COVID-19
Conditions
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.
Interventions
OTHERNo intervention
Participants are not subjected to any specific intervention.
Sponsors
Shandong University of Traditional Chinese Medicine
The Second Hospital of Shandong University
The Affiliated Hospital of Qingdao University
Yantai Yuhuangding Hospital Affiliated to Qingdao University
Yantai City Yantai Mountain Hospital
the First People's Hospital of Jining
Weifang People's Hospital
Jining Medical University
Linyi People's Hospital
Dezhou People's Hospital
The Affiliated Hospital of Binzhou Medical College
Liaocheng People's Hospital
The Second People's Hospital of Liaocheng
Linyi Maternal and Child Healthcare Hospital
Heze Hospital of Traditional Chinese Medicine
Weihai maternal and child health care hospital
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 Shandong University of Traditional Chinese Medicine
Qilu Hospital of Shandong University
The Affiliated Hospital of Weifang Medical College
Maternal and Child Health Care Hospital of Shandong Province
Ren Ji Hospital of Shanghai Jiao Tong University
Shandong University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Congenital malformation rate | 12 months after the day of embryo transfer | The number of the malformation neonates/the number of the neonates alive ×100%. |
Countries
China
Contacts
Primary ContactZi-Jiang Chen
Outcome results
None listed