Observational study on COVID-19 effects during pregnancy
Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development
This study looks at how COVID-19 infection during pregnancy affects both the mother and the baby's health to see if there are any differences compared to pregnant women who didn't have the virus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shandong University Academic / other |
| Locations | 5 sites (Jinan, Shandong and 4 other locations) |
| Trial ID | NCT06927622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the impact of COVID-19 infection on pregnancy outcomes and the development of offspring. It will collect data from pregnant women regarding their COVID-19 infection status and any medications taken, establishing a birth cohort for analysis. The study will compare outcomes between women infected with COVID-19 and those who are uninfected, focusing on adverse pregnancy outcomes and the subsequent development of the nervous system in their children. Follow-up assessments will be conducted to evaluate the long-term effects on offspring.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 years or older who are receiving regular prenatal care.
Not a fit: Patients with concomitant tumor-related diseases or severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the risks associated with COVID-19 during pregnancy and inform healthcare practices for pregnant women.
How similar studies have performed: Other studies have explored the effects of viral infections during pregnancy, but the specific focus on COVID-19 and its implications for obstetric outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Conduct regular prenatal examinations in the hospital and establish a pregnancy and childbirth health manual, planning for pregnant women who are hospitalized for delivery; * Conduct regular physical examinations in the hospital and establish a children's health manual for infants. * Age ≥ 18 years old Exclusion Criteria: * Concomitant tumor related diseases; * Individuals with severe mental disorders.
Where this trial is running
Jinan, Shandong and 4 other locations
- The Second Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Jinan Maternity and Child Health Care Hospital — Jinan, China (Recruiting)
- Qianfoshan Hospital — Jinan, China (Recruiting)
- Qilu Hospital of Shandong University — Jinan, China (Recruiting)
- Shandong Provincial Maternity and Child Health Care Hospital — Jinan, China (Recruiting)
Study contacts
- Principal investigator: Yinuo Song, Master — Shandong University
- Study coordinator: Jie Chen, Doctorate
- Email: 202216407@mail.sdu.edu.cn
- Phone: 18615656606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.