COVID-19, COVID-19 Pandemic, COVID-19 Pneumonia
Conditions
Keywords
pregnant woman, birth cohort, infant, nervous system development
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.
Interventions
None listed
Sponsors
Qilu Hospital of Shandong University
Jinan Maternity and Child Health Care Hospital
Shandong Provincial Maternity and Child Health Care Hospital
The Second Hospital of Shandong University
Qianfoshan Hospital
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST). | From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months | GDS mainly diagnoses four abilities: motor ability, object ability, speech ability, and human ability,. Thus, the development quotient of four aspects can be obtained. If the development quotient is below 65-75, it indicates serious backwardness. The DST assessment includes five functional areas: gross motor, fine motor, language, adaptability, and social behavior, to obtain developmental quotient, which is used to measure the developmental behavior of children and evaluate their level of development. A score above 130 indicates excellent performance, and a score below 70 indicates intellectual development disorder. |
| Pregnancy complications or comorbidities | Starting prenatal examination until discharge，the evaluation take up to 10 months | Obtain relevant information from medical records. Pregnancy complications refer to non pregnancy related diseases that occur before or during pregnancy, while pregnancy complications refer to any diseases that coexist with pregnancy. |
| Obtain neonatal outcomes. | The evaluation period from birth to discharge is up to 1 week | Obtain neonatal outcomes from neonatal records, including macrosomia, neonatal asphyxia, fetal distress, low birth weight infants, and deformed infants. |
| Comprehensive results of COVID-19 infection during pregnancy | Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 years | Through questionnaires, medical records and test sheets, The investigators can get whether the pregnant women have been infected with COVID-19 during pregnancy, the time of infection, pregnancy weeks, symptoms, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery method | The evaluation period from admission to delivery to discharge is up to 1 week | Natural delivery, vaginal surgery, or curettage. |
| Estimation of bleeding volume | The evaluation period from admission to delivery to discharge is up to 1 week | Total amount of bleeding during or 24 hours postpartum. |
Countries
China
Contacts
Primary ContactJie Chen, Doctorate
Backup ContactYinuo Song
Outcome results
None listed