Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital

Fetal Anomaly Clinical Trial

Official title:

Fetal Congenital Anomalies Among Egyptian Pregnant Women Attending University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174235
• Other study ID #: Beni-Suef 18
• Status: Completed
• Start date: January 14, 2016
• Est. completion date: January 14, 2019

Study information

• Verified date: November 2019
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20225
• Est. completion date: January 14, 2019
• Est. primary completion date: January 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnancy

Exclusion Criteria:

• Medical conditions, chronic drug intake.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Anomaly

Intervention

Device:
• Ultrasound scan
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)

Locations

Country	Name	City	State
Egypt	Beni-Suef University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 37 weeks