Effect of Covid 19 Infection on Fetomaternal Outcome

COVID-19 Clinical Trial

Official title:

Effect of Time of COVID 19 Infection on Fetomaternal Outcome, and Immunological Changes During the Disease Course

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05160649
• Other study ID #: S 280
• Status: Active, not recruiting
• Start date: October 10, 2021
• Est. completion date: October 2023

Study information

• Verified date: April 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria: Pregnant pt with covid 19 infection (at any gestational age) diagnosis

of infection based on any one of the following 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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Fetal Growth Retardation
• Infections
• Pneumonia

Locations

Country	Name	City	State
Egypt	Fayoum university	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First, second and third trimester fetomaternal complications.	Abdominal examination: to detect any abnormality as intra uterine growth restriction, with serial ultrasound estimation.	3 months
Primary	fetal distress	Intrapartum fetal heart rate (FHR) to detect viability and any abnormalities. Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017)	3 months
Secondary	fetal outcome	After birth: Apgar score will be used to identify distress newborns that need resuscitation and nicu admissionsigns of fetal pulmonary complication, acute respiratory distress syndrome.; The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. A score of 7 to 10 after five minutes is "reassuring." A score of 4 to 6 is "moderately abnormal." A score of 0 to 3 is concerning. It indicates a need for increased intervention, usually in assistance for breathing.	3 months
Secondary	Time of infection and fetal complications	Time from the diagnosis of SARS-CoV-2 infection to day of labour will be collected as a categorical factor and pre-determined to be analysed.	3 months