NCT05608616

Brief Summary

The spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission vertically or during delivery in pregnant women are still unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 5, 2022

Last Update Submit

November 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Outcomes of Pregnancy with COVID-19

    Prevalence of maternal and fetal morbidities and adverse obstetrical outcomes among pregnant women with COVID-19 diagnosis.

    32 months

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A retrospective analysis of prospectively collected data of pregnant women confirmed as COVID-19 infected. Maternal and fetal morbidities and adverse obstetrical outcomes among those with COVID-19 will be analyzed. Maternal outcomes will include:Venous thromboembolic events,pregnancy outcome,mode of delivery,frequency of admission to ICU,need for assistive ventilation,mortality rate Fetal outcomes will include:Frequency of NICU admission,Preterm birth,Intrauterine growth restriction,Intrauterine fetal death,Congenital fetal malformations.

You may qualify if:

  • Pregnant women of any gestational age with confirmed COVID 19 diagnosis attended and admitted at inpatient ward for management and follow up from April 2020 to December 2021at Kasr El Ainy hospital,Cairo university

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

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
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Obstetrics and Gynecology department

Study Record Dates

First Submitted

November 5, 2022

First Posted

November 8, 2022

Study Start

April 1, 2022

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations