women at risk of PAS

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Pregnant women at risk of PAS1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Estimated intraoperative blood loss

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

Time frame
At delivery / cesarean surgery
2

Adverse neonatal outcome

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

Time frame
At delivery and the immediate neonatal period
3

Inter-observer reproducibility of PCIA measurement

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

Time frame
At the time of antenatal ultrasound assessment
4

Red blood cell transfusion

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

Time frame
At delivery and during the perioperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Necmettin Erbakan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: