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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06186947
Other study ID # COVREP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Shandong University
Contact Zi-Jiang Chen
Phone +0086 531 85187856
Email chenzijiang@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
No intervention
Participants are not subjected to any specific intervention.

Locations

Country Name City State
China Institute of Women, Children and Reproductive Health Jinan Shandong

Sponsors (26)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Ongoing pregnancy rate Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation. 12 weeks after the day of embryo transfer
Secondary 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
Secondary 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
Secondary Congenital malformation rate The number of the malformation neonates/the number of the neonates alive ×100%. 12 months after the day of embryo transfer
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