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临床试验/NCT06802874
NCT06802874招募中不适用

Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年11月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Rate of hospitalization for genital blood loss

研究概览

简要总结

The primary objective is to assess in terms of frequency the adverse outcomes (premature birth, maternal-fetal haemorrhage, maternal fetal-neonatal death) of pregnancies of women attending the obstetric-gynaecological emergency department for genital bleeding beyond the 18th week of pregnancy.

详细描述

The investigators decided to conduct this study because it is important on the one hand to carefully evaluate maternal-fetal outcomes in pregnancies characterised by genital bleeding in the second and third trimesters and on the other hand to evaluate the sonographic diagnostic capacity for identifying the aetiology of these genital bleedings, in order to understand whether the possibility of identifying a specific cause of the bleeding has also improved over time as sonographic techniques have improved. This could then allow management and subsequent obstetrical controls to be adapted in a more accurate and indivudualised manner.

For the purpose of this study, no study-specific visits are planned. Data collected during pregnancy and delivery data for patients who gave birth at our centre will be analysed.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnancy beyond 18 weeks gestational age complicated by genital bleeding;
  • Age of the patient ≥18 years;
  • Delivery at the O.U. of Obstetrics and Prenatal Age Medicine

排除标准

  • 未提供

结局指标

主要结局

Rate of hospitalization for genital blood loss

时间窗: After the 18th week of pregnancy

Percentage of spontaneous deliveries, operative vaginal, cesarean sections (elective, urgent, emergent)

时间窗: After delivery, up to 24 weeks

Percentage of preterm births

时间窗: After delivery, up to 24 weeks

Frequency of antihemorrhagic therapy and maternal transfusions

时间窗: Intra-partum and post-partum, up to 24 weeks

Frequency of live births, average APGAR, average pH of umbilical artery or vein, average neonatal weight

时间窗: After delivery, up to 24 weeks

Average length of hospitalization in hours

时间窗: During Hospitalization, up to 24 weeks

次要结局

  • Frequency of finding abnormal ultrasound findings corresponding to the etiology of bleeding(During the obstetric ultrasound performed at the time of admission)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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