Covid19 Clinical Trial - Effect of Covid-19 on Outcomes of NCT04629001

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Active, not recruiting

Study information
Verified date	November 2020
Source	Assiut University
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational [Patient Registry]

To study the effect of getting Covid-19 infection during pregnancy on the outcomes of the mother and the fetus including morbidity and mortality

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	1000
Est. completion date	December 1, 2021
Est. primary completion date	September 1, 2021
Accepts healthy volunteers
Gender	Female
Age group	18 Years to 40 Years
Eligibility	Inclusion Criteria: - Normal single pregnancy Exclusion Criteria: - Pregnancy with any chronic diseases - Multiple pregnancy

Diagnostic Test:
• Covid-19 PCR , IGM
test for Covid-19

Locations
Country	Name	City	State
Egypt	Medicine	Assiut

Sponsors *(1)*
Lead Sponsor	Collaborator
Assiut University

Egypt,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Fetal morbidity		28 days