Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Concentration of cell-free fetal DNA circulating in the maternal plasma
研究概览
简要总结
The purpose of this study is to determine whether, in a high risk population (placenta praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)), the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI).
详细描述
Background: Morbidly adherent placenta (MAP) is a life-threatening condition characterized by placental villi being abnormally adherent to the myometrium. Prenatal identification of MAP is essential to anticipate the risk and plan optimal delivery conditions for these women while this is associated to a maternal outcome improvement. Prenatal identification based on Doppler ultrasound and/or MRI is associated with high rates of false-positive or false-negative findings responsible for adverse effects. Some cases reports have suggested that the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in a context of morbidly adherent placenta (MAP).
Objective: The primary objective is to determine whether the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in women with morbidly adherent placenta (MAP) compared to women with placenta praevia and previous caesarean. Secondary objectives are to determine whether cell-free fetal DNA circulating in the maternal plasma is a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI), in a high risk population (placenta praevia and previous caesarean or only prenatal suspicion of MAP).
Design: Prospective observational study of pregnant women with placenta praevia and previous cesaeran or with prenatal suspicion of placenta accreta, conducted in 5 centers.
Methods: We expect to include 83 women at risk of MAP in two years, of whom approximately 17 (20%) will have a MAP.
Main outcome measures: The primary outcome measure is concentration of cell-free fetal DNA circulating in maternal plasma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Every woman:
- •delivering in one of the 5 maternity units that participate to a Population-based prospective observational study of pregnant women with a placenta praevia and previous cesarean or with prenatal suspicion of accreta (PACCRETA) .
- •With a placenta praevia and at least one previous cesarean delivery or having a prenatal suspicion of placenta accreta
- •aged 18 or more
排除标准
- •Every woman:
- •not understanding French.
- •refusing to participate in the study
结局指标
主要结局
Concentration of cell-free fetal DNA circulating in the maternal plasma
时间窗: from 24 weeks gestation to delivery
次要结局
- Sensitivity of the concentration of cell-free fetal DNA(from 24 weeks gestation to delivery)
- Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA in association with clinical criteria ( risk factors for MAP)(from 24 weeks gestation to delivery)
- Negative predictive value of the concentration of cell-free fetal DNA(from 24 weeks gestation to delivery)
- Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of concentration of cell-free fetal DNA in association with imaging criteria magnetic resonance(from 24 weeks gestation to delivery)
- Specificity of the concentration of cell-free fetal DNA(from 24 weeks gestation to delivery)
- Sensitivity, specificity, positive predictive value (PPV) and negative (NPV) of the concentration of cell-free fetal DNA and clinical criteria in association with clinical criteria, sonographic criteria and with magnetic resonance imaging criteria(from 24 weeks gestation to delivery)
- Positive predictive value of concentration of cell-free fetal DNA(from 24 weeks gestation to delivery)