Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health: A Large Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Shandong University
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.
Detailed Description
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.
Investigators
Chen Zi-Jiang
Academician
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Women aged between 18-50 years old.
- •Patients with signed informed consent.
- •Patients with complete COVID-19 infection information.
Exclusion Criteria
- •Patients with abnormal karyotype
- •Recipients of oocyte donation.
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: 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
Time Frame: 12 weeks after the day of embryo transfer
Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.
Secondary Outcomes
- 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)