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Набор скоро начнётся NCT07452185

Evaluation of Cervical Invasion and Length in Placenta Accreta Patients

Наблюдательное Placenta Accreta Spectrum Placenta Accreta Placenta Previa

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Placenta Accreta Spectrum, Placenta Accreta, Placenta Previa. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Placental Cervical Invasion and Cervical Length in Patients With Placenta Accreta

Обзор

Placenta accreta spectrum (PAS), also called morbidly adherent placenta, is a serious pregnancy problem where the placenta attaches too deeply to the uterus wall and does not come out normally after birth. This often happens after previous cesarean sections or when the placenta is low (placenta previa). It can cause heavy bleeding, serious complications, and danger to the mother. This study will look at pregnant women with PAS at Sohag University Hospital in Egypt. Researchers will use ultrasound to check two things: How much the placenta has invaded the cervix (the lower part of the uterus). The length of the cervix. The main goals are to find out: How common cervical invasion is in PAS cases. What happens to women who have this invasion (outcomes like bleeding or surgery needs). If a short cervix is linked to early labor (preterm birth). Women with confirmed PAS will join this observational study from March 2026 to January 2028. They will have extra ultrasound scans during pregnancy. No new treatments or drugs are tested - the study only collects information from routine care and scans to better understand the condition. This research may help doctors predict risks earlier, plan safer deliveries, and improve care for mothers and babies with PAS in the future.

Подробное описание

Placenta accreta spectrum (PAS), previously termed morbidly adherent placenta, includes a spectrum of disorders characterized by abnormal adherence of placental tissue to or invasion into the myometrium, frequently associated with prior cesarean deliveries and placenta previa. The rising incidence of PAS correlates with increasing cesarean section rates worldwide, posing substantial risks such as massive postpartum hemorrhage, surgical complications, organ injury (e.g., bladder), and maternal mortality.

Cervical invasion in PAS involves extension of placental tissue into the cervical stroma or cervico-isthmic complex, potentially leading to fibrosis in the lower posterior cervical-trigonal space. This feature complicates surgical management and heightens risks of uncontrollable bleeding and adjacent organ damage. Although cervical involvement has been underrecognized as a distinct entity in many prior studies, emerging evidence links fibrosis-associated cervico-trigonal invasion to severe morbidity.

Additionally, cervical length (CL) assessment in PAS patients has shown that a short CL (≤30 mm) is associated with increased risk of massive intraoperative hemorrhage. Retrospective data suggest CL as a predictor of unscheduled deliveries and preterm birth in this population.

The current study introduces a novel multidisciplinary protocol integrating prospective evaluation of placental cervical invasion (via ultrasound) and cervical length measurement in PAS patients. This combined approach aims to provide a unified framework for enhanced risk stratification, better anticipation of complications, and optimization of surgical planning to minimize unscheduled interventions and improve maternal and neonatal outcomes.

Aim of the study To estimate the incidence of cervical invasion in placenta accreta spectrum patients, assess outcomes in those cases, evaluate cervical length in PAS patients, and investigate its relation to preterm labor.

Patients and Methods This is a prospective observational (conservative) study enrolling women diagnosed with placenta accreta spectrum. Recruitment will occur from March 2026 to January 2028 at Sohag University Hospital, a tertiary referral center in Sohag Governorate, Egypt. The hospital features advanced obstetric imaging capabilities, multidisciplinary teams including maternal-fetal medicine specialists, and neonatal intensive care support for high-risk pregnancies.

Eligible participants are pregnant women with confirmed PAS (based on prenatal ultrasound/MRI criteria). Study procedures involve serial transvaginal and transabdominal ultrasound assessments to measure cervical length and evaluate the extent of placental cervical invasion. Data will include demographic details, obstetric history, imaging findings, delivery mode, intraoperative complications, blood loss, and maternal/neonatal outcomes. No interventional treatments are introduced; management follows standard institutional protocols for PAS.

Первичные конечные точки

  • Intraoperative findings regarding cervical invasion of placenta . [Срок оценки: Intraoperative]
  • timing of delivery [Срок оценки: At delivery]
  • Cervical length before delivery [Срок оценки: Immediately prior to delivery]
  • Hysterectomy rate [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

  • Pregnant women aged 18-45 years with suspected or confirmed PAS based on prenatal ultrasound (e.g., placenta previa with at least one prior cesarean section).
  • Gestational age between 18-32 weeks at enrollment to allow for serial monitoring.
  • Singleton pregnancy.
  • High-risk features such as history of multiple cesarean sections, antepartum bleeding, or abnormal placental location on initial screening.

Критерии исключения

  • Multiple gestation.
  • Pre-existing cervical incompetence or cerclage placement prior to enrollment. -Transfer from outside facilities without complete prenatal records.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07452185 · Soh-Med--26-2-3MD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗