Clinical trial NCT06186947: Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health
Official title: Effects of COVID-19 Infection on Pregnancy Outcomes and Offspring Health: A Large Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong University of Traditional Chinese Medicine
name: The Second Hospital of Shandong University
name: The Affiliated Hospital of Qingdao University
name: Yantai Yuhuangding Hospital Affiliated to Qingdao University
name: Yantai City Yantai Mountain Hospital
name: the First People's Hospital of Jining
name: Weifang People's Hospital
name: Jining Medical University
name: Linyi People's Hospital
name: Dezhou People's Hospital
name: The Affiliated Hospital of Binzhou Medical College
name: Liaocheng People's Hospital
name: The Second People's Hospital of Liaocheng
name: Linyi Maternal and Child Healthcare Hospital
name: Heze Hospital of Traditional Chinese Medicine
name: Weihai maternal and child health care hospital
name: Weifang Maternal and Child Health Hospital
name: Tai'an City Central Hospital
name: Zibo Maternal and Child Health Care Hospital
name: Qingdao Women and Children's Hospital
name: Qilu Hospital of Shandong University
name: The Affiliated Hospital of Weifang Medical College
name: Maternal and Child Health Care Hospital of Shandong Province
name: Ren Ji Hospital of Shanghai Jiao Tong University
First posted: 2024-01-02
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with reproductive needs are recruited for study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 weeks after the day of embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 12 weeks after the day of embryo transfer
Secondary outcomes:
measure: Live birth rate
timeFrame: 10 months after the day of embryo transfer
measure: Pregnancy loss rate
timeFrame: 10 months after the day of embryo transfer
measure: Congenital malformation rate
timeFrame: 12 months after the day of embryo transfer
Other outcomes:
Locations:
city: Jinan
country: China
facility: Institute of Women, Children and Reproductive Health
state: Shandong
Study officials:
affiliation: Shandong University
name: Zi-Jiang Chen
role: STUDY_CHAIR
References: