Clinical trial NCT05139953: Impact of COVID-19 Infection During Pregnancy
Official title: Impact of COVID-19 Infection During Pregnancy on Maternal and Fetal Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19 in Pregnancy
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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

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

Eligibility 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

Primary outcomes:
measure: Studying impact of COVID-19 on pregnancy
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University hospital
state: Menoufia
Study officials:
affiliation: Menoufia University-Shebin Elkom-Egypt
name: Mohamed E Anter, MD
role: STUDY_DIRECTOR
References: