Clinical trial NCT05160649: Effect of Covid 19 Infection on Fetomaternal Outcome
Official title: Effect of Time of COVID 19 Infection on Fetomaternal Outcome, and Immunological Changes During the Disease Course
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
COVID-19 Pneumonia
Fetal Growth Retardation
Keywords: COVID19 Pneumonia
Feto-maternal infection
COVID 19 placental infection
Maternal mortality
Intrauterine fetal death
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective observational study

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First, second and third trimester fetomaternal complications.
timeFrame: 3 months
measure: fetal distress
timeFrame: 3 months
Secondary outcomes:
measure: fetal outcome
timeFrame: 3 months
measure: Time of infection and fetal complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum university
Study officials:
affiliation: Associated professor of obestatrics and gynecology Faculty of medicine Fayoume university
name: Laila E Abdelfattah, Ass. prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of clinical and chemical pathology
name: Eman E Mahmoud, lecturer
role: PRINCIPAL_INVESTIGATOR
References: