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临床试验/NCT03774667
NCT03774667Unknown不适用

Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study

Maternal and Child Health Hospital of Foshan1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2019年1月1日最近更新:
适应症

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

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)

研究者

发起方
Maternal and Child Health Hospital of Foshan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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