Evaluation of Placental Cervical Invasion and Cervical Length in Patients With Placenta Accreta
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Intraoperative findings regarding cervical invasion of placenta .
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Multiple gestation.
- •Pre-existing cervical incompetence or cerclage placement prior to enrollment. -Transfer from outside facilities without complete prenatal records.
研究组 & 干预措施
PAS patients with cervical invasion
Have cervical invasion using criteria compiled from multiple studies: ٭Extension of placental tissue into the cervical stroma or cervico-isthmic complex (CIC), with placental tissue encroaching on or beyond the internal os without clear separation . ٭Irregular cervical contour or disruption of the normal cervical architecture, including fibrosis in the lower posterior cervical-trigonal space (associated with type 4 PAS and higher morbidity) . ٭Increased vascularity within the cervical canal or stroma, detected via color Doppler showing turbulent flow or lacunae extending into the cervix (predictive of deep invasion and bleeding risk) . ٭Presence of intracervical lakes (novel marker: hypoechoic or anechoic spaces within the cervical tissue, suggestive of invasive placentation) .
PAS patients without cervical invasion
Haven't cervical invasion using criteria compiled from multiple studies: ٭Extension of placental tissue into the cervical stroma or cervico-isthmic complex (CIC), with placental tissue encroaching on or beyond the internal os without clear separation . ٭Irregular cervical contour or disruption of the normal cervical architecture, including fibrosis in the lower posterior cervical-trigonal space (associated with type 4 PAS and higher morbidity) . ٭Increased vascularity within the cervical canal or stroma, detected via color Doppler showing turbulent flow or lacunae extending into the cervix (predictive of deep invasion and bleeding risk) . ٭Presence of intracervical lakes (novel marker: hypoechoic or anechoic spaces within the cervical tissue, suggestive of invasive placentation) . Scoring systems integration:
PAS patients with short cervical length
Cervical length will be measured in admission and before delivery The final CL measurement prior to delivery was analyzed. Unscheduled delivery was defined as urgent delivery prior to the scheduled date due to either bleeding or preterm contractions. A receiver operating characteristics (ROC) curve was created, the optimal CL associated with unscheduled delivery was selected, and associations and prediction analyses were performed. Short cl < 3 cm
PAS patients with normal cervical length
Cervical length will be measured in admission and before delivery The final CL measurement prior to delivery was analyzed. Unscheduled delivery was defined as urgent delivery prior to the scheduled date due to either bleeding or preterm contractions. A receiver operating characteristics (ROC) curve was created, the optimal CL associated with unscheduled delivery was selected, and associations and prediction analyses were performed. Short cl ≥ 3 cm
结局指标
主要结局
Intraoperative findings regarding cervical invasion of placenta .
时间窗: Intraoperative
Visible placental tissue extending into or through the lower uterine segment and cervix, sometimes protruding into the cervical canal or os. Bluish/purple discoloration or bulging/distension ("bulge sign") of the lower uterine segment and cervical area due to underlying placental invasion. Prominent hypervascularity: Dense, tangled vessels (often large, tortuous, or engorged) running over the serosal surface of the lower uterus and cervix; this includes abnormal neovascularization or "rail sign"-like patterns. Adherent placenta that does not separate easily; attempts at gentle cord traction may show the "dimple sign" (uterus pulled inward without placental release). Thinned or disrupted myometrium in the lower segment/cervix, with placental villi directly attached or invading deeply (no clear cleavage plane). In more severe (percreta-like) cases involving the cervix: Placental protrusion or exophytic growth through the serosa. and confirmed by histopathology
timing of delivery
时间窗: At delivery
Gestational age in weeks and days at the time of delivery (calculated from last menstrual period or early ultrasound dating) to note the preterm labour and its association with cervical length
Cervical length before delivery
时间窗: Immediately prior to delivery
Cervical length will be measured immediately before delivery by ultrasound to estimate relation between short cervical length and preterm labor
Hysterectomy rate
时间窗: Intraoperative
Number of CS hysterectomy done for the patients of placenta accreta spectrum with cervical invasion
次要结局
未报告次要终点
研究者
Ahmed Salah Ali
Assistant lecturer of OB.&GYN. ,Sohag faculty of medicine
Sohag University