Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04822402
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2021-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Among Pregnant Women in Assiut
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
COVID-19 Among Pregnant Women in Isolation and Women Hospitals in Assiut
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 .
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 .
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 .
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: