Effect of Covid 19 Infection on Fetomaternal Outcome

NCT05160649 | Unknown

• 1 other identifier: S 280
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID19 Pneumonia; Feto-maternal infection; COVID 19 placental infection; Maternal mortality; Intrauterine fetal death

Outcome Measures

Primary Outcomes (2)

• First, second and third trimester fetomaternal complications.

  Abdominal examination: to detect any abnormality as intra uterine growth restriction, with serial ultrasound estimation.

  3 months

• 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 Outcomes (2)

• fetal outcome

  3 months

• Time of infection and fetal complications

  3 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A prospective observational study

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum university

Al Fayyum, 63514, Egypt

Location

MeSH Terms

Conditions

COVID-19; Fetal Growth Retardation; Maternal Death; Stillbirth

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parental Death; Death; Fetal Death

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology Faculty of medicine

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 16, 2021
• Study Start: October 10, 2021
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

EG (1)