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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05139953
Other study ID # 4/2021OBSGN18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date July 31, 2021

Study information

Verified date November 2021
Source Menoufia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To asses impact of the COVID-19 infection during Pregnancy on maternal and fetal outcome in relation to gestational age.


Description:

COVID-19, caused by SARS-COV-2, was first reported in the city of Wuhan, Hubei province, China, at the end of December 2019. The exact origin of human infection has not yet been clearly identified.SARS-CoV-2 is a member of the Coronavirus family, and other pathogens from this family have inflicted a range of viral infections, including Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The incubation period varies from 2 days to 2 weeks following exposure to the virus.The global pandemic caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2) has been growing at an accelerating rate. The increasing mortality rate warrants identification and protection of the vulnerable populations in society.It is well known that pregnancy-related immune suppression makes mothers more vulnerable than non-pregnant women to several viral infections, including SARS-COV, hepatitis E virus, influenza, and herpes simplex virus. Furthermore, changes in pulmonary function during pregnancy, including decreased total lung capacity and functional residual capacity, may cause susceptibility to viral pneumonia. Data on clinical outcomes of pregnant women suffering from COVID-19 are therefore relatively scarce. Recently a meta-analysis of 13 publications reported preterm births, neonatal pneumonia, and respiratory distress syndrome in infants born of COVID-19-positive mothers. The rates of cesarean deliveries and adverse pregnancy outcomes were substantially higher


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: -All medical records of the pregnant women admitted to EL Bagour Quarantine hospital, Menoufia governorate due to SARS-CoV-2 infection, as confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens. Exclusion Criteria: - Patients who had equivocal or negative testing results were excluded from the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Egypt Menoufia University hospital Shibin Al Kawm Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Studying impact of COVID-19 on pregnancy understanding of the impact of COVID-19 on pregnancy will provide critical data about the course of the disease in pregnant women and their infants . baseline
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04822402 - COVID-19 Among Pregnant Women in Assiut