- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04174235
Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital
November 20, 2019 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
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
Study Overview
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 Type
Observational
Enrollment (Actual)
20225
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Beni-Suef University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women attended Obstetrics and Gynecology Department of Beni-Suef University Hospital during the period (January 2016 to January 2019)
Description
Inclusion Criteria:
- Pregnancy
Exclusion Criteria:
- Medical conditions, chronic drug intake.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 37 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- GBD 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 14, 2016
Primary Completion (ACTUAL)
January 14, 2019
Study Completion (ACTUAL)
January 14, 2019
Study Registration Dates
First Submitted
November 20, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (ACTUAL)
November 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 22, 2019
Last Update Submitted That Met QC Criteria
November 20, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Beni-Suef 18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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