Diagnostic Accuracy of MRI to Predict Peripartum Hysterectomy and Neonatal Mortality in Total Placenta Previa: A Retrospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 277
- 试验地点
- 2
- 主要终点
- Identification of risk factors affecting neonatal mortality regardless of whether MRI scanning is used.
研究概览
简要总结
To assess the reliability of placental magnetic resonance imaging measurements in predicting peripartum hysterectomy and neonatal outcomes in patients with total placenta previa.
详细描述
Study design and patients This study analyzed the outcomes of a cohort of 372 pregnant women diagnosed with PP over five years, from November 2017 to June 2023. The patient population for the study included women between the ages of 17 and 42 who were in their third trimester of pregnancy (27th to 37th weeks of gestation) and had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or p-MRI. The resulting cohort compared a final sample population of 277 singleton pregnant women with t-PP, which comprised 150 pregnant women who underwent antenatal p-MRI examinations in the third trimester and 127 pregnant women who did not undergo a p-MRI.
Standards of reference The study covered all singleton pregnancies in which t-PP extended to both the anterior and posterior uterine walls, resulting in complete coverage of the internal cervical os by the placenta. Transvaginal and transabdominal USG were planned between 32 and 34 weeks for all patients who were followed up in our clinic due to t-PP and were scheduled to be delivered. The gestational ages of the participants were determined using the last menstrual date and crown-rump length (CRL) measurements from a first-trimester ultrasound. Two perinatologists with at least ten years of experience examined each patient's cd-USG for signs of PAS. Ultrasonographic signs identified included placental lacunae, placenta previa involving the cervix, loss of the clear zone, and bladder wall interruption.
Two radiologists with at least ten years of experience, independently of each other, evaluated p-MRI scans of pregnant women diagnosed with t-PP without prior knowledge of the original reports.
Definitive diagnosis and pathological reporting Pathological reports and approvals were granted according to a rigorous protocol involving at least two pathologists, each with a minimum of seven years of professional expertise in their field.
p-MRI image interpretations The assessment focused on analyzing the different positions of the atypical placenta in the lower uterine segment, including the anterior, posterior, anterolateral, and posterolateral locations. Precise measurements were taken to calculate the placental volume in the S1 and S2 sectors, cervical canal length, and cervical canal dilatation. Based on sagittal p-MRI scans, the placental invasion was classified into two main areas. Implementing a plane perpendicular to the upper bladder's axis facilitated the boundary of these sectors. The term S1 refers to the upper uterine segment that forms the part of the uterus that contacts the bladder's posterior wall. Likewise, the lower uterine segment, identified as S2, was formed in the lower posterior wall of the bladder. Radiologists conducted a sector-wise (S1 and S2) examination of the invasion topography, which allowed them to identify specific invasion locations, including parametrial and cervical involvement and bladder interruption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two radiologists with at least ten years of experience, independently of each other, evaluated p-MRI scans of pregnant women diagnosed with t-PP without prior knowledge of the original reports.
入排标准
- 年龄范围
- 17 Years 至 42 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •27th to 37th weeks of gestation
- •Third trimester of pregnancy
- •Pregnants had received a t-PP diagnosis via color Doppler ultrasonography (cd-USG) and/or placental MRI (p-MRI).
- •All singleton pregnancies in which t-PP extended to both the anterior and posterior uterine walls, resulting in complete coverage of the internal cervical os by the placenta
排除标准
- •Any cases of low-lying/marginal placenta previa
- •Preoperative hemoglobin level < 9 g/dL
- •Pregnant women with coagulation disorders
- •Morbid obesity
- •Multiple fetal pregnancies
- •Individuals delivered before < 27 weeks of gestation
结局指标
主要结局
Identification of risk factors affecting neonatal mortality regardless of whether MRI scanning is used.
时间窗: Assessed at the time of delivery.
Binary measure indicating whether neonatal mortality occurred (yes/no).
Clinical risk factors affecting p-TAH in patients with t-PP undergoing p-MRI.
时间窗: Assessed during the peripartum period, within the first 2 days postpartum.
Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
Assessment of risk factors affecting peripartum hysterectomy in placenta previa patients undergoing without MRI screening
时间窗: Assessed during the peripartum period, within the first two days postpartum.
Binary measure indicating whether peripartum hysterectomy occurred (yes/no).
次要结局
- Peripartum Hysterectomy Occurrence(Assessed during the peripartum period, within the first 2 days postpartum.)
- The ROC analysis of the placental volume (S1 and S2 sectors), CCL, and CCD obtained from the p-MRI scan for indications of peripartum hysterectomy(Assessed based on ROC analysis.)
研究者
Sadık Kükrer
Principal Investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
