Clinical trial NCT06927622: Corona Virus Disease 2019 Cohort Study
Official title: Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Pneumonia
COVID-19 Pandemic
COVID-19
Keywords: pregnant woman
birth cohort
infant
nervous system development
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Jinan Maternity and Child Health Care Hospital
name: Shandong Provincial Maternity and Child Health Care Hospital
name: The Second Hospital of Shandong University
name: Qianfoshan Hospital
First posted: 2025-04-15
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study is pregnant women who undergo regular prenatal examinations in hospitals, establish a prenatal care manual, plan hospital delivery, have no comorbid tumor diseases, are mentally normal, and are aged ≥ 18 years old.

Brief summary: The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.

Detailed description: The main questions it aims to answer are:

* Collect the information about Corona Virus Disease 2019 infection and medication of pregnant women to establish a birth cohort, and analyze the correlation between Corona Virus Disease 2019 infection during pregnancy and adverse pregnancy outcomes and birth outcomes.
* The offspring born in this cohort were followed up to analyze the effects of Corona Virus Disease 2019 infection during pregnancy on the nervous system development of the offspring.

Researchers will compare Corona Virus Disease 2019 infection group and uninfected group during pregnancy to see if Corona Virus Disease 2019 infection has adverse effects on pregnant women and their offspring.

Eligibility 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.

Primary outcomes:
measure: Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).
timeFrame: From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months
measure: Pregnancy complications or comorbidities
timeFrame: Starting prenatal examination until discharge，the evaluation take up to 10 months
measure: Obtain neonatal outcomes.
timeFrame: The evaluation period from birth to discharge is up to 1 week
measure: Comprehensive results of COVID-19 infection during pregnancy
timeFrame: Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 years
Secondary outcomes:
measure: Delivery method
timeFrame: The evaluation period from admission to delivery to discharge is up to 1 week
measure: Estimation of bleeding volume
timeFrame: The evaluation period from admission to delivery to discharge is up to 1 week
Other outcomes:
Locations:
city: JiNan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: JiNan
country: China
facility: Jinan Maternity and Child Health Care Hospital
city: JiNan
country: China
facility: Qianfoshan Hospital
city: JiNan
country: China
facility: Qilu Hospital of Shandong University
city: JiNan
country: China
facility: Shandong Provincial Maternity and Child Health Care Hospital
Study officials:
affiliation: The Second Hospital of Shandong University
name: Fanzhen Hong, Doctorate
role: STUDY_DIRECTOR
affiliation: Qilu Hospital of Shandong University
name: Xia Luo, Doctorate
role: STUDY_DIRECTOR
affiliation: Qianfoshan Hospital
name: Yueqin Xu, Doctorate
role: STUDY_DIRECTOR
affiliation: Jinan Maternity and Child Health Care Hospital
name: Qiuhong Yang, Doctorate
role: STUDY_DIRECTOR
affiliation: Shandong University
name: Jie Chen, Doctorate
role: STUDY_CHAIR
affiliation: Shandong University
name: Yinuo Song, Master
role: PRINCIPAL_INVESTIGATOR
References: