Clinical Outcomes of Placenta Previa - an Individualized Scoring System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Incidence of emergency cesarean section (CS)
研究概览
简要总结
The objective of the study is to develop a machine learning -based prediction model for patients with placenta previa . The model will be based on patient characteristics, clinical assessment, and disease features to predict disease course, prognosis and establish an individualized plan of care. Individualized management plan comprises timing of delivery, mode of delivery, need for hospital admission, postpartum hemorrhage management plan, and perioperative care.
The primary outcome is to predict maternal complications, primarily major antepartum hemorrhage (APH), defined as blood loss of 50-1000 ml.
详细描述
• Study settings: This multi-center study will invite at least 8 European-based tertiary centers. Data will be retrospectively collected from January 2018 to December 2023. with a total follow-up of at least 6 weeks postpartum. All women who will be diagnosed with PP during this period will be considered in the study.
• Inclusion Criteria:
- Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation).
- Aged 18 years old or above.
- Diagnosed with PP, followed-up antenatally and delivered within the same center.
- Authorization to use anonymous patient data for research purposes.
Exclusion Criteria:
- Inadequate documentation.
- Non-compliance to antenatal care.
- Previous 1 or more Cesarean deliveries.
- Previous uterine surgeries that approach the uterine cavity (myomectomy).
- Known untreated uterine septum.
- Maternal chronic medical condition that is associated with higher risk of placental insufficiency (including chronic hypertension, pregestational diabetes, chronic renal disease, autoimmune disease).
- Fetal major congenital anomalies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women diagnosed with placenta previa at time of routine second trimester ultrasound (18 to 21 weeks of gestation).
- •Aged 18 years old or above. Diagnosed with PP, followed-up antenatally and delivered within the same center.
- •Authorization to use anonymous patient data for research purposes
排除标准
- •Inadequate documentation. Non-compliance to antenatal care. Previous 1 or more Cesarean deliveries. Previous uterine surgeries that approach the uterine cavity (myomectomy). Known untreated uterine septum. Maternal chronic medical condition that is associated with higher risk of placental insufficiency (including chronic hypertension, pregestational diabetes, chronic renal disease, autoimmune disease).
- •Fetal major congenital anomalies
结局指标
主要结局
Incidence of emergency cesarean section (CS)
时间窗: 22 weeks to 37 weeks of gestation
CS that is indicated earlier than the elective planned date (36-37 weeks of gestation) due to bleeding or preterm labor
次要结局
- Peri-operative blood loss(Time between onset of cesarean section till 24 hours after the procedure)
研究者
Sherif Abdelkarim Mohammed Shazly
Chair of Middle-Eastern college of Obstetricians and Gynecologists, senior clinical fellow, principal investigator
Middle-Eastern College of Obstetricians and Gynecologists