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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

March 27, 2021

Last Update Submit

March 29, 2021

Conditions

Covid-19 in Pregnancy

Keywords

COVID-19Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Understanding of the epidemiology of COVID-19 in pregnancy .

    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 .

    baseline

Secondary Outcomes (1)

  • Developing a recommendations .

    baseline

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Descriptive cross-sectional study

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

    PMID: 31995857BACKGROUND

  • Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

    PMID: 32123347BACKGROUND

  • Sanchez-Sanchez E, Ramirez-Vargas G, Avellaneda-Lopez Y, Orellana-Pecino JI, Garcia-Marin E, Diaz-Jimenez J. Eating Habits and Physical Activity of the Spanish Population during the COVID-19 Pandemic Period. Nutrients. 2020 Sep 15;12(9):2826. doi: 10.3390/nu12092826.

    PMID: 32942695BACKGROUND

  • Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94:e202004033. Spanish.

    PMID: 32382001BACKGROUND

  • Silasi M, Cardenas I, Kwon JY, Racicot K, Aldo P, Mor G. Viral infections during pregnancy. Am J Reprod Immunol. 2015 Mar;73(3):199-213. doi: 10.1111/aji.12355. Epub 2015 Jan 13.

    PMID: 25582523BACKGROUND

  • Goodnight WH, Soper DE. Pneumonia in pregnancy. Crit Care Med. 2005 Oct;33(10 Suppl):S390-7. doi: 10.1097/01.ccm.0000182483.24836.66.

    PMID: 16215363BACKGROUND

  • Ji HL, Zhao R, Matalon S, Matthay MA. Elevated Plasmin(ogen) as a Common Risk Factor for COVID-19 Susceptibility. Physiol Rev. 2020 Jul 1;100(3):1065-1075. doi: 10.1152/physrev.00013.2020. Epub 2020 Mar 27.

    PMID: 32216698BACKGROUND

  • Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, Debenham L, Llavall AC, Dixit A, Zhou D, Balaji R, Lee SI, Qiu X, Yuan M, Coomar D, Sheikh J, Lawson H, Ansari K, van Wely M, van Leeuwen E, Kostova E, Kunst H, Khalil A, Tiberi S, Brizuela V, Broutet N, Kara E, Kim CR, Thorson A, Oladapo OT, Mofenson L, Zamora J, Thangaratinam S; for PregCOV-19 Living Systematic Review Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020 Sep 1;370:m3320. doi: 10.1136/bmj.m3320.

    PMID: 32873575BACKGROUND

  • Hsu AL, Guan M, Johannesen E, Stephens AJ, Khaleel N, Kagan N, Tuhlei BC, Wan XF. Placental SARS-CoV-2 in a pregnant woman with mild COVID-19 disease. J Med Virol. 2021 Feb;93(2):1038-1044. doi: 10.1002/jmv.26386. Epub 2020 Nov 10.

    PMID: 32749712BACKGROUND

  • Blitz MJ, Grunebaum A, Tekbali A, Bornstein E, Rochelson B, Nimaroff M, Chervenak FA. Intensive care unit admissions for pregnant and nonpregnant women with coronavirus disease 2019. Am J Obstet Gynecol. 2020 Aug;223(2):290-291. doi: 10.1016/j.ajog.2020.05.004. Epub 2020 May 7. No abstract available.

    PMID: 32387323BACKGROUND

  • Kotlyar AM, Grechukhina O, Chen A, Popkhadze S, Grimshaw A, Tal O, Taylor HS, Tal R. Vertical transmission of coronavirus disease 2019: a systematic review and meta-analysis. Am J Obstet Gynecol. 2021 Jan;224(1):35-53.e3. doi: 10.1016/j.ajog.2020.07.049. Epub 2020 Jul 31.

    PMID: 32739398BACKGROUND

  • Penfield CA, Brubaker SG, Limaye MA, Lighter J, Ratner AJ, Thomas KM, Meyer JA, Roman AS. Detection of severe acute respiratory syndrome coronavirus 2 in placental and fetal membrane samples. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100133. doi: 10.1016/j.ajogmf.2020.100133. Epub 2020 May 8. No abstract available.

    PMID: 32391518BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
20 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

March 27, 2021

First Posted

March 30, 2021

Study Start

May 1, 2021

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

March 30, 2021

Record last verified: 2021-03