Pregnancy-related diseases
Conditions
Interventions
Pregnant women who received the novel coronavirus vaccine during perinatal pregnancy:N/A
Pregnant women who were not vaccinated against COVID-19 :N/A
Sponsors
Nanfang Hospital, Southern Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: ? For women aged 18-49 who are pregnant after vaccination or pregnant at the same time but not vaccinated Is the research object; No history of SARSCoV or SARS-CoV-2 infection. ? The subject agrees to receive maternal and fetal medical records; ? Obtain the consent of the subject and sign the informed consent; ? Subjects can comply with the requirements of clinical trial protocol;
Exclusion criteria
Exclusion criteria: ? High-risk epidemiological history within 14 days prior to enrollment (community travel or residence history, if cases have been reported;Or history of contact with an infected person with SARS-CoV-2), severe acute respiratory syndrome, or SARS-CoV-2 infection (as reported by participants), and allergy to any vaccine component. ? History of asthma, angioneurotic edema, diabetes or malignancy; ? Abnormal coagulation function (such as lack of coagulation factor, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors; ? Immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, inhalation corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-concurrent dermatitis) in the past 6 months; ? History of thyroidectomy, or the need for treatment due to thyroid disease within the past 12 months; ? Autoimmune disease or immune deficiency, or parents, siblings have autoimmune disease or immune deficiency; ? If acute or newly developed chronic disease occurs at the time of vaccination, the investigator shall decide whether to continue follow-up; ? If, in the investigator's judgment, the subject has any other ineligible factors for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cesarean section rate;postpartum hemorrhage rate;hyperamniotic fluid rate/hypomniotic fluid rate;threatened abortion rate;premature rupture of membranes rate;pregnancy complications rate;premature birth rate;Perinatal neonatal mortality rate;low birth weight infant incidence;neonatal asphyxia incidence;fetal distress incidence;jaundice incidence;Rate of birth defects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions to vaccines; | — |
Countries
China
Contacts
Public ContactCaihua Yang
Nanfang Hospital, Southern Medical University
Outcome results
None listed