Hepatitis CNCT03980301
Screening Hepatitis Positive Women for Congenital Anomalies
An observational study of Hepatitis C, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Hepatitis C virus is one of the virulent viruses Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- ultrasound
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2018to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with hepatitis C virus received treatment during first trimester
Who may be able to join
- Pregnant women with hepatitis C virus received treatment during first trimester
Who cannot join
- pregnant women with hepatitis C virus who didnot receive treatment during first trimester
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening Hepatitis Positive Women for Congenital Anomalies During Pregnancy and Assessment of Liver Status of Women
Hepatitis C virus is one of the virulent viruses
Read the detailed description
Hepatitius positive women should be screened for congenital anomalies
- Conditions
- Hepatitis C
- Being tested
- ultrasound
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
screening of pregnant women with hepatitis c virus received treatment in first trimester for congenital anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies
the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies by us
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start11 Oct 2018
- Primary completion15 Jun 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Study chair, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980301
- Sponsor's protocol ID
- hepatitis
- Status last verified
- Oct 2020
- First submitted
- 6 Jun 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Hepatitis Positive Women for Congenital Anomalies During Pregnancy and Assessment of Liver Status of Women
- ClinicalTrials.gov ID
- NCT03980301
- Acronym / sponsor ID
- hepatitis
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis C virus is one of the virulent viruses
Detailed description
Hepatitius positive women should be screened for congenital anomalies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with hepatitis C virus received treatment during first trimester
Key inclusion criteria (1 listed)
- Pregnant women with hepatitis C virus received treatment during first trimester
Key exclusion criteria (1 listed)
- pregnant women with hepatitis C virus who didnot receive treatment during first trimester
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundscreening of pregnant women with hepatitis c virus received treatment in first trimester for congenital anomalies | Diagnostic test | – |
Primary outcome
the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies
Time frame: within 6 months
the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies by us
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy study chair
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of pregnant women who will be diagnosed to have fetuses with congenital anomalies (time frame: within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.