Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health

Recruiting

• Conditions: COVID-19
• Interventions: Other: No intervention

• Registration Number: NCT06186947
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2023-12-28
• Last Update Submitted: 2023-12-28
• Study First Posted: 2024-01-02
• Last Update Posted: 2024-01-02
• Primary Completion: 2024-03-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

1. Patients with abnormal karyotype
2. Recipients of oocyte donation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 group	No intervention	Patients infected by SARS CoV2 before reproductive events.
Control group	No intervention	Patients who were not infected by SARS CoV2 before reproductive events.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	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	12 weeks after the day of embryo transfer	Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.

Secondary Outcome Measures

Name	Time	Method
Congenital malformation rate	12 months after the day of embryo transfer	The number of the malformation neonates/the number of the neonates alive ×100%.
Pregnancy loss rate	10 months after the day of embryo transfer	Pregnancy loss is defined as pregnancy that eventuates in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
Live birth rate	10 months after the day of embryo transfer	Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.

Trial Locations

Locations (1)

Institute of Women, Children and Reproductive Health; 🇨🇳 Jinan, Shandong, China