COVID-19 Clinical Trial
Official title:
Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health: A Large Cohort Study
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 |
This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.
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. |
Country | Name | City | State |
---|---|---|---|
China | Institute of Women, Children and Reproductive Health | Jinan | Shandong |
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 |
China,
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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