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

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Zi-Jiang Chen; Phone Number: +0086 531 85187856; Email: chenzijiang@hotmail.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Institute of Women, Children and Reproductive Health
      • Contact: Han Zhao; Phone Number: +0086 531 82950556; Email: hanzh80@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with reproductive needs are recruited for study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 group; Patients infected by SARS CoV2 before reproductive events.	Other: No intervention; Participants are not subjected to any specific intervention.
Control group; Patients who were not infected by SARS CoV2 before reproductive events.	Other: No intervention; Participants are not subjected to any specific intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Clinical pregnancy is defined as the ultrasound confirmation of at least one gestational sac.	7 weeks after the day of embryo transfer
Ongoing pregnancy rate	Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.	12 weeks after the day of embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Qilu Hospital of Shandong University; The Affiliated Hospital of Qingdao University; The Second Hospital of Shandong University; Liaocheng People's Hospital; The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine; Linyi People's Hospital; Weifang People's Hospital; Dezhou People's Hospital; Maternal and Child Health Care Hospital of Shandong Province; The Affiliated Hospital of Shandong University of Traditional Chinese Medicine; Affiliated hospital of jining medical college; Weihai maternal and child health care hospital; The Second People's Hospital of Liaocheng; Yantai Yuhuangding Hospital Affiliated to Qingdao University; The Affiliated Hospital of Binzhou Medical College; Ren Ji Hospital of Shanghai Jiao Tong University; Yantai City Yantai Mountain Hospital; the First People's Hospital of Jining; Linyi Maternal and Child Healthcare Hospital; Heze Hospital of Traditional Chinese Medicine; Weifang Maternal and Child Health Hospital; Tai'an City Central Hospital; Zibo Maternal and Child Health Care Hospital; Qingdao Women and Children's Hospital; The Affiliated Hospital of Weifang Medical College
• Investigators: Study Chair: Zi-Jiang Chen, Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Estimated): January 1, 2024

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVREP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No