Impact of COVID-19 Infection During Pregnancy

Sponsor

Menoufia University (Other)

Overall Status

Completed

CT.gov ID

NCT05139953

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid-19 in Pregnancy	Other: No intervention

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

65 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Impact of COVID-19 Infection During Pregnancy on Maternal and Fetal Outcome

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Outcome Measures

Primary Outcome Measures

Studying impact of COVID-19 on pregnancy [baseline]
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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia University hospital	Shibīn Al Kawm	Menoufia	Egypt	11111

Sponsors and Collaborators

Menoufia University

Investigators

Study Director: Mohamed E Anter, MD, Menoufia University-Shebin Elkom-Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Elsibai Anter, Assistant professor of obstetrics and gynecology, Menoufia University

ClinicalTrials.gov Identifier:

NCT05139953

Other Study ID Numbers:

4/2021OBSGN18

First Posted:

Dec 1, 2021

Last Update Posted:

Dec 1, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 1, 2021