COVID-19 Among Pregnant Women in Assiut

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04822402
Collaborator
(none)
50
13

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    COVID-19 Among Pregnant Women in Isolation and Women Hospitals in Assiut
    Anticipated Study Start Date :
    May 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Understanding of the epidemiology of COVID-19 in pregnancy . [baseline]

      The understanding of the epidemiology of COVID-19 in pregnancy will provide critical data about the course of the disease in pregnant women and their infants .

    Secondary Outcome Measures

    1. Developing a recommendations . [baseline]

      Developing a recommendations relating to antenatal , intrapartum and postpartum care of women in order to help improvement the maternal and neonatal outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Nahla Mohamed Mohamed Mahmoud, Resident Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04822402
    Other Study ID Numbers:
    • COVID-19 among Pregnant Women
    First Posted:
    Mar 30, 2021
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nahla Mohamed Mohamed Mahmoud, Resident Doctor, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 30, 2021