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Impact of COVID-19 Infection During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05139953
Recruitment Status : Completed
First Posted : December 1, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Elsibai Anter, Menoufia University

Study Description
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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
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
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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 : July 31, 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    No intervention

Outcome Measures
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Primary Outcome Measures :
  1. Studying impact of COVID-19 on pregnancy [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population

All medical records of pregnant women admitted to EL Bagour Quarantine hospital, Menoufia governorate diagnosed with SARS-CoV-2 infection from May, 2020 were revised to collect maternal and neonatal data using a standardized data collection sheet.

The Information included:

  • Age
  • GA
  • Parity
  • Pre-existing medical condition
  • Presenting symptoms at admission; such as fever, sore throat/ nasal or sinus congestion, cough/chest pain, vomiting/diarrhea, and fatigue/myalgia, dyspnea….etc.
  • Body mass index.
  • The laboratory results at admission and on discharge
  • Lymphopenia was defined when lymphocytes count less than 1100 cells/mm3.
  • Ultrasound report upon admission to the hospital that included; fetal viability, amniotic fluid index and any placental abnormality.
  • C.T. Report if done.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05139953


Locations
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Egypt
Menoufia University hospital
Shibīn Al Kawm, Menoufia, Egypt, 11111
Sponsors and Collaborators
Menoufia University
Investigators
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Study Director: Mohamed E Anter, MD Menoufia University-Shebin Elkom-Egypt
More Information
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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: December 1, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases