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临床试验/NCT06186947
NCT06186947招募中不适用

Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health: A Large Cohort Study

Shandong University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.

详细描述

The influence of SARS-CoV-2 infection on reproductive outcomes has been uncertain. The goal of this observational study is to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health for patients with childbearing needs.

Participants will:

  1. Undergo a questionnaire to gather details on COVID-19 infection history.
  2. Provide data about reproductive history.
  3. Be invited for physical examination, laboratory tests and ultrasound scans.
  4. Undergo a long-term follow up for pregnancy outcome and offspring health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 18-50 years old.
  • Patients with signed informed consent.
  • Patients with complete COVID-19 infection information.

排除标准

  • Patients with abnormal karyotype
  • Recipients of oocyte donation.

结局指标

主要结局

Clinical pregnancy rate

时间窗: 7 weeks after the day of embryo transfer

Clinical pregnancy is defined as the ultrasound confirmation of at least one gestational sac.

Ongoing pregnancy rate

时间窗: 12 weeks after the day of embryo transfer

Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.

次要结局

  • Congenital malformation rate(12 months after the day of embryo transfer)
  • Pregnancy loss rate(10 months after the day of embryo transfer)
  • Live birth rate(10 months after the day of embryo transfer)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Zi-Jiang

Academician

Shandong University

研究点 (1)

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