Corona Virus Disease 2019 Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShandong University
About this trial
The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Concomitant tumor related diseases;
Individuals with severe mental disorders.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Measure the developmental outcomes of the nervous system using the Gesell Development Plan (GDS) or the 0-6-year-old Child Development Scale (DST).
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.
Time frame
From 6 months of birth to completion of the GDS measurement, the assessment is up to 6 months2
Pregnancy complications or comorbidities
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.
Time frame
Starting prenatal examination until discharge，the evaluation take up to 10 months3
Obtain neonatal outcomes.
Obtain neonatal outcomes from neonatal records, including macrosomia, neonatal asphyxia, fetal distress, low birth weight infants, and deformed infants.
Time frame
The evaluation period from birth to discharge is up to 1 week4
Comprehensive results of COVID-19 infection during pregnancy
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.
Time frame
Baseline data were obtained when participants were enrolled in the study and assessed for up to 1 yearsSecondary outcomes
1
Delivery method
Natural delivery, vaginal surgery, or curettage.
Time frame
The evaluation period from admission to delivery to discharge is up to 1 week2
Estimation of bleeding volume
Total amount of bleeding during or 24 hours postpartum.
Time frame
The evaluation period from admission to delivery to discharge is up to 1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong University
Lead sponsor
Qilu Hospital of Shandong University
Collaborator
Jinan Maternity and Child Health Care Hospital
Collaborator
Shandong Provincial Maternity and Child Health Care Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Qianfoshan Hospital
Collaborator
Source ClinicalTrials.gov