Fetal AnomaliesNCT03514940
Perinatal Diagnosis of GIT Anomalies
An observational study of Fetal Anomalies, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Anomalies
- What is being tested?
- ultrasound
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2018to 7 Jul 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant ladies either primi or multigravida
Who may be able to join
- pregnant women either primi or multigravida
- pregnant in 18- 24 weeks
Who cannot join
- first trimester pregnant ladies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Perinatal Diagnosis of Fetal GIT Anomalies
fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester
Read the detailed description
prenatal diagnosis of these anomalies allows for early postnatal interventions and implementation of treatment options
- Conditions
- Fetal Anomalies
- Being tested
- ultrasound
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
second trimester us scan will be made to pregnant women
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who will be diagnosed to have GIT anomalies
GIT anomalies that will be diagnosed by US and confirmed postnatal and managed operatively
Measured: within 5 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start2 May 2018
- Primary completion3 Jun 2020 (estimated)
- Study completion7 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AnomaliesStudies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, M.s.c, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514940
- Sponsor's protocol ID
- GIT
- Status last verified
- Jan 2020
- First submitted
- 22 Apr 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results will be published
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Diagnosis of Fetal GIT Anomalies
- ClinicalTrials.gov ID
- NCT03514940
- Acronym / sponsor ID
- GIT
- Conditions
- Fetal Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Study start
- 2 May 2018 (actual)
- Primary completion
- 3 Jun 2020 (estimated)
- Study completion
- 7 Jul 2020 (estimated)
- First posted
- 3 May 2018 (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.
fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester
Detailed description
prenatal diagnosis of these anomalies allows for early postnatal interventions and implementation of treatment options
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant ladies either primi or multigravida
Key inclusion criteria (2 listed)
- pregnant women either primi or multigravida
- pregnant in 18- 24 weeks
Key exclusion criteria (1 listed)
- first trimester pregnant ladies
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 |
|---|---|---|
| ultrasoundsecond trimester us scan will be made to pregnant women | Diagnostic test | – |
Primary outcome
The number of participants who will be diagnosed to have GIT anomalies
Time frame: within 5 moths
GIT anomalies that will be diagnosed by US and confirmed postnatal and managed operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No. results will be published
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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, M.s.c principal investigator
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 Fetal Anomalies, 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 2 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: status not confirmed, as of the sponsor's last update on 27 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who will be diagnosed to have GIT anomalies (time frame: within 5 moths). 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 27 Jan 2020.