Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Number of Participants with postpartum hemorrhage
研究概览
简要总结
This study aim to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa.
详细描述
Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa.
Cesarean delivery and assisted reproductive technology are associated with an increased risk of placenta previa in subsequent pregnancies. Other risk factors for previa include previous spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa.
It is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death.
This is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. For each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. The date of their admission is limited to two days.
This hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 60 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Single Pregnancy
- •Informed consent
- •Fetal gestational age 28 to < 42 weeks
排除标准
- •Multiple pregnancy
- •Refuses to consent
结局指标
主要结局
Number of Participants with postpartum hemorrhage
时间窗: 24 hours after delivery
Blood loss \> 1000ml during cesarean section or \> 500 ml during vaginal delivery
次要结局
- Number of Participants with very preterm birth(From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks)
- Number of urological injury(72 hours after delivery)
- Number of needed for extra surgical maneuvers(72 hours after delivery)
- Number of Participants with antepartum hemorrhage(From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks)
- Number of need for caesarean hysterectomy(72 hours after delivery)
- Number of needed for maternal ICU(72 hours after delivery)
- Number of Participants with preterm birth(From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks)
- Number of participant needed for blood transfusion(72 hours after delivery)
- Number of needed for neonatal ICU(72 hours after delivery)
