Effect of Covid 19 Infection on Fetomaternal Outcome

Sponsor

Fayoum University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05160649

Collaborator

(none)

Enrollment

Location

5.7

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 COVID-19 Pneumonia Fetal Growth Retardation

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 10, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

First, second and third trimester fetomaternal complications. [3 months]
Abdominal examination: to detect any abnormality as intra uterine growth restriction, with serial ultrasound estimation.
fetal distress [3 months]
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)

Secondary Outcome Measures

fetal outcome [3 months]
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.
Time of infection and fetal complications [3 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria: Pregnant pt with covid 19 infection (at any gestational age) diagnosis of infection based on any one of the following criteria:

Positive RT-PCR nasopharyngeal swab is taken (even if the result became available after labor);
Positive rapid antigen test performed before labor
Chest computed tomography (CT) scan performed before labor showing changes consistent with pneumonitis secondary to SARS-CoV-2 infection;
Positive pre-labor immunoglobulin G or immunoglobulin M antibody test; or
Clinical diagnosis made before labor (in the absence of negative RT-PCR swab results).

Exclusion Criteria:

Healthy individuals:
Acute or chronic infectious disease,
And any medication with known influence on immunological factors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fayoum university	Fayoum		Egypt	63514

Sponsors and Collaborators

Fayoum University

Investigators

Principal Investigator: Laila E Abdelfattah, Ass. prof, Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
Principal Investigator: Eman E Mahmoud, lecturer, Lecturer of clinical and chemical pathology