Effect of Covid 19 Infection on Fetomaternal Outcome

NCT ID: NCT05160649

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2023-10-31

Brief Summary

The novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was discovered for the first time in December 2019 in Wuhan (China) and the disease it causes is called coronavirus disease 2019 (COVID-19). Now, this pandemic is rapidly spreading all over the world.

Pregnant have higher rates of COVID-19, associated with hospitalizations, and severe in-hospital outcomes. Immune responses may have a potential role in the diagnosis, treatment, and prognosis of patients with COVID-19. So we need of identifying biomarkers for disease severity and progression.

Detailed Description

It is important to define whether a novel virus is transmissible from a mother to her infant, vertical infection, and there are three possible mechanisms for vertical infection - intrauterine infection (including transplacental and ascending infections), intrapartum transmission (during delivery), and postpartum infection. These mechanisms have important implications that can influence obstetrical management decisions, best practice delivery options, and neonatal care (3).

Aim of work To detect the effect of time of infection by COVID 19 on the fetomaternal outcome including vertical transmission, and the immunological and genetic changes during the disease course.

Patients and Methods:

• All pregnant women eligible for the study will undergo detailed medical history.
• Each patient will have the following data: • Patient name. • Age. • Past medical and surgical history. • Menstrual history and contraceptive history: especially emphasis on Last Menstrual Period to determine the exact gestational age.
• Clinical examination of the patients: - General examination of vital data (blood pressure, pulse, temperature, respiratory rate). CBC, PT, PTT, RBS, ALT, AST, serum creatinine), and ultrasound will be done.
• Abdominal examination: to detect any abnormality as intrauterine growth restriction, with serial ultrasound estimation.

Conditions

COVID-19; COVID-19 Pneumonia; Fetal Growth Retardation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Positive RT-PCR nasopharyngeal swab is taken (even if the result became available after labor);

2. Positive rapid antigen test performed before labor

3. Chest computed tomography (CT) scan performed before labor showing changes consistent with pneumonitis secondary to SARS-CoV-2 infection;

4. Positive pre-labor immunoglobulin G or immunoglobulin M antibody test; or

5. Clinical diagnosis made before labor (in the absence of negative RT-PCR swab results).

Exclusion Criteria

1. Healthy individuals:

2. Acute or chronic infectious disease,

3. And any medication with known influence on immunological factors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

rehab abdelhamid aboshama

lecturer of obstetrics and gynecology Faculty of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laila E Abdelfattah, Ass. prof

Role: PRINCIPAL_INVESTIGATOR

Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university

Eman E Mahmoud, lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer of clinical and chemical pathology

Locations

Fayoum university

Al Fayyum, , Egypt

Countries

Egypt

Other Identifiers

S 280

Identifier Type: -

Identifier Source: org_study_id