Clinical trial NCT04822402: COVID-19 Among Pregnant Women in Assiut
Official title: COVID-19 Among Pregnant Women in Isolation and Women Hospitals in Assiut
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19 in Pregnancy
Keywords: COVID-19
Pregnancy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Descriptive cross-sectional study

Brief summary: COVID-19 is a new disease , little is known about COVID-19 during pregnancy and to the best of our knowledge no published studies in Assiut .

Aims of the Research :

1. To describe COVID-19 among pregnant women attending isolation and women hospitals in Assiut .
2. To identify comorbidities that may affect both maternal , fetal and neonatal outcomes .
3. To correlate between COVID-19 infection and maternal, fetal and neonatal outcomes .

Detailed description: COVID-19 is the disease caused by a new corona virus on December 2019 in Wuhan, China . On February 2020, the International Committee of Taxonomy of Viruses recognized the etiology of this infection and named it "SARS-CoV-2". World Health Organization (WHO) named the disease COVID-19 , and declared it a pandemic on March 11th 2020 .

Pregnant women are at an increased risk for severe illness from COVID-19 compared to non-pregnant women . Additionally, pregnancy represents a vulnerable period, and this pandemic can negatively impact its outcomes . Therefore, pregnant women may be a group requiring special care in relation to the transmission of SARS-CoV-2 .

The modulations of the maternal immune system in pregnancy may have consequences for the clinical course of COVID-19 , for the treatment and prevention of COVID-19 in pregnancy . In addition to the systemic immunological changes, the reduction in total lung capacity and inability to clear secretions occurring during pregnancy can make pregnant more susceptible to severe respiratory infections .

There are higher levels of circulating coagulation and fibrinolytic factors during pregnancy which may be implicated in the pathogenesis of SARS-CoV-2 infection.

COVID-19 disease has a similar spectrum of symptoms in pregnant woman as in non-pregnant woman . Although most of the symptoms are less frequent during pregnancy but pregnant women are more likely to need admission to an ICU and require invasive ventilation .

Pre-existing maternal comorbidities such as increased maternal age, high body mass index, chronic hypertension and pre-existing diabetes are risk factors for the severity of infection.

The overall data from cohort studies by Allotey et al. , showed 73 deaths (0.63%) in COVID-19 positive pregnant women. The severe form of COVID-19 manifested in 13% of pregnant women, admission to an intensive care unit was required for 4% , 3% required invasive ventilation and 0.4% required extracorporeal membrane oxygenation .

Hsu et al. study on COVID-19 symptom progression during pregnancy compared to non pregnant women showed that 8.3% of the COVID-19 pregnant women had severe disease of whom 86% progressed to a critical stage and were admitted to the ICU , another study by Blitz et al. showed no significant difference between the rates of ICU admission in hospitalized COVID-19 pregnant and non-pregnant COVID-19 positive patients .

Vertical transmission happens if an infected pregnant woman transmits the infection to her fetus / infant during the fetal , intra-partum or post-partum period . Kotlyar et al. in their systematic review and meta-analysis showed a pooled proportion of 3.2% for vertical transmission of COVID-19 infection .

Other studies as Penfield et al. have shown a linkage of vertical transmission with maternal disease severity .

Eligibility criteria: Inclusion Criteria:

* Pregnant women with confirmed COVID-19 in Isolation hospitals in Assiut recorded and diagnosed by PCR swab from 1/3/2020 until the end of October 2021.

Exclusion Criteria:

* Pregnant women who are probably or suspected to be infected with COVID-19.

Primary outcomes:
measure: Understanding of the epidemiology of COVID-19 in pregnancy .
timeFrame: baseline
Secondary outcomes:
measure: Developing a recommendations .
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
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