- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07832019
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity (PCIA)
Placenta-Cervical Interface Angle: A Novel Sonographic Marker for Predicting Placenta Accreta Spectrum Severity and Perinatal Outcomes
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Hatice Sule Mazloomyar, MD
- 전화번호: 05061194179
- 이메일: haticesulemazloomyar@erbakan.edu.tr
연구 장소
-
-
Konya
-
Konya, Konya, 터키 (Türkiye), 42090
- Necmettin Erbakan University, Faculty of Medicine, Perinatology Clinic
-
연락하다:
- Hatice Şule Mazloomyar
- 전화번호: 05061194179
- 이메일: sule.icolak@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Predictive performance of the Placenta-Cervical Interface Angle (PCIA) for severe placenta accreta spectrum
기간: 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. |
From antenatal ultrasound (>=20 weeks) to postoperative histopathological confirmation at delivery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Estimated intraoperative blood loss
기간: At delivery / cesarean surgery
|
Estimated intraoperative blood loss, measured in milliliters (mL). |
At delivery / cesarean surgery
|
|
Adverse neonatal outcome
기간: 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. |
At delivery and the immediate neonatal period
|
|
Inter-observer reproducibility of PCIA measurement
기간: At the time of antenatal ultrasound assessment
|
Intraclass correlation coefficient (ICC) of the PCIA measured independently by two operators in approximately 20% of participants. |
At the time of antenatal ultrasound assessment
|
|
Red blood cell transfusion
기간: At delivery and during the perioperative period
|
Number of units of red blood cells transfused, measured in units |
At delivery and during the perioperative period
|
|
Operative time
기간: At delivery / cesarean surgery
|
Total duration of the surgical procedure, measured in minutes |
At delivery / cesarean surgery
|
|
Hysterectomy
기간: At delivery / cesarean surgery
|
Proportion of participants requiring hysterectomy, measured as percentage of participants. |
At delivery / cesarean surgery
|
|
Intensive care unit admission
기간: During the postoperative hospital stay
|
Proportion of participants requiring intensive care unit admission, measured as percentage of participants |
During the postoperative hospital stay
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ali ACAR, Prof.Dr, Necmettin Erbakan University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- NEU-2026-6714
- Ethics approval (기타 식별자: Necmettin Erbakan University Non-Interventional Clinical Research Ethics Committee (Application ID 31937))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared outside the study team.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .