Clinical Situations at High Risk of Placenta Accreta / Percreta: Impact of Diagnostic Methods and Management on Maternal Morbidity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 674
- 试验地点
- 1
- 主要终点
- Severe postpartum hemorrhage
研究概览
简要总结
The purpose of this study is to identify what factors -either individual or related to the type of management received- influence the maternal outcomes in pregnant women at high risk for placenta accreta i.e , women with placenta praevia and previous caesarean.
This population-based study conducted in 8 French regions will also provide valid estimation of the incidence of placenta accreta among all parturients and among "at risk "women. Finally, a psychological evaluation of these women up to 1 year after delivery will provide information on the impact of these conditions on women, beyond somatic complications.
详细描述
Background: No population-based study has assessed the prevalence of placenta accreta, the predictive value of prenatal diagnostic examinations, the maternal morbidity associated with its management, or its psychological effects. Moreover the technical resources necessary for the safest delivery of women at risk have not been clearly identified.
Objectives: The primary objectives are to identify individual risk factors for maternal morbidity, as well as risk factors related to types of management and healthcare facilities for postpartum hemorrhage (PPH). Secondary objectives are to 1) determine the prevalence of placenta accreta among women at risk; 2) assess the predictive value of ultrasound and MRI for the diagnosis of placenta accreta in this population; 3) evaluate psychological impact and physical complications; 4) report maternal physical complications during the year after delivery.
Design: Population-based prospective observational study of pregnant women with a placenta inserted at a uterine scar Setting; A total of 166 centers in 8 French regions, with 260,000 deliveries annually.
Methods: We expect to include 570 women at risk of placenta accreta in two years, of whom approximately 100 (20%) will have placenta accreta.
Main outcome measures: The primary outcome measure is severe maternal hemorrhage; secondary outcome measures are maternal morbidity and deaths, predictive value of ultrasound and MRI, and psychological evaluations at 1, 6 and 12 months after delivery.
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 a maternity unit of the 11 participating perinatal networks.
- •With a placenta praevia and at least one previous cesarean delivery, and / or having a placenta accreta
- •aged 18 or more
排除标准
- •Every woman:
- •not understanding French.
- •refusing to participate in the study.
研究组 & 干预措施
women at high risk of placenta accreta
Parturient women with placenta praevia and at least one previous caesarean delivery
结局指标
主要结局
Severe postpartum hemorrhage
时间窗: up to 7 days post delivery
Severe hemorrhage defined by a hemorrhage with transfusion of at least four red blood cell units.
次要结局
- Incidence of accreta or percreta placenta overall and in women with previous caesarean section and placenta praevia(At delivery)
- severe maternal morbidity(up to 6 months post-delivery)
- Predictive value of prenatal ultrasound and MRI for the diagnosis of placenta accreta in women with previous caesarean section and placenta praevia(at delivery)
- Psychological impact(at 6 month post-delivery)
- Psychological impact(at 1 year post-delivery)
- Psychological impact(at 1 month post-delivery)