Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital

• Sponsor: Beni-Suef University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04174235
• Collaborator: (none)
• Enrollment: 20,225
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 561.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Fetal Anomaly	Device: Ultrasound scan

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

• Study Type: Observational
• Actual Enrollment: 20225 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fetal Congenital Anomalies Among Egyptian Pregnant Women Attending University Hospital
• Actual Study Start Date: Jan 14, 2016
• Actual Primary Completion Date: Jan 14, 2019
• Actual Study Completion Date: Jan 14, 2019

Outcome Measures

Primary Outcome Measures

1. prevalence of fetal malformations in pregnant women [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnancy

Exclusion Criteria:

• Medical conditions, chronic drug intake.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni-Suef University	Cairo		Egypt

Sponsors and Collaborators

• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.

• Responsible Party: Nesreen Abdel Fattah Abdullah Shehata, Associate Professor in Obstetrics and Gynecology Department, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT04174235
• Other Study ID Numbers: Beni-Suef 18
• First Posted: Nov 22, 2019
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nesreen Abdel Fattah Abdullah Shehata, Associate Professor in Obstetrics and Gynecology Department, Beni-Suef University: Fetal anomalies
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Nov 22, 2019