Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT04822402
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 .
Study:
NCT04822402
Study Brief:
Protocol Section:
NCT04822402