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临床试验/NCT06889727
NCT06889727已完成不适用

Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today: a Multicentre Observational Study

Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
number of pregnancies in women with beta thalassemia followed in Italian centres

研究概览

简要总结

Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia major by Walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Transfusion dependent and nontransfusion- dependent thalassemia
  • •Pregnancy ended with the birth of a live or dead foetus
  • •Pregnancy ended in miscarriage or voluntary abortion
  • •Pregnancy in progress

排除标准

  • •Other types of anemia
  • •Pregnancy not initiated despite assisted fertilization practices
  • •Subjects unwilling to sign informed consent

结局指标

主要结局

number of pregnancies in women with beta thalassemia followed in Italian centres

时间窗: 15 YEARS

To evaluate the number of pregnancies in women with beta thalassemia followed in Italian centres and how the increase in the average age of the thalassemia population impact on the number of new pregnancies over time

number of pregnancies after hormonal stimulation

时间窗: 15 YEARS

number of pregnancies after hormonal stimulation

likelihood of miscarriage

时间窗: 15 YEARS

To evaluate the likelihood of miscarriage

number of pregnancies spontaneously

时间窗: 15 YEARS

many pregnancies occurred spontaneously

foetal death

时间窗: 15 YEARS

To evaluate foetal death

次要结局

未报告次要终点

研究者

发起方
Fondazione per la Ricerca sulle Anemie ed Emoglobinopatie in Italia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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