Fetal AnomalyNCT04174235
Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital
An observational study of Fetal Anomaly, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths. The aim is to assess the prevalence of fetal malformations in pregnant women attending University hospital Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fetal Anomaly
- What is being tested?
- Ultrasound scan
- Type of treatment
- Medical device
- How many people
- 20,225 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2016to 14 Jan 2019
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women attended Obstetrics and Gynecology Department of Beni-Suef University Hospital during the period (January 2016 to January 2019)
Who may be able to join
- Pregnancy
Who cannot join
- Medical conditions, chronic drug intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Congenital Anomalies Among Egyptian Pregnant Women Attending University Hospital
Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths. The aim is to assess the prevalence of fetal malformations in pregnant women attending University hospital
Read the detailed description
This prospective cohort study of 20225 pregnant women attended Obstetrics Department of Beni-Suef University Hospital during period (January 2016 to January 2019). A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit): ▪ Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.
- Conditions
- Fetal Anomaly
- Being tested
- Ultrasound scan
- Keywords
- Fetal anomalies
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanDevice
A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit)
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of fetal malformations in pregnant women
Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.
Measured: Up to 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start14 Jan 2016
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fetal AnomalyStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- 20,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174235
- Sponsor's protocol ID
- Beni-Suef 18
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Busby A, Abramsky L, Dolk H, Armstrong B; Eurocat Folic Acid Working Group. Preventing neural tube defects in Europe: population based study. BMJ. 2005 Mar 12;330(7491):574-5. doi: 10.1136/bmj.330.7491.574. No abstract available.
PubMed 15760997GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.
PubMed 25530442
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Congenital Anomalies Among Egyptian Pregnant Women Attending University Hospital
- ClinicalTrials.gov ID
- NCT04174235
- Acronym / sponsor ID
- Beni-Suef 18
- Conditions
- Fetal Anomaly
- Keywords
- Fetal anomalies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,225 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 22 Nov 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.
Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths. The aim is to assess the prevalence of fetal malformations in pregnant women attending University hospital
Detailed description
This prospective cohort study of 20225 pregnant women attended Obstetrics Department of Beni-Suef University Hospital during period (January 2016 to January 2019). A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit): ▪ Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women attended Obstetrics and Gynecology Department of Beni-Suef University Hospital during the period (January 2016 to January 2019)
Key inclusion criteria (1 listed)
- Pregnancy
Key exclusion criteria (1 listed)
- Medical conditions, chronic drug intake.
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 |
|---|---|---|
| Ultrasound scanA full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit) | Device | – |
Primary outcome
prevalence of fetal malformations in pregnant women
Time frame: Up to 37 weeks
Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.
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 22 Nov 2019.
- Background: PubMed 15760997Busby A, Abramsky L, Dolk H, Armstrong B; Eurocat Folic Acid Working Group. Preventing neural tube defects in Europe: population based study. BMJ. 2005 Mar 12;330(7491):574-5. doi: 10.1136/bmj.330.7491.574. No abstract available.
- Background: PubMed 25530442GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Jan 10;385(9963):117-71. doi: 10.1016/S0140-6736(14)61682-2. Epub 2014 Dec 18.
- Individual participant dataSharing planned: No
Related trials for Fetal Anomaly
RecruitingObservational study
Transabdominal Versus Transvaginal Ultrasound at 9-14 Weeks in High-Risk Pregnancies
Pregnancy at Increased Risk of Fetal Congenital Anomalies
Active, not recruiting
Hydrops: Diagnosing & Redefining Outcomes With Precision Study
Hydrops Fetalis, Birth Defect
Enrolling by invitation
Genomic Sequencing for Evaluation of Fetal Structural Anomalies
Fetal Structural Anomalies
RecruitingObservational study
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
High Risk Pregnancy, Congenital Heart Disease
Recruiting
Amnioinfusion for Fetal Renal Failure
Multicystic Dysplastic Kidney, Polycystic Kidney Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anomaly, run by Beni-Suef University 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 22 Nov 2019. 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?
prevalence of fetal malformations in pregnant women (time frame: Up to 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174235, which also lists 2 linked publications.
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 22 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.